Hefty rewards pay off in smoking-cessation study

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A new study finds it pays to pay people to stop lighting up: Smokers were more likely to quit if they had an opportunity to gain rewards worth $600 than if they simply received free cessation aids or free e-cigarettes.

The wide majority of the more than 6,000 smokers in the randomized study didn’t quit despite offers of various incentives. All the same, “programs that offered financial incentives tripled the rates of smoking cessation, reduced employers’ costs per successful quit, as compared with programs that offered cessation aids alone, and yielded total costs that compared favorably with the costs of employing smokers,” the study authors wrote.

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The study, led by Scott D. Halpern, MD, PhD, of the University of Pennsylvania, was published online May 23 in the New England Journal of Medicine.

The researchers reached out to employees and spouses at 54 companies that use wellness programs provided by the Vitality Institute, which supports research into health promotion. The institute provided grant support for the study.

Just over 6,000 employees and spouses who smoked were assigned to five groups. One group received usual care. The others received interventions: free smoking-cessation aids (nicotine replacement therapy, bupropion, or varenicline); free e-cigarettes; up to $600 worth of an unidentified “reward incentive” plus free cessation aids; and up to $600 via a redeemable deposit, plus free cessation aids.

Participants could only get the entire reward incentive or the full $600 redeemable deposit if they showed signs of sustained smoking cessation via blood or urine test at 1, 3, and 6 months.

The median age in the groups ranged from 43 to 45 years, and most were not college graduates. Just over half were women, and roughly 90% said they wanted to quit smoking.

 

 


Overall, 20% of the 6,006 participants logged onto the trial website, a sign that they were “engaged.” The number was highest in the free e-cigarette and reward groups (21%-23%) and lowest in the usual care group (16%).

The researchers focused on how many participants abstained from smoking – as confirmed by blood or urine test – for 6 months past the target quit date. The test data confirmed that just 1.3% of the total participants, 80 people, sustained cessation over 6 months.

Only 0.1% of the usual-care group sustained smoking cessation, and the number wasn’t much higher (0.5%) in the free cessation aids group.

One percent of those in the free e-cigarette group sustained cessation. However, the researchers noted there wasn’t a significant difference in the quit rates between the usual care, free cessation aid, and free e-cigarette groups.

 

 

SOURCE: Halpern SD et al. N Engl J Med. 2018 May 23. doi: 10.1056/NEJMsa1715757.

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A new study finds it pays to pay people to stop lighting up: Smokers were more likely to quit if they had an opportunity to gain rewards worth $600 than if they simply received free cessation aids or free e-cigarettes.

The wide majority of the more than 6,000 smokers in the randomized study didn’t quit despite offers of various incentives. All the same, “programs that offered financial incentives tripled the rates of smoking cessation, reduced employers’ costs per successful quit, as compared with programs that offered cessation aids alone, and yielded total costs that compared favorably with the costs of employing smokers,” the study authors wrote.

milosluz/istockphoto.com
The study, led by Scott D. Halpern, MD, PhD, of the University of Pennsylvania, was published online May 23 in the New England Journal of Medicine.

The researchers reached out to employees and spouses at 54 companies that use wellness programs provided by the Vitality Institute, which supports research into health promotion. The institute provided grant support for the study.

Just over 6,000 employees and spouses who smoked were assigned to five groups. One group received usual care. The others received interventions: free smoking-cessation aids (nicotine replacement therapy, bupropion, or varenicline); free e-cigarettes; up to $600 worth of an unidentified “reward incentive” plus free cessation aids; and up to $600 via a redeemable deposit, plus free cessation aids.

Participants could only get the entire reward incentive or the full $600 redeemable deposit if they showed signs of sustained smoking cessation via blood or urine test at 1, 3, and 6 months.

The median age in the groups ranged from 43 to 45 years, and most were not college graduates. Just over half were women, and roughly 90% said they wanted to quit smoking.

 

 


Overall, 20% of the 6,006 participants logged onto the trial website, a sign that they were “engaged.” The number was highest in the free e-cigarette and reward groups (21%-23%) and lowest in the usual care group (16%).

