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Mitchel is a reporter for MDedge based in the Philadelphia area. He started with the company in 1992, when it was International Medical News Group (IMNG), and has since covered a range of medical specialties. Mitchel trained as a virologist at Roswell Park Memorial Institute in Buffalo, and then worked briefly as a researcher at Boston Children's Hospital before pivoting to journalism as a AAAS Mass Media Fellow in 1980. His first reporting job was with Science Digest magazine, and from the mid-1980s to early-1990s he was a reporter with Medical World News. @mitchelzoler
Simplified formula validated for MRI Crohn’s disease assessment
WASHINGTON – The same Spanish research team who introduced an MRI-based formula for scoring the activity of luminal Crohn’s disease in 2011 have developed and validated a new, simplified version of their MRI score that speeds assessment.
“The simplified version of the MaRIA [Magnetic Resonance Index of Activity] score allows a faster and easier assessment of inflammation and quantification of severity in Crohn’s disease by keeping high accuracy for diagnosis and therapeutic response,” Ingrid Ordás, MD, said at the annual Digestive Disease Week®. The main advantage of the simplified MaRIA is that it is a “less time-consuming calculation that is not confounded by missing segments,” said Dr. Ordás, a gastroenterologist at the Hospital Clinic of Barcelona.
Although the data reported by Dr. Ordás included the derivation results, which used 98 patients enrolled in two separate prospective studies, and a separate prospective validation cohort of 37 patients, all these patients were evaluated by clinicians at the Hospital Clinic of Barcelona, and hence further validation with patients enrolled at other sites is now needed, Dr. Ordás said in an interview. Further accumulation of evidence for high sensitivity and specificity of Crohn’s disease assessment using the simplified MaRIA could allow it to replace endoscopy as the standard tool for assessing disease activity and severity in patients with luminal Crohn’s disease.
The derivation phase of the study identified four features that significantly correlated with disease activity and severity: bowel wall thickening to more than 3 mm, mural edema, perienteric fat stranding, and mucosal ulcerations. Limiting assessment to these four features cut in half the elements in the original MaRIA (Inflamm Bowel Dis. 2011 Aug;17[8];1759-68). Fat stranding – loss of the usual sharp interface between the wall and mesentery because of fluid – is a new parameter in the simplified MaRIA. The other three elements had been in the original index, but several other elements are now gone, including relative contrast enhancement wall signal intensity and consideration of lymph nodes.
In the validation phase, the researchers compared the MaRIA findings of the validation cohort with endoscopy findings both at baseline and then after they had received treatment. The sensitivity and specificity of the simplified MaRIA depended on the cutoff used, but as an example, a patient with a simplified MaRIA of 1 or greater as having active disease had a sensitivity of 90%, specificity of 81%, and an area under the receiver operator characteristic curve of 0.91. Using a simplified MaRIA of at least 2 as indicative of severe disease had a sensitivity of 85%, a specificity of 92%, and an AUROC of 0.94, Dr. Ordás reported.
Further assessment in patients who underwent treatment showed that reductions in the simplified MaRIA significantly correlated with treatment responses and remained essentially unchanged in patients who did not have clinical response to treatment. The analysis also showed a strong, positive correlation coefficient of 0.83 when the simplified MaRIA of an individual patient, compared with the patient’s Crohn’s disease endoscopy index of severity, and a correlation coefficient of 0.94 when a patient’s simplified MaRIA determined by one clinician, compared with the index score calculated by a second clinician.
Dr. Ordás had no disclosures to report.
SOURCE: Ordás I et al. DDW 2018, Presentation 437.
WASHINGTON – The same Spanish research team who introduced an MRI-based formula for scoring the activity of luminal Crohn’s disease in 2011 have developed and validated a new, simplified version of their MRI score that speeds assessment.
“The simplified version of the MaRIA [Magnetic Resonance Index of Activity] score allows a faster and easier assessment of inflammation and quantification of severity in Crohn’s disease by keeping high accuracy for diagnosis and therapeutic response,” Ingrid Ordás, MD, said at the annual Digestive Disease Week®. The main advantage of the simplified MaRIA is that it is a “less time-consuming calculation that is not confounded by missing segments,” said Dr. Ordás, a gastroenterologist at the Hospital Clinic of Barcelona.
Although the data reported by Dr. Ordás included the derivation results, which used 98 patients enrolled in two separate prospective studies, and a separate prospective validation cohort of 37 patients, all these patients were evaluated by clinicians at the Hospital Clinic of Barcelona, and hence further validation with patients enrolled at other sites is now needed, Dr. Ordás said in an interview. Further accumulation of evidence for high sensitivity and specificity of Crohn’s disease assessment using the simplified MaRIA could allow it to replace endoscopy as the standard tool for assessing disease activity and severity in patients with luminal Crohn’s disease.
The derivation phase of the study identified four features that significantly correlated with disease activity and severity: bowel wall thickening to more than 3 mm, mural edema, perienteric fat stranding, and mucosal ulcerations. Limiting assessment to these four features cut in half the elements in the original MaRIA (Inflamm Bowel Dis. 2011 Aug;17[8];1759-68). Fat stranding – loss of the usual sharp interface between the wall and mesentery because of fluid – is a new parameter in the simplified MaRIA. The other three elements had been in the original index, but several other elements are now gone, including relative contrast enhancement wall signal intensity and consideration of lymph nodes.
In the validation phase, the researchers compared the MaRIA findings of the validation cohort with endoscopy findings both at baseline and then after they had received treatment. The sensitivity and specificity of the simplified MaRIA depended on the cutoff used, but as an example, a patient with a simplified MaRIA of 1 or greater as having active disease had a sensitivity of 90%, specificity of 81%, and an area under the receiver operator characteristic curve of 0.91. Using a simplified MaRIA of at least 2 as indicative of severe disease had a sensitivity of 85%, a specificity of 92%, and an AUROC of 0.94, Dr. Ordás reported.
Further assessment in patients who underwent treatment showed that reductions in the simplified MaRIA significantly correlated with treatment responses and remained essentially unchanged in patients who did not have clinical response to treatment. The analysis also showed a strong, positive correlation coefficient of 0.83 when the simplified MaRIA of an individual patient, compared with the patient’s Crohn’s disease endoscopy index of severity, and a correlation coefficient of 0.94 when a patient’s simplified MaRIA determined by one clinician, compared with the index score calculated by a second clinician.
Dr. Ordás had no disclosures to report.
SOURCE: Ordás I et al. DDW 2018, Presentation 437.
WASHINGTON – The same Spanish research team who introduced an MRI-based formula for scoring the activity of luminal Crohn’s disease in 2011 have developed and validated a new, simplified version of their MRI score that speeds assessment.
“The simplified version of the MaRIA [Magnetic Resonance Index of Activity] score allows a faster and easier assessment of inflammation and quantification of severity in Crohn’s disease by keeping high accuracy for diagnosis and therapeutic response,” Ingrid Ordás, MD, said at the annual Digestive Disease Week®. The main advantage of the simplified MaRIA is that it is a “less time-consuming calculation that is not confounded by missing segments,” said Dr. Ordás, a gastroenterologist at the Hospital Clinic of Barcelona.
Although the data reported by Dr. Ordás included the derivation results, which used 98 patients enrolled in two separate prospective studies, and a separate prospective validation cohort of 37 patients, all these patients were evaluated by clinicians at the Hospital Clinic of Barcelona, and hence further validation with patients enrolled at other sites is now needed, Dr. Ordás said in an interview. Further accumulation of evidence for high sensitivity and specificity of Crohn’s disease assessment using the simplified MaRIA could allow it to replace endoscopy as the standard tool for assessing disease activity and severity in patients with luminal Crohn’s disease.
The derivation phase of the study identified four features that significantly correlated with disease activity and severity: bowel wall thickening to more than 3 mm, mural edema, perienteric fat stranding, and mucosal ulcerations. Limiting assessment to these four features cut in half the elements in the original MaRIA (Inflamm Bowel Dis. 2011 Aug;17[8];1759-68). Fat stranding – loss of the usual sharp interface between the wall and mesentery because of fluid – is a new parameter in the simplified MaRIA. The other three elements had been in the original index, but several other elements are now gone, including relative contrast enhancement wall signal intensity and consideration of lymph nodes.
In the validation phase, the researchers compared the MaRIA findings of the validation cohort with endoscopy findings both at baseline and then after they had received treatment. The sensitivity and specificity of the simplified MaRIA depended on the cutoff used, but as an example, a patient with a simplified MaRIA of 1 or greater as having active disease had a sensitivity of 90%, specificity of 81%, and an area under the receiver operator characteristic curve of 0.91. Using a simplified MaRIA of at least 2 as indicative of severe disease had a sensitivity of 85%, a specificity of 92%, and an AUROC of 0.94, Dr. Ordás reported.
Further assessment in patients who underwent treatment showed that reductions in the simplified MaRIA significantly correlated with treatment responses and remained essentially unchanged in patients who did not have clinical response to treatment. The analysis also showed a strong, positive correlation coefficient of 0.83 when the simplified MaRIA of an individual patient, compared with the patient’s Crohn’s disease endoscopy index of severity, and a correlation coefficient of 0.94 when a patient’s simplified MaRIA determined by one clinician, compared with the index score calculated by a second clinician.
Dr. Ordás had no disclosures to report.
SOURCE: Ordás I et al. DDW 2018, Presentation 437.
REPORTING FROM DDW 2018
Key clinical point: Researchers devised a simplified way to use MRI to noninvasively assess Crohn’s disease activity.
Major finding: The simplified, MRI-based formula identified Crohn’s disease activity with 90% sensitivity and 81% specificity.
Study details: The validation study included 37 patients with luminal Crohn’s disease at a single center in Barcelona.
Disclosures: Dr. Ordás had no disclosures to report.
Source: Ordás I et al. DDW 2018, Presentation 437.
Endoscopic weight loss interventions need lifestyle component
WASHINGTON – and used in the context of a multidimensional lifestyle intervention, Shelby Sullivan, MD, said at the annual Digestive Disease Week.®
Regardless of which endoscopic intervention a clinician uses, the chances for successful and complication-free weight loss highly depends on enlisting adjunctive care by specialists, including a dietitian, behavior coach, psychologist, exercise specialist, and an endocrine or obesity-specialist physician, said Dr. Sullivan, director of the gastroenterology metabolic and bariatric program at the University of Colorado, Aurora. Often it’s more cost effective to arrange for collaboration with these adjunctive specialists as consultants rather than having them on staff, she noted.
A weight loss program that provides at least 14 interventions with the patient over a 6-month period has led to a 5% greater increase in weight loss compared with a moderate-intensity program that includes 6-13 encounters with members of the weight-loss team, Dr. Sullivan said. These intervention episodes need not all be individual or one on one, but can include group sessions, telephone consults, and even online coaching sessions, according to 2013 recommendations from The Obesity Society, the American College of Cardiology, and the American Heart Association (Obesity. 2014 Jun 24;22[S2]:S5-S39). “Patient contact is the key to success with weight loss,” Dr. Sullivan said. She also strongly suggested that clinicians who wish to offer an obesity intervention “get training in delivering basic obesity education.”
Another tip for providers is to have protocols in place to both prevent and, when necessary, manage potential complications. This can involve administration of additional antibiotics beyond what’s used for prophylaxis, treatment with additional IV fluid, and imaging. Complication prevention and management of complications when they occur are two of the most important steps to take to make sure that an elective obesity intervention practice runs smoothly, Dr. Sullivan said. “Make sure you can manage these patients safely,” she admonished. Also, be sure to arrange in advance for institutional approval for using whatever devices the procedure requires, and make sure you have malpractice coverage for any novel devices or procedures. Approval for use of a novel device often requires documentation of specialized training or certification.
Endoscopic weight loss procedures often are not fully or even partially covered by health insurance, which means that patients will pay most or all of the costs out of pocket and, hence, the clinician should look on this practice as a “concierge service.” Therefore, the clinician should be especially attuned to ensuring that the staff is uniformly courteous, and be alert for any overt or covert obesity bias the staff may have that could mar a patient’s experience. You need a “reliable and compassionate” staff, Dr. Sullivan advised, and the staff should schedule patient appointments that minimize wait times.
Marketing and procedure pricing are other concerns for the physician who is contemplating an obestiy-intervention practice. A great marketing tool is delivering seminars to patients, either in person or on the Internet. The general format for such a seminar addresses the health risks of obesity, the range of intervention options in addition to what you are offering, and the objective risks and benefits for each of the intervention options. Prospective patients who respond to your presentation and contact you should receive very prompt callbacks. Regarding pricing, Dr. Sullivan recommended making sure that the price you charge will fully cover all costs, including the potential cost of complications.
