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Insurer denials of DAA therapy for HCV on the rise
About one in three patients had lack of fill approval by insurers, contributing to a continued lack of access to hepatitis C virus (HCV) therapy across insurance types, despite availability of new, highly effective regimens and relaxation of restrictions on reimbursement, according to Charitha Gowda, MD, of Ohio State University, Columbus, and her coauthors.
“To achieve the goal of HCV elimination, access to antiviral treatment must be improved,” they wrote.
The study by Dr. Gowda and colleagues included 9,025 patients in 45 states who had a DAA prescription submitted to one large, independent pharmacy provider between January 2016 and April 2017. Of those patients, most (4,702) were covered by Medicaid, while 2,502 were covered commercially, and 1,821 were covered by Medicare.
Over the 16-month study period, 3,200 patients (35.5%) had an absolute denial of treatment, defined as lack of fill approval by the insurer.
Absolute denials were significantly more frequent in patients with commercial insurance (52.4%), as compared with Medicaid (34.5%) and Medicare (14.7%).
Absolute denials increased significantly over the 16-month study period, from 27.7% in the first quarter evaluated to 43.8% in the last, researchers noted, adding that each insurance type had a significant increase in absolute denials over time.
While DAAs are associated with very high cure rates, their high costs have led to restrictions to access by both private and public insurers. However, over the past few years, restrictions in DAA reimbursement have been relaxed in a variety of settings because of advocacy efforts, greater price competition, and class action lawsuits/threats of legal action, Dr. Gowda and colleagues noted.
“The reason for this higher than expected denial rate is unclear, but may be due to attempts to treat chronic HCV-infected patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist,” Dr. Gowda and colleagues wrote in their report.
The study was supported by the Penn Center for AIDS Research and the National Institutes of Health. Dr. Gowda had no conflicts of interest to report. Two coauthors reported grant support and/or advisory board fees from Gilead.
SOURCE: Gowda C et al. Open Forum Infect Dis. 2018 Jun 7 doi: 10.1093/ofid/ofy076.
About one in three patients had lack of fill approval by insurers, contributing to a continued lack of access to hepatitis C virus (HCV) therapy across insurance types, despite availability of new, highly effective regimens and relaxation of restrictions on reimbursement, according to Charitha Gowda, MD, of Ohio State University, Columbus, and her coauthors.
“To achieve the goal of HCV elimination, access to antiviral treatment must be improved,” they wrote.
The study by Dr. Gowda and colleagues included 9,025 patients in 45 states who had a DAA prescription submitted to one large, independent pharmacy provider between January 2016 and April 2017. Of those patients, most (4,702) were covered by Medicaid, while 2,502 were covered commercially, and 1,821 were covered by Medicare.
Over the 16-month study period, 3,200 patients (35.5%) had an absolute denial of treatment, defined as lack of fill approval by the insurer.
Absolute denials were significantly more frequent in patients with commercial insurance (52.4%), as compared with Medicaid (34.5%) and Medicare (14.7%).
Absolute denials increased significantly over the 16-month study period, from 27.7% in the first quarter evaluated to 43.8% in the last, researchers noted, adding that each insurance type had a significant increase in absolute denials over time.
While DAAs are associated with very high cure rates, their high costs have led to restrictions to access by both private and public insurers. However, over the past few years, restrictions in DAA reimbursement have been relaxed in a variety of settings because of advocacy efforts, greater price competition, and class action lawsuits/threats of legal action, Dr. Gowda and colleagues noted.
“The reason for this higher than expected denial rate is unclear, but may be due to attempts to treat chronic HCV-infected patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist,” Dr. Gowda and colleagues wrote in their report.
The study was supported by the Penn Center for AIDS Research and the National Institutes of Health. Dr. Gowda had no conflicts of interest to report. Two coauthors reported grant support and/or advisory board fees from Gilead.
SOURCE: Gowda C et al. Open Forum Infect Dis. 2018 Jun 7 doi: 10.1093/ofid/ofy076.
About one in three patients had lack of fill approval by insurers, contributing to a continued lack of access to hepatitis C virus (HCV) therapy across insurance types, despite availability of new, highly effective regimens and relaxation of restrictions on reimbursement, according to Charitha Gowda, MD, of Ohio State University, Columbus, and her coauthors.
“To achieve the goal of HCV elimination, access to antiviral treatment must be improved,” they wrote.
The study by Dr. Gowda and colleagues included 9,025 patients in 45 states who had a DAA prescription submitted to one large, independent pharmacy provider between January 2016 and April 2017. Of those patients, most (4,702) were covered by Medicaid, while 2,502 were covered commercially, and 1,821 were covered by Medicare.
Over the 16-month study period, 3,200 patients (35.5%) had an absolute denial of treatment, defined as lack of fill approval by the insurer.
Absolute denials were significantly more frequent in patients with commercial insurance (52.4%), as compared with Medicaid (34.5%) and Medicare (14.7%).
Absolute denials increased significantly over the 16-month study period, from 27.7% in the first quarter evaluated to 43.8% in the last, researchers noted, adding that each insurance type had a significant increase in absolute denials over time.
While DAAs are associated with very high cure rates, their high costs have led to restrictions to access by both private and public insurers. However, over the past few years, restrictions in DAA reimbursement have been relaxed in a variety of settings because of advocacy efforts, greater price competition, and class action lawsuits/threats of legal action, Dr. Gowda and colleagues noted.
“The reason for this higher than expected denial rate is unclear, but may be due to attempts to treat chronic HCV-infected patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist,” Dr. Gowda and colleagues wrote in their report.
The study was supported by the Penn Center for AIDS Research and the National Institutes of Health. Dr. Gowda had no conflicts of interest to report. Two coauthors reported grant support and/or advisory board fees from Gilead.
SOURCE: Gowda C et al. Open Forum Infect Dis. 2018 Jun 7 doi: 10.1093/ofid/ofy076.
FROM OPEN FORUM INFECTIOUS DISEASES
Key clinical point: Insurance denials of direct-acting antiviral (DAA) prescriptions have increased over time, contrary to expectations.
Major finding: A total of 35.5% of patients had an absolute denial of treatment, defined as lack of fill approval by the insurer.
Study details: A cohort study including 9,025 patients who had a DAA prescription submitted to a national specialty pharmacy between January 2016 and April 2017.
Disclosures: The study was supported by the Penn Center for AIDS Research and the National Institutes of Health. Two coauthors reported grant support and/or advisory board fees from Gilead.
Source: Gowda C et al. Open Forum Infect Dis. 2018 Jun 7.
Tenapanor shows safety, efficacy for irritable bowel syndrome
WASHINGTON –
These data combined with results from an already reported additional phase 3 trial and a phase 2 study will go to the Food and Drug Administration later in 2018 in an application for marketing approval for tenapanor, William D. Chey, MD, said at the annual Digestive Disease Week.®
“Tenapanor may represent a novel, effective treatment option” for patients with constipation-predominant irritable bowel syndrome (IBS-C), said Dr. Chey, a professor of medicine and director of the GI Physiology Laboratory at the University of Michigan in Ann Arbor.
The study results met the trial’s primary endpoint, the percentage of patients with a combined response consisting of at least a 30% drop from baseline in reported abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week for 6 of the first 12 weeks of treatment. This combined response occurred in 37% of patients treated with tenapanor at a dosage of 50 mg orally b.i.d., compared with a 24% rate among the placebo-control patients, a statistically significant difference, Dr. Chey reported.
The most common adverse effect seen in the tenapanor-treated patients was diarrhea, which occurred in 16% of the drug-treated patients and in 4% of controls. “I think diarrhea is an expected adverse effect,” Dr. Chey said. Overall, treatment-related adverse effects occurred in 23% of tenapanor-treated patients and in 9% of controls, serious adverse effects occurred in 4% of patients on tenapanor and in 3% of controls, and adverse effects leading to treatment discontinuation occurred in 8% on tenapanor and in 1% of controls. Aside from diarrhea, the other most common adverse effects linked with tenapanor treatment were abdominal distension, in 3%, and flatulence, also in 3%.
Tenapanor is an inhibitor of sodium/hydrogen exchanger isoform 3, the predominant intestinal sodium transporter. Through this inhibition tenapanor reduces sodium uptake in the gut, causing increased intestinal fluid volume and shorter transit time and thereby softening stool consistency and increasing bowel movement frequency. Dr. Chey and his colleagues previously reported results from a phase 2 study of tenapanor (Am J Gastroenterol. 2017 Feb;112[2]:763-74), and from a phase 3 study with 606 patients reported at a meeting in late 2017. Results from these two studies were similar to those from the new study.
The current study, A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C (T3MPO-2) enrolled 593 patients at 114 U.S. centers. Enrolled patients met the Rome III criteria for IBS-C and had an average CSMB frequency of less than 3/week. The researchers treated and followed patients for 26 weeks, although the primary endpoint occurred after 12 weeks on treatment, and 481 of the enrolled patients remained in the study through 26 weeks. At baseline, patients had an average of 0.12 CSBM/week and an average abdominal pain score of 6.26, indicative of moderate to severe abdominal pain. These characteristics identified the enrolled patients as being “on the more severe spectrum of what we see in clinical practice,” Dr. Chey noted.
Secondary endpoints included the combined endpoint with the target rate of CSBM achieved in at least 9 of the first 12 weeks, 18% on the active drug and 5% on placebo, and in at least 13 of the 26 weeks on treatment, 36% on tenapanor and 24% on placebo. After 26 weeks on treatment, 55% of patients on tenapanor rated themselves as quite satisfied or very satisfied with their treatment, compared with 33% of the placebo-control patients.
T3MPO-2 was funded by Ardelyx, the company developing tenapanor. Dr. Chey has been a consultant to and has received research funding from Ardelyx and from several other companies. A coauthor on the study was an Ardelyx employee.
[email protected]
On Twitter @mitchelzoler
WASHINGTON –
These data combined with results from an already reported additional phase 3 trial and a phase 2 study will go to the Food and Drug Administration later in 2018 in an application for marketing approval for tenapanor, William D. Chey, MD, said at the annual Digestive Disease Week.®
“Tenapanor may represent a novel, effective treatment option” for patients with constipation-predominant irritable bowel syndrome (IBS-C), said Dr. Chey, a professor of medicine and director of the GI Physiology Laboratory at the University of Michigan in Ann Arbor.
The study results met the trial’s primary endpoint, the percentage of patients with a combined response consisting of at least a 30% drop from baseline in reported abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week for 6 of the first 12 weeks of treatment. This combined response occurred in 37% of patients treated with tenapanor at a dosage of 50 mg orally b.i.d., compared with a 24% rate among the placebo-control patients, a statistically significant difference, Dr. Chey reported.
The most common adverse effect seen in the tenapanor-treated patients was diarrhea, which occurred in 16% of the drug-treated patients and in 4% of controls. “I think diarrhea is an expected adverse effect,” Dr. Chey said. Overall, treatment-related adverse effects occurred in 23% of tenapanor-treated patients and in 9% of controls, serious adverse effects occurred in 4% of patients on tenapanor and in 3% of controls, and adverse effects leading to treatment discontinuation occurred in 8% on tenapanor and in 1% of controls. Aside from diarrhea, the other most common adverse effects linked with tenapanor treatment were abdominal distension, in 3%, and flatulence, also in 3%.
Tenapanor is an inhibitor of sodium/hydrogen exchanger isoform 3, the predominant intestinal sodium transporter. Through this inhibition tenapanor reduces sodium uptake in the gut, causing increased intestinal fluid volume and shorter transit time and thereby softening stool consistency and increasing bowel movement frequency. Dr. Chey and his colleagues previously reported results from a phase 2 study of tenapanor (Am J Gastroenterol. 2017 Feb;112[2]:763-74), and from a phase 3 study with 606 patients reported at a meeting in late 2017. Results from these two studies were similar to those from the new study.
The current study, A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C (T3MPO-2) enrolled 593 patients at 114 U.S. centers. Enrolled patients met the Rome III criteria for IBS-C and had an average CSMB frequency of less than 3/week. The researchers treated and followed patients for 26 weeks, although the primary endpoint occurred after 12 weeks on treatment, and 481 of the enrolled patients remained in the study through 26 weeks. At baseline, patients had an average of 0.12 CSBM/week and an average abdominal pain score of 6.26, indicative of moderate to severe abdominal pain. These characteristics identified the enrolled patients as being “on the more severe spectrum of what we see in clinical practice,” Dr. Chey noted.
Secondary endpoints included the combined endpoint with the target rate of CSBM achieved in at least 9 of the first 12 weeks, 18% on the active drug and 5% on placebo, and in at least 13 of the 26 weeks on treatment, 36% on tenapanor and 24% on placebo. After 26 weeks on treatment, 55% of patients on tenapanor rated themselves as quite satisfied or very satisfied with their treatment, compared with 33% of the placebo-control patients.
T3MPO-2 was funded by Ardelyx, the company developing tenapanor. Dr. Chey has been a consultant to and has received research funding from Ardelyx and from several other companies. A coauthor on the study was an Ardelyx employee.
[email protected]
On Twitter @mitchelzoler
WASHINGTON –
These data combined with results from an already reported additional phase 3 trial and a phase 2 study will go to the Food and Drug Administration later in 2018 in an application for marketing approval for tenapanor, William D. Chey, MD, said at the annual Digestive Disease Week.®
“Tenapanor may represent a novel, effective treatment option” for patients with constipation-predominant irritable bowel syndrome (IBS-C), said Dr. Chey, a professor of medicine and director of the GI Physiology Laboratory at the University of Michigan in Ann Arbor.
The study results met the trial’s primary endpoint, the percentage of patients with a combined response consisting of at least a 30% drop from baseline in reported abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week for 6 of the first 12 weeks of treatment. This combined response occurred in 37% of patients treated with tenapanor at a dosage of 50 mg orally b.i.d., compared with a 24% rate among the placebo-control patients, a statistically significant difference, Dr. Chey reported.
The most common adverse effect seen in the tenapanor-treated patients was diarrhea, which occurred in 16% of the drug-treated patients and in 4% of controls. “I think diarrhea is an expected adverse effect,” Dr. Chey said. Overall, treatment-related adverse effects occurred in 23% of tenapanor-treated patients and in 9% of controls, serious adverse effects occurred in 4% of patients on tenapanor and in 3% of controls, and adverse effects leading to treatment discontinuation occurred in 8% on tenapanor and in 1% of controls. Aside from diarrhea, the other most common adverse effects linked with tenapanor treatment were abdominal distension, in 3%, and flatulence, also in 3%.
Tenapanor is an inhibitor of sodium/hydrogen exchanger isoform 3, the predominant intestinal sodium transporter. Through this inhibition tenapanor reduces sodium uptake in the gut, causing increased intestinal fluid volume and shorter transit time and thereby softening stool consistency and increasing bowel movement frequency. Dr. Chey and his colleagues previously reported results from a phase 2 study of tenapanor (Am J Gastroenterol. 2017 Feb;112[2]:763-74), and from a phase 3 study with 606 patients reported at a meeting in late 2017. Results from these two studies were similar to those from the new study.
The current study, A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C (T3MPO-2) enrolled 593 patients at 114 U.S. centers. Enrolled patients met the Rome III criteria for IBS-C and had an average CSMB frequency of less than 3/week. The researchers treated and followed patients for 26 weeks, although the primary endpoint occurred after 12 weeks on treatment, and 481 of the enrolled patients remained in the study through 26 weeks. At baseline, patients had an average of 0.12 CSBM/week and an average abdominal pain score of 6.26, indicative of moderate to severe abdominal pain. These characteristics identified the enrolled patients as being “on the more severe spectrum of what we see in clinical practice,” Dr. Chey noted.
Secondary endpoints included the combined endpoint with the target rate of CSBM achieved in at least 9 of the first 12 weeks, 18% on the active drug and 5% on placebo, and in at least 13 of the 26 weeks on treatment, 36% on tenapanor and 24% on placebo. After 26 weeks on treatment, 55% of patients on tenapanor rated themselves as quite satisfied or very satisfied with their treatment, compared with 33% of the placebo-control patients.
T3MPO-2 was funded by Ardelyx, the company developing tenapanor. Dr. Chey has been a consultant to and has received research funding from Ardelyx and from several other companies. A coauthor on the study was an Ardelyx employee.
[email protected]
On Twitter @mitchelzoler
REPORTING FROM DDW 2018
Key clinical point: New drug shows safety and efficacy for irritable bowel syndrome.
Major finding: The combined primary endpoint occurred in 37% of tenapanor-treated patients and in 24% of patients on placebo.
Study details: T3MPO-2, a multicenter U.S. trial with 593 patients.
Disclosures: T3MPO-2 was funded by Ardelyx, the company developing tenapanor. Dr. Chey has been a consultant to and has received research funding from Ardelyx and from several other companies. A coauthor on the study was an Ardelyx employee.
More Smoke-Free Campuses, Not Enough Screening and Counseling
People with mental and/or substance abuse disorders are more than twice as likely to smoke cigarettes as people without those disorders, and are more likely to die of a smoking-related illness than from a behavioral health condition. Yet many people are not screened for tobacco use in behavioral health facilities. According to the Centers for Disease Control and Prevention (CDC) and Substance Abuse and Mental Health Services Administration (SAMHSA), in 2016, only half of mental health treatment facilities and 64% of substance abuse treatment facilities reported screening patients for tobacco use.
Even fewer facilities provide counseling and treatments. Only 38% of mental health facilities offer tobacco cessation counseling, 25% offer nicotine replacement therapy (NRT), and 22% offer non-nicotine cessation medications. Of substance abuse treatment facilities, 47% offer tobacco cessation counseling, 26% offer NRT, and 20% offer non-nicotine cessation medications. Oklahoma and New York had the highest percentage of programs.
On the other hand, 49% of mental health and 33% of substance abuse treatment facilities now have smoke-free campuses in the 50 states, Washington DC, and Puerto Rico. That number varies by state, ranging from 20% of mental health facilities in Idaho to 78% in Oklahoma, and 10% of substance abuse treatment facilities in Idaho to 83% in New York.
Practical steps can boost the availability of smoking cessation screening and programs. The CDC recommends integrating screening and treatment protocols into workflows and electronic health record systems. The CDC also advises providing outreach to behavioral health providers who reinforce the message that patients can benefit from evidence-based cessation treatment.
The report is based on data from the 2016 National Mental Health Services Survey and the 2016 National Survey of Substance Abuse Treatment Services.
People with mental and/or substance abuse disorders are more than twice as likely to smoke cigarettes as people without those disorders, and are more likely to die of a smoking-related illness than from a behavioral health condition. Yet many people are not screened for tobacco use in behavioral health facilities. According to the Centers for Disease Control and Prevention (CDC) and Substance Abuse and Mental Health Services Administration (SAMHSA), in 2016, only half of mental health treatment facilities and 64% of substance abuse treatment facilities reported screening patients for tobacco use.
Even fewer facilities provide counseling and treatments. Only 38% of mental health facilities offer tobacco cessation counseling, 25% offer nicotine replacement therapy (NRT), and 22% offer non-nicotine cessation medications. Of substance abuse treatment facilities, 47% offer tobacco cessation counseling, 26% offer NRT, and 20% offer non-nicotine cessation medications. Oklahoma and New York had the highest percentage of programs.
On the other hand, 49% of mental health and 33% of substance abuse treatment facilities now have smoke-free campuses in the 50 states, Washington DC, and Puerto Rico. That number varies by state, ranging from 20% of mental health facilities in Idaho to 78% in Oklahoma, and 10% of substance abuse treatment facilities in Idaho to 83% in New York.
Practical steps can boost the availability of smoking cessation screening and programs. The CDC recommends integrating screening and treatment protocols into workflows and electronic health record systems. The CDC also advises providing outreach to behavioral health providers who reinforce the message that patients can benefit from evidence-based cessation treatment.
The report is based on data from the 2016 National Mental Health Services Survey and the 2016 National Survey of Substance Abuse Treatment Services.
People with mental and/or substance abuse disorders are more than twice as likely to smoke cigarettes as people without those disorders, and are more likely to die of a smoking-related illness than from a behavioral health condition. Yet many people are not screened for tobacco use in behavioral health facilities. According to the Centers for Disease Control and Prevention (CDC) and Substance Abuse and Mental Health Services Administration (SAMHSA), in 2016, only half of mental health treatment facilities and 64% of substance abuse treatment facilities reported screening patients for tobacco use.
Even fewer facilities provide counseling and treatments. Only 38% of mental health facilities offer tobacco cessation counseling, 25% offer nicotine replacement therapy (NRT), and 22% offer non-nicotine cessation medications. Of substance abuse treatment facilities, 47% offer tobacco cessation counseling, 26% offer NRT, and 20% offer non-nicotine cessation medications. Oklahoma and New York had the highest percentage of programs.