The researchers focused on how many participants abstained from smoking – as confirmed by blood or urine test – for 6 months past the target quit date. The test data confirmed that just 1.3% of the total participants, 80 people, sustained cessation over 6 months.

Only 0.1% of the usual-care group sustained smoking cessation, and the number wasn’t much higher (0.5%) in the free cessation aids group.

One percent of those in the free e-cigarette group sustained cessation. However, the researchers noted there wasn’t a significant difference in the quit rates between the usual care, free cessation aid, and free e-cigarette groups.

 

 

SOURCE: Halpern SD et al. N Engl J Med. 2018 May 23. doi: 10.1056/NEJMsa1715757.

 

A new study finds it pays to pay people to stop lighting up: Smokers were more likely to quit if they had an opportunity to gain rewards worth $600 than if they simply received free cessation aids or free e-cigarettes.

The wide majority of the more than 6,000 smokers in the randomized study didn’t quit despite offers of various incentives. All the same, “programs that offered financial incentives tripled the rates of smoking cessation, reduced employers’ costs per successful quit, as compared with programs that offered cessation aids alone, and yielded total costs that compared favorably with the costs of employing smokers,” the study authors wrote.

milosluz/istockphoto.com
The study, led by Scott D. Halpern, MD, PhD, of the University of Pennsylvania, was published online May 23 in the New England Journal of Medicine.

The researchers reached out to employees and spouses at 54 companies that use wellness programs provided by the Vitality Institute, which supports research into health promotion. The institute provided grant support for the study.

Just over 6,000 employees and spouses who smoked were assigned to five groups. One group received usual care. The others received interventions: free smoking-cessation aids (nicotine replacement therapy, bupropion, or varenicline); free e-cigarettes; up to $600 worth of an unidentified “reward incentive” plus free cessation aids; and up to $600 via a redeemable deposit, plus free cessation aids.

Participants could only get the entire reward incentive or the full $600 redeemable deposit if they showed signs of sustained smoking cessation via blood or urine test at 1, 3, and 6 months.

The median age in the groups ranged from 43 to 45 years, and most were not college graduates. Just over half were women, and roughly 90% said they wanted to quit smoking.

 

 


Overall, 20% of the 6,006 participants logged onto the trial website, a sign that they were “engaged.” The number was highest in the free e-cigarette and reward groups (21%-23%) and lowest in the usual care group (16%).

The researchers focused on how many participants abstained from smoking – as confirmed by blood or urine test – for 6 months past the target quit date. The test data confirmed that just 1.3% of the total participants, 80 people, sustained cessation over 6 months.

Only 0.1% of the usual-care group sustained smoking cessation, and the number wasn’t much higher (0.5%) in the free cessation aids group.

One percent of those in the free e-cigarette group sustained cessation. However, the researchers noted there wasn’t a significant difference in the quit rates between the usual care, free cessation aid, and free e-cigarette groups.

 

 

SOURCE: Halpern SD et al. N Engl J Med. 2018 May 23. doi: 10.1056/NEJMsa1715757.

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Key clinical point: Smokers are more likely to sustain cessation if they receive incentives worth $600.

Major finding: Cessation rates for 6 months past target quit date reached as high as 2.9% in smokers who had the opportunity to gain rewards, while they didn’t top 1% in those who received free cessation aids or free e-cigarettes.

Study details: A randomized, prospective study of 6,006 smokers (employees of 54 companies and spouses) who were assigned to usual care or one of four intervention groups.

Disclosures: The study received grant support from the Vitality Institute. Most of the study authors reported no relevant disclosures. One reported serving on the scientific advisory board of VAL Health, and another reported various grants and personal fees.

Source: Halpern SD et al. N Engl J Med. 2018 May 23. doi: 10.1056/NEJMsa1715757.

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Doctors’ pay involves a lot of unseen work

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Thu, 03/28/2019 - 14:37

 

“Doctors make a lot of money.” We hear that a lot, always from people who aren’t part of the profession.

Last month, I had to do my tax forms. Not my annual forms, but the quarterly withholding ones for the IRS, and for the state, along with the Arizona Department of Economic Security forms.