WASHINGTON – and used in the context of a multidimensional lifestyle intervention, Shelby Sullivan, MD, said at the annual Digestive Disease Week.®
Regardless of which endoscopic intervention a clinician uses, the chances for successful and complication-free weight loss highly depends on enlisting adjunctive care by specialists, including a dietitian, behavior coach, psychologist, exercise specialist, and an endocrine or obesity-specialist physician, said Dr. Sullivan, director of the gastroenterology metabolic and bariatric program at the University of Colorado, Aurora. Often it’s more cost effective to arrange for collaboration with these adjunctive specialists as consultants rather than having them on staff, she noted.
A weight loss program that provides at least 14 interventions with the patient over a 6-month period has led to a 5% greater increase in weight loss compared with a moderate-intensity program that includes 6-13 encounters with members of the weight-loss team, Dr. Sullivan said. These intervention episodes need not all be individual or one on one, but can include group sessions, telephone consults, and even online coaching sessions, according to 2013 recommendations from The Obesity Society, the American College of Cardiology, and the American Heart Association (Obesity. 2014 Jun 24;22[S2]:S5-S39). “Patient contact is the key to success with weight loss,” Dr. Sullivan said. She also strongly suggested that clinicians who wish to offer an obesity intervention “get training in delivering basic obesity education.”
Another tip for providers is to have protocols in place to both prevent and, when necessary, manage potential complications. This can involve administration of additional antibiotics beyond what’s used for prophylaxis, treatment with additional IV fluid, and imaging. Complication prevention and management of complications when they occur are two of the most important steps to take to make sure that an elective obesity intervention practice runs smoothly, Dr. Sullivan said. “Make sure you can manage these patients safely,” she admonished. Also, be sure to arrange in advance for institutional approval for using whatever devices the procedure requires, and make sure you have malpractice coverage for any novel devices or procedures. Approval for use of a novel device often requires documentation of specialized training or certification.
Endoscopic weight loss procedures often are not fully or even partially covered by health insurance, which means that patients will pay most or all of the costs out of pocket and, hence, the clinician should look on this practice as a “concierge service.” Therefore, the clinician should be especially attuned to ensuring that the staff is uniformly courteous, and be alert for any overt or covert obesity bias the staff may have that could mar a patient’s experience. You need a “reliable and compassionate” staff, Dr. Sullivan advised, and the staff should schedule patient appointments that minimize wait times.
Marketing and procedure pricing are other concerns for the physician who is contemplating an obestiy-intervention practice. A great marketing tool is delivering seminars to patients, either in person or on the Internet. The general format for such a seminar addresses the health risks of obesity, the range of intervention options in addition to what you are offering, and the objective risks and benefits for each of the intervention options. Prospective patients who respond to your presentation and contact you should receive very prompt callbacks. Regarding pricing, Dr. Sullivan recommended making sure that the price you charge will fully cover all costs, including the potential cost of complications.
WASHINGTON – and used in the context of a multidimensional lifestyle intervention, Shelby Sullivan, MD, said at the annual Digestive Disease Week.®
Regardless of which endoscopic intervention a clinician uses, the chances for successful and complication-free weight loss highly depends on enlisting adjunctive care by specialists, including a dietitian, behavior coach, psychologist, exercise specialist, and an endocrine or obesity-specialist physician, said Dr. Sullivan, director of the gastroenterology metabolic and bariatric program at the University of Colorado, Aurora. Often it’s more cost effective to arrange for collaboration with these adjunctive specialists as consultants rather than having them on staff, she noted.
A weight loss program that provides at least 14 interventions with the patient over a 6-month period has led to a 5% greater increase in weight loss compared with a moderate-intensity program that includes 6-13 encounters with members of the weight-loss team, Dr. Sullivan said. These intervention episodes need not all be individual or one on one, but can include group sessions, telephone consults, and even online coaching sessions, according to 2013 recommendations from The Obesity Society, the American College of Cardiology, and the American Heart Association (Obesity. 2014 Jun 24;22[S2]:S5-S39). “Patient contact is the key to success with weight loss,” Dr. Sullivan said. She also strongly suggested that clinicians who wish to offer an obesity intervention “get training in delivering basic obesity education.”
Another tip for providers is to have protocols in place to both prevent and, when necessary, manage potential complications. This can involve administration of additional antibiotics beyond what’s used for prophylaxis, treatment with additional IV fluid, and imaging. Complication prevention and management of complications when they occur are two of the most important steps to take to make sure that an elective obesity intervention practice runs smoothly, Dr. Sullivan said. “Make sure you can manage these patients safely,” she admonished. Also, be sure to arrange in advance for institutional approval for using whatever devices the procedure requires, and make sure you have malpractice coverage for any novel devices or procedures. Approval for use of a novel device often requires documentation of specialized training or certification.
Endoscopic weight loss procedures often are not fully or even partially covered by health insurance, which means that patients will pay most or all of the costs out of pocket and, hence, the clinician should look on this practice as a “concierge service.” Therefore, the clinician should be especially attuned to ensuring that the staff is uniformly courteous, and be alert for any overt or covert obesity bias the staff may have that could mar a patient’s experience. You need a “reliable and compassionate” staff, Dr. Sullivan advised, and the staff should schedule patient appointments that minimize wait times.
Marketing and procedure pricing are other concerns for the physician who is contemplating an obestiy-intervention practice. A great marketing tool is delivering seminars to patients, either in person or on the Internet. The general format for such a seminar addresses the health risks of obesity, the range of intervention options in addition to what you are offering, and the objective risks and benefits for each of the intervention options. Prospective patients who respond to your presentation and contact you should receive very prompt callbacks. Regarding pricing, Dr. Sullivan recommended making sure that the price you charge will fully cover all costs, including the potential cost of complications.
EXPERT ANALYSIS FROM DDW 2018
Nerve growth factor inhibitor shows phase 3 efficacy in osteoarthritis
Two subcutaneous dosages of the nerve growth factor–inhibitor tanezumab showed significant benefits in patients with osteoarthritic joint pain in a multicenter, randomized, phase 3 trial of 698 patients run primarily at U.S. centers.
The 16-week responses to two subcutaneous injections with tanezumab spaced 8 weeks apart showed statistically significant improvements in pain, physical function, and patient global self assessment, compared with placebo, the primary endpoints for the study, Pfizer and Lilly jointly reported. The two companies together are developing tanezumab for an indication for osteoarthritic pain, as well as for chronic lower back pain and pain from cancer metastases.
The company announcement said that patients showed good tolerance to the tanezumab treatments, with no new safety signals and no osteonecrosis seen. About 1% of patients on tanezumab stopped treatment because of an adverse effect, and less than 1.5% of patients on the drug had progressive osteoarthritis during treatment, compared with no patients in the placebo group.
The study enrolled patients at any one of 98 centers in the United States, Puerto Rico, or Canada with confirmed moderate or severe osteoarthritis of the knee or hip that either produced pain refractory to conventional pain medications or involved patients unable to take these medications. The researchers randomized patients to receive two 2.5-mg doses of tanezumab, a 2.5-mg dose followed 8 weeks later by a 5-mg dose, or two placebo doses. The primary outcomes were changes from baseline when measured 16 weeks after the start of treatment in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, the WOMAC physical function subscale, and patient’s global assessment of osteoarthritis. Both of the tested tanezumab regimens produced statistically significant improvements in each of the three measures, compared with the placebo control patients, the companies reported.
Tanezumab is a humanized monoclonal antibody that binds to and inhibits nerve growth factor. This inhibition may prevent pain signals from reaching the spinal cord and brain, according to the companies’ report. In June 2017, the two companies announced that development of tanezumab had received “Fast Track” designation from the Food and Drug Administration for the indications of treating chronic osteoarthritic pain and chronic lower back pain.
Two subcutaneous dosages of the nerve growth factor–inhibitor tanezumab showed significant benefits in patients with osteoarthritic joint pain in a multicenter, randomized, phase 3 trial of 698 patients run primarily at U.S. centers.
The 16-week responses to two subcutaneous injections with tanezumab spaced 8 weeks apart showed statistically significant improvements in pain, physical function, and patient global self assessment, compared with placebo, the primary endpoints for the study, Pfizer and Lilly jointly reported. The two companies together are developing tanezumab for an indication for osteoarthritic pain, as well as for chronic lower back pain and pain from cancer metastases.
The company announcement said that patients showed good tolerance to the tanezumab treatments, with no new safety signals and no osteonecrosis seen. About 1% of patients on tanezumab stopped treatment because of an adverse effect, and less than 1.5% of patients on the drug had progressive osteoarthritis during treatment, compared with no patients in the placebo group.
The study enrolled patients at any one of 98 centers in the United States, Puerto Rico, or Canada with confirmed moderate or severe osteoarthritis of the knee or hip that either produced pain refractory to conventional pain medications or involved patients unable to take these medications. The researchers randomized patients to receive two 2.5-mg doses of tanezumab, a 2.5-mg dose followed 8 weeks later by a 5-mg dose, or two placebo doses. The primary outcomes were changes from baseline when measured 16 weeks after the start of treatment in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, the WOMAC physical function subscale, and patient’s global assessment of osteoarthritis. Both of the tested tanezumab regimens produced statistically significant improvements in each of the three measures, compared with the placebo control patients, the companies reported.
Tanezumab is a humanized monoclonal antibody that binds to and inhibits nerve growth factor. This inhibition may prevent pain signals from reaching the spinal cord and brain, according to the companies’ report. In June 2017, the two companies announced that development of tanezumab had received “Fast Track” designation from the Food and Drug Administration for the indications of treating chronic osteoarthritic pain and chronic lower back pain.
Two subcutaneous dosages of the nerve growth factor–inhibitor tanezumab showed significant benefits in patients with osteoarthritic joint pain in a multicenter, randomized, phase 3 trial of 698 patients run primarily at U.S. centers.
The 16-week responses to two subcutaneous injections with tanezumab spaced 8 weeks apart showed statistically significant improvements in pain, physical function, and patient global self assessment, compared with placebo, the primary endpoints for the study, Pfizer and Lilly jointly reported. The two companies together are developing tanezumab for an indication for osteoarthritic pain, as well as for chronic lower back pain and pain from cancer metastases.
The company announcement said that patients showed good tolerance to the tanezumab treatments, with no new safety signals and no osteonecrosis seen. About 1% of patients on tanezumab stopped treatment because of an adverse effect, and less than 1.5% of patients on the drug had progressive osteoarthritis during treatment, compared with no patients in the placebo group.
The study enrolled patients at any one of 98 centers in the United States, Puerto Rico, or Canada with confirmed moderate or severe osteoarthritis of the knee or hip that either produced pain refractory to conventional pain medications or involved patients unable to take these medications. The researchers randomized patients to receive two 2.5-mg doses of tanezumab, a 2.5-mg dose followed 8 weeks later by a 5-mg dose, or two placebo doses. The primary outcomes were changes from baseline when measured 16 weeks after the start of treatment in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, the WOMAC physical function subscale, and patient’s global assessment of osteoarthritis. Both of the tested tanezumab regimens produced statistically significant improvements in each of the three measures, compared with the placebo control patients, the companies reported.
Tanezumab is a humanized monoclonal antibody that binds to and inhibits nerve growth factor. This inhibition may prevent pain signals from reaching the spinal cord and brain, according to the companies’ report. In June 2017, the two companies announced that development of tanezumab had received “Fast Track” designation from the Food and Drug Administration for the indications of treating chronic osteoarthritic pain and chronic lower back pain.
TAVR requirements tweaked in a 6-year update
Transcatheter aortic valve replacement has entered a new stage of development, and so needed a tweaked set of standards for how existing programs operate and what new program need to open, said a panel of experts formed by the four U.S. societies with the closest links to this procedure.
U.S. transcatheter aortic valve replacement (TAVR) programs have “matured as a therapeutic option” since its commercial U.S. introduction in 2012, said a revised statement of operator and institutional recommendations and requirements issued on July 18 by the American Association for Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. A writing panel formed by these four groups prepared the revision, published online in the Journal of the American College of Cardiology on July 18, to replace the first set of recommendations for running U.S. TAVR programs that came out in 2012 (J Am Coll Cardiol. 2012 May 29;59[22]:2028-42).
“The main thrust is to ensure and allow for the metrics of quality TAVR,” said Joseph E. Bavaria, MD, cochair of the writing panel and professor of surgery and codirector of the transcatheter valve program at the University of Pennsylvania in Philadelphia. “We’re trying to force continuous quality improvement across U.S. TAVR teams,” Dr. Bavaria explained in an interview.
The key to this change will be the data collected on every U.S. TAVR patient in the Transcatheter Valve Therapy registry maintained by the American College of Cardiology and the Society of Thoracic Surgeons, which now has data on more than 120,000 patients who have undergone TAVR at what are now 582 active U.S. TAVR programs, noted Carl L. Tommaso, MD, an interventional cardiologist with NorthShore Medical Group in Bannockburn, Ill., and cochair of the writing panel. “You need to do risk adjustment to measure quality of care,” and the robust database that now exists has begun to make this possible, said Dr. Tommaso, who neither performs TAVR procedures nor participates on a TAVR team. Statistical analyses based on this substantial and always-expanding database of TAVR patients now allows for risk-adjusted assessment of in hospital and 30-day mortality, and risk-adjusted evaluation of 1-year mortality and quality-of-life outcomes are expected within the next couple of years.