On the other hand, 49% of mental health and 33% of substance abuse treatment facilities now have smoke-free campuses in the 50 states, Washington DC, and Puerto Rico. That number varies by state, ranging from 20% of mental health facilities in Idaho to 78% in Oklahoma, and 10% of substance abuse treatment facilities in Idaho to 83% in New York.
Practical steps can boost the availability of smoking cessation screening and programs. The CDC recommends integrating screening and treatment protocols into workflows and electronic health record systems. The CDC also advises providing outreach to behavioral health providers who reinforce the message that patients can benefit from evidence-based cessation treatment.
The report is based on data from the 2016 National Mental Health Services Survey and the 2016 National Survey of Substance Abuse Treatment Services.
Depression follows job loss after acute MI
Patients who experienced adverse changes in employment status after acute myocardial infarction (AMI) reported increased depression and lower quality of life, according to results published June 12 in Circulation: Cardiovascular Quality and Outcomes.
At 1-year follow-up, 27.4% of patients with adverse employment change scored high on measures of depression, compared with 16.7% of patients who did not experience a change in status. These patients also reported lower health status and difficulty affording medications, wrote Haider J. Warraich, MD, a cardiologist at Duke University in Durham, N.C., and coauthors.
Baseline data were collected for all patients according to CathPCI Registry standards, and follow-up was conducted via telephone 6 weeks, 6 months, 1 year, and 15 months after discharge. After 1 year, patients who reported working full or part time were defined as working. Adverse change in employment was defined as those who “reported working immediately before the index MI hospitalization but were either no longer working or working fewer hours,” Dr. Warraich and his colleagues reported.
Depression was defined by a Patient Health Questionnaire (PHQ) score greater than 3. Health status was assessed using the EuroQoL-5 Dimensions (EQ-5D) visual analog scale. Medication adherence was assessed using three questions at the follow-up interview, and patients were also asked to rank the financial hardship of their monthly medication costs on a scale of 1-5.
Among patients working at baseline, 492 (10%) reported an adverse change in employment after a year. Of these, 349 (7%) were no longer working, and 143 (3%) were working less than before. Of those with an adverse change in employment, 172 reported involuntary job loss such as being laid off or no longer working due to health concerns. Just 27 patients reported retirement.
The number of readmissions within the first year was the factor most strongly associated with adverse change in employment. Baseline smoking status, hypertension, and postdischarge bleeding were also significantly associated with adverse change in employment, the authors said.
At 1 year follow-up, patients with an adverse change in employment were more likely than those with no change to report depression (27.4% with PHQ score greater than 3, compared with 16.7% in the no-change group). These patients also reported lower health status (mean EuroQoL score of 73 compared with 78) and moderate to extreme financial hardship with medication costs (41.0% compared with 28.4%), though there was no difference in medication adherence, the authors reported.
The results indicate that, although job loss in acute MI patients has dropped in comparison with previous studies, patients who experience an adverse change in employment are still “at increased risk of depression, lower quality of life, and increased financial hardship with medication costs compared with those who continue working,” the authors wrote.
“These results underscore the need for interventions to address this patient-centered outcome and its health impact,” they concluded.
Daiichi Sankyo and Lilly USA funded TRANSLATE-ACS. This analysis was funded in part by a grant from the National Heart, Lung, and Blood Institute.
SOURCE: Warraich H et al. Circ Cardiovasc Qual Outcomes. 2018 Jun 12. doi: 10.1161/circoutcomes.117.004528.
The results of this study are promising, as previous research has shown up to 51% adverse change in employment status at 1-year follow-up.
Nevertheless, the rate of work loss reported in this study requires continued improvements to patient-centered care. Providing such care requires a shift that recognizes that the success of treatments is dependent on patients not only adhering to treatments but also actively engaging in their own self-care.
The U.S. workforce is aging, with a 72% increase since 2000 in the number of workers 55 years and older. Nearly half the workforce is female, and racial and ethnic minority groups make up 25% of it. These same populations experience poorer cardiovascular outcomes after AMI, highlighting the importance of incorporating patient preferences about return to work and continued employment into patient care planning.
Moving forward, future work is required to understand the barriers to successful return to work for these patients. The need for interventions that support successful return to work requires continued attention by researchers and clinicians.
Rachel P. Dreyer, PhD, of Yale University in New Haven, Conn., and Victoria Vaughan Dickson, PhD, of New York University, made these comments in an editorial published with the study (Circ Cardiovasc Qual Outcomes. 2018 Jun 12. doi: 10.1161/circoutcomes.118.004806.)
The results of this study are promising, as previous research has shown up to 51% adverse change in employment status at 1-year follow-up.
Nevertheless, the rate of work loss reported in this study requires continued improvements to patient-centered care. Providing such care requires a shift that recognizes that the success of treatments is dependent on patients not only adhering to treatments but also actively engaging in their own self-care.
The U.S. workforce is aging, with a 72% increase since 2000 in the number of workers 55 years and older. Nearly half the workforce is female, and racial and ethnic minority groups make up 25% of it. These same populations experience poorer cardiovascular outcomes after AMI, highlighting the importance of incorporating patient preferences about return to work and continued employment into patient care planning.
Moving forward, future work is required to understand the barriers to successful return to work for these patients. The need for interventions that support successful return to work requires continued attention by researchers and clinicians.
Rachel P. Dreyer, PhD, of Yale University in New Haven, Conn., and Victoria Vaughan Dickson, PhD, of New York University, made these comments in an editorial published with the study (Circ Cardiovasc Qual Outcomes. 2018 Jun 12. doi: 10.1161/circoutcomes.118.004806.)
The results of this study are promising, as previous research has shown up to 51% adverse change in employment status at 1-year follow-up.
Nevertheless, the rate of work loss reported in this study requires continued improvements to patient-centered care. Providing such care requires a shift that recognizes that the success of treatments is dependent on patients not only adhering to treatments but also actively engaging in their own self-care.
The U.S. workforce is aging, with a 72% increase since 2000 in the number of workers 55 years and older. Nearly half the workforce is female, and racial and ethnic minority groups make up 25% of it. These same populations experience poorer cardiovascular outcomes after AMI, highlighting the importance of incorporating patient preferences about return to work and continued employment into patient care planning.
Moving forward, future work is required to understand the barriers to successful return to work for these patients. The need for interventions that support successful return to work requires continued attention by researchers and clinicians.
Rachel P. Dreyer, PhD, of Yale University in New Haven, Conn., and Victoria Vaughan Dickson, PhD, of New York University, made these comments in an editorial published with the study (Circ Cardiovasc Qual Outcomes. 2018 Jun 12. doi: 10.1161/circoutcomes.118.004806.)
Patients who experienced adverse changes in employment status after acute myocardial infarction (AMI) reported increased depression and lower quality of life, according to results published June 12 in Circulation: Cardiovascular Quality and Outcomes.
At 1-year follow-up, 27.4% of patients with adverse employment change scored high on measures of depression, compared with 16.7% of patients who did not experience a change in status. These patients also reported lower health status and difficulty affording medications, wrote Haider J. Warraich, MD, a cardiologist at Duke University in Durham, N.C., and coauthors.
Baseline data were collected for all patients according to CathPCI Registry standards, and follow-up was conducted via telephone 6 weeks, 6 months, 1 year, and 15 months after discharge. After 1 year, patients who reported working full or part time were defined as working. Adverse change in employment was defined as those who “reported working immediately before the index MI hospitalization but were either no longer working or working fewer hours,” Dr. Warraich and his colleagues reported.
Depression was defined by a Patient Health Questionnaire (PHQ) score greater than 3. Health status was assessed using the EuroQoL-5 Dimensions (EQ-5D) visual analog scale. Medication adherence was assessed using three questions at the follow-up interview, and patients were also asked to rank the financial hardship of their monthly medication costs on a scale of 1-5.
Among patients working at baseline, 492 (10%) reported an adverse change in employment after a year. Of these, 349 (7%) were no longer working, and 143 (3%) were working less than before. Of those with an adverse change in employment, 172 reported involuntary job loss such as being laid off or no longer working due to health concerns. Just 27 patients reported retirement.
The number of readmissions within the first year was the factor most strongly associated with adverse change in employment. Baseline smoking status, hypertension, and postdischarge bleeding were also significantly associated with adverse change in employment, the authors said.
At 1 year follow-up, patients with an adverse change in employment were more likely than those with no change to report depression (27.4% with PHQ score greater than 3, compared with 16.7% in the no-change group). These patients also reported lower health status (mean EuroQoL score of 73 compared with 78) and moderate to extreme financial hardship with medication costs (41.0% compared with 28.4%), though there was no difference in medication adherence, the authors reported.
The results indicate that, although job loss in acute MI patients has dropped in comparison with previous studies, patients who experience an adverse change in employment are still “at increased risk of depression, lower quality of life, and increased financial hardship with medication costs compared with those who continue working,” the authors wrote.
“These results underscore the need for interventions to address this patient-centered outcome and its health impact,” they concluded.
Daiichi Sankyo and Lilly USA funded TRANSLATE-ACS. This analysis was funded in part by a grant from the National Heart, Lung, and Blood Institute.
SOURCE: Warraich H et al. Circ Cardiovasc Qual Outcomes. 2018 Jun 12. doi: 10.1161/circoutcomes.117.004528.
Patients who experienced adverse changes in employment status after acute myocardial infarction (AMI) reported increased depression and lower quality of life, according to results published June 12 in Circulation: Cardiovascular Quality and Outcomes.
At 1-year follow-up, 27.4% of patients with adverse employment change scored high on measures of depression, compared with 16.7% of patients who did not experience a change in status. These patients also reported lower health status and difficulty affording medications, wrote Haider J. Warraich, MD, a cardiologist at Duke University in Durham, N.C., and coauthors.
Baseline data were collected for all patients according to CathPCI Registry standards, and follow-up was conducted via telephone 6 weeks, 6 months, 1 year, and 15 months after discharge. After 1 year, patients who reported working full or part time were defined as working. Adverse change in employment was defined as those who “reported working immediately before the index MI hospitalization but were either no longer working or working fewer hours,” Dr. Warraich and his colleagues reported.
Depression was defined by a Patient Health Questionnaire (PHQ) score greater than 3. Health status was assessed using the EuroQoL-5 Dimensions (EQ-5D) visual analog scale. Medication adherence was assessed using three questions at the follow-up interview, and patients were also asked to rank the financial hardship of their monthly medication costs on a scale of 1-5.
Among patients working at baseline, 492 (10%) reported an adverse change in employment after a year. Of these, 349 (7%) were no longer working, and 143 (3%) were working less than before. Of those with an adverse change in employment, 172 reported involuntary job loss such as being laid off or no longer working due to health concerns. Just 27 patients reported retirement.
The number of readmissions within the first year was the factor most strongly associated with adverse change in employment. Baseline smoking status, hypertension, and postdischarge bleeding were also significantly associated with adverse change in employment, the authors said.
At 1 year follow-up, patients with an adverse change in employment were more likely than those with no change to report depression (27.4% with PHQ score greater than 3, compared with 16.7% in the no-change group). These patients also reported lower health status (mean EuroQoL score of 73 compared with 78) and moderate to extreme financial hardship with medication costs (41.0% compared with 28.4%), though there was no difference in medication adherence, the authors reported.
The results indicate that, although job loss in acute MI patients has dropped in comparison with previous studies, patients who experience an adverse change in employment are still “at increased risk of depression, lower quality of life, and increased financial hardship with medication costs compared with those who continue working,” the authors wrote.
“These results underscore the need for interventions to address this patient-centered outcome and its health impact,” they concluded.
Daiichi Sankyo and Lilly USA funded TRANSLATE-ACS. This analysis was funded in part by a grant from the National Heart, Lung, and Blood Institute.
SOURCE: Warraich H et al. Circ Cardiovasc Qual Outcomes. 2018 Jun 12. doi: 10.1161/circoutcomes.117.004528.
FROM CIRCULATION: CARDIOVASCULAR QUALITY AND OUTCOMES
Key clinical point: Patients who lost their jobs or lost hours of employment after AMI reported increased depression, lower quality of life, and difficulty affording medications.
Major finding: At 1-year follow-up, 27.4% of patients with adverse employment change scored high on measures of depression, compared with 16.7% of patients who did not experience a change in status; these patients also reported lower health status and difficulty affording medications.
Study details: An analysis of 9,319 AMI patients from the (TRANSLATE-ACS) study.
Disclosures: Daiichi Sankyo and Lilly USA funded TRANSLATE-ACS. This analysis was funded in part by a grant from the National Heart, Lung, and Blood Institute.
Source: Warraich H et al. Circ Cardiovasc Qual Outcomes. 2018 Jun 12. doi: 10.1161/circoutcomes.117.004528.
Hepatitis A Outbreak in a Childcare Facility
In young children, hepatitis A is usually asymptomatic. So a childcare facility (CCF) in Ireland surprised by an outbreak of hepatitis A that infected 7 adults and 5 children, hospitalizing 6 of the adults. By the time the investigation and interventions were over, > 554 contacts had been followed up, and it had all cost > €45,000 ($53,000).
The outbreak was traced to a man with hepatitis A whose child had been unwell for 3 weeks with fever, fatigue, abdominal pain, diarrhea, pale stools, and possible jaundice. The child (and an infected cousin) attended a local CCF but because several other cases seemed to be limited to the family and their friends, no one immediately considered the CCF as a possible source of infection. However, approximately 10 days after the first 2 cases were reported, an outbreak was officially declared.
At the time, 93 children were attending the CCF. All 7 adults were household contacts of children in the CCF. None of the 23-member CCF staff developed symptoms of hepatitis A.
As many as 70% of infections are asymptomatic in children under age 6, the researchers note, but that group is often a source of transmission due to suboptimal hygiene. Transmission is usually fecal-oral and person-to-person. Although the initial source of outbreak was not identified, the subsequent transmission suggested person-to-person spread. The researchers say the distribution of cases suggests that the transmission probably happened in the school, with asymptomatic children infecting their families, highlighting the fact that symptomatic cases of hepatitis A only represent a portion of the cases in an outbreak.
A preschool inspection report that preceded the outbreak highlighted deficiencies in the staff’s handwashing practices. An infection control audit undertaken because of the outbreak found a number of deficits, including lack of foot-operated bins and the use of cloth covers on furnishings rather than waterproof material. Medical expenses, including hospitalization, serology, and vaccine, cost between €43,400 - €47, 400 ($51,000 - $56,000).
The researchers say the delayed notification to public health of the first case probably contributed to the extent of the outbreak. Medical professionals, they note, should be aware that although uncommon, hepatitis A still occurs. Prompt recognition and notification can mitigate the significant morbidity associated with the infection.
Source:
O'Connor L, McGovern E, O'Meara M, et al. Epidemiol Infect. 2018;146(6):705-711.
In young children, hepatitis A is usually asymptomatic. So a childcare facility (CCF) in Ireland surprised by an outbreak of hepatitis A that infected 7 adults and 5 children, hospitalizing 6 of the adults. By the time the investigation and interventions were over, > 554 contacts had been followed up, and it had all cost > €45,000 ($53,000).
The outbreak was traced to a man with hepatitis A whose child had been unwell for 3 weeks with fever, fatigue, abdominal pain, diarrhea, pale stools, and possible jaundice. The child (and an infected cousin) attended a local CCF but because several other cases seemed to be limited to the family and their friends, no one immediately considered the CCF as a possible source of infection. However, approximately 10 days after the first 2 cases were reported, an outbreak was officially declared.
At the time, 93 children were attending the CCF. All 7 adults were household contacts of children in the CCF. None of the 23-member CCF staff developed symptoms of hepatitis A.
As many as 70% of infections are asymptomatic in children under age 6, the researchers note, but that group is often a source of transmission due to suboptimal hygiene. Transmission is usually fecal-oral and person-to-person. Although the initial source of outbreak was not identified, the subsequent transmission suggested person-to-person spread. The researchers say the distribution of cases suggests that the transmission probably happened in the school, with asymptomatic children infecting their families, highlighting the fact that symptomatic cases of hepatitis A only represent a portion of the cases in an outbreak.
A preschool inspection report that preceded the outbreak highlighted deficiencies in the staff’s handwashing practices. An infection control audit undertaken because of the outbreak found a number of deficits, including lack of foot-operated bins and the use of cloth covers on furnishings rather than waterproof material. Medical expenses, including hospitalization, serology, and vaccine, cost between €43,400 - €47, 400 ($51,000 - $56,000).
The researchers say the delayed notification to public health of the first case probably contributed to the extent of the outbreak. Medical professionals, they note, should be aware that although uncommon, hepatitis A still occurs. Prompt recognition and notification can mitigate the significant morbidity associated with the infection.
Source:
O'Connor L, McGovern E, O'Meara M, et al. Epidemiol Infect. 2018;146(6):705-711.
In young children, hepatitis A is usually asymptomatic. So a childcare facility (CCF) in Ireland surprised by an outbreak of hepatitis A that infected 7 adults and 5 children, hospitalizing 6 of the adults. By the time the investigation and interventions were over, > 554 contacts had been followed up, and it had all cost > €45,000 ($53,000).
The outbreak was traced to a man with hepatitis A whose child had been unwell for 3 weeks with fever, fatigue, abdominal pain, diarrhea, pale stools, and possible jaundice. The child (and an infected cousin) attended a local CCF but because several other cases seemed to be limited to the family and their friends, no one immediately considered the CCF as a possible source of infection. However, approximately 10 days after the first 2 cases were reported, an outbreak was officially declared.
At the time, 93 children were attending the CCF. All 7 adults were household contacts of children in the CCF. None of the 23-member CCF staff developed symptoms of hepatitis A.
As many as 70% of infections are asymptomatic in children under age 6, the researchers note, but that group is often a source of transmission due to suboptimal hygiene. Transmission is usually fecal-oral and person-to-person. Although the initial source of outbreak was not identified, the subsequent transmission suggested person-to-person spread. The researchers say the distribution of cases suggests that the transmission probably happened in the school, with asymptomatic children infecting their families, highlighting the fact that symptomatic cases of hepatitis A only represent a portion of the cases in an outbreak.
A preschool inspection report that preceded the outbreak highlighted deficiencies in the staff’s handwashing practices. An infection control audit undertaken because of the outbreak found a number of deficits, including lack of foot-operated bins and the use of cloth covers on furnishings rather than waterproof material. Medical expenses, including hospitalization, serology, and vaccine, cost between €43,400 - €47, 400 ($51,000 - $56,000).
The researchers say the delayed notification to public health of the first case probably contributed to the extent of the outbreak. Medical professionals, they note, should be aware that although uncommon, hepatitis A still occurs. Prompt recognition and notification can mitigate the significant morbidity associated with the infection.
Source:
O'Connor L, McGovern E, O'Meara M, et al. Epidemiol Infect. 2018;146(6):705-711.
Chemo-free combo provides potential first-line option for FL
CHICAGO—A chemotherapy-free combination of lenalidomide plus rituximab shows similar efficacy and a different safety profile to chemotherapy plus rituximab (R-chemo) followed by rituximab maintenance in patients with previously untreated follicular lymphoma (FL).
According to investigators, the multicenter, international phase 3 RELEVANCE trial is the first to evaluate the chemo-free combination against the standard of care, R-chemo with rituximab maintenance.
“These results show that lenalidomide plus rituximab, a novel immunomodulatory approach, is a potential first-line option for patients with FL requiring treatment,” said investigator Nathan H. Fowler, MD, of the University of Texas MD Anderson Cancer Center in Houston.
Dr Fowler presented the results of the study at the 2018 ASCO Annual Meeting (abstract 7500).
The current standard of care in previously untreated symptomatic FL is immunochemotherapy induction followed by rituximab maintenance.
The immunomodulatory agent lenalidomide has complementary mechanisms with rituximab. Phase 2 studies of combined immunotherapy with lenalidomide and rituximab demonstrated 3-year progression-free survival (PFS) of 79%-81% in previously untreated FL, Dr Fowler said.
Phase 3 RELEVANCE trial (NCT01650701)
Investigators evaluated 1030 previously untreated grade 1-3a FL patients who required therapy.
Patients in the lenalidomide-rituximab group (n=513) received lenalidomide doses of 20 mg per day on days 2 to 22 and 28 for 6 to 12 cycles. Responders continued on therapy at 10 mg per day for a total of 18 cycles.
The rituximab dose was 375 mg/m2 weekly in cycle 1 and day 1 in cycles 2 to 6 and continued in responders for 12 additional cycles.