My bank prints out the forms for me to sign, but being compulsive, I want to run the numbers myself. So I sit down, tally things up on paper, make sure the numbers all match, then send the forms in. Sometimes, I discover mistakes here or there, so have to pick through the previous quarter’s payroll to find out where I went wrong and how to correct it.

The whole thing takes me about 2 hours every 3 months. I suppose I could hire an accountant or office manager to deal with that stuff, but in solo practice, you do everything you can to keep the overhead low. So I do it myself.

Eight hours a year doesn’t sound too bad, but it got me thinking about all the other ways that work creeps into my home time.

I’m usually at the office around 5:00 a.m., when I start with reviewing charts, doing paperwork, and catching up on dictations until patients start at 8:00 a.m. From then on, they’re a steady stream until 4:00 p.m., when we close up and head home.

I get home and then have 1-2 hours of time paying bills, sorting mail, and catching up on phone calls and other unresolved issues.

 

 


On weekends, there’s always other stuff. Payroll for the coming weeks, office bills, and credit card statements I didn’t get to during the week, CME, forms, licensing paperwork, etc.

I’d guess about 15 hours/week goes into nonpatient-related stuff. Each year that’s more than 700 hours (or a little over a month) of extra time. Tack that on to the roughly 60 hours that I spend seeing patients between the office and hospital.

People say we make “a lot” (whatever that is), but they don’t see everything behind it. The 7-12 years of post-college training. The student loans of $200,000 and dating back to when I was 26 years old. The rising costs of overhead and dropping rates of reimbursement. The denied payments in disputes over claims. And, as mentioned above, the huge amount of time this job takes for stuff beyond just seeing patients.

We don’t get paid by the hour, but if we did, the rate would probably be a lot lower than what most would expect.
 

 


I suppose I could become employed, and let someone else worry about those things. But the financial impact doesn’t go away. Someone else still has to be doing those things, and since doctors are the ones who generate income in the majority of medical practices, the salaries for everyone else come out of ours. Plus, as I’ve previously written about, I’ve been employed before and got sick of the meetings and memos about cost-sharing, productivity numbers, and dollars earned per square foot.

But whenever I hear the refrain about our field being overpaid, I think about the actual hours the public doesn’t see (or care about). This isn’t a job for slackers, and most of us work long hours to make ends meet. It’s a side of being a doctor that’s rarely, if ever, seen outside the field.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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“Doctors make a lot of money.” We hear that a lot, always from people who aren’t part of the profession.

Last month, I had to do my tax forms. Not my annual forms, but the quarterly withholding ones for the IRS, and for the state, along with the Arizona Department of Economic Security forms.

My bank prints out the forms for me to sign, but being compulsive, I want to run the numbers myself. So I sit down, tally things up on paper, make sure the numbers all match, then send the forms in. Sometimes, I discover mistakes here or there, so have to pick through the previous quarter’s payroll to find out where I went wrong and how to correct it.

The whole thing takes me about 2 hours every 3 months. I suppose I could hire an accountant or office manager to deal with that stuff, but in solo practice, you do everything you can to keep the overhead low. So I do it myself.

Eight hours a year doesn’t sound too bad, but it got me thinking about all the other ways that work creeps into my home time.

I’m usually at the office around 5:00 a.m., when I start with reviewing charts, doing paperwork, and catching up on dictations until patients start at 8:00 a.m. From then on, they’re a steady stream until 4:00 p.m., when we close up and head home.

I get home and then have 1-2 hours of time paying bills, sorting mail, and catching up on phone calls and other unresolved issues.

 

 


On weekends, there’s always other stuff. Payroll for the coming weeks, office bills, and credit card statements I didn’t get to during the week, CME, forms, licensing paperwork, etc.

I’d guess about 15 hours/week goes into nonpatient-related stuff. Each year that’s more than 700 hours (or a little over a month) of extra time. Tack that on to the roughly 60 hours that I spend seeing patients between the office and hospital.

People say we make “a lot” (whatever that is), but they don’t see everything behind it. The 7-12 years of post-college training. The student loans of $200,000 and dating back to when I was 26 years old. The rising costs of overhead and dropping rates of reimbursement. The denied payments in disputes over claims. And, as mentioned above, the huge amount of time this job takes for stuff beyond just seeing patients.