“We’re still not yet at the point of having good, risk-adjusted models” for all these measures, but our hope is that in the next 2-7 years we can move completely to quality measures, as has already been done for percutaneous coronary interventions” and away from procedure volume, which currently serves as a surrogate marker for a TAVR program’s competence.
The new document continues to call for TAVR programs to average at least 50 TAVR procedures a year or at least 100 every 2 years, but primarily to insure that each TAVR program can generate enough data about its performance to produce statistically reliable numbers.
“The volume floors are only there because you can’t measure quality without volume,” said Dr. Bavaria. “It’s impossible to measure quality without a certain procedure volume.”
Dr. Bavaria stressed, however, that the goal of the new document is not to limit TAVR programs based on their procedure volume, especially because another goal of the document is to ensure reasonable geographic access to TAVR for U.S. patients. “This document does not advocate for any program to shut down,” he declared. On top of that, “we have no problem with new programs,” although the document noted that “the major threat to low volume sites growing and achieving higher levels of experience is the opening of additional sites in the same geographic region.”
In 2017, 204 of the 525 sites (39%) performing TAVR at that time were performing fewer than 50 procedures annually, the document said, but added that many TAVR centers now operate in what are predominantly rural regions “and it is important that they remain active if they can document acceptable quality even if they should fall below volume thresholds to maintain patient access to care.”
Dr. Tommaso said that perhaps a TAVR center in Alaska, for example, might not meet the 50 cases/year standard, “but I don’t think anyone would worry if the volume was low because we’re serving patients in Alaska.” Currently, 84% of TAVR centers that have been operating for more than 2 years meet the 50 procedures/year threshold, he added. And TAVR centers now operate in 49 of the 50 states, with only Wyoming lacking a TAVR facility within its borders. Despite this, use of TAVR among Wyoming residents is comparable to the rate in Illinois, Dr. Bavaria said.
Both cochairs also highlighted that, with TAVR now approved for patients at moderate risk for aortic-valve surgery, the number of patients who are TAVR candidates has grown, and it’s possible that pending trial results will soon broaden TAVR’s availability to low-risk patients, a step that would greatly further expand the potential patient pool for the procedure.
The revised recommendations and requirements will make it “a little easier to start a new program, except now, for the first time, you need to start with an operator who is already experienced with TAVR,” noted Dr. Bavaria. “The TAVR technology is now mature enough that it’s inappropriate to have learning-curve mortality.” But aside from this the new standards lower the bar a bit for a center’s volume of percutaneous coronary interventions and surgical aortic valve replacements. The revision also maintains that an examination by and consultation with a single cardiac surgeon by a prospective TAVR patient is adequate, similar to the 2012 document, although the Center for Medicare & Medicaid Services mandated in its coverage decision that prospective TAVR patients consult with two cardiac surgeons, the so-called “two-surgeon rule.” If CMS eliminated the two-surgeon rule it would “streamline” the process that patients go through when being assessed for TAVR, Dr. Tommaso observed, and both he and Dr. Bavaria expressed hope that the new document might prompt CMS to reconsider this guidance.
“We felt that two surgeons weren’t needed,” but the document specifies that both the surgeon and the cardiologist whom a prospective patient consults before finalizing plans for the intervention should both be members of the multidisciplinary team that performs the procedure. Until now, these clinicians weren’t specified as necessarily members of the TAVR team, Dr. Bavaria said.
One additional new element in the revised document is specification of shared decision making as the mechanism patients should go through when considering TAVR relative to their other management options, Dr. Tommaso said.Dr. Bavaria and Dr. Tommaso had no disclosures.
SOURCE: Bavaria JE et al. JACC. 2018 Jul18. doi:10.1016/j.jacc.2018.07.002.
Transcatheter aortic valve replacement has entered a new stage of development, and so needed a tweaked set of standards for how existing programs operate and what new program need to open, said a panel of experts formed by the four U.S. societies with the closest links to this procedure.
U.S. transcatheter aortic valve replacement (TAVR) programs have “matured as a therapeutic option” since its commercial U.S. introduction in 2012, said a revised statement of operator and institutional recommendations and requirements issued on July 18 by the American Association for Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. A writing panel formed by these four groups prepared the revision, published online in the Journal of the American College of Cardiology on July 18, to replace the first set of recommendations for running U.S. TAVR programs that came out in 2012 (J Am Coll Cardiol. 2012 May 29;59[22]:2028-42).
“The main thrust is to ensure and allow for the metrics of quality TAVR,” said Joseph E. Bavaria, MD, cochair of the writing panel and professor of surgery and codirector of the transcatheter valve program at the University of Pennsylvania in Philadelphia. “We’re trying to force continuous quality improvement across U.S. TAVR teams,” Dr. Bavaria explained in an interview.
The key to this change will be the data collected on every U.S. TAVR patient in the Transcatheter Valve Therapy registry maintained by the American College of Cardiology and the Society of Thoracic Surgeons, which now has data on more than 120,000 patients who have undergone TAVR at what are now 582 active U.S. TAVR programs, noted Carl L. Tommaso, MD, an interventional cardiologist with NorthShore Medical Group in Bannockburn, Ill., and cochair of the writing panel. “You need to do risk adjustment to measure quality of care,” and the robust database that now exists has begun to make this possible, said Dr. Tommaso, who neither performs TAVR procedures nor participates on a TAVR team. Statistical analyses based on this substantial and always-expanding database of TAVR patients now allows for risk-adjusted assessment of in hospital and 30-day mortality, and risk-adjusted evaluation of 1-year mortality and quality-of-life outcomes are expected within the next couple of years.
“We’re still not yet at the point of having good, risk-adjusted models” for all these measures, but our hope is that in the next 2-7 years we can move completely to quality measures, as has already been done for percutaneous coronary interventions” and away from procedure volume, which currently serves as a surrogate marker for a TAVR program’s competence.
The new document continues to call for TAVR programs to average at least 50 TAVR procedures a year or at least 100 every 2 years, but primarily to insure that each TAVR program can generate enough data about its performance to produce statistically reliable numbers.
“The volume floors are only there because you can’t measure quality without volume,” said Dr. Bavaria. “It’s impossible to measure quality without a certain procedure volume.”
Dr. Bavaria stressed, however, that the goal of the new document is not to limit TAVR programs based on their procedure volume, especially because another goal of the document is to ensure reasonable geographic access to TAVR for U.S. patients. “This document does not advocate for any program to shut down,” he declared. On top of that, “we have no problem with new programs,” although the document noted that “the major threat to low volume sites growing and achieving higher levels of experience is the opening of additional sites in the same geographic region.”
In 2017, 204 of the 525 sites (39%) performing TAVR at that time were performing fewer than 50 procedures annually, the document said, but added that many TAVR centers now operate in what are predominantly rural regions “and it is important that they remain active if they can document acceptable quality even if they should fall below volume thresholds to maintain patient access to care.”
Dr. Tommaso said that perhaps a TAVR center in Alaska, for example, might not meet the 50 cases/year standard, “but I don’t think anyone would worry if the volume was low because we’re serving patients in Alaska.” Currently, 84% of TAVR centers that have been operating for more than 2 years meet the 50 procedures/year threshold, he added. And TAVR centers now operate in 49 of the 50 states, with only Wyoming lacking a TAVR facility within its borders. Despite this, use of TAVR among Wyoming residents is comparable to the rate in Illinois, Dr. Bavaria said.
Both cochairs also highlighted that, with TAVR now approved for patients at moderate risk for aortic-valve surgery, the number of patients who are TAVR candidates has grown, and it’s possible that pending trial results will soon broaden TAVR’s availability to low-risk patients, a step that would greatly further expand the potential patient pool for the procedure.
The revised recommendations and requirements will make it “a little easier to start a new program, except now, for the first time, you need to start with an operator who is already experienced with TAVR,” noted Dr. Bavaria. “The TAVR technology is now mature enough that it’s inappropriate to have learning-curve mortality.” But aside from this the new standards lower the bar a bit for a center’s volume of percutaneous coronary interventions and surgical aortic valve replacements. The revision also maintains that an examination by and consultation with a single cardiac surgeon by a prospective TAVR patient is adequate, similar to the 2012 document, although the Center for Medicare & Medicaid Services mandated in its coverage decision that prospective TAVR patients consult with two cardiac surgeons, the so-called “two-surgeon rule.” If CMS eliminated the two-surgeon rule it would “streamline” the process that patients go through when being assessed for TAVR, Dr. Tommaso observed, and both he and Dr. Bavaria expressed hope that the new document might prompt CMS to reconsider this guidance.
“We felt that two surgeons weren’t needed,” but the document specifies that both the surgeon and the cardiologist whom a prospective patient consults before finalizing plans for the intervention should both be members of the multidisciplinary team that performs the procedure. Until now, these clinicians weren’t specified as necessarily members of the TAVR team, Dr. Bavaria said.
One additional new element in the revised document is specification of shared decision making as the mechanism patients should go through when considering TAVR relative to their other management options, Dr. Tommaso said.Dr. Bavaria and Dr. Tommaso had no disclosures.
SOURCE: Bavaria JE et al. JACC. 2018 Jul18. doi:10.1016/j.jacc.2018.07.002.
Transcatheter aortic valve replacement has entered a new stage of development, and so needed a tweaked set of standards for how existing programs operate and what new program need to open, said a panel of experts formed by the four U.S. societies with the closest links to this procedure.
U.S. transcatheter aortic valve replacement (TAVR) programs have “matured as a therapeutic option” since its commercial U.S. introduction in 2012, said a revised statement of operator and institutional recommendations and requirements issued on July 18 by the American Association for Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. A writing panel formed by these four groups prepared the revision, published online in the Journal of the American College of Cardiology on July 18, to replace the first set of recommendations for running U.S. TAVR programs that came out in 2012 (J Am Coll Cardiol. 2012 May 29;59[22]:2028-42).
“The main thrust is to ensure and allow for the metrics of quality TAVR,” said Joseph E. Bavaria, MD, cochair of the writing panel and professor of surgery and codirector of the transcatheter valve program at the University of Pennsylvania in Philadelphia. “We’re trying to force continuous quality improvement across U.S. TAVR teams,” Dr. Bavaria explained in an interview.
The key to this change will be the data collected on every U.S. TAVR patient in the Transcatheter Valve Therapy registry maintained by the American College of Cardiology and the Society of Thoracic Surgeons, which now has data on more than 120,000 patients who have undergone TAVR at what are now 582 active U.S. TAVR programs, noted Carl L. Tommaso, MD, an interventional cardiologist with NorthShore Medical Group in Bannockburn, Ill., and cochair of the writing panel. “You need to do risk adjustment to measure quality of care,” and the robust database that now exists has begun to make this possible, said Dr. Tommaso, who neither performs TAVR procedures nor participates on a TAVR team. Statistical analyses based on this substantial and always-expanding database of TAVR patients now allows for risk-adjusted assessment of in hospital and 30-day mortality, and risk-adjusted evaluation of 1-year mortality and quality-of-life outcomes are expected within the next couple of years.
“We’re still not yet at the point of having good, risk-adjusted models” for all these measures, but our hope is that in the next 2-7 years we can move completely to quality measures, as has already been done for percutaneous coronary interventions” and away from procedure volume, which currently serves as a surrogate marker for a TAVR program’s competence.
The new document continues to call for TAVR programs to average at least 50 TAVR procedures a year or at least 100 every 2 years, but primarily to insure that each TAVR program can generate enough data about its performance to produce statistically reliable numbers.
“The volume floors are only there because you can’t measure quality without volume,” said Dr. Bavaria. “It’s impossible to measure quality without a certain procedure volume.”
Dr. Bavaria stressed, however, that the goal of the new document is not to limit TAVR programs based on their procedure volume, especially because another goal of the document is to ensure reasonable geographic access to TAVR for U.S. patients. “This document does not advocate for any program to shut down,” he declared. On top of that, “we have no problem with new programs,” although the document noted that “the major threat to low volume sites growing and achieving higher levels of experience is the opening of additional sites in the same geographic region.”
In 2017, 204 of the 525 sites (39%) performing TAVR at that time were performing fewer than 50 procedures annually, the document said, but added that many TAVR centers now operate in what are predominantly rural regions “and it is important that they remain active if they can document acceptable quality even if they should fall below volume thresholds to maintain patient access to care.”
Dr. Tommaso said that perhaps a TAVR center in Alaska, for example, might not meet the 50 cases/year standard, “but I don’t think anyone would worry if the volume was low because we’re serving patients in Alaska.” Currently, 84% of TAVR centers that have been operating for more than 2 years meet the 50 procedures/year threshold, he added. And TAVR centers now operate in 49 of the 50 states, with only Wyoming lacking a TAVR facility within its borders. Despite this, use of TAVR among Wyoming residents is comparable to the rate in Illinois, Dr. Bavaria said.