Patients in the R-chemo arm (n=517) received the investigator’s choice of standard rituximab-CHOP, rituximab-bendamustine, or rituximab-CVP, followed by 12 cycles of rituximab.
Most patients (72%) in the R-chemo arm received R-CHOP.
Baseline characteristics were similar in both groups, Dr Fowler said.
Co-primary endpoints were complete remission/complete remission unconfirmed (CR/Cru) at 120 weeks and PFS.
Results
At a median follow-up of 37.9 months, the superiority for lenalidomide and rituximab over rituximab-chemotherapy was not established.
For the lenalidomide-rituximab patients, the CR/Cru was 48% and 3-year PFS was 77% as compared to 53% and 78%, respectively, for rituximab-chemotherapy patients, as assessed by an independent review committee.
Overall survival was 94% in both groups.
Safety
“Important differences in safety profiles were observed between the arms,” Dr Fowler said.
Rituximab-chemotherapy patients had more frequent neutropenia, febrile neutropenia, growth factor usage, nausea, vomiting, neuropathy, and alopecia.
Lenalidomide and rituximab showed more cutaneous reactions, tumor flare, and diarrhea.
Toxicity profiles differed, with higher grade 4 neutropenia (31% vs 8%) and febrile neutropenia (7% vs 2%) with rituximab-chemotherapy compared with lenalidomide-rituximab, respectively.
More patients experienced grade 3/4 cutaneous events (7% vs 1%) with lenalidomide-rituximab.
Second primary malignancies were slightly higher with rituximab-chemotherapy (10%) than with lenalidomide-rituximab (7%). Grade 5 adverse events were 1% in both groups.
About 70% of patients completed treatment in both groups.
“Lenalidomide and rituximab was not superior to rituximab-chemotherapy based on mature CR/Cru at 120 weeks and interim PFS,” Dr Fowler said. “Both treatments showed similar efficacy results. Treatment effects on PFS were consistent across pre-specified subgroups.”
Dr Fowler presented data as of May 31, 2017. Continued follow-up on PFS and OS is ongoing.
The study is sponsored by Celgene Corporation and the Lymphoma Academic Research Organisation (LYSARC).
CHICAGO—A chemotherapy-free combination of lenalidomide plus rituximab shows similar efficacy and a different safety profile to chemotherapy plus rituximab (R-chemo) followed by rituximab maintenance in patients with previously untreated follicular lymphoma (FL).
According to investigators, the multicenter, international phase 3 RELEVANCE trial is the first to evaluate the chemo-free combination against the standard of care, R-chemo with rituximab maintenance.
“These results show that lenalidomide plus rituximab, a novel immunomodulatory approach, is a potential first-line option for patients with FL requiring treatment,” said investigator Nathan H. Fowler, MD, of the University of Texas MD Anderson Cancer Center in Houston.
Dr Fowler presented the results of the study at the 2018 ASCO Annual Meeting (abstract 7500).
The current standard of care in previously untreated symptomatic FL is immunochemotherapy induction followed by rituximab maintenance.
The immunomodulatory agent lenalidomide has complementary mechanisms with rituximab. Phase 2 studies of combined immunotherapy with lenalidomide and rituximab demonstrated 3-year progression-free survival (PFS) of 79%-81% in previously untreated FL, Dr Fowler said.
Phase 3 RELEVANCE trial (NCT01650701)
Investigators evaluated 1030 previously untreated grade 1-3a FL patients who required therapy.
Patients in the lenalidomide-rituximab group (n=513) received lenalidomide doses of 20 mg per day on days 2 to 22 and 28 for 6 to 12 cycles. Responders continued on therapy at 10 mg per day for a total of 18 cycles.
The rituximab dose was 375 mg/m2 weekly in cycle 1 and day 1 in cycles 2 to 6 and continued in responders for 12 additional cycles.
Patients in the R-chemo arm (n=517) received the investigator’s choice of standard rituximab-CHOP, rituximab-bendamustine, or rituximab-CVP, followed by 12 cycles of rituximab.
Most patients (72%) in the R-chemo arm received R-CHOP.
Baseline characteristics were similar in both groups, Dr Fowler said.
Co-primary endpoints were complete remission/complete remission unconfirmed (CR/Cru) at 120 weeks and PFS.
Results
At a median follow-up of 37.9 months, the superiority for lenalidomide and rituximab over rituximab-chemotherapy was not established.
For the lenalidomide-rituximab patients, the CR/Cru was 48% and 3-year PFS was 77% as compared to 53% and 78%, respectively, for rituximab-chemotherapy patients, as assessed by an independent review committee.
Overall survival was 94% in both groups.
Safety
“Important differences in safety profiles were observed between the arms,” Dr Fowler said.
Rituximab-chemotherapy patients had more frequent neutropenia, febrile neutropenia, growth factor usage, nausea, vomiting, neuropathy, and alopecia.
Lenalidomide and rituximab showed more cutaneous reactions, tumor flare, and diarrhea.
Toxicity profiles differed, with higher grade 4 neutropenia (31% vs 8%) and febrile neutropenia (7% vs 2%) with rituximab-chemotherapy compared with lenalidomide-rituximab, respectively.
More patients experienced grade 3/4 cutaneous events (7% vs 1%) with lenalidomide-rituximab.
Second primary malignancies were slightly higher with rituximab-chemotherapy (10%) than with lenalidomide-rituximab (7%). Grade 5 adverse events were 1% in both groups.
About 70% of patients completed treatment in both groups.
“Lenalidomide and rituximab was not superior to rituximab-chemotherapy based on mature CR/Cru at 120 weeks and interim PFS,” Dr Fowler said. “Both treatments showed similar efficacy results. Treatment effects on PFS were consistent across pre-specified subgroups.”
Dr Fowler presented data as of May 31, 2017. Continued follow-up on PFS and OS is ongoing.
The study is sponsored by Celgene Corporation and the Lymphoma Academic Research Organisation (LYSARC).
CHICAGO—A chemotherapy-free combination of lenalidomide plus rituximab shows similar efficacy and a different safety profile to chemotherapy plus rituximab (R-chemo) followed by rituximab maintenance in patients with previously untreated follicular lymphoma (FL).
According to investigators, the multicenter, international phase 3 RELEVANCE trial is the first to evaluate the chemo-free combination against the standard of care, R-chemo with rituximab maintenance.
“These results show that lenalidomide plus rituximab, a novel immunomodulatory approach, is a potential first-line option for patients with FL requiring treatment,” said investigator Nathan H. Fowler, MD, of the University of Texas MD Anderson Cancer Center in Houston.
Dr Fowler presented the results of the study at the 2018 ASCO Annual Meeting (abstract 7500).
The current standard of care in previously untreated symptomatic FL is immunochemotherapy induction followed by rituximab maintenance.
The immunomodulatory agent lenalidomide has complementary mechanisms with rituximab. Phase 2 studies of combined immunotherapy with lenalidomide and rituximab demonstrated 3-year progression-free survival (PFS) of 79%-81% in previously untreated FL, Dr Fowler said.
Phase 3 RELEVANCE trial (NCT01650701)
Investigators evaluated 1030 previously untreated grade 1-3a FL patients who required therapy.
Patients in the lenalidomide-rituximab group (n=513) received lenalidomide doses of 20 mg per day on days 2 to 22 and 28 for 6 to 12 cycles. Responders continued on therapy at 10 mg per day for a total of 18 cycles.
The rituximab dose was 375 mg/m2 weekly in cycle 1 and day 1 in cycles 2 to 6 and continued in responders for 12 additional cycles.
Patients in the R-chemo arm (n=517) received the investigator’s choice of standard rituximab-CHOP, rituximab-bendamustine, or rituximab-CVP, followed by 12 cycles of rituximab.
Most patients (72%) in the R-chemo arm received R-CHOP.
Baseline characteristics were similar in both groups, Dr Fowler said.
Co-primary endpoints were complete remission/complete remission unconfirmed (CR/Cru) at 120 weeks and PFS.
Results
At a median follow-up of 37.9 months, the superiority for lenalidomide and rituximab over rituximab-chemotherapy was not established.
For the lenalidomide-rituximab patients, the CR/Cru was 48% and 3-year PFS was 77% as compared to 53% and 78%, respectively, for rituximab-chemotherapy patients, as assessed by an independent review committee.
Overall survival was 94% in both groups.
Safety
“Important differences in safety profiles were observed between the arms,” Dr Fowler said.
Rituximab-chemotherapy patients had more frequent neutropenia, febrile neutropenia, growth factor usage, nausea, vomiting, neuropathy, and alopecia.
Lenalidomide and rituximab showed more cutaneous reactions, tumor flare, and diarrhea.
Toxicity profiles differed, with higher grade 4 neutropenia (31% vs 8%) and febrile neutropenia (7% vs 2%) with rituximab-chemotherapy compared with lenalidomide-rituximab, respectively.
More patients experienced grade 3/4 cutaneous events (7% vs 1%) with lenalidomide-rituximab.
Second primary malignancies were slightly higher with rituximab-chemotherapy (10%) than with lenalidomide-rituximab (7%). Grade 5 adverse events were 1% in both groups.
About 70% of patients completed treatment in both groups.
“Lenalidomide and rituximab was not superior to rituximab-chemotherapy based on mature CR/Cru at 120 weeks and interim PFS,” Dr Fowler said. “Both treatments showed similar efficacy results. Treatment effects on PFS were consistent across pre-specified subgroups.”
Dr Fowler presented data as of May 31, 2017. Continued follow-up on PFS and OS is ongoing.
The study is sponsored by Celgene Corporation and the Lymphoma Academic Research Organisation (LYSARC).
Getting Ahead of the Pain
ANSWER
The image reveals a hypodense extra-axial fluid collection in the right frontoparietal region, measuring 8 to 10 mm in diameter. There is some mass effect and evidence of right-to-left shift. These findings are consistent with a subacute subdural hematoma, possibly secondary to the patient’s anticoagulant use. (The patient later recalled bumping his head a couple of months prior—but that may have been incidental.)
Arrangements were made for him at a local hospital where neurosurgical services were available. He underwent successful evacuation and was subsequently symptom free.
ANSWER
The image reveals a hypodense extra-axial fluid collection in the right frontoparietal region, measuring 8 to 10 mm in diameter. There is some mass effect and evidence of right-to-left shift. These findings are consistent with a subacute subdural hematoma, possibly secondary to the patient’s anticoagulant use. (The patient later recalled bumping his head a couple of months prior—but that may have been incidental.)
Arrangements were made for him at a local hospital where neurosurgical services were available. He underwent successful evacuation and was subsequently symptom free.
ANSWER
The image reveals a hypodense extra-axial fluid collection in the right frontoparietal region, measuring 8 to 10 mm in diameter. There is some mass effect and evidence of right-to-left shift. These findings are consistent with a subacute subdural hematoma, possibly secondary to the patient’s anticoagulant use. (The patient later recalled bumping his head a couple of months prior—but that may have been incidental.)
Arrangements were made for him at a local hospital where neurosurgical services were available. He underwent successful evacuation and was subsequently symptom free.
An 80-year-old man presents to urgent care for intermittent severe headaches. The pain is reportedly bifrontal, slightly worse on the right side than the left. He denies any recent injury or trauma, as well as symptoms including fever, chills, nausea, vomiting, and visual disturbance.
His medical history is significant for hypertension and hyperlipidemia. His current medications include prasugrel and aspirin.
On examination, you note an elderly male who is awake, alert, and oriented x 3. His vital signs are normal. His physical exam is overall normal, with no focal findings or neurologic deficits.
Noncontrast CT of the head is obtained at a local hospital. As you review the images, you see the following cut (shown). What is your impression?
Bariatric revision mortality linked to age, comorbidities
WASHINGTON – and appears to be rising in recent years, according to two studies presented at the annual Digestive Disease Week®.
Violeta B. Popov, MD, of New York University, and a team of researchers used the Nationwide Inpatient Sample (NIS) to look at mortality risk, costs, and risk factors for complications in revisional bariatric procedures.
In one presentation, Dr. Popov noted that revision after bariatric surgery occurred in approximately 8% of cases for a variety of reasons including lap band adjustment, weight regain, gastric reflux problems, and rarely, because of staple-line leaks. Referring to findings based on the Bariatric Outcomes Longitudinal Database (BOLD), Dr. Popov said that mortality after primary bariatric surgery is estimated at around 0.2% and revisional procedures carry nearly the same low level of mortality risk. BOLD was developed by the American Society of Metabolic and Bariatric Surgery and reflects outcomes from certified Bariatric Centers of Excellence from 2007 to 2012. However, Dr. Popov noted, the outcomes derived from BOLD may well be better than those from noncertified centers (Gastrointest Surg. 2015 Jan;19[1]:171-8).
Dr. Popov reported that the number of revisional procedures has doubled over recent years, from 6% of all bariatric procedures in 2011 to 13% in 2015. The reasons behind the increase could be related to the number of patients switching to a different bariatric approach, the removal of lap bands, and possibly the increase in the number of primary bariatric surgeries performed by less-skilled operators, Dr. Popov said.
The investigators aimed to determine the mortality trends for these procedures in addition to evaluating costs and risk factors for complications. They conducted a retrospective cohort study using the 2014 NIS, comprising 14,280 patients who underwent revisional bariatric surgery. The primary outcome was postoperative in-hospital mortality, with secondary outcomes of cost, length of hospital stay (LOS), and ICU stay. The variables included a variety of comorbidities, alcohol use, smoking, income, and insurance status.
The mean age of this sample was 68 years and 58.8% were female. Outcomes for revisional bariatric surgery were worse in several categories than were found in the BOLD study in terms of LOS, costs, and mortality, and postoperative in-hospital mortality was unexpectedly high at 2.1% (290 patients). A total of 3.3% of the patients had an ICU stay, one-quarter of whom died.
On univariate analysis, comorbidities (age, coagulopathy, chronic kidney disease, anemia, and chronic heart failure) and the combined number of chronic conditions were all significant predictors of mortality. Multivariate analysis identified age (odds ratio, 1.08; 95% confidence interval, 1.04-1.20; P less than .001), alcohol use (OR, 4.0; 95% CI, 1.3-11.7; P = .01), coagulopathy (OR, 5.4; 95% CI, 2.2-13.3; P less than .001), and insurance status (Medicaid vs. private; OR, 4.0; 95% CI, 1.7-9.9; P = .002) as the most significant predictors of mortality after a revisional bariatric procedure.
In a poster, Dr. Popov and her colleagues presented data from the NIS database looking at 10-year mortality and outcome trends for revisional surgery versus primary Roux-en-Y gastric bypass (RYGB) surgery. Inpatient mortality for RYGB decreased from 2.54% in 2003 to 1.80% in 2014, but was still substantially higher than the BOLD findings. But mortality for revisional surgery increased: 1.90% versus 2.03%. LOS for RYGB decreased from 5.9 days to 5.4 but increased for revisional surgery from 4.6 to 5.4 days. Cost for both procedures, adjusted for inflation, more than doubled between 2003 and 2014. And patients requiring ICU admission for both procedures went from 1% in 2003 to 3% in 2014.
The limitations of both analyses are their retrospective design, the NIS bias inferred by the inclusion of only inpatient procedures, and the lack of laboratory data or data on body mass index. In addition, during the study period, primary bariatric surgery began to be performed as an outpatient procedure. “Low-risk procedures performed in outpatient facilities will not be captured in the database and thus the higher mortality for these higher risk patients is expected,” Dr. Popov said. These patients are likely to be sicker and have more comorbidities. Revisional procedures are typically done in the hospital, but there are some low-risk revisional procedures such as lap band removal that could be done as outpatient procedures. Dr. Popov had confidence that the NIS database reflects real-world outcomes for revisional bariatric procedures.
She concluded that the explanation for the increase in mortality risk for revisional bariatric surgery may be because of more of these procedures being done outside centers of excellence and more, older patients with comorbidities having the surgery, and that nonsurgical alternatives should be explored for the older sicker patients.
Dr. Popova disclosed ownership of shares in Embarcadero Technologies but no conflicts of interest.
SOURCE: Popov VB et al. DDW 2018, Abstract 324.
WASHINGTON – and appears to be rising in recent years, according to two studies presented at the annual Digestive Disease Week®.
Violeta B. Popov, MD, of New York University, and a team of researchers used the Nationwide Inpatient Sample (NIS) to look at mortality risk, costs, and risk factors for complications in revisional bariatric procedures.
In one presentation, Dr. Popov noted that revision after bariatric surgery occurred in approximately 8% of cases for a variety of reasons including lap band adjustment, weight regain, gastric reflux problems, and rarely, because of staple-line leaks. Referring to findings based on the Bariatric Outcomes Longitudinal Database (BOLD), Dr. Popov said that mortality after primary bariatric surgery is estimated at around 0.2% and revisional procedures carry nearly the same low level of mortality risk. BOLD was developed by the American Society of Metabolic and Bariatric Surgery and reflects outcomes from certified Bariatric Centers of Excellence from 2007 to 2012. However, Dr. Popov noted, the outcomes derived from BOLD may well be better than those from noncertified centers (Gastrointest Surg. 2015 Jan;19[1]:171-8).
Dr. Popov reported that the number of revisional procedures has doubled over recent years, from 6% of all bariatric procedures in 2011 to 13% in 2015. The reasons behind the increase could be related to the number of patients switching to a different bariatric approach, the removal of lap bands, and possibly the increase in the number of primary bariatric surgeries performed by less-skilled operators, Dr. Popov said.
The investigators aimed to determine the mortality trends for these procedures in addition to evaluating costs and risk factors for complications. They conducted a retrospective cohort study using the 2014 NIS, comprising 14,280 patients who underwent revisional bariatric surgery. The primary outcome was postoperative in-hospital mortality, with secondary outcomes of cost, length of hospital stay (LOS), and ICU stay. The variables included a variety of comorbidities, alcohol use, smoking, income, and insurance status.
The mean age of this sample was 68 years and 58.8% were female. Outcomes for revisional bariatric surgery were worse in several categories than were found in the BOLD study in terms of LOS, costs, and mortality, and postoperative in-hospital mortality was unexpectedly high at 2.1% (290 patients). A total of 3.3% of the patients had an ICU stay, one-quarter of whom died.
On univariate analysis, comorbidities (age, coagulopathy, chronic kidney disease, anemia, and chronic heart failure) and the combined number of chronic conditions were all significant predictors of mortality. Multivariate analysis identified age (odds ratio, 1.08; 95% confidence interval, 1.04-1.20; P less than .001), alcohol use (OR, 4.0; 95% CI, 1.3-11.7; P = .01), coagulopathy (OR, 5.4; 95% CI, 2.2-13.3; P less than .001), and insurance status (Medicaid vs. private; OR, 4.0; 95% CI, 1.7-9.9; P = .002) as the most significant predictors of mortality after a revisional bariatric procedure.
In a poster, Dr. Popov and her colleagues presented data from the NIS database looking at 10-year mortality and outcome trends for revisional surgery versus primary Roux-en-Y gastric bypass (RYGB) surgery. Inpatient mortality for RYGB decreased from 2.54% in 2003 to 1.80% in 2014, but was still substantially higher than the BOLD findings. But mortality for revisional surgery increased: 1.90% versus 2.03%. LOS for RYGB decreased from 5.9 days to 5.4 but increased for revisional surgery from 4.6 to 5.4 days. Cost for both procedures, adjusted for inflation, more than doubled between 2003 and 2014. And patients requiring ICU admission for both procedures went from 1% in 2003 to 3% in 2014.
The limitations of both analyses are their retrospective design, the NIS bias inferred by the inclusion of only inpatient procedures, and the lack of laboratory data or data on body mass index. In addition, during the study period, primary bariatric surgery began to be performed as an outpatient procedure. “Low-risk procedures performed in outpatient facilities will not be captured in the database and thus the higher mortality for these higher risk patients is expected,” Dr. Popov said. These patients are likely to be sicker and have more comorbidities. Revisional procedures are typically done in the hospital, but there are some low-risk revisional procedures such as lap band removal that could be done as outpatient procedures. Dr. Popov had confidence that the NIS database reflects real-world outcomes for revisional bariatric procedures.
She concluded that the explanation for the increase in mortality risk for revisional bariatric surgery may be because of more of these procedures being done outside centers of excellence and more, older patients with comorbidities having the surgery, and that nonsurgical alternatives should be explored for the older sicker patients.
Dr. Popova disclosed ownership of shares in Embarcadero Technologies but no conflicts of interest.
SOURCE: Popov VB et al. DDW 2018, Abstract 324.
WASHINGTON – and appears to be rising in recent years, according to two studies presented at the annual Digestive Disease Week®.