We don’t get paid by the hour, but if we did, the rate would probably be a lot lower than what most would expect.
 

 


I suppose I could become employed, and let someone else worry about those things. But the financial impact doesn’t go away. Someone else still has to be doing those things, and since doctors are the ones who generate income in the majority of medical practices, the salaries for everyone else come out of ours. Plus, as I’ve previously written about, I’ve been employed before and got sick of the meetings and memos about cost-sharing, productivity numbers, and dollars earned per square foot.

But whenever I hear the refrain about our field being overpaid, I think about the actual hours the public doesn’t see (or care about). This isn’t a job for slackers, and most of us work long hours to make ends meet. It’s a side of being a doctor that’s rarely, if ever, seen outside the field.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

 

“Doctors make a lot of money.” We hear that a lot, always from people who aren’t part of the profession.

Last month, I had to do my tax forms. Not my annual forms, but the quarterly withholding ones for the IRS, and for the state, along with the Arizona Department of Economic Security forms.

My bank prints out the forms for me to sign, but being compulsive, I want to run the numbers myself. So I sit down, tally things up on paper, make sure the numbers all match, then send the forms in. Sometimes, I discover mistakes here or there, so have to pick through the previous quarter’s payroll to find out where I went wrong and how to correct it.

The whole thing takes me about 2 hours every 3 months. I suppose I could hire an accountant or office manager to deal with that stuff, but in solo practice, you do everything you can to keep the overhead low. So I do it myself.

Eight hours a year doesn’t sound too bad, but it got me thinking about all the other ways that work creeps into my home time.

I’m usually at the office around 5:00 a.m., when I start with reviewing charts, doing paperwork, and catching up on dictations until patients start at 8:00 a.m. From then on, they’re a steady stream until 4:00 p.m., when we close up and head home.

I get home and then have 1-2 hours of time paying bills, sorting mail, and catching up on phone calls and other unresolved issues.

 

 


On weekends, there’s always other stuff. Payroll for the coming weeks, office bills, and credit card statements I didn’t get to during the week, CME, forms, licensing paperwork, etc.

I’d guess about 15 hours/week goes into nonpatient-related stuff. Each year that’s more than 700 hours (or a little over a month) of extra time. Tack that on to the roughly 60 hours that I spend seeing patients between the office and hospital.

People say we make “a lot” (whatever that is), but they don’t see everything behind it. The 7-12 years of post-college training. The student loans of $200,000 and dating back to when I was 26 years old. The rising costs of overhead and dropping rates of reimbursement. The denied payments in disputes over claims. And, as mentioned above, the huge amount of time this job takes for stuff beyond just seeing patients.

We don’t get paid by the hour, but if we did, the rate would probably be a lot lower than what most would expect.
 

 


I suppose I could become employed, and let someone else worry about those things. But the financial impact doesn’t go away. Someone else still has to be doing those things, and since doctors are the ones who generate income in the majority of medical practices, the salaries for everyone else come out of ours. Plus, as I’ve previously written about, I’ve been employed before and got sick of the meetings and memos about cost-sharing, productivity numbers, and dollars earned per square foot.

But whenever I hear the refrain about our field being overpaid, I think about the actual hours the public doesn’t see (or care about). This isn’t a job for slackers, and most of us work long hours to make ends meet. It’s a side of being a doctor that’s rarely, if ever, seen outside the field.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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Older CLL and NHL patients are more vulnerable to toxicities

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Older patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) have an increased odds of experiencing treatment-related toxicities, even when treated with novel agents, according to findings reported in the Journal of Geriatric Oncology.

An analysis of 1,199 patients showed that CLL patients aged 65 years and older had significantly higher odds than younger patients of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI, 1.39-1.55).

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Likewise, in NHL patients, the odds of experiencing a grade three or four non-hematologic toxicity were significantly higher for older patients (OR, 1.89; P = .017; 95% CI,1.64-2.17), though the odds of hematologic toxicity did not differ significantly between age groups, wrote Michael Tallarico, MD, of the University of Chicago Comprehensive Cancer Center, and his coauthors.