Both cochairs also highlighted that, with TAVR now approved for patients at moderate risk for aortic-valve surgery, the number of patients who are TAVR candidates has grown, and it’s possible that pending trial results will soon broaden TAVR’s availability to low-risk patients, a step that would greatly further expand the potential patient pool for the procedure.
The revised recommendations and requirements will make it “a little easier to start a new program, except now, for the first time, you need to start with an operator who is already experienced with TAVR,” noted Dr. Bavaria. “The TAVR technology is now mature enough that it’s inappropriate to have learning-curve mortality.” But aside from this the new standards lower the bar a bit for a center’s volume of percutaneous coronary interventions and surgical aortic valve replacements. The revision also maintains that an examination by and consultation with a single cardiac surgeon by a prospective TAVR patient is adequate, similar to the 2012 document, although the Center for Medicare & Medicaid Services mandated in its coverage decision that prospective TAVR patients consult with two cardiac surgeons, the so-called “two-surgeon rule.” If CMS eliminated the two-surgeon rule it would “streamline” the process that patients go through when being assessed for TAVR, Dr. Tommaso observed, and both he and Dr. Bavaria expressed hope that the new document might prompt CMS to reconsider this guidance.
“We felt that two surgeons weren’t needed,” but the document specifies that both the surgeon and the cardiologist whom a prospective patient consults before finalizing plans for the intervention should both be members of the multidisciplinary team that performs the procedure. Until now, these clinicians weren’t specified as necessarily members of the TAVR team, Dr. Bavaria said.
One additional new element in the revised document is specification of shared decision making as the mechanism patients should go through when considering TAVR relative to their other management options, Dr. Tommaso said.Dr. Bavaria and Dr. Tommaso had no disclosures.
SOURCE: Bavaria JE et al. JACC. 2018 Jul18. doi:10.1016/j.jacc.2018.07.002.
FROM JACC
Prolonged opioid use among U.S. IBD patients doubled during 2002-2016
WASHINGTON – based on statistics gathered in a database that included medical records from more than 40 million American patients.
Prolonged opioid treatment, defined as filling at least two prescriptions for an opioid at least 90 days apart in a calendar year, rose among patients diagnosed with either Crohn’s disease or ulcerative colitis from a low of 14% in 2002 to 26% in 2016, reaching a peak during the period of 29% in 2014, Marc Landsman, MD, said at the annual Digestive Disease Week.®
The sharpest rise during the 15-year period examined was an increase in this level of opioid use from 15% in 2004 to 21% in 2005. Prolonged opioid use remained at or above 26% of all U.S. patients identified with IBD in the database during each year from 2011 to 2016, said Dr. Landsman, a gastroenterologist at the MetroHealth Medical Center in Cleveland. He suggested that a multidisciplinary approach to pain relief including alternative approaches to pain management, “will be vital” for pain management in IBD patients.
“Pain is a very important symptom of IBD. Opioids have been easy to prescribe, but they may not be the correct drug to prescribe,” commented Gil Y. Melmed, MD, director of clinical inflammatory bowel disease at Cedars-Sinai Medical Center in Los Angeles. He agreed with Dr. Landsman that a more multidisciplinary approach to pain management, including behavioral interventions, might reduce reliance on opioids in these patients. In addition, good control of an IBD patient’s inflammatory disease with, for example, a tumor necrosis factor inhibitor often produces substantial pain reduction, although some patients may also need surgery to relieve obstructive pain, Dr. Melmed said in an interview.The analysis run by Dr. Landsman and his associates used data in the Explorys database that included 276,340 unique patients with a diagnosis in their insurance record of IBD who also underwent either flexible sigmoidoscopy or colonoscopy during the year when they first received the diagnosis.
The study also analyzed the type of medical insurance used by patients who received prolonged opioid treatment. During 2002, 43% of patients who received an opioid for a prolonged period had Medicare coverage, 35% had private insurance, and 20% had Medicaid coverage. The prevalence of Medicare and private insurance coverage among opioid recipients steadily shifted during the next 14 years, so that in 2016 private insurance was the most prevalent coverage among the IBD patients on prolonged opioid use, at 46%, with 33% on Medicare coverage and 15% covered by Medicaid. The changes in the prevalence of Medicare and private insurance coverage from 2002 to 2016 were statistically significant, Dr. Landsman said.
Dr. Landsman and Dr. Melmed had no relevant disclosures.
SOURCE: Landsman M et al. DDW 2018. Presentation 14.
WASHINGTON – based on statistics gathered in a database that included medical records from more than 40 million American patients.
Prolonged opioid treatment, defined as filling at least two prescriptions for an opioid at least 90 days apart in a calendar year, rose among patients diagnosed with either Crohn’s disease or ulcerative colitis from a low of 14% in 2002 to 26% in 2016, reaching a peak during the period of 29% in 2014, Marc Landsman, MD, said at the annual Digestive Disease Week.®
The sharpest rise during the 15-year period examined was an increase in this level of opioid use from 15% in 2004 to 21% in 2005. Prolonged opioid use remained at or above 26% of all U.S. patients identified with IBD in the database during each year from 2011 to 2016, said Dr. Landsman, a gastroenterologist at the MetroHealth Medical Center in Cleveland. He suggested that a multidisciplinary approach to pain relief including alternative approaches to pain management, “will be vital” for pain management in IBD patients.
“Pain is a very important symptom of IBD. Opioids have been easy to prescribe, but they may not be the correct drug to prescribe,” commented Gil Y. Melmed, MD, director of clinical inflammatory bowel disease at Cedars-Sinai Medical Center in Los Angeles. He agreed with Dr. Landsman that a more multidisciplinary approach to pain management, including behavioral interventions, might reduce reliance on opioids in these patients. In addition, good control of an IBD patient’s inflammatory disease with, for example, a tumor necrosis factor inhibitor often produces substantial pain reduction, although some patients may also need surgery to relieve obstructive pain, Dr. Melmed said in an interview.The analysis run by Dr. Landsman and his associates used data in the Explorys database that included 276,340 unique patients with a diagnosis in their insurance record of IBD who also underwent either flexible sigmoidoscopy or colonoscopy during the year when they first received the diagnosis.
The study also analyzed the type of medical insurance used by patients who received prolonged opioid treatment. During 2002, 43% of patients who received an opioid for a prolonged period had Medicare coverage, 35% had private insurance, and 20% had Medicaid coverage. The prevalence of Medicare and private insurance coverage among opioid recipients steadily shifted during the next 14 years, so that in 2016 private insurance was the most prevalent coverage among the IBD patients on prolonged opioid use, at 46%, with 33% on Medicare coverage and 15% covered by Medicaid. The changes in the prevalence of Medicare and private insurance coverage from 2002 to 2016 were statistically significant, Dr. Landsman said.
Dr. Landsman and Dr. Melmed had no relevant disclosures.
SOURCE: Landsman M et al. DDW 2018. Presentation 14.
WASHINGTON – based on statistics gathered in a database that included medical records from more than 40 million American patients.
Prolonged opioid treatment, defined as filling at least two prescriptions for an opioid at least 90 days apart in a calendar year, rose among patients diagnosed with either Crohn’s disease or ulcerative colitis from a low of 14% in 2002 to 26% in 2016, reaching a peak during the period of 29% in 2014, Marc Landsman, MD, said at the annual Digestive Disease Week.®
The sharpest rise during the 15-year period examined was an increase in this level of opioid use from 15% in 2004 to 21% in 2005. Prolonged opioid use remained at or above 26% of all U.S. patients identified with IBD in the database during each year from 2011 to 2016, said Dr. Landsman, a gastroenterologist at the MetroHealth Medical Center in Cleveland. He suggested that a multidisciplinary approach to pain relief including alternative approaches to pain management, “will be vital” for pain management in IBD patients.
“Pain is a very important symptom of IBD. Opioids have been easy to prescribe, but they may not be the correct drug to prescribe,” commented Gil Y. Melmed, MD, director of clinical inflammatory bowel disease at Cedars-Sinai Medical Center in Los Angeles. He agreed with Dr. Landsman that a more multidisciplinary approach to pain management, including behavioral interventions, might reduce reliance on opioids in these patients. In addition, good control of an IBD patient’s inflammatory disease with, for example, a tumor necrosis factor inhibitor often produces substantial pain reduction, although some patients may also need surgery to relieve obstructive pain, Dr. Melmed said in an interview.The analysis run by Dr. Landsman and his associates used data in the Explorys database that included 276,340 unique patients with a diagnosis in their insurance record of IBD who also underwent either flexible sigmoidoscopy or colonoscopy during the year when they first received the diagnosis.
The study also analyzed the type of medical insurance used by patients who received prolonged opioid treatment. During 2002, 43% of patients who received an opioid for a prolonged period had Medicare coverage, 35% had private insurance, and 20% had Medicaid coverage. The prevalence of Medicare and private insurance coverage among opioid recipients steadily shifted during the next 14 years, so that in 2016 private insurance was the most prevalent coverage among the IBD patients on prolonged opioid use, at 46%, with 33% on Medicare coverage and 15% covered by Medicaid. The changes in the prevalence of Medicare and private insurance coverage from 2002 to 2016 were statistically significant, Dr. Landsman said.
Dr. Landsman and Dr. Melmed had no relevant disclosures.
SOURCE: Landsman M et al. DDW 2018. Presentation 14.
REPORTING FROM DDW 2018
Key clinical point: Prolonged opioid use by IBD patients increased substantially during 2002-2016.
Major finding: The incidence of prolonged opioid use among U.S. IBD patients rose from 14% in 2002 to 26% in 2016.
Study details: Review of 276,340 U.S. patients diagnosed with IBD contained in a large insurance database.
Disclosures: Dr. Landsman and Dr. Melmed had no relevant disclosures.
Source: Landsman M et al. DDW 2018. Presentation 14.
Fecal transplantation suggests IBS efficacy in small, randomized studies
WASHINGTON –
In the more positive of the two studies, patients with “bloating-predominant” IBS received a freshly prepared FMT from either a selected donor or from their own stool as a placebo control. After 12 weeks, the percentage of patients reporting clinically meaningful improvements in both abdominal bloating and in IBS symptoms was roughly twice as high, about 56%, among the 43 actively treated patients as the 26% rate of patients reporting these changes among 19 controls, Tom Holvoet, MD, said at the annual Digestive Disease Week.®Further follow-up of 22 patients who had significant improvement of their IBS symptoms at 12 weeks after treatment showed that, 1 year later, 6 of the 22 (27%) maintained their improved state while the other 73% of patients relapsed, suggesting that retreatment may be necessary for many, said Dr. Holvoet, a gastroenterologist at Ghent (Belgium) University. Five of the six patients who showed a prolonged response had received a donor FMT, while the sixth patient was from the control group that received a transplant of material prepared from the patient’s own stool.
“I think some patients would be willing to have multiple treatments,” Dr. Holvoet said in an interview. “These are highly motivated patients; you need to be highly motivated to undergo this treatment, and if they see an effect they’ll be motivated for retreatment,” he predicted.
The single-center study enrolled patients 18-75 years old with refractory IBS, based on the Rome III criteria, with intermittent diarrhea and severe bloating. Each patient received a single FMT. Patients in the active-treatment arm received their FMT from either of two donors selected for their “rich microbial diversity,” and demonstrated efficacy in an earlier pilot study with 12 patients (Gut. 2017 May;66[5]:980-2). In addition to a higher rate of improvement of abdominal bloating and IBS symptoms, the donor FMT also led to a significantly better improvement in IBS-related quality of life. Preliminary analysis of the intestinal microbiome profile of patients in the study suggested that specific changes to the microbiome were linked with treatment success.
Dr. Holvoet highlighted that more research is needed to identify ideal patients to treat this way, and to simplify and streamline the FMT process.
“Our study is a good first step, but we need to figure out what is happening in these patients,” Dr. Holvoet said in an interview.
Results from the second study failed to show a statistically significant benefit from FMT, compared with placebo, for the primary endpoint, but it did show benefit in one secondary endpoint.
This study enrolled 48 patients 19-65 years old with moderate to severe, diarrhea-predominant IBS, based on the Rome III definitions, at any of three U.S. centers. The researchers randomized patients to either immediate treatment for 3 days with an encapsulated, frozen fecal preparation obtained from the OpenBiome stool bank or placebo capsules. After 12 weeks, the average change from baseline in the IBS–Symptom Severity Score (SSS), the study’s primary endpoint, was virtually identical in both arms of the study. In both treatment groups the average baseline IBS-SSS was nearly 300, and in both treatment groups the SSS dropped sharply after 1 week into the study and then remained stable at this lower level in both groups during the next 11 weeks. Patients then underwent a second round of treatment in a crossover design. During a second 12 weeks of follow-up the average IBS-SSS remained steady among the patients who received placebo as their second treatment, but the patients who received active treatment as their second dose showed a further significant decline in their SSS, so that after the second 12-week follow-up the average score was 76 points lower in patients who recently had active treatment than those who recently received placebo, a statistically significant difference for this clinically meaningful point difference, reported Lawrence J. Brandt, MD, professor of medicine and surgery at Albert Einstein College of Medicine in New York.