Violeta B. Popov, MD, of New York University, and a team of researchers used the Nationwide Inpatient Sample (NIS) to look at mortality risk, costs, and risk factors for complications in revisional bariatric procedures.
In one presentation, Dr. Popov noted that revision after bariatric surgery occurred in approximately 8% of cases for a variety of reasons including lap band adjustment, weight regain, gastric reflux problems, and rarely, because of staple-line leaks. Referring to findings based on the Bariatric Outcomes Longitudinal Database (BOLD), Dr. Popov said that mortality after primary bariatric surgery is estimated at around 0.2% and revisional procedures carry nearly the same low level of mortality risk. BOLD was developed by the American Society of Metabolic and Bariatric Surgery and reflects outcomes from certified Bariatric Centers of Excellence from 2007 to 2012. However, Dr. Popov noted, the outcomes derived from BOLD may well be better than those from noncertified centers (Gastrointest Surg. 2015 Jan;19[1]:171-8).
Dr. Popov reported that the number of revisional procedures has doubled over recent years, from 6% of all bariatric procedures in 2011 to 13% in 2015. The reasons behind the increase could be related to the number of patients switching to a different bariatric approach, the removal of lap bands, and possibly the increase in the number of primary bariatric surgeries performed by less-skilled operators, Dr. Popov said.
The investigators aimed to determine the mortality trends for these procedures in addition to evaluating costs and risk factors for complications. They conducted a retrospective cohort study using the 2014 NIS, comprising 14,280 patients who underwent revisional bariatric surgery. The primary outcome was postoperative in-hospital mortality, with secondary outcomes of cost, length of hospital stay (LOS), and ICU stay. The variables included a variety of comorbidities, alcohol use, smoking, income, and insurance status.
The mean age of this sample was 68 years and 58.8% were female. Outcomes for revisional bariatric surgery were worse in several categories than were found in the BOLD study in terms of LOS, costs, and mortality, and postoperative in-hospital mortality was unexpectedly high at 2.1% (290 patients). A total of 3.3% of the patients had an ICU stay, one-quarter of whom died.
On univariate analysis, comorbidities (age, coagulopathy, chronic kidney disease, anemia, and chronic heart failure) and the combined number of chronic conditions were all significant predictors of mortality. Multivariate analysis identified age (odds ratio, 1.08; 95% confidence interval, 1.04-1.20; P less than .001), alcohol use (OR, 4.0; 95% CI, 1.3-11.7; P = .01), coagulopathy (OR, 5.4; 95% CI, 2.2-13.3; P less than .001), and insurance status (Medicaid vs. private; OR, 4.0; 95% CI, 1.7-9.9; P = .002) as the most significant predictors of mortality after a revisional bariatric procedure.
In a poster, Dr. Popov and her colleagues presented data from the NIS database looking at 10-year mortality and outcome trends for revisional surgery versus primary Roux-en-Y gastric bypass (RYGB) surgery. Inpatient mortality for RYGB decreased from 2.54% in 2003 to 1.80% in 2014, but was still substantially higher than the BOLD findings. But mortality for revisional surgery increased: 1.90% versus 2.03%. LOS for RYGB decreased from 5.9 days to 5.4 but increased for revisional surgery from 4.6 to 5.4 days. Cost for both procedures, adjusted for inflation, more than doubled between 2003 and 2014. And patients requiring ICU admission for both procedures went from 1% in 2003 to 3% in 2014.
The limitations of both analyses are their retrospective design, the NIS bias inferred by the inclusion of only inpatient procedures, and the lack of laboratory data or data on body mass index. In addition, during the study period, primary bariatric surgery began to be performed as an outpatient procedure. “Low-risk procedures performed in outpatient facilities will not be captured in the database and thus the higher mortality for these higher risk patients is expected,” Dr. Popov said. These patients are likely to be sicker and have more comorbidities. Revisional procedures are typically done in the hospital, but there are some low-risk revisional procedures such as lap band removal that could be done as outpatient procedures. Dr. Popov had confidence that the NIS database reflects real-world outcomes for revisional bariatric procedures.
She concluded that the explanation for the increase in mortality risk for revisional bariatric surgery may be because of more of these procedures being done outside centers of excellence and more, older patients with comorbidities having the surgery, and that nonsurgical alternatives should be explored for the older sicker patients.
Dr. Popova disclosed ownership of shares in Embarcadero Technologies but no conflicts of interest.
SOURCE: Popov VB et al. DDW 2018, Abstract 324.
REPORTING FROM DDW 2018
Key clinical point: Revisional bariatric procedures may carry a greater mortality risk than previous studies have suggested.
Major finding: The mortality rate in the sample was 2.1%.
Study details: The 2014 Nationwide Inpatient Sample database, comprising 14,280 patients who underwent revisional bariatric surgery.
Disclosures: Dr. Popova disclosed ownership of shares in Embarcadero Technologies but no conflicts of interest.
Source: Popov VB et al. DDW 2018, Abstract 324.
Take precautions as cancer picture in MS remains hazy
NASHVILLE, TENN. – With much unknown about the risks of cancer and vaccination associated with immunosuppressants used in multiple sclerosis treatment, a neurologist advised colleagues to be aware of the potential dangers and take appropriate precautions.
For example, Eric Williamson, MD, of the University of Pennsylvania and Philadelphia Veterans Administration Hospital, said he goes a step further than recommending that adult female patients with MS who take ocrelizumab (Ocrevus) get regular mammograms. Per policy, he also double-checks to make sure that patients actually get screened.
“I know two women who were diagnosed with breast cancer before they began on their treatment because we asked about mammograms,” said Dr. Williamson, who spoke in a presentation about the risks of immunosuppressants in MS at the annual meeting of the Consortium of Multiple Sclerosis Centers.
In regard to cancer as a whole, he said, “it’s unclear if there is any true increased risk in MS patients.” But this doesn’t mean there is no danger, he said, since research into immunosuppressants in other contexts show that they can boost the risk of cancer by three times to as much as several hundred times.
In transplant patients, he said, immunosuppressants are linked to higher rates of lymphoproliferative tumors (such as those linked to Epstein-Barr virus), Kaposi sarcoma, and cutaneous, renal, hepatobiliary, and anogenital tumors.
Research is also hazy in regard to specific immunosuppressants used to treat MS. Two reports published about a decade ago raised the possibility that natalizumab (Tysabri) may have sparked a slightly higher risk cancer in patients taking the drug for Crohn’s disease and MS, respectively; the latter report hinted at a higher risk of melanoma specifically. However, Dr. Williamson said postmarketing surveillance has not detected any further sign of trouble (N Engl J Med. 2006;354:899‐910; N Engl J Med. 2008;358;647‐8).
Another drug, ocrelizumab (Ocrevus), has sparked questions about a possible breast cancer risk. As Genentech, its manufacturer, notes: “breast cancer occurred in 6 of 781 females treated with Ocrevus and none of 668 females treated with Rebif [interferon beta-1a] or placebo.”
However, a researcher reported ocrelizumab open-label extension study data at the 2017 CMSC annual meeting and said, “incidence rates of malignancies and breast cancer observed with ocrelizumab treatment in MS remain within the range of epidemiologic background data.”
For now, Dr. Williamson, said, it may take decades to understand if there’s actually an increased breast cancer risk with ocrelizumab.
Skin cancer is a concern for fingolimod (Gilenya), Dr. Williamson said, specifically basal cell carcinoma and melanoma. It’s debatable whether patients should be required to see a dermatologist or make annual visits, he said. Per policy, his VA employer requires these patients to visit a dermatologist.
Whatever the case, it’s important to keep in mind that skin cancer screenings are advisable in general, he said.
Guidance on vaccinations
On the vaccination front, Dr. Williamson said vaccines are a good idea for MS patients – as long as they’re “relatively safe” – because some infectious diseases appear to be more severe in this population.
Flu is a special danger, Dr. Williamson said. He recommends the flu vaccine to patients “because people with MS are at higher risk of influenza-related complications or hospitalizations.”
With guidance from a report led by Dr. Williamson, the National Multiple Sclerosis Society offers recommendations about whether patients with MS should use various vaccines (Curr Neurol Neurosci Rep. 2016;16:36).
Dr. Williamson cautioned that patients with MS who take dimethyl fumarate (Tecfidera), ocrelizumab (Ocrevus), and fingolimod (Gilenya) should not use live vaccines. The drugs can pose issues in regard to other vaccines, too, he said (Plos ONE 2013; 8:e78532; Neurol Res 2012;34:730-3; Neurology. 2013;81:552-8).
Autoimmune risk with alemtuzumab
Alemtuzumab (Lemtrada) has been linked to autoimmune thyroid disorders, especially Graves’ disease, Dr. Williamson said. It’s estimated to affect 17%-41% of patients (Front Endocrinol [Lausanne]. 2017;8:254).
Potentially life-threatening idiopathic thrombocytopenic purpura occurs in 2% of patients on Lemtrada, he said, and anti-GMB nephropathy/Goodpasture’s syndrome has been reported in 0.1%.
Dr. Williamson also noted case reports of autoimmune hemolytic anemia and hepatitis. Earlier this year, three reports in Neurology noted acute coronary syndrome in one patient, hemophagocytic lymphohistiocytosis (HLH) in two patients, and acute acalculous cholecystitis in eight patients (Neurology. 2018 Mar 30. doi: 10.1212/WNL.0000000000005422, doi: 10.1212/WNL.0000000000005420, doi: 10.1212/WNL.0000000000005417).
Dr. Williamson disclosed past consulting for Bayer, Biogen, Celgene, Genentech, EMD Serono, Teva, and Novartis, and current research support from Actelion and Alexion.
NASHVILLE, TENN. – With much unknown about the risks of cancer and vaccination associated with immunosuppressants used in multiple sclerosis treatment, a neurologist advised colleagues to be aware of the potential dangers and take appropriate precautions.
For example, Eric Williamson, MD, of the University of Pennsylvania and Philadelphia Veterans Administration Hospital, said he goes a step further than recommending that adult female patients with MS who take ocrelizumab (Ocrevus) get regular mammograms. Per policy, he also double-checks to make sure that patients actually get screened.
“I know two women who were diagnosed with breast cancer before they began on their treatment because we asked about mammograms,” said Dr. Williamson, who spoke in a presentation about the risks of immunosuppressants in MS at the annual meeting of the Consortium of Multiple Sclerosis Centers.
In regard to cancer as a whole, he said, “it’s unclear if there is any true increased risk in MS patients.” But this doesn’t mean there is no danger, he said, since research into immunosuppressants in other contexts show that they can boost the risk of cancer by three times to as much as several hundred times.
In transplant patients, he said, immunosuppressants are linked to higher rates of lymphoproliferative tumors (such as those linked to Epstein-Barr virus), Kaposi sarcoma, and cutaneous, renal, hepatobiliary, and anogenital tumors.
Research is also hazy in regard to specific immunosuppressants used to treat MS. Two reports published about a decade ago raised the possibility that natalizumab (Tysabri) may have sparked a slightly higher risk cancer in patients taking the drug for Crohn’s disease and MS, respectively; the latter report hinted at a higher risk of melanoma specifically. However, Dr. Williamson said postmarketing surveillance has not detected any further sign of trouble (N Engl J Med. 2006;354:899‐910; N Engl J Med. 2008;358;647‐8).
Another drug, ocrelizumab (Ocrevus), has sparked questions about a possible breast cancer risk. As Genentech, its manufacturer, notes: “breast cancer occurred in 6 of 781 females treated with Ocrevus and none of 668 females treated with Rebif [interferon beta-1a] or placebo.”
However, a researcher reported ocrelizumab open-label extension study data at the 2017 CMSC annual meeting and said, “incidence rates of malignancies and breast cancer observed with ocrelizumab treatment in MS remain within the range of epidemiologic background data.”
For now, Dr. Williamson, said, it may take decades to understand if there’s actually an increased breast cancer risk with ocrelizumab.
Skin cancer is a concern for fingolimod (Gilenya), Dr. Williamson said, specifically basal cell carcinoma and melanoma. It’s debatable whether patients should be required to see a dermatologist or make annual visits, he said. Per policy, his VA employer requires these patients to visit a dermatologist.
Whatever the case, it’s important to keep in mind that skin cancer screenings are advisable in general, he said.
Guidance on vaccinations
On the vaccination front, Dr. Williamson said vaccines are a good idea for MS patients – as long as they’re “relatively safe” – because some infectious diseases appear to be more severe in this population.
Flu is a special danger, Dr. Williamson said. He recommends the flu vaccine to patients “because people with MS are at higher risk of influenza-related complications or hospitalizations.”
With guidance from a report led by Dr. Williamson, the National Multiple Sclerosis Society offers recommendations about whether patients with MS should use various vaccines (Curr Neurol Neurosci Rep. 2016;16:36).
Dr. Williamson cautioned that patients with MS who take dimethyl fumarate (Tecfidera), ocrelizumab (Ocrevus), and fingolimod (Gilenya) should not use live vaccines. The drugs can pose issues in regard to other vaccines, too, he said (Plos ONE 2013; 8:e78532; Neurol Res 2012;34:730-3; Neurology. 2013;81:552-8).
Autoimmune risk with alemtuzumab
Alemtuzumab (Lemtrada) has been linked to autoimmune thyroid disorders, especially Graves’ disease, Dr. Williamson said. It’s estimated to affect 17%-41% of patients (Front Endocrinol [Lausanne]. 2017;8:254).
Potentially life-threatening idiopathic thrombocytopenic purpura occurs in 2% of patients on Lemtrada, he said, and anti-GMB nephropathy/Goodpasture’s syndrome has been reported in 0.1%.
Dr. Williamson also noted case reports of autoimmune hemolytic anemia and hepatitis. Earlier this year, three reports in Neurology noted acute coronary syndrome in one patient, hemophagocytic lymphohistiocytosis (HLH) in two patients, and acute acalculous cholecystitis in eight patients (Neurology. 2018 Mar 30. doi: 10.1212/WNL.0000000000005422, doi: 10.1212/WNL.0000000000005420, doi: 10.1212/WNL.0000000000005417).
Dr. Williamson disclosed past consulting for Bayer, Biogen, Celgene, Genentech, EMD Serono, Teva, and Novartis, and current research support from Actelion and Alexion.
NASHVILLE, TENN. – With much unknown about the risks of cancer and vaccination associated with immunosuppressants used in multiple sclerosis treatment, a neurologist advised colleagues to be aware of the potential dangers and take appropriate precautions.
For example, Eric Williamson, MD, of the University of Pennsylvania and Philadelphia Veterans Administration Hospital, said he goes a step further than recommending that adult female patients with MS who take ocrelizumab (Ocrevus) get regular mammograms. Per policy, he also double-checks to make sure that patients actually get screened.
“I know two women who were diagnosed with breast cancer before they began on their treatment because we asked about mammograms,” said Dr. Williamson, who spoke in a presentation about the risks of immunosuppressants in MS at the annual meeting of the Consortium of Multiple Sclerosis Centers.
In regard to cancer as a whole, he said, “it’s unclear if there is any true increased risk in MS patients.” But this doesn’t mean there is no danger, he said, since research into immunosuppressants in other contexts show that they can boost the risk of cancer by three times to as much as several hundred times.
In transplant patients, he said, immunosuppressants are linked to higher rates of lymphoproliferative tumors (such as those linked to Epstein-Barr virus), Kaposi sarcoma, and cutaneous, renal, hepatobiliary, and anogenital tumors.
Research is also hazy in regard to specific immunosuppressants used to treat MS. Two reports published about a decade ago raised the possibility that natalizumab (Tysabri) may have sparked a slightly higher risk cancer in patients taking the drug for Crohn’s disease and MS, respectively; the latter report hinted at a higher risk of melanoma specifically. However, Dr. Williamson said postmarketing surveillance has not detected any further sign of trouble (N Engl J Med. 2006;354:899‐910; N Engl J Med. 2008;358;647‐8).
Another drug, ocrelizumab (Ocrevus), has sparked questions about a possible breast cancer risk. As Genentech, its manufacturer, notes: “breast cancer occurred in 6 of 781 females treated with Ocrevus and none of 668 females treated with Rebif [interferon beta-1a] or placebo.”
However, a researcher reported ocrelizumab open-label extension study data at the 2017 CMSC annual meeting and said, “incidence rates of malignancies and breast cancer observed with ocrelizumab treatment in MS remain within the range of epidemiologic background data.”
For now, Dr. Williamson, said, it may take decades to understand if there’s actually an increased breast cancer risk with ocrelizumab.
Skin cancer is a concern for fingolimod (Gilenya), Dr. Williamson said, specifically basal cell carcinoma and melanoma. It’s debatable whether patients should be required to see a dermatologist or make annual visits, he said. Per policy, his VA employer requires these patients to visit a dermatologist.
Whatever the case, it’s important to keep in mind that skin cancer screenings are advisable in general, he said.
Guidance on vaccinations
On the vaccination front, Dr. Williamson said vaccines are a good idea for MS patients – as long as they’re “relatively safe” – because some infectious diseases appear to be more severe in this population.
Flu is a special danger, Dr. Williamson said. He recommends the flu vaccine to patients “because people with MS are at higher risk of influenza-related complications or hospitalizations.”
With guidance from a report led by Dr. Williamson, the National Multiple Sclerosis Society offers recommendations about whether patients with MS should use various vaccines (Curr Neurol Neurosci Rep. 2016;16:36).
Dr. Williamson cautioned that patients with MS who take dimethyl fumarate (Tecfidera), ocrelizumab (Ocrevus), and fingolimod (Gilenya) should not use live vaccines. The drugs can pose issues in regard to other vaccines, too, he said (Plos ONE 2013; 8:e78532; Neurol Res 2012;34:730-3; Neurology. 2013;81:552-8).
Autoimmune risk with alemtuzumab
Alemtuzumab (Lemtrada) has been linked to autoimmune thyroid disorders, especially Graves’ disease, Dr. Williamson said. It’s estimated to affect 17%-41% of patients (Front Endocrinol [Lausanne]. 2017;8:254).
Potentially life-threatening idiopathic thrombocytopenic purpura occurs in 2% of patients on Lemtrada, he said, and anti-GMB nephropathy/Goodpasture’s syndrome has been reported in 0.1%.
Dr. Williamson also noted case reports of autoimmune hemolytic anemia and hepatitis. Earlier this year, three reports in Neurology noted acute coronary syndrome in one patient, hemophagocytic lymphohistiocytosis (HLH) in two patients, and acute acalculous cholecystitis in eight patients (Neurology. 2018 Mar 30. doi: 10.1212/WNL.0000000000005422, doi: 10.1212/WNL.0000000000005420, doi: 10.1212/WNL.0000000000005417).
Dr. Williamson disclosed past consulting for Bayer, Biogen, Celgene, Genentech, EMD Serono, Teva, and Novartis, and current research support from Actelion and Alexion.
REPORTING FROM THE CMSC ANNUAL MEETING
Open vs Percutaneous vs Arthroscopic Surgical Treatment of Lateral Epicondylitis: An Updated Systematic Review
ABSTRACT
This study was performed to compare outcomes of open, arthroscopic, and percutaneous surgical techniques for lateral epicondylitis. We searched PubMed (MEDLINE) for literature published between January 1, 2004 and May 23, 2015 using these key words: lateral epicondylitis AND (surgery OR operative OR surgical OR open OR arthroscopic OR percutaneous). Meta-analyses were performed for outcomes reported in 3 studies using 2-sample and 2-proportion Z-tests. Thirty-five studies including 1640 elbows (1055 open, 401 arthroscopic, 184 percutaneous) met the inclusion criteria. There were no differences between groups regarding duration to return to work, complication rate, or patient satisfaction. A greater proportion of patients were pain free in the open group than in the arthroscopic group (70% vs 60%). Despite the absence of a difference among techniques regarding return to work and subjective function, we recommend open débridement as the technique most likely to achieve a pain-free outcome.
Continue to: Lateral epicondylitis affects...