Investigators analyzed data obtained from the Alliance for Clinical Trials in Oncology to compare the incidence of toxicities between age groups. Of the 1,199 patients included in the analysis, 409 were 65 years of age or older, and 790 were younger than 65 years. Among these patients, 438 received only therapy with novel agents including biologic combinations, monoclonal antibodies, cell cycle inhibitors, chemoimmunotherapy, and immunomodulators, and 761 received novel agents in addition to chemotherapy.

Overall, 68% of CLL patients and 35% of NHL patients had at least one grade three or four hematologic toxicity, compared with 48% and 54% for nonhematologic toxicities, respectively.

Older CLL patients with at least one grade three or four toxicity in the first 3 months had similar overall survival (OS) and progression-free survival (PFS) as those without a toxicity. In contrast, older NHL patients with at least one grade three or four hematologic toxicity in the first 3 months had worse OS (HR, 3.14; P = .006; 95% CI, 2.25-4.39) and PFS (HR, 3.06; P = .011; 95% CI, 2.10-4.45) than patients without these toxicities. Nonhematologic toxicities were not significantly associated with survival outcomes for patients with NHL.

“The observed associations between hematologic toxicity and OS/PFS among older patients with NHL require further investigation,” the researchers wrote. “These findings could represent a direct effect of toxicity due to decreased physiologic reserve, decreased drug clearance, or an increased sensitivity of tissue to novel agents.”

The study was supported by a National Institutes of Health grant. Researchers reported relationships with Bartlett, KITE, Pfizer, Seattle Genetics, Roche-Genentech, Celgene, Pharmacyclics, and Gilead.

SOURCE: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.

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Older patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) have an increased odds of experiencing treatment-related toxicities, even when treated with novel agents, according to findings reported in the Journal of Geriatric Oncology.

An analysis of 1,199 patients showed that CLL patients aged 65 years and older had significantly higher odds than younger patients of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI, 1.39-1.55).

iStock/Thinkstock.com
Likewise, in NHL patients, the odds of experiencing a grade three or four non-hematologic toxicity were significantly higher for older patients (OR, 1.89; P = .017; 95% CI,1.64-2.17), though the odds of hematologic toxicity did not differ significantly between age groups, wrote Michael Tallarico, MD, of the University of Chicago Comprehensive Cancer Center, and his coauthors.

Investigators analyzed data obtained from the Alliance for Clinical Trials in Oncology to compare the incidence of toxicities between age groups. Of the 1,199 patients included in the analysis, 409 were 65 years of age or older, and 790 were younger than 65 years. Among these patients, 438 received only therapy with novel agents including biologic combinations, monoclonal antibodies, cell cycle inhibitors, chemoimmunotherapy, and immunomodulators, and 761 received novel agents in addition to chemotherapy.

Overall, 68% of CLL patients and 35% of NHL patients had at least one grade three or four hematologic toxicity, compared with 48% and 54% for nonhematologic toxicities, respectively.

Older CLL patients with at least one grade three or four toxicity in the first 3 months had similar overall survival (OS) and progression-free survival (PFS) as those without a toxicity. In contrast, older NHL patients with at least one grade three or four hematologic toxicity in the first 3 months had worse OS (HR, 3.14; P = .006; 95% CI, 2.25-4.39) and PFS (HR, 3.06; P = .011; 95% CI, 2.10-4.45) than patients without these toxicities. Nonhematologic toxicities were not significantly associated with survival outcomes for patients with NHL.

“The observed associations between hematologic toxicity and OS/PFS among older patients with NHL require further investigation,” the researchers wrote. “These findings could represent a direct effect of toxicity due to decreased physiologic reserve, decreased drug clearance, or an increased sensitivity of tissue to novel agents.”

The study was supported by a National Institutes of Health grant. Researchers reported relationships with Bartlett, KITE, Pfizer, Seattle Genetics, Roche-Genentech, Celgene, Pharmacyclics, and Gilead.

SOURCE: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.

 

Older patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) have an increased odds of experiencing treatment-related toxicities, even when treated with novel agents, according to findings reported in the Journal of Geriatric Oncology.