In addition, the 12 patients in the study who had postinfection IBS showed the most dramatic reduction from baseline in their IBS-SSS 12 weeks after active treatment, compared with placebo. In contrast, 33 other patients in the study with noninfectious IBS etiologies showed on average no difference between active and placebo treatment in their 12-week change in SSS.
Preliminary findings in this study also showed some correlations between certain microbiome changes and better clinical responses to FMT, Dr. Brandt noted.
Dr. Holvoet and Dr. Brandt had no disclosures.
SOURCE: Holvoet T et al. DDW 2018. Presentation 617; Aroniadis OC et al. Presentation 742.
WASHINGTON –
In the more positive of the two studies, patients with “bloating-predominant” IBS received a freshly prepared FMT from either a selected donor or from their own stool as a placebo control. After 12 weeks, the percentage of patients reporting clinically meaningful improvements in both abdominal bloating and in IBS symptoms was roughly twice as high, about 56%, among the 43 actively treated patients as the 26% rate of patients reporting these changes among 19 controls, Tom Holvoet, MD, said at the annual Digestive Disease Week.®Further follow-up of 22 patients who had significant improvement of their IBS symptoms at 12 weeks after treatment showed that, 1 year later, 6 of the 22 (27%) maintained their improved state while the other 73% of patients relapsed, suggesting that retreatment may be necessary for many, said Dr. Holvoet, a gastroenterologist at Ghent (Belgium) University. Five of the six patients who showed a prolonged response had received a donor FMT, while the sixth patient was from the control group that received a transplant of material prepared from the patient’s own stool.
“I think some patients would be willing to have multiple treatments,” Dr. Holvoet said in an interview. “These are highly motivated patients; you need to be highly motivated to undergo this treatment, and if they see an effect they’ll be motivated for retreatment,” he predicted.
The single-center study enrolled patients 18-75 years old with refractory IBS, based on the Rome III criteria, with intermittent diarrhea and severe bloating. Each patient received a single FMT. Patients in the active-treatment arm received their FMT from either of two donors selected for their “rich microbial diversity,” and demonstrated efficacy in an earlier pilot study with 12 patients (Gut. 2017 May;66[5]:980-2). In addition to a higher rate of improvement of abdominal bloating and IBS symptoms, the donor FMT also led to a significantly better improvement in IBS-related quality of life. Preliminary analysis of the intestinal microbiome profile of patients in the study suggested that specific changes to the microbiome were linked with treatment success.
Dr. Holvoet highlighted that more research is needed to identify ideal patients to treat this way, and to simplify and streamline the FMT process.
“Our study is a good first step, but we need to figure out what is happening in these patients,” Dr. Holvoet said in an interview.
Results from the second study failed to show a statistically significant benefit from FMT, compared with placebo, for the primary endpoint, but it did show benefit in one secondary endpoint.
This study enrolled 48 patients 19-65 years old with moderate to severe, diarrhea-predominant IBS, based on the Rome III definitions, at any of three U.S. centers. The researchers randomized patients to either immediate treatment for 3 days with an encapsulated, frozen fecal preparation obtained from the OpenBiome stool bank or placebo capsules. After 12 weeks, the average change from baseline in the IBS–Symptom Severity Score (SSS), the study’s primary endpoint, was virtually identical in both arms of the study. In both treatment groups the average baseline IBS-SSS was nearly 300, and in both treatment groups the SSS dropped sharply after 1 week into the study and then remained stable at this lower level in both groups during the next 11 weeks. Patients then underwent a second round of treatment in a crossover design. During a second 12 weeks of follow-up the average IBS-SSS remained steady among the patients who received placebo as their second treatment, but the patients who received active treatment as their second dose showed a further significant decline in their SSS, so that after the second 12-week follow-up the average score was 76 points lower in patients who recently had active treatment than those who recently received placebo, a statistically significant difference for this clinically meaningful point difference, reported Lawrence J. Brandt, MD, professor of medicine and surgery at Albert Einstein College of Medicine in New York.
In addition, the 12 patients in the study who had postinfection IBS showed the most dramatic reduction from baseline in their IBS-SSS 12 weeks after active treatment, compared with placebo. In contrast, 33 other patients in the study with noninfectious IBS etiologies showed on average no difference between active and placebo treatment in their 12-week change in SSS.
Preliminary findings in this study also showed some correlations between certain microbiome changes and better clinical responses to FMT, Dr. Brandt noted.
Dr. Holvoet and Dr. Brandt had no disclosures.
SOURCE: Holvoet T et al. DDW 2018. Presentation 617; Aroniadis OC et al. Presentation 742.
WASHINGTON –
In the more positive of the two studies, patients with “bloating-predominant” IBS received a freshly prepared FMT from either a selected donor or from their own stool as a placebo control. After 12 weeks, the percentage of patients reporting clinically meaningful improvements in both abdominal bloating and in IBS symptoms was roughly twice as high, about 56%, among the 43 actively treated patients as the 26% rate of patients reporting these changes among 19 controls, Tom Holvoet, MD, said at the annual Digestive Disease Week.®Further follow-up of 22 patients who had significant improvement of their IBS symptoms at 12 weeks after treatment showed that, 1 year later, 6 of the 22 (27%) maintained their improved state while the other 73% of patients relapsed, suggesting that retreatment may be necessary for many, said Dr. Holvoet, a gastroenterologist at Ghent (Belgium) University. Five of the six patients who showed a prolonged response had received a donor FMT, while the sixth patient was from the control group that received a transplant of material prepared from the patient’s own stool.
“I think some patients would be willing to have multiple treatments,” Dr. Holvoet said in an interview. “These are highly motivated patients; you need to be highly motivated to undergo this treatment, and if they see an effect they’ll be motivated for retreatment,” he predicted.
The single-center study enrolled patients 18-75 years old with refractory IBS, based on the Rome III criteria, with intermittent diarrhea and severe bloating. Each patient received a single FMT. Patients in the active-treatment arm received their FMT from either of two donors selected for their “rich microbial diversity,” and demonstrated efficacy in an earlier pilot study with 12 patients (Gut. 2017 May;66[5]:980-2). In addition to a higher rate of improvement of abdominal bloating and IBS symptoms, the donor FMT also led to a significantly better improvement in IBS-related quality of life. Preliminary analysis of the intestinal microbiome profile of patients in the study suggested that specific changes to the microbiome were linked with treatment success.
Dr. Holvoet highlighted that more research is needed to identify ideal patients to treat this way, and to simplify and streamline the FMT process.
“Our study is a good first step, but we need to figure out what is happening in these patients,” Dr. Holvoet said in an interview.
Results from the second study failed to show a statistically significant benefit from FMT, compared with placebo, for the primary endpoint, but it did show benefit in one secondary endpoint.
This study enrolled 48 patients 19-65 years old with moderate to severe, diarrhea-predominant IBS, based on the Rome III definitions, at any of three U.S. centers. The researchers randomized patients to either immediate treatment for 3 days with an encapsulated, frozen fecal preparation obtained from the OpenBiome stool bank or placebo capsules. After 12 weeks, the average change from baseline in the IBS–Symptom Severity Score (SSS), the study’s primary endpoint, was virtually identical in both arms of the study. In both treatment groups the average baseline IBS-SSS was nearly 300, and in both treatment groups the SSS dropped sharply after 1 week into the study and then remained stable at this lower level in both groups during the next 11 weeks. Patients then underwent a second round of treatment in a crossover design. During a second 12 weeks of follow-up the average IBS-SSS remained steady among the patients who received placebo as their second treatment, but the patients who received active treatment as their second dose showed a further significant decline in their SSS, so that after the second 12-week follow-up the average score was 76 points lower in patients who recently had active treatment than those who recently received placebo, a statistically significant difference for this clinically meaningful point difference, reported Lawrence J. Brandt, MD, professor of medicine and surgery at Albert Einstein College of Medicine in New York.
In addition, the 12 patients in the study who had postinfection IBS showed the most dramatic reduction from baseline in their IBS-SSS 12 weeks after active treatment, compared with placebo. In contrast, 33 other patients in the study with noninfectious IBS etiologies showed on average no difference between active and placebo treatment in their 12-week change in SSS.
Preliminary findings in this study also showed some correlations between certain microbiome changes and better clinical responses to FMT, Dr. Brandt noted.
Dr. Holvoet and Dr. Brandt had no disclosures.
SOURCE: Holvoet T et al. DDW 2018. Presentation 617; Aroniadis OC et al. Presentation 742.
REPORTING FROM DDW 2018
Key clinical point: Results from two small randomized studies suggest that fecal microbiome transplantation may help some IBS patients.
Major finding: In one study, fecal transplantation linked with a doubling of patients having reduced IBS symptoms, compared with placebo, .
Study details: A single-center randomized study with 62 patients and a multicenter randomized crossover study with 48 patients.
Disclosures: Dr. Holvoet and Dr. Brandt had no disclosures.
Source: Holvoet T et al. DDW 2018. Presentation 617; Aroniadis OC et al. Presentation 742.
Machine learning software boosts colonoscopists’ adenoma detection rates
WASHINGTON –
When tested on 36,076 archived colonoscopy images, the polyp recognition program developed through machine learning had a sensitivity for polyp detection of 98%, a specificity of 93%, a positive predictive value of 0.758 and a negative predictive value of 0.995, Priyam V. Tripathi, MD, said at the annual Digestive Disease Week.® The program also showed an area under the receiver operator characteristic curve of 0.99, indicating nearly perfect ability to discriminate between images of polyps and normal colonic tissue, said Dr. Tripathi, a gastroenterologist at the University of California, Irvine.
She and her associates initially developed the polyp-recognition program with machine learning engineering that involved 4,088 images of polyps and 4,553 images of normal tissue drawn from the extensive colonoscopy video archive maintained at UC Irvine. Refinement of the program continues as it undergoes further use. The program can review 98 images a second, making it more than fast enough to aid during real-time colonoscopy examinations, Dr. Tripathi explained in a video interview. As an operator withdraws the colonoscope and views the images, the program is designed to monitor the pictures along with the operator and trigger alerts that flag high-probability lesions by framing them in a colored box on the screen. The operator can then examine these sites with more attention and decide whether they warrant biopsy or polypectomy.
A second validation study used the program to review 20 archived colonoscopy videos along with an expert panel. During the original examinations, the operators of these 20 procedures identified 28 polyps. The expert review confirmed these 28 and identified eight additional polyps. The researchers then assessed the same videos with the recognition program and confirmed the original 28 plus the added eight and also found nine additional polyps that had been missed twice by clinicians. Dr. Tripathi and her associates recently published results from this validation study (Gastroenterology. 2018 Jun 18. doi: 10.1053/j.gastro.2018.06.037).
The next step is a prospective, multicenter study to compare the adenoma detection rate of operators aided by the recognition program with their detection rate without the program, she said.
“The adenoma detection rate is the key marker,” noted William E. Karnes, MD, a gastroenterologist at UC Irvine and senior investigator on these studies. “If the adenoma detection rate rises, we won’t know whether it’s the artificial intelligence that’s the reason, or whether it’s the artificial intelligence watching the operator” and motivating the gastroenterologist to do a more thorough job, Dr. Karnes noted in an interview. “But it doesn’t matter as long as the software is easy to use. It can potentially close the gap in adenoma detection rates. There are a lot of missed polyps” in routine practice right now.
SOURCE: Tripathi PV et al. DDW 2018. Presentation 133.
WASHINGTON –
When tested on 36,076 archived colonoscopy images, the polyp recognition program developed through machine learning had a sensitivity for polyp detection of 98%, a specificity of 93%, a positive predictive value of 0.758 and a negative predictive value of 0.995, Priyam V. Tripathi, MD, said at the annual Digestive Disease Week.® The program also showed an area under the receiver operator characteristic curve of 0.99, indicating nearly perfect ability to discriminate between images of polyps and normal colonic tissue, said Dr. Tripathi, a gastroenterologist at the University of California, Irvine.
She and her associates initially developed the polyp-recognition program with machine learning engineering that involved 4,088 images of polyps and 4,553 images of normal tissue drawn from the extensive colonoscopy video archive maintained at UC Irvine. Refinement of the program continues as it undergoes further use. The program can review 98 images a second, making it more than fast enough to aid during real-time colonoscopy examinations, Dr. Tripathi explained in a video interview. As an operator withdraws the colonoscope and views the images, the program is designed to monitor the pictures along with the operator and trigger alerts that flag high-probability lesions by framing them in a colored box on the screen. The operator can then examine these sites with more attention and decide whether they warrant biopsy or polypectomy.