Lateral epicondylitis affects 1% to 3% of adults each year. Although common, symptoms of lateral epicondylitis resolve spontaneously within a year of symptom onset in 80% of cases, and only 3% of patients who seek medical treatment ultimately require surgical intervention within 2 years of symptom onset.1 Despite a relatively low percentage of patients who require surgery, Sanders and colleagues1 noted a significant increase in the rate of surgical intervention from 1.1% to 3.2% of cases in the last 15 years. Surgical intervention is generally indicated when pain and functional disability persist after 6 to 12 months of nonsurgical treatment. Traditional surgical treatment involves open release/débridement of the extensor carpi radialis (ECRB) origin; however, with the increasing prevalence of surgical intervention, surgeons have demonstrated a rising interest in less invasive techniques like arthroscopic release/débridement and percutaneous tenotomy as alternatives to traditional open débridement. While favorable results have been reported for all 3 techniques, there is no current consensus regarding the optimal surgical technique. In 2007, Lo and Safran2 reported no difference in the results of open, percutaneous, and arthroscopic techniques regarding any outcome measure in a systematic review of 33 papers. We conducted a repeat systematic review of the current literature to update Lo and Safran’s2 review and to ascertain if more recent literature demonstrates superiority of 1 technique regarding pain relief, subjective questionnaire data, subjective satisfaction, restoration of strength, and return to work. We hypothesized that return to work would be accelerated, pain decreased, and function improved in the early postoperative period in the arthroscopic and percutaneous groups, but there would be no difference in ultimate pain, functional outcome, or subjective satisfaction.
METHODS
SEARCH STRATEGY AND STUDY SELECTION
We conducted a systematic review of the literature to update the topic of surgical intervention with lateral epicondylitis since the publication of the most recent review by Lo and Safran2 in 2007, which included all relevant studies published up to 2004. To include all relevant studies published since that time, we searched PubMed (MEDLINE) for all literature published from January 1, 2004 to May 23, 2015 using the following key words: lateral epicondylitis AND (surgery OR operative OR surgical OR open OR arthroscopic OR percutaneous). General search terms were utilized to avoid unintentional exclusion of relevant studies. Two authors reviewed the abstracts of all resultant citations. Table 1 outlines the inclusion and exclusion criteria for the search. References from all included studies were reviewed for applicable articles that were not captured by the initial broad search strategy. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) trial flow chart shows the study selection algorithm (Figure 1).
Table 1. Inclusion and Exclusion Criteria for the Analyzed Studies
Inclusion Criteria | Exclusion Criteria |
|
|
DATA EXTRACTION AND ANALYSIS
Data were extracted from the included studies by 2 reviewers using data abstraction forms. All study, subject, and surgery parameters were collected. The study and subject demographic parameters analyzed included year of publication, level of evidence, presence of study financial conflict of interest, number of subjects and elbows, gender, age, proportion in whom the dominant extremity was involved, proportion who were laborers, proportion who had a workman’s compensation claim, duration of symptoms prior to surgical intervention, and surgical technique employed (open, arthroscopic, or percutaneous). We recorded the following clinical outcomes: proportion of patients with complete pain relief, proportion who were partially or completely satisfied, proportion who were improved, duration to return to work, grip strength, Disabilities of the Arm, Shoulder, and Hand (DASH) score, visual analog scale (VAS) pain score, and complication rate.
Continue to: Statistical analysis...
STATISTICAL ANALYSIS
Data from all studies were pooled and descriptive statistics were reported as weighted mean ± weighted standard deviation for continuous variables and frequency with percentage for categorical variables. A meta-analysis was performed for all outcome measures that were reported in 3 or more studies within a specific treatment cohort. Data were analyzed using 2-sample and 2-proportion Z-tests. Results were considered statistically significant at P < .05.
RESULTS
LITERATURE RESEARCH
Using the aforementioned search strategy, 154 studies were identified. Following application of the inclusion and exclusion criteria, 35 studies were included in the analysis (Figure 1). One study compared open and percutaneous techniques, and another compared arthroscopic and percutaneous techniques, rendering a total of 19 studies examining open surgical techniques for treatment of lateral epicondylitis,3-21 12 studies examining arthroscopic techniques,14,22-32 and 6 studies reporting percutaneous surgical treatment of lateral epicondylitis29,33-37 (Table 2). There was1 level I study (3%), 6 level III studies (17%), and 28 level IV studies (80%).
Table 2. Study Demographic Data for Open, Arthroscopic, and Percutaneous Lateral Epicondylectomy
| Open | Arthroscopic | Percutaneous | Total |
Number of studies | 19 | 12 | 6 | 35 |
Level of evidence |
|
|
|
|
I | 1 (5%) | 0 | 0 | 1 (3%) |
II | 0 | 0 | 0 | 0 |
III | 3 (16%) | 4 (33%) | 1 (17%) | 6 (17%) |
IV | 15 (79%) | 8 (67%) | 5 (83%) | 28 (80%) |
US: International | 8:12 | 3:9 | 1:5 | 12:24 |
Journals of publication |
|
|
|
|
AJSM | 3 | 1 | 1 | 5 |
JSES | 2 | 2 | 1 | 5 |
Arthroscopy | 2 | 2 | 0 | 3 |
KSSTA | 1 | 2 | 0 | 3 |
CORR | 0 | 2 | 0 | 2 |
JHS | 0 | 1 | 0 | 1 |
JOS | 1 | 1 | 0 | 2 |
AJO | 2 | 0 | 0 | 2 |
Other | 8 | 1 | 4 | 12 |
Abbreviations: AJO, The American Journal of Orthopedics; AJSM, American Journal of Sports Medicine; Arthroscopy, The Journal of Arthroscopy and Related Surgery; CORR, Clinical Orthopaedics & Related Research; JHS, Journal of Hand Surgery; JOS, Journal of Orthopaedic Surgery; JSES, Journal of Shoulder and Elbow Surgery; KSSTA, Knee Surgery, Sports Traumatology, and Arthroscopy.
SUBJECT DEMOGRAPHICS
The 35 included studies comprised 1579 patients and 1640 elbows. Among these, 1055 (64%) elbows underwent open (O), 401 (25%) underwent arthroscopic (A), and 184 (11%) underwent percutaneous (P) treatment. The average age was 45.7 years, 47% of the patients were male, 43% were laborers, 31% had worker’s compensation claims, and the dominant extremity was involved in 62% of patients. The percutaneous cohort was older than the open cohort (P = 46.9, O = 45.4, A = 45.8; P = .036). The duration of symptoms was shorter in the percutaneous cohort than in the other 2 groups and shorter in the arthroscopic cohort than in the open cohort (P = 8 months, O = 23 months, A = 18 months; P < .001). There were no significant differences between groups regarding gender, occupation, worker’s compensation status, or involvement of the dominant extremity (Table 3).
Table 3. Subject Demographics for Open, Arthroscopic, and Percutaneous Groups
| Open | Arthroscopic | Percutaneous |
Subjects (N) | 999 | 397 | 183 |
Elbows (N) | 1055 | 401 | 184 |
Elbows with follow-up (%) | 915 (87%) | 350 (87%) | 181 (98%) |
Males (%) | 427 (47%) | 173 (49%) | 78 (43%) |
Females (%) | 488 (53%) | 177 (51%) | 103 (57%) |
Mean age (years) | 45.4 | 45.8 | 46.9 |
Dominant elbow (%) | 70% | 69% | 53% |
Laborer (%) | 56% | 53% | 48% |
Work comp (%) | 36% | 30% | NR |
Symptoms to operation (months) | 23 | 18 | 8 |
Min. symptoms to operation (months) | 6 | 6 | 3 |
Mean follow-up (months) | 60 | 44 | 11 |
MATA-ANALYSIS CLINICAL OUTCOMES
Clinical outcome results were pooled for all studies reporting the same outcome measure for the same technique (open, arthroscopic, or percutaneous). A meta-analysis was performed for all outcome measures that were reported in a minimum of 3 studies utilizing the same surgical technique (Table 4).
PAIN RELIEF
Thirteen open studies,3,5,7,8,11-16,18,19,21 7 arthroscopic studies14,22-24,26,27,31 and 0 percutaneous studies reported the proportion of patients who were pain free at final follow-up. The proportion of patients who were pain free following open débridement was greater than that in the arthroscopic cohort (O = 70%, A = 60%; P = .009) (Table 4).
Continue to: Subjective improvement and satisfaction...
SUBJECTIVE IMPROVEMENT AND SATISFACTION
Nine open studies, 6 arthroscopic studies, and 1 percutaneous study reported the proportion of patients who felt that their condition had been improved as a result of surgery. There was no difference in the proportion of patients who experienced improvement between the open and arthroscopic cohorts. Four open studies,3,11,12 5 arthroscopic studies,22,26,28,29,32 and 2 percutaneous studies29,36 reported the proportion of patients who were satisfied or partially satisfied with the results of the procedure. There was no difference between the open and arthroscopic groups in the proportion of patients who were satisfied or partially satisfied (Table 4).
RETURN TO WORK
The duration to return to work following surgery was reported in 5 open studies,4,5,10,13,14 9 arthroscopic studies,14,23-29,32 and 2 percutaneous studies.29,36 There was no statistically significant difference between the open and arthroscopic groups with regard to duration to return to work (O = 6.5 weeks, A = 6 weeks; P = .601). The percutaneous technique could not be included in the meta-analysis due to the presence of only 2 studies, but the pooled mean duration to return to work in these 2 studies was 5.5 weeks (Table 4).
GRIP STRENGTH
Postoperative grip strength was reported in 2 open studies,10,19 4 arthroscopic studies,28,30,32 and 2 percutaneous studies.35-36 A meta-analysis could not be performed on all the groups due to the presence of only 2 open and 2 percutaneous studies reporting grip strength. The pooled averages were O = 38.3 kg, A = 34.8 kg, and P = 27.1 kg (Table 4).
DASH SCORE
The postoperative DASH score was reported in 4 open studies,4,15,17,19,20 5 arthroscopic studies,28-31 and 3 percutaneous studies.29,33,36 At final follow-up, the mean DASH score was higher in the arthroscopic group than in the open and percutaneous groups (A = 12.8, O = 19.5, P = 25.3; P < .001 for both comparisons), and the mean DASH score was significantly higher in the open group than in the percutaneous group (P = .029). The reporting of DASH scores in the early postoperative period was not sufficiently consistent to allow us to test our hypothesis that there would be early differences in function between groups (Table 4).
VAS PAIN SCORE
Postoperative VAS pain scores were reported in 11 open studies,6,8-10,12,15,19-21 8 arthroscopic studies,24-26,29-32 and 5 percutaneous studies.29,33,35-37 At final follow-up, there was a lower mean VAS score in the arthroscopic group than in the open and percutaneous groups (A = 1.1, O = 1.9, and P = 2.5; P < .001 for both comparisons) and a lower mean VAS score in the open group than in the percutaneous group (P = .002) (Table 4). Reporting of VAS scores in the early postoperative period in the included studies wan not sufficiently consistent to allow us to test our hypothesis that there would be early differences in pain between groups.
COMPLICATIONS
The complication rate was reported in 15 open studies, 10 arthroscopic studies, and 3 percutaneous studies. There was no difference in the complication rate between the open and arthroscopic techniques (O = 2.4%, A = 1.9%; P = .629) (Table 4). Complications noted in the open cohort included superficial wound infection (6), hematoma (5), synovial fistula (2), seroma (2), and posterior interosseous nerve palsy (1). Complications noted in the arthroscopic cohort included superficial infection (3), hematoma (1), and transient paresthesia (1). Of note, there were no complications in the percutaneous group.
Continue to: Discussion...
DISCUSSION
The primary purpose of this review was to determine if definitive evidence suggests that any 1 of open, percutaneous, or arthroscopic surgical treatment is superior to the other 2 for relieving pain, improving functionality, restoring strength, or accelerating return to work. The most striking finding of this study was a significantly higher proportion of patients who were pain free at final follow-up in the open group than in the arthroscopic group (70% vs 60%, P = .009) (Table 4). At final follow-up, there were no significant differences between groups regarding duration to return to work, proportion who were improved, proportion who were satisfied or partially satisfied, and complication rate. Average VAS and DASH scores at final follow-up were lower in the arthroscopic group than in the open and percutaneous groups (Figure 2). However, although the difference between mean DASH scores in the arthroscopic and open groups (6.7 points) was statistically significant, it is likely not clinically significant, as the minimal clinically important difference (MCID) for the DASH score is 10 points, as demonstrated by Sorensen and colleagues.38 Although it has not been specifically defined for lateral epicondylitis, the MCID for VAS pain has been reported in the literature to range from 1.0 to 1.4.39-40 Therefore, as for the DASH score, the difference witnessed between the open and arthroscopic groups (0.8) is likely not clinically significant. Of note, the differences between values for arthroscopic and percutaneous techniques are greater than the MCID.
In light of a recent increase in the prevalence of surgical intervention for lateral epicondylitis, many authors have promoted arthroscopic and percutaneous techniques as alternatives to traditional open débridement with the goal of achieving the same results with decreased morbidity and accelerated return to work. Given the increased proportion of patients who were pain free at final follow-up in the open cohort, it is our contention that open release/débridement of the common extensor/ECRB origin allows the surgeon to fully appreciate the extent of tendinotic tissue that is contributing to the patient’s symptoms and to address the pathology in its entirety. Other authors have also questioned whether the full extent of extra-articular tendinosis can be accurately identified arthroscopically. Cummins41 demonstrated, in a series of 18 patients who underwent arthroscopic ECRB débridement, that 6 patients had residual tendinosis upon open evaluation and 10 had residual tendinosis on histologic assessment. Additionally, in the same series, residual tendinopathy was associated with poorer clinical outcomes.
The improved visualization associated with an open technique comes at minimal expense, as the incision was only 1.5 cm to 5 cm in 13 of 15 papers reporting incision length.3,4,6,8-11,13,15,18-20 This increased exposure may not translate into increased morbidity, as there was no increase in the duration to return to work nor the complication rate. As a result of the extensive instrumentation necessary for arthroscopic techniques, open techniques also appear to be less expensive. Analyses in the literature have suggested increased expenditures associated with arthroscopic treatment ranging from 23%42 to 100%43 greater than those of open treatment.
Although obvious, it should be noted that a percutaneous tenotomy does not permit assessment of the extent of pathologic tendinosis. As a result of an inability to visualize and débride pathologic tissue, percutaneous tenotomy rendered inferior outcomes to open and arthroscopic techniques in terms of both postoperative VAS pain score and DASH score. Nonetheless, it is a relatively rapid and simple technique and resulted in zero complications in 184 elbows. Overall, percutaneous tenotomy appears to be an inferior technique to open and arthroscopic techniques in terms of achieving complete pain relief and optimal functional recovery; however, it may be useful in those who wish to avoid a more invasive intervention.
LIMITATIONS
The most significant limitation of this study was the heterogeneity in the techniques utilized in each group. Among the 19 papers in the open cohort, 11 used techniques aimed at lengthening or release of the extensor origin, 7 performed débridement of tendinotic tissue at the ECRB origin, and 1 compared these approaches. Exposures ranged from 1.5 cm to 8 cm in length, 3 techniques added tendon repair following débridement, and 2 utilized a radiofrequency device.
Among the 12 papers in the arthroscopic cohort, 8 performed arthroscopic (inside-out) débridement of the tendinotic tissue at the ECRB origin, 3 performed arthroscopic release of the ECRB tendon, and 1 performed endoscopic ECRB release in an outside-in fashion. Four techniques added posterior synovial plica excision and 4 added decortication of the lateral epicondyle débridement or release. Some authors advocate for arthroscopic intervention on the grounds that it permits evaluation and correction of other intra-articular pathology. With this in mind, some authors have suggested that a synovial fold (plica) adjacent to the radiocapitellar joint may contribute to lateral elbow pain.27,44 Nevertheless, in the only comparative trial in the literature, Rhyou and Kim30 demonstrated that excision of posterior synovial fold failed to enhance pain relief or function in a retrospective cohort study comparing arthroscopic débridement with and without plica excision.
Continue to: Some authors advocate...
Some authors advocate decorticating the non-articular, lateral epicondyle with a shaver to stimulate bleeding and promote a healing response. However, 1 study in our review compared arthroscopic ECRB release with and without decortication and found that decortication significantly increased pain up to 4 weeks postoperatively, increased duration to return to work, and did not improve the ultimate clinical result.25 Of note, others have used a similar rationale to advocate drilling the lateral epicondyle when utilizing an open technique. However, Dunn and colleagues8 note that they have modified the Nirschl technique to eliminate drilling because they feel it increases postoperative pain and may damage the extensor digitorum communis origin.
Among the 6 papers in the percutaneous tenotomy cohort, 2 performed tenotomy with a hypodermic needle, 2 with a scalpel through a limited incision (0.5 cm-1 cm), 1 using a TX1 tissue removal system (Tenex Health), and 1 with a percutaneous radiofrequency probe. In 3 techniques, ultrasound was used to direct the tenotomy.
The quality of this review is also limited by the studies included for analysis, as with any systematic review. Because 28 of the 35 included studies were classified as evidence level IV, the likelihood of methodological bias is increased. The majority of studies contained ≥1 demonstrable biases, including selection, detection, attrition biases, or a combination. Selection bias is prevalent among predominantly level IV studies, in which the authors have selected their preferred surgical technique. There was heterogeneity in the reporting of preoperative variables and the outcome measures that were utilized. Scoring systems, such as the Nirschl Tennis Elbow Score and the Mayo Elbow Performance Index, would have been valuable in comparing the groups had they been more consistently reported. The heterogeneity in clinical outcome tools and the lack of reported outcome variance or standard deviations prevented a formal meta-analysis of some of these outcome measures. Due to inconsistent reporting, we were also unable to test our hypothesis that there would be less pain and improved function in the arthroscopic and/or percutaneous cohorts in the early postoperative period compared to the open cohort due to the less invasive techniques used. Although the differences in DASH and VAS scores at final follow-up likely did not meet the MCID threshold, these differences may have been greater and more clinically relevant in the early postoperative period.
CONCLUSION
We hypothesized that the arthroscopic and percutaneous groups would experience accelerated return to work and reduced pain in the early postoperative period but no difference in ultimate pain, functional outcome, or subjective satisfaction. There is no difference between open, arthroscopic, and percutaneous surgical treatment for lateral epicondylitis regarding return to work and subjective satisfaction; however, open treatment led to a greater percentage of patients being pain free at final follow-up. While arthroscopic treatment led to better pain and functional scores at final follow-up, the absolute differences were quite small and likely not clinically significant. In light of the available evidence, we recommend open débridement as the best means of minimizing cost and achieving a pain-free outcome in the long term. For future investigators, it would be useful to perform a randomized clinical study directly comparing open, arthroscopic, and percutaneous techniques, including assessment of pain and functional scores in the early postoperative period, and to further evaluate differences in cost among the various techniques.
This paper will be judged for the Resident Writer’s Award.
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- Bigorre N, Raimbeau G, Fouque PA, Cast YS, Rabarin F, Cesari B. Lateral epicondylitis treatment by extensor carpi radialis fasciotomy and radial nerve decompression: is outcome influenced by the occupational disease compensation aspect? Orthop Traumatol Surg Res. 2011;97(2):159-163. doi:10.1016/j.otsr.2010.11.007.
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- Dunn JH, Kim JJ, Davis L, Nirschl RP. Ten- to 14-year follow-up of the Nirschl surgical technique for lateral epicondylitis. Am J Sports Med. 2008;36(2):261-266. doi:10.1177/0363546507308932.
- Manon-Matos Y, Oron A, Wolff TW. Combined common extensor and supinator aponeurotomy for the treatment of lateral epicondylitis. Tech Hand Up Extrem Surg. 2013;17(3):179-181. doi:10.1097/BTH.0b013e31829e0eeb.
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- Pruzansky ME, Gantsoudes GD, Watters N. Late surgical results of reattachment to bone in repair of chronic lateral epicondylitis. Am J Orthop. 2009;38(6):295-299.
- Rayan F, Rao V Sr, Purushothamdas S, Mukundan C, Shafqat SO. Common extensor origin release in recalcitrant lateral epicondylitis – role justified? J Orthop Surg Res. 2010;5:31. doi:10.1186/1749-799X-5-31.
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- Rubenthaler F, Wiese M, Senge A, Keller L, Wittenberg RH. Long-term follow-up of open and endoscopic Hohmann procedures for lateral epicondylitis. Arthroscopy. 2005;21(6):684-690. doi:10.1016/j.arthro.2005.03.017.
- Ruch DS, Orr SB, Richard MJ, Leversedge FJ, Mithani SK, Laino DK. A comparison of debridement with and without anconeus muscle flap for treatment of refractory lateral epicondylitis. J Shoulder Elbow Surg. 2015;24(2):236-241. doi:10.1016/j.jse.2014.09.035.
- Siddiqui MA, Koh J, Kua J, Cheung T, Chang P. Functional outcome assessment after open tennis elbow release: what are the predictor parameters? Singapore Med J. 2011;52(2):73-76.
- Solheim E, Hegna J, Øyen J. Extensor tendon release in tennis elbow: results and prognostic factors in 80 elbows. Knee Surg Sports Traumatol Arthrosc. 2011;19(6):1023-1027. doi:10.1007/s00167-011-1477-1.