An analysis of 1,199 patients showed that CLL patients aged 65 years and older had significantly higher odds than younger patients of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI, 1.39-1.55).

iStock/Thinkstock.com
Likewise, in NHL patients, the odds of experiencing a grade three or four non-hematologic toxicity were significantly higher for older patients (OR, 1.89; P = .017; 95% CI,1.64-2.17), though the odds of hematologic toxicity did not differ significantly between age groups, wrote Michael Tallarico, MD, of the University of Chicago Comprehensive Cancer Center, and his coauthors.

Investigators analyzed data obtained from the Alliance for Clinical Trials in Oncology to compare the incidence of toxicities between age groups. Of the 1,199 patients included in the analysis, 409 were 65 years of age or older, and 790 were younger than 65 years. Among these patients, 438 received only therapy with novel agents including biologic combinations, monoclonal antibodies, cell cycle inhibitors, chemoimmunotherapy, and immunomodulators, and 761 received novel agents in addition to chemotherapy.

Overall, 68% of CLL patients and 35% of NHL patients had at least one grade three or four hematologic toxicity, compared with 48% and 54% for nonhematologic toxicities, respectively.

Older CLL patients with at least one grade three or four toxicity in the first 3 months had similar overall survival (OS) and progression-free survival (PFS) as those without a toxicity. In contrast, older NHL patients with at least one grade three or four hematologic toxicity in the first 3 months had worse OS (HR, 3.14; P = .006; 95% CI, 2.25-4.39) and PFS (HR, 3.06; P = .011; 95% CI, 2.10-4.45) than patients without these toxicities. Nonhematologic toxicities were not significantly associated with survival outcomes for patients with NHL.

“The observed associations between hematologic toxicity and OS/PFS among older patients with NHL require further investigation,” the researchers wrote. “These findings could represent a direct effect of toxicity due to decreased physiologic reserve, decreased drug clearance, or an increased sensitivity of tissue to novel agents.”

The study was supported by a National Institutes of Health grant. Researchers reported relationships with Bartlett, KITE, Pfizer, Seattle Genetics, Roche-Genentech, Celgene, Pharmacyclics, and Gilead.

SOURCE: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.

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Key clinical point: CLL and NHL patients aged 65 years and older have a higher odds of treatment-related toxicities with novel agents.

Major finding: Older CLL patients had significantly higher odds of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI 1.39-1.55).

Study details: An analysis of data from 1,199 CLL and NHL patients in the Alliance for Clinical Trials in Oncology.

Disclosures: The study was supported by a National Institutes of Health grant. Researchers reported relationships with Bartlett, KITE, Pfizer, Seattle Genetics, Roche-Genentech, Celgene, Pharmacyclics, and Gilead.

Source: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.

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Comorbid spondyloarthritis and fibromyalgia lower response to TNF inhibitors

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Fri, 01/18/2019 - 17:41

 

– Individuals with axial spondyloarthritis (axSpA) who have comorbid fibromyalgia do respond to biologic therapy but at a seemingly lower rate if they have a high symptom score during early assessments.

Data from the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR-AS) showed that participants with axSpA who were starting biologic therapy with a tumor necrosis factor inhibitor (TNFi) for the first time also had worse disease activity at baseline if they met fibromyalgia research criteria than if they did not.

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Dr. Gary Macfarlane
These findings show that there are “considerable unmet needs” for patients with axSpA and comorbid fibromyalgia, even though they had some improvement, Gary J. Macfarlane, MBChB, PhD, the BSRBR-AS’s chief investigator, reported at the British Society for Rheumatology annual conference.

“The issue of fibromyalgia as a comorbidity in axial SpA has been the subject of current considerable interest,” said Dr. Macfarlane, who is Clinical Chair in Epidemiology at the University of Aberdeen (Scotland), where the BSRBR-AS is run. This is for several reasons: “One is the challenge of identifying patients with axial SpA who have comorbid fibromyalgia.

“The second is the concern that comorbid fibromyalgia may have an effect on disease indices such as BASDAI [Bath Ankylosing Spondylitis Disease Activity Index],” Dr. Macfarlane observed.

This leads to the third issue: “Are patients with comorbid fibromyalgia inappropriately receiving biological therapy, and how do they respond if they do receive it?”