A second validation study used the program to review 20 archived colonoscopy videos along with an expert panel. During the original examinations, the operators of these 20 procedures identified 28 polyps. The expert review confirmed these 28 and identified eight additional polyps. The researchers then assessed the same videos with the recognition program and confirmed the original 28 plus the added eight and also found nine additional polyps that had been missed twice by clinicians. Dr. Tripathi and her associates recently published results from this validation study (Gastroenterology. 2018 Jun 18. doi: 10.1053/j.gastro.2018.06.037).
The next step is a prospective, multicenter study to compare the adenoma detection rate of operators aided by the recognition program with their detection rate without the program, she said.
“The adenoma detection rate is the key marker,” noted William E. Karnes, MD, a gastroenterologist at UC Irvine and senior investigator on these studies. “If the adenoma detection rate rises, we won’t know whether it’s the artificial intelligence that’s the reason, or whether it’s the artificial intelligence watching the operator” and motivating the gastroenterologist to do a more thorough job, Dr. Karnes noted in an interview. “But it doesn’t matter as long as the software is easy to use. It can potentially close the gap in adenoma detection rates. There are a lot of missed polyps” in routine practice right now.
SOURCE: Tripathi PV et al. DDW 2018. Presentation 133.
WASHINGTON –
When tested on 36,076 archived colonoscopy images, the polyp recognition program developed through machine learning had a sensitivity for polyp detection of 98%, a specificity of 93%, a positive predictive value of 0.758 and a negative predictive value of 0.995, Priyam V. Tripathi, MD, said at the annual Digestive Disease Week.® The program also showed an area under the receiver operator characteristic curve of 0.99, indicating nearly perfect ability to discriminate between images of polyps and normal colonic tissue, said Dr. Tripathi, a gastroenterologist at the University of California, Irvine.
She and her associates initially developed the polyp-recognition program with machine learning engineering that involved 4,088 images of polyps and 4,553 images of normal tissue drawn from the extensive colonoscopy video archive maintained at UC Irvine. Refinement of the program continues as it undergoes further use. The program can review 98 images a second, making it more than fast enough to aid during real-time colonoscopy examinations, Dr. Tripathi explained in a video interview. As an operator withdraws the colonoscope and views the images, the program is designed to monitor the pictures along with the operator and trigger alerts that flag high-probability lesions by framing them in a colored box on the screen. The operator can then examine these sites with more attention and decide whether they warrant biopsy or polypectomy.
A second validation study used the program to review 20 archived colonoscopy videos along with an expert panel. During the original examinations, the operators of these 20 procedures identified 28 polyps. The expert review confirmed these 28 and identified eight additional polyps. The researchers then assessed the same videos with the recognition program and confirmed the original 28 plus the added eight and also found nine additional polyps that had been missed twice by clinicians. Dr. Tripathi and her associates recently published results from this validation study (Gastroenterology. 2018 Jun 18. doi: 10.1053/j.gastro.2018.06.037).
The next step is a prospective, multicenter study to compare the adenoma detection rate of operators aided by the recognition program with their detection rate without the program, she said.
“The adenoma detection rate is the key marker,” noted William E. Karnes, MD, a gastroenterologist at UC Irvine and senior investigator on these studies. “If the adenoma detection rate rises, we won’t know whether it’s the artificial intelligence that’s the reason, or whether it’s the artificial intelligence watching the operator” and motivating the gastroenterologist to do a more thorough job, Dr. Karnes noted in an interview. “But it doesn’t matter as long as the software is easy to use. It can potentially close the gap in adenoma detection rates. There are a lot of missed polyps” in routine practice right now.
SOURCE: Tripathi PV et al. DDW 2018. Presentation 133.
REPORTING FROM DDW 2018
Key clinical point: New software provides real-time aid to colonoscopists for identifying adenomatous polyps.
Major finding: The software was 98% sensitive, 93% specific, and had a negative predictive value of 0.995 for ruling out adenomatous polyps.
Study details: Single-center review of 36,076 images of polyps and normal colonic tissue.
Disclosures: The software development has no commercial funding. Dr. Tripathi had no disclosures. Dr. Karnes is cofounder of Docbot/Qualoscopy, a company that markets colonoscopy software.
Source: Tripathi PV et al. DDW 2018. Presentation 133.
Glucocorticoids linked with surgical infections in RA patients
AMSTERDAM – Patients with rheumatoid arthritis who underwent elective knee or hip arthroplasty had a doubled rate of hospitalization for infection when they averaged more than 10 mg/day oral prednisone during the 3 months before surgery, based on a review of about 11,000 U.S. insurance claims.
“Limiting glucocorticoid exposure before surgery should be a focus of perioperative management,” Michael D. George, MD, said at the European Congress of Rheumatology. “Glucocorticoid use, especially greater than 10 mg/day, is associated with a greater risk of infection and hospital readmission,” said Dr. George, a rheumatologist at the University of Pennsylvania in Philadelphia.
The analysis also showed that treatment with any biologic drug – including abatacept (Orencia), rituximab (Rituxan), tocilizumab (Actemra), and any of several tumor necrosis factor (TNF) inhibitors – had a similar impact on both postsurgical infections requiring hospitalization and 30-day hospital readmissions.
The findings suggest “it’s more important to reduce glucocorticoids than biological drugs,” commented John D. Isaacs, MD, professor of clinical rheumatology at Newcastle University in Newcastle upon Tyne, England. “This is a really important question that has been very difficult to answer.”
Dr. George and his associates used data from patients with rheumatoid arthritis during 2006-2015 who underwent knee or hip arthroplasty and were in databases from Medicare, or MarketScan, which includes commercial insurers. This identified 11,021 RA patients on any of several biologic drugs before their surgery: 16% on abatacept, 4% on rituximab, 4% on tocilizumab, and the remaining 76% on a TNF inhibitor, either adalimumab (Humira), etanercept (Enbrel), or infliximab (Remicade). About 43% of all patients were on a glucocorticoid during the 3 months before surgery. Biologic use was defined as a minimum of one dose within 8 weeks of surgery, and at least three total dosages during the prior year, except for rituximab, which was at least one dose given 16 weeks before surgery and at least two doses during the prior year.
The rate of hospitalized infections ranged from 6.6% to 8.5% depending on the biologic drug used, and 30-day readmissions ranged from 4.8% to 6.8%. A third outcome the analysis assessed was prosthetic joint infection during 1-year follow-up, which was again similar across most of the biologics, except for patients on tocilizumab, who had prosthetic joint infections roughly threefold more often than the other patients. Although this was a statistically significant difference, Dr. George discounted the finding given the very small number of tocilizumab-treated patients who had these infections and said that any conclusion about tocilizumab’s effect on this outcome had to await data from more patients.
The glucocorticoid analysis divided patients into four subgroups: those not on a glucocorticoid, those on an average daily dosage of 5 mg/day prednisone or equivalent or less, patients on 6-10 mg/day prednisone, and those on more than 10 mg/day. In a propensity-weighted analysis, these three escalating levels of glucocorticoid use showed a dose-response relationship to the rates of both hospitalized infections and 30-day readmissions. At the highest level of glucocorticoid use, hospitalized infections occurred twice as often as in patients not on a glucocorticoid, and 30-day readmissions were more than 50% higher than in those not on an oral steroid, both statistically significant differences. For the outcome of 1-year prosthetic joint infections, the analysis again showed a dose-related link among glucocorticoid users, topping out with a greater than 50% increased rate among those on the highest glucocorticoid dosages when compared with nonusers, but this difference was not statistically significant.
The study was partially funded by Bristol-Myers Squibb, the company that markets abatacept. Dr. George has received research funding from Bristol-Myers Squibb, and some of his coauthors on the study are employees of the company.
SOURCE: George MD et al. EULAR 2018. Abstract OP0228.
AMSTERDAM – Patients with rheumatoid arthritis who underwent elective knee or hip arthroplasty had a doubled rate of hospitalization for infection when they averaged more than 10 mg/day oral prednisone during the 3 months before surgery, based on a review of about 11,000 U.S. insurance claims.
“Limiting glucocorticoid exposure before surgery should be a focus of perioperative management,” Michael D. George, MD, said at the European Congress of Rheumatology. “Glucocorticoid use, especially greater than 10 mg/day, is associated with a greater risk of infection and hospital readmission,” said Dr. George, a rheumatologist at the University of Pennsylvania in Philadelphia.
The analysis also showed that treatment with any biologic drug – including abatacept (Orencia), rituximab (Rituxan), tocilizumab (Actemra), and any of several tumor necrosis factor (TNF) inhibitors – had a similar impact on both postsurgical infections requiring hospitalization and 30-day hospital readmissions.
The findings suggest “it’s more important to reduce glucocorticoids than biological drugs,” commented John D. Isaacs, MD, professor of clinical rheumatology at Newcastle University in Newcastle upon Tyne, England. “This is a really important question that has been very difficult to answer.”
Dr. George and his associates used data from patients with rheumatoid arthritis during 2006-2015 who underwent knee or hip arthroplasty and were in databases from Medicare, or MarketScan, which includes commercial insurers. This identified 11,021 RA patients on any of several biologic drugs before their surgery: 16% on abatacept, 4% on rituximab, 4% on tocilizumab, and the remaining 76% on a TNF inhibitor, either adalimumab (Humira), etanercept (Enbrel), or infliximab (Remicade). About 43% of all patients were on a glucocorticoid during the 3 months before surgery. Biologic use was defined as a minimum of one dose within 8 weeks of surgery, and at least three total dosages during the prior year, except for rituximab, which was at least one dose given 16 weeks before surgery and at least two doses during the prior year.
The rate of hospitalized infections ranged from 6.6% to 8.5% depending on the biologic drug used, and 30-day readmissions ranged from 4.8% to 6.8%. A third outcome the analysis assessed was prosthetic joint infection during 1-year follow-up, which was again similar across most of the biologics, except for patients on tocilizumab, who had prosthetic joint infections roughly threefold more often than the other patients. Although this was a statistically significant difference, Dr. George discounted the finding given the very small number of tocilizumab-treated patients who had these infections and said that any conclusion about tocilizumab’s effect on this outcome had to await data from more patients.
The glucocorticoid analysis divided patients into four subgroups: those not on a glucocorticoid, those on an average daily dosage of 5 mg/day prednisone or equivalent or less, patients on 6-10 mg/day prednisone, and those on more than 10 mg/day. In a propensity-weighted analysis, these three escalating levels of glucocorticoid use showed a dose-response relationship to the rates of both hospitalized infections and 30-day readmissions. At the highest level of glucocorticoid use, hospitalized infections occurred twice as often as in patients not on a glucocorticoid, and 30-day readmissions were more than 50% higher than in those not on an oral steroid, both statistically significant differences. For the outcome of 1-year prosthetic joint infections, the analysis again showed a dose-related link among glucocorticoid users, topping out with a greater than 50% increased rate among those on the highest glucocorticoid dosages when compared with nonusers, but this difference was not statistically significant.
The study was partially funded by Bristol-Myers Squibb, the company that markets abatacept. Dr. George has received research funding from Bristol-Myers Squibb, and some of his coauthors on the study are employees of the company.
SOURCE: George MD et al. EULAR 2018. Abstract OP0228.
AMSTERDAM – Patients with rheumatoid arthritis who underwent elective knee or hip arthroplasty had a doubled rate of hospitalization for infection when they averaged more than 10 mg/day oral prednisone during the 3 months before surgery, based on a review of about 11,000 U.S. insurance claims.
“Limiting glucocorticoid exposure before surgery should be a focus of perioperative management,” Michael D. George, MD, said at the European Congress of Rheumatology. “Glucocorticoid use, especially greater than 10 mg/day, is associated with a greater risk of infection and hospital readmission,” said Dr. George, a rheumatologist at the University of Pennsylvania in Philadelphia.
The analysis also showed that treatment with any biologic drug – including abatacept (Orencia), rituximab (Rituxan), tocilizumab (Actemra), and any of several tumor necrosis factor (TNF) inhibitors – had a similar impact on both postsurgical infections requiring hospitalization and 30-day hospital readmissions.
The findings suggest “it’s more important to reduce glucocorticoids than biological drugs,” commented John D. Isaacs, MD, professor of clinical rheumatology at Newcastle University in Newcastle upon Tyne, England. “This is a really important question that has been very difficult to answer.”
Dr. George and his associates used data from patients with rheumatoid arthritis during 2006-2015 who underwent knee or hip arthroplasty and were in databases from Medicare, or MarketScan, which includes commercial insurers. This identified 11,021 RA patients on any of several biologic drugs before their surgery: 16% on abatacept, 4% on rituximab, 4% on tocilizumab, and the remaining 76% on a TNF inhibitor, either adalimumab (Humira), etanercept (Enbrel), or infliximab (Remicade). About 43% of all patients were on a glucocorticoid during the 3 months before surgery. Biologic use was defined as a minimum of one dose within 8 weeks of surgery, and at least three total dosages during the prior year, except for rituximab, which was at least one dose given 16 weeks before surgery and at least two doses during the prior year.