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- Grewal R, MacDermid JC, Shah P, King GJ. Functional outcome of arthroscopic extensor carpi radialis brevis tendon release in chronic lateral epicondylitis. J Hand Surg Am. 2009;34(5):849-857. doi:10.1016/j.jhsa.2009.02.006.
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- Wada T, Moriya T, Iba K, et al. Functional outcomes after arthroscopic treatment of lateral epicondylitis. J Orthop Sci. 2009;14(2):167-174. doi:10.1007/s00776-008-1304-9.
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ABSTRACT
This study was performed to compare outcomes of open, arthroscopic, and percutaneous surgical techniques for lateral epicondylitis. We searched PubMed (MEDLINE) for literature published between January 1, 2004 and May 23, 2015 using these key words: lateral epicondylitis AND (surgery OR operative OR surgical OR open OR arthroscopic OR percutaneous). Meta-analyses were performed for outcomes reported in 3 studies using 2-sample and 2-proportion Z-tests. Thirty-five studies including 1640 elbows (1055 open, 401 arthroscopic, 184 percutaneous) met the inclusion criteria. There were no differences between groups regarding duration to return to work, complication rate, or patient satisfaction. A greater proportion of patients were pain free in the open group than in the arthroscopic group (70% vs 60%). Despite the absence of a difference among techniques regarding return to work and subjective function, we recommend open débridement as the technique most likely to achieve a pain-free outcome.
Continue to: Lateral epicondylitis affects...
Lateral epicondylitis affects 1% to 3% of adults each year. Although common, symptoms of lateral epicondylitis resolve spontaneously within a year of symptom onset in 80% of cases, and only 3% of patients who seek medical treatment ultimately require surgical intervention within 2 years of symptom onset.1 Despite a relatively low percentage of patients who require surgery, Sanders and colleagues1 noted a significant increase in the rate of surgical intervention from 1.1% to 3.2% of cases in the last 15 years. Surgical intervention is generally indicated when pain and functional disability persist after 6 to 12 months of nonsurgical treatment. Traditional surgical treatment involves open release/débridement of the extensor carpi radialis (ECRB) origin; however, with the increasing prevalence of surgical intervention, surgeons have demonstrated a rising interest in less invasive techniques like arthroscopic release/débridement and percutaneous tenotomy as alternatives to traditional open débridement. While favorable results have been reported for all 3 techniques, there is no current consensus regarding the optimal surgical technique. In 2007, Lo and Safran2 reported no difference in the results of open, percutaneous, and arthroscopic techniques regarding any outcome measure in a systematic review of 33 papers. We conducted a repeat systematic review of the current literature to update Lo and Safran’s2 review and to ascertain if more recent literature demonstrates superiority of 1 technique regarding pain relief, subjective questionnaire data, subjective satisfaction, restoration of strength, and return to work. We hypothesized that return to work would be accelerated, pain decreased, and function improved in the early postoperative period in the arthroscopic and percutaneous groups, but there would be no difference in ultimate pain, functional outcome, or subjective satisfaction.
METHODS
SEARCH STRATEGY AND STUDY SELECTION
We conducted a systematic review of the literature to update the topic of surgical intervention with lateral epicondylitis since the publication of the most recent review by Lo and Safran2 in 2007, which included all relevant studies published up to 2004. To include all relevant studies published since that time, we searched PubMed (MEDLINE) for all literature published from January 1, 2004 to May 23, 2015 using the following key words: lateral epicondylitis AND (surgery OR operative OR surgical OR open OR arthroscopic OR percutaneous). General search terms were utilized to avoid unintentional exclusion of relevant studies. Two authors reviewed the abstracts of all resultant citations. Table 1 outlines the inclusion and exclusion criteria for the search. References from all included studies were reviewed for applicable articles that were not captured by the initial broad search strategy. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) trial flow chart shows the study selection algorithm (Figure 1).
Table 1. Inclusion and Exclusion Criteria for the Analyzed Studies
Inclusion Criteria | Exclusion Criteria |
|
|
DATA EXTRACTION AND ANALYSIS
Data were extracted from the included studies by 2 reviewers using data abstraction forms. All study, subject, and surgery parameters were collected. The study and subject demographic parameters analyzed included year of publication, level of evidence, presence of study financial conflict of interest, number of subjects and elbows, gender, age, proportion in whom the dominant extremity was involved, proportion who were laborers, proportion who had a workman’s compensation claim, duration of symptoms prior to surgical intervention, and surgical technique employed (open, arthroscopic, or percutaneous). We recorded the following clinical outcomes: proportion of patients with complete pain relief, proportion who were partially or completely satisfied, proportion who were improved, duration to return to work, grip strength, Disabilities of the Arm, Shoulder, and Hand (DASH) score, visual analog scale (VAS) pain score, and complication rate.
Continue to: Statistical analysis...
STATISTICAL ANALYSIS
Data from all studies were pooled and descriptive statistics were reported as weighted mean ± weighted standard deviation for continuous variables and frequency with percentage for categorical variables. A meta-analysis was performed for all outcome measures that were reported in 3 or more studies within a specific treatment cohort. Data were analyzed using 2-sample and 2-proportion Z-tests. Results were considered statistically significant at P < .05.
RESULTS
LITERATURE RESEARCH
Using the aforementioned search strategy, 154 studies were identified. Following application of the inclusion and exclusion criteria, 35 studies were included in the analysis (Figure 1). One study compared open and percutaneous techniques, and another compared arthroscopic and percutaneous techniques, rendering a total of 19 studies examining open surgical techniques for treatment of lateral epicondylitis,3-21 12 studies examining arthroscopic techniques,14,22-32 and 6 studies reporting percutaneous surgical treatment of lateral epicondylitis29,33-37 (Table 2). There was1 level I study (3%), 6 level III studies (17%), and 28 level IV studies (80%).
Table 2. Study Demographic Data for Open, Arthroscopic, and Percutaneous Lateral Epicondylectomy
| Open | Arthroscopic | Percutaneous | Total |
Number of studies | 19 | 12 | 6 | 35 |
Level of evidence |
|
|
|
|
I | 1 (5%) | 0 | 0 | 1 (3%) |
II | 0 | 0 | 0 | 0 |
III | 3 (16%) | 4 (33%) | 1 (17%) | 6 (17%) |
IV | 15 (79%) | 8 (67%) | 5 (83%) | 28 (80%) |
US: International | 8:12 | 3:9 | 1:5 | 12:24 |
Journals of publication |
|
|
|
|
AJSM | 3 | 1 | 1 | 5 |
JSES | 2 | 2 | 1 | 5 |
Arthroscopy | 2 | 2 | 0 | 3 |
KSSTA | 1 | 2 | 0 | 3 |
CORR | 0 | 2 | 0 | 2 |
JHS | 0 | 1 | 0 | 1 |
JOS | 1 | 1 | 0 | 2 |
AJO | 2 | 0 | 0 | 2 |
Other | 8 | 1 | 4 | 12 |
Abbreviations: AJO, The American Journal of Orthopedics; AJSM, American Journal of Sports Medicine; Arthroscopy, The Journal of Arthroscopy and Related Surgery; CORR, Clinical Orthopaedics & Related Research; JHS, Journal of Hand Surgery; JOS, Journal of Orthopaedic Surgery; JSES, Journal of Shoulder and Elbow Surgery; KSSTA, Knee Surgery, Sports Traumatology, and Arthroscopy.
SUBJECT DEMOGRAPHICS
The 35 included studies comprised 1579 patients and 1640 elbows. Among these, 1055 (64%) elbows underwent open (O), 401 (25%) underwent arthroscopic (A), and 184 (11%) underwent percutaneous (P) treatment. The average age was 45.7 years, 47% of the patients were male, 43% were laborers, 31% had worker’s compensation claims, and the dominant extremity was involved in 62% of patients. The percutaneous cohort was older than the open cohort (P = 46.9, O = 45.4, A = 45.8; P = .036). The duration of symptoms was shorter in the percutaneous cohort than in the other 2 groups and shorter in the arthroscopic cohort than in the open cohort (P = 8 months, O = 23 months, A = 18 months; P < .001). There were no significant differences between groups regarding gender, occupation, worker’s compensation status, or involvement of the dominant extremity (Table 3).
Table 3. Subject Demographics for Open, Arthroscopic, and Percutaneous Groups
| Open | Arthroscopic | Percutaneous |
Subjects (N) | 999 | 397 | 183 |
Elbows (N) | 1055 | 401 | 184 |
Elbows with follow-up (%) | 915 (87%) | 350 (87%) | 181 (98%) |
Males (%) | 427 (47%) | 173 (49%) | 78 (43%) |
Females (%) | 488 (53%) | 177 (51%) | 103 (57%) |
Mean age (years) | 45.4 | 45.8 | 46.9 |
Dominant elbow (%) | 70% | 69% | 53% |
Laborer (%) | 56% | 53% | 48% |
Work comp (%) | 36% | 30% | NR |
Symptoms to operation (months) | 23 | 18 | 8 |
Min. symptoms to operation (months) | 6 | 6 | 3 |
Mean follow-up (months) | 60 | 44 | 11 |
MATA-ANALYSIS CLINICAL OUTCOMES
Clinical outcome results were pooled for all studies reporting the same outcome measure for the same technique (open, arthroscopic, or percutaneous). A meta-analysis was performed for all outcome measures that were reported in a minimum of 3 studies utilizing the same surgical technique (Table 4).
PAIN RELIEF
Thirteen open studies,3,5,7,8,11-16,18,19,21 7 arthroscopic studies14,22-24,26,27,31 and 0 percutaneous studies reported the proportion of patients who were pain free at final follow-up. The proportion of patients who were pain free following open débridement was greater than that in the arthroscopic cohort (O = 70%, A = 60%; P = .009) (Table 4).
Continue to: Subjective improvement and satisfaction...
SUBJECTIVE IMPROVEMENT AND SATISFACTION
Nine open studies, 6 arthroscopic studies, and 1 percutaneous study reported the proportion of patients who felt that their condition had been improved as a result of surgery. There was no difference in the proportion of patients who experienced improvement between the open and arthroscopic cohorts. Four open studies,3,11,12 5 arthroscopic studies,22,26,28,29,32 and 2 percutaneous studies29,36 reported the proportion of patients who were satisfied or partially satisfied with the results of the procedure. There was no difference between the open and arthroscopic groups in the proportion of patients who were satisfied or partially satisfied (Table 4).
RETURN TO WORK
The duration to return to work following surgery was reported in 5 open studies,4,5,10,13,14 9 arthroscopic studies,14,23-29,32 and 2 percutaneous studies.29,36 There was no statistically significant difference between the open and arthroscopic groups with regard to duration to return to work (O = 6.5 weeks, A = 6 weeks; P = .601). The percutaneous technique could not be included in the meta-analysis due to the presence of only 2 studies, but the pooled mean duration to return to work in these 2 studies was 5.5 weeks (Table 4).
GRIP STRENGTH
Postoperative grip strength was reported in 2 open studies,10,19 4 arthroscopic studies,28,30,32 and 2 percutaneous studies.35-36 A meta-analysis could not be performed on all the groups due to the presence of only 2 open and 2 percutaneous studies reporting grip strength. The pooled averages were O = 38.3 kg, A = 34.8 kg, and P = 27.1 kg (Table 4).
DASH SCORE
The postoperative DASH score was reported in 4 open studies,4,15,17,19,20 5 arthroscopic studies,28-31 and 3 percutaneous studies.29,33,36 At final follow-up, the mean DASH score was higher in the arthroscopic group than in the open and percutaneous groups (A = 12.8, O = 19.5, P = 25.3; P < .001 for both comparisons), and the mean DASH score was significantly higher in the open group than in the percutaneous group (P = .029). The reporting of DASH scores in the early postoperative period was not sufficiently consistent to allow us to test our hypothesis that there would be early differences in function between groups (Table 4).
VAS PAIN SCORE
Postoperative VAS pain scores were reported in 11 open studies,6,8-10,12,15,19-21 8 arthroscopic studies,24-26,29-32 and 5 percutaneous studies.29,33,35-37 At final follow-up, there was a lower mean VAS score in the arthroscopic group than in the open and percutaneous groups (A = 1.1, O = 1.9, and P = 2.5; P < .001 for both comparisons) and a lower mean VAS score in the open group than in the percutaneous group (P = .002) (Table 4). Reporting of VAS scores in the early postoperative period in the included studies wan not sufficiently consistent to allow us to test our hypothesis that there would be early differences in pain between groups.
COMPLICATIONS
The complication rate was reported in 15 open studies, 10 arthroscopic studies, and 3 percutaneous studies. There was no difference in the complication rate between the open and arthroscopic techniques (O = 2.4%, A = 1.9%; P = .629) (Table 4). Complications noted in the open cohort included superficial wound infection (6), hematoma (5), synovial fistula (2), seroma (2), and posterior interosseous nerve palsy (1). Complications noted in the arthroscopic cohort included superficial infection (3), hematoma (1), and transient paresthesia (1). Of note, there were no complications in the percutaneous group.
Continue to: Discussion...
DISCUSSION
The primary purpose of this review was to determine if definitive evidence suggests that any 1 of open, percutaneous, or arthroscopic surgical treatment is superior to the other 2 for relieving pain, improving functionality, restoring strength, or accelerating return to work. The most striking finding of this study was a significantly higher proportion of patients who were pain free at final follow-up in the open group than in the arthroscopic group (70% vs 60%, P = .009) (Table 4). At final follow-up, there were no significant differences between groups regarding duration to return to work, proportion who were improved, proportion who were satisfied or partially satisfied, and complication rate. Average VAS and DASH scores at final follow-up were lower in the arthroscopic group than in the open and percutaneous groups (Figure 2). However, although the difference between mean DASH scores in the arthroscopic and open groups (6.7 points) was statistically significant, it is likely not clinically significant, as the minimal clinically important difference (MCID) for the DASH score is 10 points, as demonstrated by Sorensen and colleagues.38 Although it has not been specifically defined for lateral epicondylitis, the MCID for VAS pain has been reported in the literature to range from 1.0 to 1.4.39-40 Therefore, as for the DASH score, the difference witnessed between the open and arthroscopic groups (0.8) is likely not clinically significant. Of note, the differences between values for arthroscopic and percutaneous techniques are greater than the MCID.
In light of a recent increase in the prevalence of surgical intervention for lateral epicondylitis, many authors have promoted arthroscopic and percutaneous techniques as alternatives to traditional open débridement with the goal of achieving the same results with decreased morbidity and accelerated return to work. Given the increased proportion of patients who were pain free at final follow-up in the open cohort, it is our contention that open release/débridement of the common extensor/ECRB origin allows the surgeon to fully appreciate the extent of tendinotic tissue that is contributing to the patient’s symptoms and to address the pathology in its entirety. Other authors have also questioned whether the full extent of extra-articular tendinosis can be accurately identified arthroscopically. Cummins41 demonstrated, in a series of 18 patients who underwent arthroscopic ECRB débridement, that 6 patients had residual tendinosis upon open evaluation and 10 had residual tendinosis on histologic assessment. Additionally, in the same series, residual tendinopathy was associated with poorer clinical outcomes.
The improved visualization associated with an open technique comes at minimal expense, as the incision was only 1.5 cm to 5 cm in 13 of 15 papers reporting incision length.3,4,6,8-11,13,15,18-20 This increased exposure may not translate into increased morbidity, as there was no increase in the duration to return to work nor the complication rate. As a result of the extensive instrumentation necessary for arthroscopic techniques, open techniques also appear to be less expensive. Analyses in the literature have suggested increased expenditures associated with arthroscopic treatment ranging from 23%42 to 100%43 greater than those of open treatment.
Although obvious, it should be noted that a percutaneous tenotomy does not permit assessment of the extent of pathologic tendinosis. As a result of an inability to visualize and débride pathologic tissue, percutaneous tenotomy rendered inferior outcomes to open and arthroscopic techniques in terms of both postoperative VAS pain score and DASH score. Nonetheless, it is a relatively rapid and simple technique and resulted in zero complications in 184 elbows. Overall, percutaneous tenotomy appears to be an inferior technique to open and arthroscopic techniques in terms of achieving complete pain relief and optimal functional recovery; however, it may be useful in those who wish to avoid a more invasive intervention.
LIMITATIONS
The most significant limitation of this study was the heterogeneity in the techniques utilized in each group. Among the 19 papers in the open cohort, 11 used techniques aimed at lengthening or release of the extensor origin, 7 performed débridement of tendinotic tissue at the ECRB origin, and 1 compared these approaches. Exposures ranged from 1.5 cm to 8 cm in length, 3 techniques added tendon repair following débridement, and 2 utilized a radiofrequency device.
Among the 12 papers in the arthroscopic cohort, 8 performed arthroscopic (inside-out) débridement of the tendinotic tissue at the ECRB origin, 3 performed arthroscopic release of the ECRB tendon, and 1 performed endoscopic ECRB release in an outside-in fashion. Four techniques added posterior synovial plica excision and 4 added decortication of the lateral epicondyle débridement or release. Some authors advocate for arthroscopic intervention on the grounds that it permits evaluation and correction of other intra-articular pathology. With this in mind, some authors have suggested that a synovial fold (plica) adjacent to the radiocapitellar joint may contribute to lateral elbow pain.27,44 Nevertheless, in the only comparative trial in the literature, Rhyou and Kim30 demonstrated that excision of posterior synovial fold failed to enhance pain relief or function in a retrospective cohort study comparing arthroscopic débridement with and without plica excision.
Continue to: Some authors advocate...
Some authors advocate decorticating the non-articular, lateral epicondyle with a shaver to stimulate bleeding and promote a healing response. However, 1 study in our review compared arthroscopic ECRB release with and without decortication and found that decortication significantly increased pain up to 4 weeks postoperatively, increased duration to return to work, and did not improve the ultimate clinical result.25 Of note, others have used a similar rationale to advocate drilling the lateral epicondyle when utilizing an open technique. However, Dunn and colleagues8 note that they have modified the Nirschl technique to eliminate drilling because they feel it increases postoperative pain and may damage the extensor digitorum communis origin.
Among the 6 papers in the percutaneous tenotomy cohort, 2 performed tenotomy with a hypodermic needle, 2 with a scalpel through a limited incision (0.5 cm-1 cm), 1 using a TX1 tissue removal system (Tenex Health), and 1 with a percutaneous radiofrequency probe. In 3 techniques, ultrasound was used to direct the tenotomy.
The quality of this review is also limited by the studies included for analysis, as with any systematic review. Because 28 of the 35 included studies were classified as evidence level IV, the likelihood of methodological bias is increased. The majority of studies contained ≥1 demonstrable biases, including selection, detection, attrition biases, or a combination. Selection bias is prevalent among predominantly level IV studies, in which the authors have selected their preferred surgical technique. There was heterogeneity in the reporting of preoperative variables and the outcome measures that were utilized. Scoring systems, such as the Nirschl Tennis Elbow Score and the Mayo Elbow Performance Index, would have been valuable in comparing the groups had they been more consistently reported. The heterogeneity in clinical outcome tools and the lack of reported outcome variance or standard deviations prevented a formal meta-analysis of some of these outcome measures. Due to inconsistent reporting, we were also unable to test our hypothesis that there would be less pain and improved function in the arthroscopic and/or percutaneous cohorts in the early postoperative period compared to the open cohort due to the less invasive techniques used. Although the differences in DASH and VAS scores at final follow-up likely did not meet the MCID threshold, these differences may have been greater and more clinically relevant in the early postoperative period.
CONCLUSION
We hypothesized that the arthroscopic and percutaneous groups would experience accelerated return to work and reduced pain in the early postoperative period but no difference in ultimate pain, functional outcome, or subjective satisfaction. There is no difference between open, arthroscopic, and percutaneous surgical treatment for lateral epicondylitis regarding return to work and subjective satisfaction; however, open treatment led to a greater percentage of patients being pain free at final follow-up. While arthroscopic treatment led to better pain and functional scores at final follow-up, the absolute differences were quite small and likely not clinically significant. In light of the available evidence, we recommend open débridement as the best means of minimizing cost and achieving a pain-free outcome in the long term. For future investigators, it would be useful to perform a randomized clinical study directly comparing open, arthroscopic, and percutaneous techniques, including assessment of pain and functional scores in the early postoperative period, and to further evaluate differences in cost among the various techniques.
This paper will be judged for the Resident Writer’s Award.