The rate of hospitalized infections ranged from 6.6% to 8.5% depending on the biologic drug used, and 30-day readmissions ranged from 4.8% to 6.8%. A third outcome the analysis assessed was prosthetic joint infection during 1-year follow-up, which was again similar across most of the biologics, except for patients on tocilizumab, who had prosthetic joint infections roughly threefold more often than the other patients. Although this was a statistically significant difference, Dr. George discounted the finding given the very small number of tocilizumab-treated patients who had these infections and said that any conclusion about tocilizumab’s effect on this outcome had to await data from more patients.
The glucocorticoid analysis divided patients into four subgroups: those not on a glucocorticoid, those on an average daily dosage of 5 mg/day prednisone or equivalent or less, patients on 6-10 mg/day prednisone, and those on more than 10 mg/day. In a propensity-weighted analysis, these three escalating levels of glucocorticoid use showed a dose-response relationship to the rates of both hospitalized infections and 30-day readmissions. At the highest level of glucocorticoid use, hospitalized infections occurred twice as often as in patients not on a glucocorticoid, and 30-day readmissions were more than 50% higher than in those not on an oral steroid, both statistically significant differences. For the outcome of 1-year prosthetic joint infections, the analysis again showed a dose-related link among glucocorticoid users, topping out with a greater than 50% increased rate among those on the highest glucocorticoid dosages when compared with nonusers, but this difference was not statistically significant.
The study was partially funded by Bristol-Myers Squibb, the company that markets abatacept. Dr. George has received research funding from Bristol-Myers Squibb, and some of his coauthors on the study are employees of the company.
SOURCE: George MD et al. EULAR 2018. Abstract OP0228.
REPORTING FROM THE EULAR 2018 CONGRESS
Key clinical point:
Major finding: RA patients on more than 10 mg/day prednisone had a more than twofold higher rate of postsurgical hospitalized infections.
Study details: Review of Medicare and MarketScan administrative claims data for 11,021 patients with rheumatoid arthritis who underwent joint surgery.
Disclosures: The study was partially funded by Bristol-Myers Squibb, the company that markets abatacept (Orencia). Dr. George has received research funding from Bristol-Myers Squibb, and some of his coauthors on the study are employees of the company.
Source: George MD et al. EULAR 2018. Abstract OP0228.
CRISS hailed as transforming systemic sclerosis drug development
AMSTERDAM – A new way to assess clinically meaningful, multiorgan changes in patients receiving treatment for systemic sclerosis has transformed the way new drugs for this disease are judged.
The Combined Response Index for Systemic Sclerosis (CRISS) “will change how we look at drugs” for systemic sclerosis, Daniel E. Furst, MD, said at the European Congress of Rheumatology.
The CRISS was close to 10 years in the making. “First we had to decide what measures were important, then we had to run a prospective study entering all the data, and then we had to do a very sophisticated statistical analysis and put the results in front of experts and ask: Does this make sense?” Dr. Furst recalled in an interview. Now the combined endpoint measure has been “fully validated,” and is under consideration by the Food and Drug Administration as an endpoint for drug trials, he noted.
“I think that now, after 10 years, we finally came up with what will be the equivalent” of the American College of Rheumatology 20% improvement (ACR 20) in core-set measures of rheumatoid arthritis (Arthritis Res Ther. 2014 Jan 3;16[1]:101). “I think CRISS will make a huge difference because when you do a combined measure, like the ACR 20, it becomes more clinically and statistically powerful,” said Dr. Furst, professor of medicine (emeritus) at the University of California, Los Angeles, an adjunct professor at the University of Washington, Seattle, and research professor at the University of Florence (Italy). He is also in part-time practice in Los Angeles and Seattle.
In a talk he gave at the meeting on recent clinical studies of new drugs for treating patients with systemic sclerosis, many of the reports included CRISS as a measure of patient response to treatment.
The CRISS involves a two-step assessment of how a patient has responded to therapy. First, patients are considered not improved by their treatment if they develop any one of these four outcomes following treatment if it appears linked to the disease process:
- A new scleroderma renal crisis.
- A decline in forced vital capacity of 15% or more of predicted.
- A new decline of left ventricular ejection fraction to 45% or less.
- New onset of pulmonary arterial hypertension that requires treatment.
If none of these apply, the next step is to assess treatment response by measuring changes in five parameters and then integrating them into a single number using a mathematical formula. The five elements in the equation are:
- Modified Rodnan skin score.
- Percent of predicted forced vital capacity.
- Health Assessment Questionnaire-Disability Index.
- Patient’s global assessment.
- Physician’s global assessment.
When factored together, changes in these five measures determine the probability that the patient responded to the intervention.
One limitation of the CRISS is that it only measures change from baseline, which makes it similar to the ACR 20, Dr. Furst noted. Another useful score would be one that reflects the status of a patient with systemic sclerosis at a specific point in time, a type of disease activity score. Dr. Furst said that he and others active in the systemic sclerosis field would like to develop a method that provides this type of patient assessment. Another addition would be to develop a “minimally clinically important change” in the score, which would make the CRISS more intuitive to understand.
Dr. Furst has received research support from Amgen, Bristol-Myers Squibb, Celgene, Corbus, Genentech-Roche, GlaxoSmithKline, Pfizer, and Novartis.
SOURCE: Furst DE. EULAR 2018. Abstract SP0012.
AMSTERDAM – A new way to assess clinically meaningful, multiorgan changes in patients receiving treatment for systemic sclerosis has transformed the way new drugs for this disease are judged.
The Combined Response Index for Systemic Sclerosis (CRISS) “will change how we look at drugs” for systemic sclerosis, Daniel E. Furst, MD, said at the European Congress of Rheumatology.
The CRISS was close to 10 years in the making. “First we had to decide what measures were important, then we had to run a prospective study entering all the data, and then we had to do a very sophisticated statistical analysis and put the results in front of experts and ask: Does this make sense?” Dr. Furst recalled in an interview. Now the combined endpoint measure has been “fully validated,” and is under consideration by the Food and Drug Administration as an endpoint for drug trials, he noted.
“I think that now, after 10 years, we finally came up with what will be the equivalent” of the American College of Rheumatology 20% improvement (ACR 20) in core-set measures of rheumatoid arthritis (Arthritis Res Ther. 2014 Jan 3;16[1]:101). “I think CRISS will make a huge difference because when you do a combined measure, like the ACR 20, it becomes more clinically and statistically powerful,” said Dr. Furst, professor of medicine (emeritus) at the University of California, Los Angeles, an adjunct professor at the University of Washington, Seattle, and research professor at the University of Florence (Italy). He is also in part-time practice in Los Angeles and Seattle.
In a talk he gave at the meeting on recent clinical studies of new drugs for treating patients with systemic sclerosis, many of the reports included CRISS as a measure of patient response to treatment.
The CRISS involves a two-step assessment of how a patient has responded to therapy. First, patients are considered not improved by their treatment if they develop any one of these four outcomes following treatment if it appears linked to the disease process:
- A new scleroderma renal crisis.
- A decline in forced vital capacity of 15% or more of predicted.
- A new decline of left ventricular ejection fraction to 45% or less.
- New onset of pulmonary arterial hypertension that requires treatment.
If none of these apply, the next step is to assess treatment response by measuring changes in five parameters and then integrating them into a single number using a mathematical formula. The five elements in the equation are:
- Modified Rodnan skin score.
- Percent of predicted forced vital capacity.
- Health Assessment Questionnaire-Disability Index.
- Patient’s global assessment.
- Physician’s global assessment.
When factored together, changes in these five measures determine the probability that the patient responded to the intervention.
One limitation of the CRISS is that it only measures change from baseline, which makes it similar to the ACR 20, Dr. Furst noted. Another useful score would be one that reflects the status of a patient with systemic sclerosis at a specific point in time, a type of disease activity score. Dr. Furst said that he and others active in the systemic sclerosis field would like to develop a method that provides this type of patient assessment. Another addition would be to develop a “minimally clinically important change” in the score, which would make the CRISS more intuitive to understand.
Dr. Furst has received research support from Amgen, Bristol-Myers Squibb, Celgene, Corbus, Genentech-Roche, GlaxoSmithKline, Pfizer, and Novartis.
SOURCE: Furst DE. EULAR 2018. Abstract SP0012.
AMSTERDAM – A new way to assess clinically meaningful, multiorgan changes in patients receiving treatment for systemic sclerosis has transformed the way new drugs for this disease are judged.
The Combined Response Index for Systemic Sclerosis (CRISS) “will change how we look at drugs” for systemic sclerosis, Daniel E. Furst, MD, said at the European Congress of Rheumatology.
The CRISS was close to 10 years in the making. “First we had to decide what measures were important, then we had to run a prospective study entering all the data, and then we had to do a very sophisticated statistical analysis and put the results in front of experts and ask: Does this make sense?” Dr. Furst recalled in an interview. Now the combined endpoint measure has been “fully validated,” and is under consideration by the Food and Drug Administration as an endpoint for drug trials, he noted.
“I think that now, after 10 years, we finally came up with what will be the equivalent” of the American College of Rheumatology 20% improvement (ACR 20) in core-set measures of rheumatoid arthritis (Arthritis Res Ther. 2014 Jan 3;16[1]:101). “I think CRISS will make a huge difference because when you do a combined measure, like the ACR 20, it becomes more clinically and statistically powerful,” said Dr. Furst, professor of medicine (emeritus) at the University of California, Los Angeles, an adjunct professor at the University of Washington, Seattle, and research professor at the University of Florence (Italy). He is also in part-time practice in Los Angeles and Seattle.
In a talk he gave at the meeting on recent clinical studies of new drugs for treating patients with systemic sclerosis, many of the reports included CRISS as a measure of patient response to treatment.
The CRISS involves a two-step assessment of how a patient has responded to therapy. First, patients are considered not improved by their treatment if they develop any one of these four outcomes following treatment if it appears linked to the disease process:
- A new scleroderma renal crisis.
- A decline in forced vital capacity of 15% or more of predicted.
- A new decline of left ventricular ejection fraction to 45% or less.
- New onset of pulmonary arterial hypertension that requires treatment.
If none of these apply, the next step is to assess treatment response by measuring changes in five parameters and then integrating them into a single number using a mathematical formula. The five elements in the equation are:
- Modified Rodnan skin score.
- Percent of predicted forced vital capacity.
- Health Assessment Questionnaire-Disability Index.
- Patient’s global assessment.
- Physician’s global assessment.
When factored together, changes in these five measures determine the probability that the patient responded to the intervention.
One limitation of the CRISS is that it only measures change from baseline, which makes it similar to the ACR 20, Dr. Furst noted. Another useful score would be one that reflects the status of a patient with systemic sclerosis at a specific point in time, a type of disease activity score. Dr. Furst said that he and others active in the systemic sclerosis field would like to develop a method that provides this type of patient assessment. Another addition would be to develop a “minimally clinically important change” in the score, which would make the CRISS more intuitive to understand.
Dr. Furst has received research support from Amgen, Bristol-Myers Squibb, Celgene, Corbus, Genentech-Roche, GlaxoSmithKline, Pfizer, and Novartis.
SOURCE: Furst DE. EULAR 2018. Abstract SP0012.
REPORTING FROM THE EULAR 2018 CONGRESS
Patch-based AF screening boosts diagnosis rate
People at increased risk for atrial fibrillation who wore a screening ECG patch for about 2 weeks had their arrhythmia diagnosis rate boosted by 200%-800% during 4 months of follow-up, compared with conventionally followed adults in a randomized, novel-design trial with more than 2,600 randomized participants.
The patients who wore an ECG patch had a 3.9% rate of atrial fibrillation (AF) diagnosis in the study’s intention-to-treat analysis, and a 5.1% rate in the per protocol analysis that were the coprimary endpoints for the study, compared with rates of 0.9% and 0.6%, respectively, among people followed with usual care and diagnosed with AF based only on clinical findings.
Patients who underwent ECG screening for AF using a patch, compared with those followed with usual care, had more AF diagnoses, greater treatment with anticoagulation over the following year, and increased use of health care resources after 1 year, Steven R. Steinhubl, MD, and his associates reported in JAMA.
The mSToPS (mHealth Screening to Prevent Strokes) trial enrolled adults covered by an Aetna commercial or Medicare health plan who fell into a high-risk group for AF onset: Those aged 75 years or older or with at least one of several specified comorbidities. This identified more than 359,000 eligible insured patients. Dr. Steinhubl and his associates invited more than 100,000 people to participate, of whom 2,659 consented and met further eligibility screens. They randomized these people to either undergo immediate ECG patch screening, or have their screening delayed for 4 months while undergoing clinical follow-up.
The researchers sent two commercially available patches to the 1,366 people randomized to immediate screening, with instructions that they wear one patch for 2 weeks immediately, and wear the second patch for 2 weeks starting 3 months after they removed the first patch. Participants mailed their patches to a central site for analysis. Diagnosis of AF was based on an adjudicated episode of at least 30 seconds, and the researchers alerted participants and their individual physicians about diagnostic positives.
Among the 1,366 immediate patch recipients, a third never wore a patch for at least 30 minutes and were excluded from the per protocol analysis. The 908 patch users from the immediate screening subgroup as well as the patch users from the delayed subgroup wore each patch for an average of nearly 12 days, and about two-thirds wore both assigned patches. People diagnosed with AF had, on average, nearly 10 discrete episodes during screening, with a median episode duration of 186 minutes. The median AF burden among those who screened positive was 0.9%, reported Dr. Steinhubl, a cardiologist and director of digital medicine at the Scripps Translational Science Institute in La Jolla, Calif.
The researchers also compared medical interventions during the year following entry among all 1,738 screened patients (from both the immediate and delayed screening subgroups) and a matched group of 3,476 unscreened people who had consented to participate in the study. This showed that AF screening was linked to a doubled rate of anticoagulant treatment initiation. The ECG patch screening also identified 70 additional people with various other potentially actionable cardiac arrhythmias.
Of the 1,738 people who wore at least one patch for more than 30 minutes, 40 (2%) had skin irritation, 32 stopped using the patch prematurely because of irritation, and 2 people sought medical treatment for their irritation, which involved topical treatment.
mSToPS was funded by Janssen. Dr. Steinhubl has received research funding from Janssen, DynoSense, EasyG, Spry Health, and Striiv.
SOURCE: Steinhubl SR et al. JAMA. 2018 July 10;320[2]:149-55.
The results from mSToPS provide strong support for the use of continuous rhythm monitoring to screen for atrial fibrillation (AF) in at-risk populations, showing a detection rate as high as 5.1% after 4 months in the per protocol analysis. Screening people using a wearable ECG patch for a 2-week interval appears to have detected a substantial proportion of patients who might otherwise be detected with more inconvenient, invasive, costly, or longer monitoring approaches.
Existing epidemiologic and outcomes data support interventions for risk factors and symptoms of AF early in the disease process, but clinical trials demonstrating improved cardiovascular outcomes such as reduced stroke occurrence will be necessary to take action and screen for AF at the population level. Before the findings of mSToPS can be incorporated into clinical practice, clinicians need to consider two major questions about structured AF screening: Does earlier or more sensitive detection of AF improve clinical outcomes? And is this approach cost effective?
Benjamin A. Steinberg, MD , an electrophysiologist at the University of Utah, Salt Lake City, and Jonathan P. Piccini, MD , an electrophysiologist at Duke University, Durham, N.C., made these comments in an accompanying editorial ( JAMA. 2018 Jul 10;320[2]:139-41 ). Dr. Steinberg reported receiving research grants or personal fees from Boston Scientific, Biosense Webster, and Janssen. Dr. Piccini reported consulting with Allergen, Bayer, Johnson & Johnson, Medtronic, Sanofi, and Phillips, and receiving research funding from Abbott, ARCA Biopharma, Boston Scientific, Gilead, Janssen, and Verily.
The results from mSToPS provide strong support for the use of continuous rhythm monitoring to screen for atrial fibrillation (AF) in at-risk populations, showing a detection rate as high as 5.1% after 4 months in the per protocol analysis. Screening people using a wearable ECG patch for a 2-week interval appears to have detected a substantial proportion of patients who might otherwise be detected with more inconvenient, invasive, costly, or longer monitoring approaches.
Existing epidemiologic and outcomes data support interventions for risk factors and symptoms of AF early in the disease process, but clinical trials demonstrating improved cardiovascular outcomes such as reduced stroke occurrence will be necessary to take action and screen for AF at the population level. Before the findings of mSToPS can be incorporated into clinical practice, clinicians need to consider two major questions about structured AF screening: Does earlier or more sensitive detection of AF improve clinical outcomes? And is this approach cost effective?
Benjamin A. Steinberg, MD , an electrophysiologist at the University of Utah, Salt Lake City, and Jonathan P. Piccini, MD , an electrophysiologist at Duke University, Durham, N.C., made these comments in an accompanying editorial ( JAMA. 2018 Jul 10;320[2]:139-41 ). Dr. Steinberg reported receiving research grants or personal fees from Boston Scientific, Biosense Webster, and Janssen. Dr. Piccini reported consulting with Allergen, Bayer, Johnson & Johnson, Medtronic, Sanofi, and Phillips, and receiving research funding from Abbott, ARCA Biopharma, Boston Scientific, Gilead, Janssen, and Verily.
The results from mSToPS provide strong support for the use of continuous rhythm monitoring to screen for atrial fibrillation (AF) in at-risk populations, showing a detection rate as high as 5.1% after 4 months in the per protocol analysis. Screening people using a wearable ECG patch for a 2-week interval appears to have detected a substantial proportion of patients who might otherwise be detected with more inconvenient, invasive, costly, or longer monitoring approaches.
Existing epidemiologic and outcomes data support interventions for risk factors and symptoms of AF early in the disease process, but clinical trials demonstrating improved cardiovascular outcomes such as reduced stroke occurrence will be necessary to take action and screen for AF at the population level. Before the findings of mSToPS can be incorporated into clinical practice, clinicians need to consider two major questions about structured AF screening: Does earlier or more sensitive detection of AF improve clinical outcomes? And is this approach cost effective?
Benjamin A. Steinberg, MD , an electrophysiologist at the University of Utah, Salt Lake City, and Jonathan P. Piccini, MD , an electrophysiologist at Duke University, Durham, N.C., made these comments in an accompanying editorial ( JAMA. 2018 Jul 10;320[2]:139-41 ). Dr. Steinberg reported receiving research grants or personal fees from Boston Scientific, Biosense Webster, and Janssen. Dr. Piccini reported consulting with Allergen, Bayer, Johnson & Johnson, Medtronic, Sanofi, and Phillips, and receiving research funding from Abbott, ARCA Biopharma, Boston Scientific, Gilead, Janssen, and Verily.
People at increased risk for atrial fibrillation who wore a screening ECG patch for about 2 weeks had their arrhythmia diagnosis rate boosted by 200%-800% during 4 months of follow-up, compared with conventionally followed adults in a randomized, novel-design trial with more than 2,600 randomized participants.
The patients who wore an ECG patch had a 3.9% rate of atrial fibrillation (AF) diagnosis in the study’s intention-to-treat analysis, and a 5.1% rate in the per protocol analysis that were the coprimary endpoints for the study, compared with rates of 0.9% and 0.6%, respectively, among people followed with usual care and diagnosed with AF based only on clinical findings.
Patients who underwent ECG screening for AF using a patch, compared with those followed with usual care, had more AF diagnoses, greater treatment with anticoagulation over the following year, and increased use of health care resources after 1 year, Steven R. Steinhubl, MD, and his associates reported in JAMA.
The mSToPS (mHealth Screening to Prevent Strokes) trial enrolled adults covered by an Aetna commercial or Medicare health plan who fell into a high-risk group for AF onset: Those aged 75 years or older or with at least one of several specified comorbidities. This identified more than 359,000 eligible insured patients. Dr. Steinhubl and his associates invited more than 100,000 people to participate, of whom 2,659 consented and met further eligibility screens. They randomized these people to either undergo immediate ECG patch screening, or have their screening delayed for 4 months while undergoing clinical follow-up.
The researchers sent two commercially available patches to the 1,366 people randomized to immediate screening, with instructions that they wear one patch for 2 weeks immediately, and wear the second patch for 2 weeks starting 3 months after they removed the first patch. Participants mailed their patches to a central site for analysis. Diagnosis of AF was based on an adjudicated episode of at least 30 seconds, and the researchers alerted participants and their individual physicians about diagnostic positives.
Among the 1,366 immediate patch recipients, a third never wore a patch for at least 30 minutes and were excluded from the per protocol analysis. The 908 patch users from the immediate screening subgroup as well as the patch users from the delayed subgroup wore each patch for an average of nearly 12 days, and about two-thirds wore both assigned patches. People diagnosed with AF had, on average, nearly 10 discrete episodes during screening, with a median episode duration of 186 minutes. The median AF burden among those who screened positive was 0.9%, reported Dr. Steinhubl, a cardiologist and director of digital medicine at the Scripps Translational Science Institute in La Jolla, Calif.
The researchers also compared medical interventions during the year following entry among all 1,738 screened patients (from both the immediate and delayed screening subgroups) and a matched group of 3,476 unscreened people who had consented to participate in the study. This showed that AF screening was linked to a doubled rate of anticoagulant treatment initiation. The ECG patch screening also identified 70 additional people with various other potentially actionable cardiac arrhythmias.
Of the 1,738 people who wore at least one patch for more than 30 minutes, 40 (2%) had skin irritation, 32 stopped using the patch prematurely because of irritation, and 2 people sought medical treatment for their irritation, which involved topical treatment.
mSToPS was funded by Janssen. Dr. Steinhubl has received research funding from Janssen, DynoSense, EasyG, Spry Health, and Striiv.
SOURCE: Steinhubl SR et al. JAMA. 2018 July 10;320[2]:149-55.
People at increased risk for atrial fibrillation who wore a screening ECG patch for about 2 weeks had their arrhythmia diagnosis rate boosted by 200%-800% during 4 months of follow-up, compared with conventionally followed adults in a randomized, novel-design trial with more than 2,600 randomized participants.
The patients who wore an ECG patch had a 3.9% rate of atrial fibrillation (AF) diagnosis in the study’s intention-to-treat analysis, and a 5.1% rate in the per protocol analysis that were the coprimary endpoints for the study, compared with rates of 0.9% and 0.6%, respectively, among people followed with usual care and diagnosed with AF based only on clinical findings.
Patients who underwent ECG screening for AF using a patch, compared with those followed with usual care, had more AF diagnoses, greater treatment with anticoagulation over the following year, and increased use of health care resources after 1 year, Steven R. Steinhubl, MD, and his associates reported in JAMA.
The mSToPS (mHealth Screening to Prevent Strokes) trial enrolled adults covered by an Aetna commercial or Medicare health plan who fell into a high-risk group for AF onset: Those aged 75 years or older or with at least one of several specified comorbidities. This identified more than 359,000 eligible insured patients. Dr. Steinhubl and his associates invited more than 100,000 people to participate, of whom 2,659 consented and met further eligibility screens. They randomized these people to either undergo immediate ECG patch screening, or have their screening delayed for 4 months while undergoing clinical follow-up.
The researchers sent two commercially available patches to the 1,366 people randomized to immediate screening, with instructions that they wear one patch for 2 weeks immediately, and wear the second patch for 2 weeks starting 3 months after they removed the first patch. Participants mailed their patches to a central site for analysis. Diagnosis of AF was based on an adjudicated episode of at least 30 seconds, and the researchers alerted participants and their individual physicians about diagnostic positives.
Among the 1,366 immediate patch recipients, a third never wore a patch for at least 30 minutes and were excluded from the per protocol analysis. The 908 patch users from the immediate screening subgroup as well as the patch users from the delayed subgroup wore each patch for an average of nearly 12 days, and about two-thirds wore both assigned patches. People diagnosed with AF had, on average, nearly 10 discrete episodes during screening, with a median episode duration of 186 minutes. The median AF burden among those who screened positive was 0.9%, reported Dr. Steinhubl, a cardiologist and director of digital medicine at the Scripps Translational Science Institute in La Jolla, Calif.
The researchers also compared medical interventions during the year following entry among all 1,738 screened patients (from both the immediate and delayed screening subgroups) and a matched group of 3,476 unscreened people who had consented to participate in the study. This showed that AF screening was linked to a doubled rate of anticoagulant treatment initiation. The ECG patch screening also identified 70 additional people with various other potentially actionable cardiac arrhythmias.
Of the 1,738 people who wore at least one patch for more than 30 minutes, 40 (2%) had skin irritation, 32 stopped using the patch prematurely because of irritation, and 2 people sought medical treatment for their irritation, which involved topical treatment.
mSToPS was funded by Janssen. Dr. Steinhubl has received research funding from Janssen, DynoSense, EasyG, Spry Health, and Striiv.
SOURCE: Steinhubl SR et al. JAMA. 2018 July 10;320[2]:149-55.
FROM JAMA
Key clinical point: An ECG patch detected atrial fibrillation in high-risk people 200%-800% more often than clinical diagnosis.
Major finding: ECG patches identified a 3.9% incidence of atrial fibrillation during 4 months, compared with a 0.9% rate using clinical diagnoses.
Study details: A randomized trial with 2,659 people at high risk for incident atrial fibrillation.
Disclosures: mSToPS was funded by Janssen. Dr. Steinhubl has received research funding from Janssen, DynoSense, EasyG, Spry Health, and Striiv.
Source: Steinhubl SR et al. JAMA. 2018 Jul 10;320[2]:149-55.