ABSTRACT
This study was performed to compare outcomes of open, arthroscopic, and percutaneous surgical techniques for lateral epicondylitis. We searched PubMed (MEDLINE) for literature published between January 1, 2004 and May 23, 2015 using these key words: lateral epicondylitis AND (surgery OR operative OR surgical OR open OR arthroscopic OR percutaneous). Meta-analyses were performed for outcomes reported in 3 studies using 2-sample and 2-proportion Z-tests. Thirty-five studies including 1640 elbows (1055 open, 401 arthroscopic, 184 percutaneous) met the inclusion criteria. There were no differences between groups regarding duration to return to work, complication rate, or patient satisfaction. A greater proportion of patients were pain free in the open group than in the arthroscopic group (70% vs 60%). Despite the absence of a difference among techniques regarding return to work and subjective function, we recommend open débridement as the technique most likely to achieve a pain-free outcome.
Continue to: Lateral epicondylitis affects...
Lateral epicondylitis affects 1% to 3% of adults each year. Although common, symptoms of lateral epicondylitis resolve spontaneously within a year of symptom onset in 80% of cases, and only 3% of patients who seek medical treatment ultimately require surgical intervention within 2 years of symptom onset.1 Despite a relatively low percentage of patients who require surgery, Sanders and colleagues1 noted a significant increase in the rate of surgical intervention from 1.1% to 3.2% of cases in the last 15 years. Surgical intervention is generally indicated when pain and functional disability persist after 6 to 12 months of nonsurgical treatment. Traditional surgical treatment involves open release/débridement of the extensor carpi radialis (ECRB) origin; however, with the increasing prevalence of surgical intervention, surgeons have demonstrated a rising interest in less invasive techniques like arthroscopic release/débridement and percutaneous tenotomy as alternatives to traditional open débridement. While favorable results have been reported for all 3 techniques, there is no current consensus regarding the optimal surgical technique. In 2007, Lo and Safran2 reported no difference in the results of open, percutaneous, and arthroscopic techniques regarding any outcome measure in a systematic review of 33 papers. We conducted a repeat systematic review of the current literature to update Lo and Safran’s2 review and to ascertain if more recent literature demonstrates superiority of 1 technique regarding pain relief, subjective questionnaire data, subjective satisfaction, restoration of strength, and return to work. We hypothesized that return to work would be accelerated, pain decreased, and function improved in the early postoperative period in the arthroscopic and percutaneous groups, but there would be no difference in ultimate pain, functional outcome, or subjective satisfaction.
METHODS
SEARCH STRATEGY AND STUDY SELECTION
We conducted a systematic review of the literature to update the topic of surgical intervention with lateral epicondylitis since the publication of the most recent review by Lo and Safran2 in 2007, which included all relevant studies published up to 2004. To include all relevant studies published since that time, we searched PubMed (MEDLINE) for all literature published from January 1, 2004 to May 23, 2015 using the following key words: lateral epicondylitis AND (surgery OR operative OR surgical OR open OR arthroscopic OR percutaneous). General search terms were utilized to avoid unintentional exclusion of relevant studies. Two authors reviewed the abstracts of all resultant citations. Table 1 outlines the inclusion and exclusion criteria for the search. References from all included studies were reviewed for applicable articles that were not captured by the initial broad search strategy. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) trial flow chart shows the study selection algorithm (Figure 1).
Table 1. Inclusion and Exclusion Criteria for the Analyzed Studies
Inclusion Criteria | Exclusion Criteria |
|
|
DATA EXTRACTION AND ANALYSIS
Data were extracted from the included studies by 2 reviewers using data abstraction forms. All study, subject, and surgery parameters were collected. The study and subject demographic parameters analyzed included year of publication, level of evidence, presence of study financial conflict of interest, number of subjects and elbows, gender, age, proportion in whom the dominant extremity was involved, proportion who were laborers, proportion who had a workman’s compensation claim, duration of symptoms prior to surgical intervention, and surgical technique employed (open, arthroscopic, or percutaneous). We recorded the following clinical outcomes: proportion of patients with complete pain relief, proportion who were partially or completely satisfied, proportion who were improved, duration to return to work, grip strength, Disabilities of the Arm, Shoulder, and Hand (DASH) score, visual analog scale (VAS) pain score, and complication rate.
Continue to: Statistical analysis...
STATISTICAL ANALYSIS
Data from all studies were pooled and descriptive statistics were reported as weighted mean ± weighted standard deviation for continuous variables and frequency with percentage for categorical variables. A meta-analysis was performed for all outcome measures that were reported in 3 or more studies within a specific treatment cohort. Data were analyzed using 2-sample and 2-proportion Z-tests. Results were considered statistically significant at P < .05.
RESULTS
LITERATURE RESEARCH
Using the aforementioned search strategy, 154 studies were identified. Following application of the inclusion and exclusion criteria, 35 studies were included in the analysis (Figure 1). One study compared open and percutaneous techniques, and another compared arthroscopic and percutaneous techniques, rendering a total of 19 studies examining open surgical techniques for treatment of lateral epicondylitis,3-21 12 studies examining arthroscopic techniques,14,22-32 and 6 studies reporting percutaneous surgical treatment of lateral epicondylitis29,33-37 (Table 2). There was1 level I study (3%), 6 level III studies (17%), and 28 level IV studies (80%).
Table 2. Study Demographic Data for Open, Arthroscopic, and Percutaneous Lateral Epicondylectomy
| Open | Arthroscopic | Percutaneous | Total |
Number of studies | 19 | 12 | 6 | 35 |
Level of evidence |
|
|
|
|
I | 1 (5%) | 0 | 0 | 1 (3%) |
II | 0 | 0 | 0 | 0 |
III | 3 (16%) | 4 (33%) | 1 (17%) | 6 (17%) |
IV | 15 (79%) | 8 (67%) | 5 (83%) | 28 (80%) |
US: International | 8:12 | 3:9 | 1:5 | 12:24 |
Journals of publication |
|
|
|
|
AJSM | 3 | 1 | 1 | 5 |
JSES | 2 | 2 | 1 | 5 |
Arthroscopy | 2 | 2 | 0 | 3 |
KSSTA | 1 | 2 | 0 | 3 |
CORR | 0 | 2 | 0 | 2 |
JHS | 0 | 1 | 0 | 1 |
JOS | 1 | 1 | 0 | 2 |
AJO | 2 | 0 | 0 | 2 |
Other | 8 | 1 | 4 | 12 |
Abbreviations: AJO, The American Journal of Orthopedics; AJSM, American Journal of Sports Medicine; Arthroscopy, The Journal of Arthroscopy and Related Surgery; CORR, Clinical Orthopaedics & Related Research; JHS, Journal of Hand Surgery; JOS, Journal of Orthopaedic Surgery; JSES, Journal of Shoulder and Elbow Surgery; KSSTA, Knee Surgery, Sports Traumatology, and Arthroscopy.
SUBJECT DEMOGRAPHICS
The 35 included studies comprised 1579 patients and 1640 elbows. Among these, 1055 (64%) elbows underwent open (O), 401 (25%) underwent arthroscopic (A), and 184 (11%) underwent percutaneous (P) treatment. The average age was 45.7 years, 47% of the patients were male, 43% were laborers, 31% had worker’s compensation claims, and the dominant extremity was involved in 62% of patients. The percutaneous cohort was older than the open cohort (P = 46.9, O = 45.4, A = 45.8; P = .036). The duration of symptoms was shorter in the percutaneous cohort than in the other 2 groups and shorter in the arthroscopic cohort than in the open cohort (P = 8 months, O = 23 months, A = 18 months; P < .001). There were no significant differences between groups regarding gender, occupation, worker’s compensation status, or involvement of the dominant extremity (Table 3).
Table 3. Subject Demographics for Open, Arthroscopic, and Percutaneous Groups
| Open | Arthroscopic | Percutaneous |
Subjects (N) | 999 | 397 | 183 |
Elbows (N) | 1055 | 401 | 184 |
Elbows with follow-up (%) | 915 (87%) | 350 (87%) | 181 (98%) |
Males (%) | 427 (47%) | 173 (49%) | 78 (43%) |
Females (%) | 488 (53%) | 177 (51%) | 103 (57%) |
Mean age (years) | 45.4 | 45.8 | 46.9 |
Dominant elbow (%) | 70% | 69% | 53% |
Laborer (%) | 56% | 53% | 48% |
Work comp (%) | 36% | 30% | NR |
Symptoms to operation (months) | 23 | 18 | 8 |
Min. symptoms to operation (months) | 6 | 6 | 3 |
Mean follow-up (months) | 60 | 44 | 11 |
MATA-ANALYSIS CLINICAL OUTCOMES
Clinical outcome results were pooled for all studies reporting the same outcome measure for the same technique (open, arthroscopic, or percutaneous). A meta-analysis was performed for all outcome measures that were reported in a minimum of 3 studies utilizing the same surgical technique (Table 4).
PAIN RELIEF
Thirteen open studies,3,5,7,8,11-16,18,19,21 7 arthroscopic studies14,22-24,26,27,31 and 0 percutaneous studies reported the proportion of patients who were pain free at final follow-up. The proportion of patients who were pain free following open débridement was greater than that in the arthroscopic cohort (O = 70%, A = 60%; P = .009) (Table 4).
Continue to: Subjective improvement and satisfaction...
SUBJECTIVE IMPROVEMENT AND SATISFACTION
Nine open studies, 6 arthroscopic studies, and 1 percutaneous study reported the proportion of patients who felt that their condition had been improved as a result of surgery. There was no difference in the proportion of patients who experienced improvement between the open and arthroscopic cohorts. Four open studies,3,11,12 5 arthroscopic studies,22,26,28,29,32 and 2 percutaneous studies29,36 reported the proportion of patients who were satisfied or partially satisfied with the results of the procedure. There was no difference between the open and arthroscopic groups in the proportion of patients who were satisfied or partially satisfied (Table 4).
RETURN TO WORK
The duration to return to work following surgery was reported in 5 open studies,4,5,10,13,14 9 arthroscopic studies,14,23-29,32 and 2 percutaneous studies.29,36 There was no statistically significant difference between the open and arthroscopic groups with regard to duration to return to work (O = 6.5 weeks, A = 6 weeks; P = .601). The percutaneous technique could not be included in the meta-analysis due to the presence of only 2 studies, but the pooled mean duration to return to work in these 2 studies was 5.5 weeks (Table 4).
GRIP STRENGTH
Postoperative grip strength was reported in 2 open studies,10,19 4 arthroscopic studies,28,30,32 and 2 percutaneous studies.35-36 A meta-analysis could not be performed on all the groups due to the presence of only 2 open and 2 percutaneous studies reporting grip strength. The pooled averages were O = 38.3 kg, A = 34.8 kg, and P = 27.1 kg (Table 4).
DASH SCORE
The postoperative DASH score was reported in 4 open studies,4,15,17,19,20 5 arthroscopic studies,28-31 and 3 percutaneous studies.29,33,36 At final follow-up, the mean DASH score was higher in the arthroscopic group than in the open and percutaneous groups (A = 12.8, O = 19.5, P = 25.3; P < .001 for both comparisons), and the mean DASH score was significantly higher in the open group than in the percutaneous group (P = .029). The reporting of DASH scores in the early postoperative period was not sufficiently consistent to allow us to test our hypothesis that there would be early differences in function between groups (Table 4).
VAS PAIN SCORE
Postoperative VAS pain scores were reported in 11 open studies,6,8-10,12,15,19-21 8 arthroscopic studies,24-26,29-32 and 5 percutaneous studies.29,33,35-37 At final follow-up, there was a lower mean VAS score in the arthroscopic group than in the open and percutaneous groups (A = 1.1, O = 1.9, and P = 2.5; P < .001 for both comparisons) and a lower mean VAS score in the open group than in the percutaneous group (P = .002) (Table 4). Reporting of VAS scores in the early postoperative period in the included studies wan not sufficiently consistent to allow us to test our hypothesis that there would be early differences in pain between groups.
COMPLICATIONS
The complication rate was reported in 15 open studies, 10 arthroscopic studies, and 3 percutaneous studies. There was no difference in the complication rate between the open and arthroscopic techniques (O = 2.4%, A = 1.9%; P = .629) (Table 4). Complications noted in the open cohort included superficial wound infection (6), hematoma (5), synovial fistula (2), seroma (2), and posterior interosseous nerve palsy (1). Complications noted in the arthroscopic cohort included superficial infection (3), hematoma (1), and transient paresthesia (1). Of note, there were no complications in the percutaneous group.
Continue to: Discussion...
DISCUSSION
The primary purpose of this review was to determine if definitive evidence suggests that any 1 of open, percutaneous, or arthroscopic surgical treatment is superior to the other 2 for relieving pain, improving functionality, restoring strength, or accelerating return to work. The most striking finding of this study was a significantly higher proportion of patients who were pain free at final follow-up in the open group than in the arthroscopic group (70% vs 60%, P = .009) (Table 4). At final follow-up, there were no significant differences between groups regarding duration to return to work, proportion who were improved, proportion who were satisfied or partially satisfied, and complication rate. Average VAS and DASH scores at final follow-up were lower in the arthroscopic group than in the open and percutaneous groups (Figure 2). However, although the difference between mean DASH scores in the arthroscopic and open groups (6.7 points) was statistically significant, it is likely not clinically significant, as the minimal clinically important difference (MCID) for the DASH score is 10 points, as demonstrated by Sorensen and colleagues.38 Although it has not been specifically defined for lateral epicondylitis, the MCID for VAS pain has been reported in the literature to range from 1.0 to 1.4.39-40 Therefore, as for the DASH score, the difference witnessed between the open and arthroscopic groups (0.8) is likely not clinically significant. Of note, the differences between values for arthroscopic and percutaneous techniques are greater than the MCID.
In light of a recent increase in the prevalence of surgical intervention for lateral epicondylitis, many authors have promoted arthroscopic and percutaneous techniques as alternatives to traditional open débridement with the goal of achieving the same results with decreased morbidity and accelerated return to work. Given the increased proportion of patients who were pain free at final follow-up in the open cohort, it is our contention that open release/débridement of the common extensor/ECRB origin allows the surgeon to fully appreciate the extent of tendinotic tissue that is contributing to the patient’s symptoms and to address the pathology in its entirety. Other authors have also questioned whether the full extent of extra-articular tendinosis can be accurately identified arthroscopically. Cummins41 demonstrated, in a series of 18 patients who underwent arthroscopic ECRB débridement, that 6 patients had residual tendinosis upon open evaluation and 10 had residual tendinosis on histologic assessment. Additionally, in the same series, residual tendinopathy was associated with poorer clinical outcomes.
The improved visualization associated with an open technique comes at minimal expense, as the incision was only 1.5 cm to 5 cm in 13 of 15 papers reporting incision length.3,4,6,8-11,13,15,18-20 This increased exposure may not translate into increased morbidity, as there was no increase in the duration to return to work nor the complication rate. As a result of the extensive instrumentation necessary for arthroscopic techniques, open techniques also appear to be less expensive. Analyses in the literature have suggested increased expenditures associated with arthroscopic treatment ranging from 23%42 to 100%43 greater than those of open treatment.
Although obvious, it should be noted that a percutaneous tenotomy does not permit assessment of the extent of pathologic tendinosis. As a result of an inability to visualize and débride pathologic tissue, percutaneous tenotomy rendered inferior outcomes to open and arthroscopic techniques in terms of both postoperative VAS pain score and DASH score. Nonetheless, it is a relatively rapid and simple technique and resulted in zero complications in 184 elbows. Overall, percutaneous tenotomy appears to be an inferior technique to open and arthroscopic techniques in terms of achieving complete pain relief and optimal functional recovery; however, it may be useful in those who wish to avoid a more invasive intervention.
LIMITATIONS
The most significant limitation of this study was the heterogeneity in the techniques utilized in each group. Among the 19 papers in the open cohort, 11 used techniques aimed at lengthening or release of the extensor origin, 7 performed débridement of tendinotic tissue at the ECRB origin, and 1 compared these approaches. Exposures ranged from 1.5 cm to 8 cm in length, 3 techniques added tendon repair following débridement, and 2 utilized a radiofrequency device.
Among the 12 papers in the arthroscopic cohort, 8 performed arthroscopic (inside-out) débridement of the tendinotic tissue at the ECRB origin, 3 performed arthroscopic release of the ECRB tendon, and 1 performed endoscopic ECRB release in an outside-in fashion. Four techniques added posterior synovial plica excision and 4 added decortication of the lateral epicondyle débridement or release. Some authors advocate for arthroscopic intervention on the grounds that it permits evaluation and correction of other intra-articular pathology. With this in mind, some authors have suggested that a synovial fold (plica) adjacent to the radiocapitellar joint may contribute to lateral elbow pain.27,44 Nevertheless, in the only comparative trial in the literature, Rhyou and Kim30 demonstrated that excision of posterior synovial fold failed to enhance pain relief or function in a retrospective cohort study comparing arthroscopic débridement with and without plica excision.
Continue to: Some authors advocate...
Some authors advocate decorticating the non-articular, lateral epicondyle with a shaver to stimulate bleeding and promote a healing response. However, 1 study in our review compared arthroscopic ECRB release with and without decortication and found that decortication significantly increased pain up to 4 weeks postoperatively, increased duration to return to work, and did not improve the ultimate clinical result.25 Of note, others have used a similar rationale to advocate drilling the lateral epicondyle when utilizing an open technique. However, Dunn and colleagues8 note that they have modified the Nirschl technique to eliminate drilling because they feel it increases postoperative pain and may damage the extensor digitorum communis origin.
Among the 6 papers in the percutaneous tenotomy cohort, 2 performed tenotomy with a hypodermic needle, 2 with a scalpel through a limited incision (0.5 cm-1 cm), 1 using a TX1 tissue removal system (Tenex Health), and 1 with a percutaneous radiofrequency probe. In 3 techniques, ultrasound was used to direct the tenotomy.
The quality of this review is also limited by the studies included for analysis, as with any systematic review. Because 28 of the 35 included studies were classified as evidence level IV, the likelihood of methodological bias is increased. The majority of studies contained ≥1 demonstrable biases, including selection, detection, attrition biases, or a combination. Selection bias is prevalent among predominantly level IV studies, in which the authors have selected their preferred surgical technique. There was heterogeneity in the reporting of preoperative variables and the outcome measures that were utilized. Scoring systems, such as the Nirschl Tennis Elbow Score and the Mayo Elbow Performance Index, would have been valuable in comparing the groups had they been more consistently reported. The heterogeneity in clinical outcome tools and the lack of reported outcome variance or standard deviations prevented a formal meta-analysis of some of these outcome measures. Due to inconsistent reporting, we were also unable to test our hypothesis that there would be less pain and improved function in the arthroscopic and/or percutaneous cohorts in the early postoperative period compared to the open cohort due to the less invasive techniques used. Although the differences in DASH and VAS scores at final follow-up likely did not meet the MCID threshold, these differences may have been greater and more clinically relevant in the early postoperative period.
CONCLUSION
We hypothesized that the arthroscopic and percutaneous groups would experience accelerated return to work and reduced pain in the early postoperative period but no difference in ultimate pain, functional outcome, or subjective satisfaction. There is no difference between open, arthroscopic, and percutaneous surgical treatment for lateral epicondylitis regarding return to work and subjective satisfaction; however, open treatment led to a greater percentage of patients being pain free at final follow-up. While arthroscopic treatment led to better pain and functional scores at final follow-up, the absolute differences were quite small and likely not clinically significant. In light of the available evidence, we recommend open débridement as the best means of minimizing cost and achieving a pain-free outcome in the long term. For future investigators, it would be useful to perform a randomized clinical study directly comparing open, arthroscopic, and percutaneous techniques, including assessment of pain and functional scores in the early postoperative period, and to further evaluate differences in cost among the various techniques.
This paper will be judged for the Resident Writer’s Award.
- Sanders TL Jr, Maradit Kremers H, Bryan AJ, Ransom JE, Smith J, Morrey BF. The epidemiology and health care burden of tennis elbow: a population-based study. Am J Sports Med. 2015;43(5):1066-1071. doi:10.1177/0363546514568087.
- Lo MY, Safran MR. Surgical treatment of lateral epicondylitis: a systematic review. Clin Orthop Relat Res. 2007;463:98-106. doi:10.1097/BLO.0b013e3181483dc4.
- Balk ML, Hagberg WC, Buterbaugh GA, Imbriglia JE. Outcome of surgery for lateral epicondylitis (tennis elbow): effect of worker’s compensation. Am J Orthop. 2005;34(3):122-126; discussion 126.
- Barth J, Mahieu P, Hollevoet N. Extensor tendon and fascia sectioning of extensors at the musculotendinous unit in lateral epicondylitis. Acta Orthop Belg. 2013;79(3):266-270.
- Bigorre N, Raimbeau G, Fouque PA, Cast YS, Rabarin F, Cesari B. Lateral epicondylitis treatment by extensor carpi radialis fasciotomy and radial nerve decompression: is outcome influenced by the occupational disease compensation aspect? Orthop Traumatol Surg Res. 2011;97(2):159-163. doi:10.1016/j.otsr.2010.11.007.
- Cho BK, Kim YM, Kim DS, et al. Mini-open muscle resection procedure under local anesthesia for lateral and medial epicondylitis. Clin Orthop Surg. 2009;1(3):123-127. doi:10.4055/cios.2009.1.3.123.
- Coleman B, Quinlan JF, Matheson JA. Surgical treatment for lateral epicondylitis: a long-term follow-up of results. J Shoulder Elbow Surg. 2010;19(3):363-367. doi:10.1016/j.jse.2009.09.008.
- Dunn JH, Kim JJ, Davis L, Nirschl RP. Ten- to 14-year follow-up of the Nirschl surgical technique for lateral epicondylitis. Am J Sports Med. 2008;36(2):261-266. doi:10.1177/0363546507308932.
- Manon-Matos Y, Oron A, Wolff TW. Combined common extensor and supinator aponeurotomy for the treatment of lateral epicondylitis. Tech Hand Up Extrem Surg. 2013;17(3):179-181. doi:10.1097/BTH.0b013e31829e0eeb.
- Meknas K, Odden-Miland A, Mercer JB, Castillejo M, Johansen O. Radiofrequency microtenotomy: a promising method for treatment of recalcitrant lateral epicondylitis. Am J Sports Med. 2008;36(10):1960-1965. doi:10.1177/0363546508318045.
- Pruzansky ME, Gantsoudes GD, Watters N. Late surgical results of reattachment to bone in repair of chronic lateral epicondylitis. Am J Orthop. 2009;38(6):295-299.
- Rayan F, Rao V Sr, Purushothamdas S, Mukundan C, Shafqat SO. Common extensor origin release in recalcitrant lateral epicondylitis – role justified? J Orthop Surg Res. 2010;5:31. doi:10.1186/1749-799X-5-31.
- Reddy VR, Satheesan KS, Bayliss N. Outcome of Boyd-McLeod procedure for recalcitrant lateral epicondylitis of elbow. Rheumatol Int. 2011;31(8):1081-1084. doi:10.1007/s00296-010-1450-1.
- Rubenthaler F, Wiese M, Senge A, Keller L, Wittenberg RH. Long-term follow-up of open and endoscopic Hohmann procedures for lateral epicondylitis. Arthroscopy. 2005;21(6):684-690. doi:10.1016/j.arthro.2005.03.017.
- Ruch DS, Orr SB, Richard MJ, Leversedge FJ, Mithani SK, Laino DK. A comparison of debridement with and without anconeus muscle flap for treatment of refractory lateral epicondylitis. J Shoulder Elbow Surg. 2015;24(2):236-241. doi:10.1016/j.jse.2014.09.035.
- Siddiqui MA, Koh J, Kua J, Cheung T, Chang P. Functional outcome assessment after open tennis elbow release: what are the predictor parameters? Singapore Med J. 2011;52(2):73-76.
- Solheim E, Hegna J, Øyen J. Extensor tendon release in tennis elbow: results and prognostic factors in 80 elbows. Knee Surg Sports Traumatol Arthrosc. 2011;19(6):1023-1027. doi:10.1007/s00167-011-1477-1.
- Svernlöv B, Adolfsson L. Outcome of release of the lateral extensor muscle origin for epicondylitis. Scand J Plast Reconstr Surg Hand Surg. 2006;40(3):161-165. doi:10.1080/02844310500491492.
- Tasto JP, Cummings J, Medlock V, Hardesty R, Amiel D. Microtenotomy using a radiofrequency probe to treat lateral epicondylitis. Arthroscopy. 2005;21(7):851-860. doi:10.1016/j.arthro.2005.03.019.
- Thornton SJ, Rogers JR, Prickett WD, Dunn WR, Allen AA, Hannafin JA. Treatment of recalcitrant lateral epicondylitis with suture anchor repair. Am J Sports Med. 2005;33(10):1558-1564. doi:10.1177/0363546505276758.
- Wang AW, Erak S. Fractional lengthening of forearm extensors for resistant lateral epicondylitis. ANZ J Surg. 2007;77(11):981-984. doi:10.1111/j.1445-2197.2007.04294.x.
- Baker CL Jr, Baker CL 3rd. Long-term follow-up of arthroscopic treatment of lateral epicondylitis. Am J Sports Med. 2008;36(2):254-260. doi:10.1177/0363546507311599.
- Grewal R, MacDermid JC, Shah P, King GJ. Functional outcome of arthroscopic extensor carpi radialis brevis tendon release in chronic lateral epicondylitis. J Hand Surg Am. 2009;34(5):849-857. doi:10.1016/j.jhsa.2009.02.006.
- Jerosch J, Schunck J. Arthroscopic treatment of lateral epicondylitis: indication, technique and early results. Knee Surg Sports Traumatol Arthrosc. 2006;14(4):379-382. doi:10.1007/s00167-005-0662-5.
- Kim JW, Chun CH, Shim DM, et al. Arthroscopic treatment of lateral epicondylitis: comparison of the outcome of ECRB release with and without decortication. Knee Surg Sports Traumatol Arthrosc. 2011;19(7):1178-1183. doi:10.1007/s00167-011-1507-z.
- Lattermann C, Romeo AA, Anbari A, et al. Arthroscopic debridement of the extensor carpi radialis brevis for recalcitrant lateral epicondylitis. J Shoulder Elbow Surg. 2010;19(5):651-656. doi:10.1016/j.jse.2010.02.008.
- Mullett H, Sprague M, Brown G, Hausman M. Arthroscopic treatment of lateral epicondylitis: clinical and cadaveric studies. Clin Orthop Relat Res. 2005;439:123-128. doi:10.1097/01.blo.0000176143.08886.fe.
- Oki G, Iba K, Sasaki K, Yamashita T, Wada T. Time to functional recovery after arthroscopic surgery for tennis elbow. J Shoulder Elbow Surg. 2014;23(10):1527-1531. doi:10.1016/j.jse.2014.05.010.
- Othman AM. Arthroscopic versus percutaneous release of common extensor origin for treatment of chronic tennis elbow. Arch Orthop Trauma Surg. 2011;131(3):383-388. doi:10.1007/s00402-011-1260-2.
- Rhyou IH, Kim KW. Is posterior synovial plica excision necessary for refractory lateral epicondylitis of the elbow? Clin Orthop Relat Res. 2013;471(1):284-290. doi:10.1007/s11999-012-2585-z.
- Wada T, Moriya T, Iba K, et al. Functional outcomes after arthroscopic treatment of lateral epicondylitis. J Orthop Sci. 2009;14(2):167-174. doi:10.1007/s00776-008-1304-9.
- Yoon JP, Chung SW, Yi JH, et al. Prognostic factors of arthroscopic extensor carpi radialis brevis release for lateral epicondylitis. Arthroscopy. 2015;31(7):1232-1237. doi:10.1016/j.arthro.2015.02.006.
- Barnes DE, Beckley JM, Smith J. Percutaneous ultrasonic tenotomy for chronic elbow tendinosis: a prospective study. J Shoulder Elbow Surg. 2015;24(1):67-73. doi:10.1016/j.jse.2014.07.017.
- Kaleli T, Ozturk C, Temiz A, Tirelioglu O. Surgical treatment of tennis elbow: percutaneous release of the common extensor origin. Acta Orthop Belg. 2004;70(2):131-133.
- Lin MT, Chou LW, Chen HS, Kao MJ. Percutaneous soft tissue release for treating chronic recurrent myofascial pain associated with lateral epicondylitis: 6 case studies. Evid Based Complement Alternat Med. 2012;2012:142941. doi:10.1155/2012/142941.
- Lin CL, Lee JS, Su WR, Kuo LC, Tai TW, Jou IM. Clinical and ultrasonographic results of ultrasonographically guided percutaneous radiofrequency lesioning in the treatment of recalcitrant lateral epicondylitis. Am J Sports Med. 2011;39(11):2429-2435. doi:10.1177/0363546511417096.
- Zhu J, Hu B, Xing C, Li J. Ultrasound-guided, minimally invasive, percutaneous needle puncture treatment for tennis elbow. Adv Ther. 2008;25(10):1031-1036. doi:10.1007/s12325-008-0099-6.
- Sorensen AA, Howard D, Tan WH, Ketchersid J, Calfee RP. Minimal clinically important differences of 3 patient-related outcomes instruments. J Hand Surg Am. 2013;38(4):641-649. doi:10.1016/j.jhsa.2012.12.032.
- Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001;18(3):205-207. doi:10.1136/emj.18.3.205.
- Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg. 2009;18(6):927-932. doi:10.1016/j.jse.2009.03.021.
- Cummins CA. Lateral epicondylitis: in vivo assessment of arthroscopic debridement and correlation with patient outcomes. Am J Sports Med. 2006;34(9):1486-1491. doi:10.1177/0363546506288016.
- Stapleton TR, Baker CL. Arthroscopic treatment of lateral epicondylitis: a clinical study. Arthroscopy. 1996;1:365-366.
- Hastings H. Open treatment for lateral tennis elbow good for certain indications. Orthop Today. 2009;2:1-2.
- Duparc F, Putz R, Michot C, Muller JM, Fréger P. The synovial fold of the humeroradial joint: anatomical and histological features, and clinical relevance in lateral epicondylalgia of the elbow. Surg Radiol Anat. 2002;24(5):302-307. doi:10.1007/s00276-002-0055-0.
- Sanders TL Jr, Maradit Kremers H, Bryan AJ, Ransom JE, Smith J, Morrey BF. The epidemiology and health care burden of tennis elbow: a population-based study. Am J Sports Med. 2015;43(5):1066-1071. doi:10.1177/0363546514568087.
- Lo MY, Safran MR. Surgical treatment of lateral epicondylitis: a systematic review. Clin Orthop Relat Res. 2007;463:98-106. doi:10.1097/BLO.0b013e3181483dc4.
- Balk ML, Hagberg WC, Buterbaugh GA, Imbriglia JE. Outcome of surgery for lateral epicondylitis (tennis elbow): effect of worker’s compensation. Am J Orthop. 2005;34(3):122-126; discussion 126.
- Barth J, Mahieu P, Hollevoet N. Extensor tendon and fascia sectioning of extensors at the musculotendinous unit in lateral epicondylitis. Acta Orthop Belg. 2013;79(3):266-270.
- Bigorre N, Raimbeau G, Fouque PA, Cast YS, Rabarin F, Cesari B. Lateral epicondylitis treatment by extensor carpi radialis fasciotomy and radial nerve decompression: is outcome influenced by the occupational disease compensation aspect? Orthop Traumatol Surg Res. 2011;97(2):159-163. doi:10.1016/j.otsr.2010.11.007.
- Cho BK, Kim YM, Kim DS, et al. Mini-open muscle resection procedure under local anesthesia for lateral and medial epicondylitis. Clin Orthop Surg. 2009;1(3):123-127. doi:10.4055/cios.2009.1.3.123.
- Coleman B, Quinlan JF, Matheson JA. Surgical treatment for lateral epicondylitis: a long-term follow-up of results. J Shoulder Elbow Surg. 2010;19(3):363-367. doi:10.1016/j.jse.2009.09.008.
- Dunn JH, Kim JJ, Davis L, Nirschl RP. Ten- to 14-year follow-up of the Nirschl surgical technique for lateral epicondylitis. Am J Sports Med. 2008;36(2):261-266. doi:10.1177/0363546507308932.
- Manon-Matos Y, Oron A, Wolff TW. Combined common extensor and supinator aponeurotomy for the treatment of lateral epicondylitis. Tech Hand Up Extrem Surg. 2013;17(3):179-181. doi:10.1097/BTH.0b013e31829e0eeb.
- Meknas K, Odden-Miland A, Mercer JB, Castillejo M, Johansen O. Radiofrequency microtenotomy: a promising method for treatment of recalcitrant lateral epicondylitis. Am J Sports Med. 2008;36(10):1960-1965. doi:10.1177/0363546508318045.
- Pruzansky ME, Gantsoudes GD, Watters N. Late surgical results of reattachment to bone in repair of chronic lateral epicondylitis. Am J Orthop. 2009;38(6):295-299.
- Rayan F, Rao V Sr, Purushothamdas S, Mukundan C, Shafqat SO. Common extensor origin release in recalcitrant lateral epicondylitis – role justified? J Orthop Surg Res. 2010;5:31. doi:10.1186/1749-799X-5-31.
- Reddy VR, Satheesan KS, Bayliss N. Outcome of Boyd-McLeod procedure for recalcitrant lateral epicondylitis of elbow. Rheumatol Int. 2011;31(8):1081-1084. doi:10.1007/s00296-010-1450-1.
- Rubenthaler F, Wiese M, Senge A, Keller L, Wittenberg RH. Long-term follow-up of open and endoscopic Hohmann procedures for lateral epicondylitis. Arthroscopy. 2005;21(6):684-690. doi:10.1016/j.arthro.2005.03.017.
- Ruch DS, Orr SB, Richard MJ, Leversedge FJ, Mithani SK, Laino DK. A comparison of debridement with and without anconeus muscle flap for treatment of refractory lateral epicondylitis. J Shoulder Elbow Surg. 2015;24(2):236-241. doi:10.1016/j.jse.2014.09.035.
- Siddiqui MA, Koh J, Kua J, Cheung T, Chang P. Functional outcome assessment after open tennis elbow release: what are the predictor parameters? Singapore Med J. 2011;52(2):73-76.
- Solheim E, Hegna J, Øyen J. Extensor tendon release in tennis elbow: results and prognostic factors in 80 elbows. Knee Surg Sports Traumatol Arthrosc. 2011;19(6):1023-1027. doi:10.1007/s00167-011-1477-1.
- Svernlöv B, Adolfsson L. Outcome of release of the lateral extensor muscle origin for epicondylitis. Scand J Plast Reconstr Surg Hand Surg. 2006;40(3):161-165. doi:10.1080/02844310500491492.
- Tasto JP, Cummings J, Medlock V, Hardesty R, Amiel D. Microtenotomy using a radiofrequency probe to treat lateral epicondylitis. Arthroscopy. 2005;21(7):851-860. doi:10.1016/j.arthro.2005.03.019.
- Thornton SJ, Rogers JR, Prickett WD, Dunn WR, Allen AA, Hannafin JA. Treatment of recalcitrant lateral epicondylitis with suture anchor repair. Am J Sports Med. 2005;33(10):1558-1564. doi:10.1177/0363546505276758.
- Wang AW, Erak S. Fractional lengthening of forearm extensors for resistant lateral epicondylitis. ANZ J Surg. 2007;77(11):981-984. doi:10.1111/j.1445-2197.2007.04294.x.
- Baker CL Jr, Baker CL 3rd. Long-term follow-up of arthroscopic treatment of lateral epicondylitis. Am J Sports Med. 2008;36(2):254-260. doi:10.1177/0363546507311599.
- Grewal R, MacDermid JC, Shah P, King GJ. Functional outcome of arthroscopic extensor carpi radialis brevis tendon release in chronic lateral epicondylitis. J Hand Surg Am. 2009;34(5):849-857. doi:10.1016/j.jhsa.2009.02.006.
- Jerosch J, Schunck J. Arthroscopic treatment of lateral epicondylitis: indication, technique and early results. Knee Surg Sports Traumatol Arthrosc. 2006;14(4):379-382. doi:10.1007/s00167-005-0662-5.
- Kim JW, Chun CH, Shim DM, et al. Arthroscopic treatment of lateral epicondylitis: comparison of the outcome of ECRB release with and without decortication. Knee Surg Sports Traumatol Arthrosc. 2011;19(7):1178-1183. doi:10.1007/s00167-011-1507-z.
- Lattermann C, Romeo AA, Anbari A, et al. Arthroscopic debridement of the extensor carpi radialis brevis for recalcitrant lateral epicondylitis. J Shoulder Elbow Surg. 2010;19(5):651-656. doi:10.1016/j.jse.2010.02.008.
- Mullett H, Sprague M, Brown G, Hausman M. Arthroscopic treatment of lateral epicondylitis: clinical and cadaveric studies. Clin Orthop Relat Res. 2005;439:123-128. doi:10.1097/01.blo.0000176143.08886.fe.
- Oki G, Iba K, Sasaki K, Yamashita T, Wada T. Time to functional recovery after arthroscopic surgery for tennis elbow. J Shoulder Elbow Surg. 2014;23(10):1527-1531. doi:10.1016/j.jse.2014.05.010.
- Othman AM. Arthroscopic versus percutaneous release of common extensor origin for treatment of chronic tennis elbow. Arch Orthop Trauma Surg. 2011;131(3):383-388. doi:10.1007/s00402-011-1260-2.
- Rhyou IH, Kim KW. Is posterior synovial plica excision necessary for refractory lateral epicondylitis of the elbow? Clin Orthop Relat Res. 2013;471(1):284-290. doi:10.1007/s11999-012-2585-z.
- Wada T, Moriya T, Iba K, et al. Functional outcomes after arthroscopic treatment of lateral epicondylitis. J Orthop Sci. 2009;14(2):167-174. doi:10.1007/s00776-008-1304-9.
- Yoon JP, Chung SW, Yi JH, et al. Prognostic factors of arthroscopic extensor carpi radialis brevis release for lateral epicondylitis. Arthroscopy. 2015;31(7):1232-1237. doi:10.1016/j.arthro.2015.02.006.
- Barnes DE, Beckley JM, Smith J. Percutaneous ultrasonic tenotomy for chronic elbow tendinosis: a prospective study. J Shoulder Elbow Surg. 2015;24(1):67-73. doi:10.1016/j.jse.2014.07.017.
- Kaleli T, Ozturk C, Temiz A, Tirelioglu O. Surgical treatment of tennis elbow: percutaneous release of the common extensor origin. Acta Orthop Belg. 2004;70(2):131-133.
- Lin MT, Chou LW, Chen HS, Kao MJ. Percutaneous soft tissue release for treating chronic recurrent myofascial pain associated with lateral epicondylitis: 6 case studies. Evid Based Complement Alternat Med. 2012;2012:142941. doi:10.1155/2012/142941.
- Lin CL, Lee JS, Su WR, Kuo LC, Tai TW, Jou IM. Clinical and ultrasonographic results of ultrasonographically guided percutaneous radiofrequency lesioning in the treatment of recalcitrant lateral epicondylitis. Am J Sports Med. 2011;39(11):2429-2435. doi:10.1177/0363546511417096.
- Zhu J, Hu B, Xing C, Li J. Ultrasound-guided, minimally invasive, percutaneous needle puncture treatment for tennis elbow. Adv Ther. 2008;25(10):1031-1036. doi:10.1007/s12325-008-0099-6.
- Sorensen AA, Howard D, Tan WH, Ketchersid J, Calfee RP. Minimal clinically important differences of 3 patient-related outcomes instruments. J Hand Surg Am. 2013;38(4):641-649. doi:10.1016/j.jhsa.2012.12.032.
- Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001;18(3):205-207. doi:10.1136/emj.18.3.205.
- Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg. 2009;18(6):927-932. doi:10.1016/j.jse.2009.03.021.
- Cummins CA. Lateral epicondylitis: in vivo assessment of arthroscopic debridement and correlation with patient outcomes. Am J Sports Med. 2006;34(9):1486-1491. doi:10.1177/0363546506288016.
- Stapleton TR, Baker CL. Arthroscopic treatment of lateral epicondylitis: a clinical study. Arthroscopy. 1996;1:365-366.
- Hastings H. Open treatment for lateral tennis elbow good for certain indications. Orthop Today. 2009;2:1-2.
- Duparc F, Putz R, Michot C, Muller JM, Fréger P. The synovial fold of the humeroradial joint: anatomical and histological features, and clinical relevance in lateral epicondylalgia of the elbow. Surg Radiol Anat. 2002;24(5):302-307. doi:10.1007/s00276-002-0055-0.
TAKE-HOME POINTS
- While favorable results have been reported for open, arthroscopic, and percutaneous surgical techniques, there is no current consensus regarding the optimal technique for lateral epicondylitis.
- There is no difference between open, arthroscopic, and percutaneous surgical treatment for lateral epicondylitis regarding return to work and subjective satisfaction.
- Open treatment led to a greater percentage of patients being pain free at final follow-up.
- While arthroscopic treatment led to better pain and functional scores at final follow-up, the absolute differences were quite small and likely not clinically significant.
- We recommend open débridement as the best means of minimizing cost and achieving a pain-free outcome in the long-term.