Previous data from the BSRBR-AS have shown that approximately one in five patients with axSpA meet research criteria for fibromyalgia (Arthritis Rheumatol. 2017;69:2144-50) and that the prevalence of the comorbidity was higher in those who met Assessment of SpondyloArthritis International Society imaging criteria and lower in those who only met clinical criteria (25% vs. 10%).

 

 


The current aims of the study presented by Dr. Macfarlane were to first quantify the extent to which meeting fibromyalgia criteria was associated with higher measures of disease activity and impact, and then to see if meeting these criteria was associated with a poorer response to first use of a TNFi.

In order to find out, Dr. Macfarlane and his associates examined data from the prospective BSRBR-AS, which has been running since 2012. The BSRBR-AS recruits patients with ASAS-confirmed axSpA who are newly starting biologics from 83 U.K. centers.



At recruitment and at 3 months, patients starting biologic treatment undergo several assessments, which since 2015 has included research criteria for fibromyalgia (J Rheumatol. 2011;38:1113–22). The latter incorporate a Widespread Pain Index rated 0-19 and a Symptom Severity Scale rated 0-12 and cover items such as fatigue and waking up unrefreshed, and the presence of lower abdominal pain or headaches.

To date, around 1,750 participants in the BSRBR-AS have completed the fibromyalgia criteria, Dr. Macfarlane said.

 

 


Across the board, baseline measures of disease activity were lower in patients who met the fibromyalgia criteria versus those who did not. This included the BASDAI and the Bath Ankylosing Spondylitis Functional Index, where scores were approximately 6.5 and 4.5 for each measure.

“Quality of life was significantly lower in those who were fibromyalgia positive,” Dr. Macfarlane said. Indeed, whatever the measure used, from the disease-specific Ankylosing Spondylitis Quality of Life (ASQoL) Scale to the general EuroQoL Quality of Life Scale, there were significant differences between those who did and did not meet fibromyalgia criteria. There were also higher scores for depression, anxiety, poorer-quality sleep, and higher levels of fatigue.

Patients treated with TNFi therapy showed improvement in both BASDAI and ASQoL scores regardless of whether they met fibromyalgia criteria, but crucially, the responses were still lower and significantly different from those without fibromyalgia.

An ASAS20 response to TNFi therapy was met by “slightly fewer” patients who met the fibromyalgia criteria than by those who did not at all follow-up points: at 3 months (about 35% vs. 45%), 6 months (about 58% vs. 61%), and 12 months (about 60% vs. 62%).

A high score on the Symptom Severity Scale but not the Widespread Pain Index of the fibromyalgia criteria was associated with a lower response to TNFi therapy at 3 months. “Such patients may benefit from the use of TNFi and nonpharmacological therapy,” Dr. Macfarlane said.

 

 


The BSRBR-AS is funded by the British Society for Rheumatology, which in turn receives funding from AbbVie, Pfizer, and UCB. Dr. Macfarlane did not provide any disclosures but has previously acknowledged receiving an honorarium from Pfizer and research funding from AbbVie and Pfizer for the Scotland Registry for Ankylosing Spondylitis study.

SOURCE: Macfarlane GJ et al. Rheumatology. 2018;57(Suppl. 3):key075.183.

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– Individuals with axial spondyloarthritis (axSpA) who have comorbid fibromyalgia do respond to biologic therapy but at a seemingly lower rate if they have a high symptom score during early assessments.

Data from the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR-AS) showed that participants with axSpA who were starting biologic therapy with a tumor necrosis factor inhibitor (TNFi) for the first time also had worse disease activity at baseline if they met fibromyalgia research criteria than if they did not.

Sara Freeman/MDedge News
Dr. Gary Macfarlane
These findings show that there are “considerable unmet needs” for patients with axSpA and comorbid fibromyalgia, even though they had some improvement, Gary J. Macfarlane, MBChB, PhD, the BSRBR-AS’s chief investigator, reported at the British Society for Rheumatology annual conference.

“The issue of fibromyalgia as a comorbidity in axial SpA has been the subject of current considerable interest,” said Dr. Macfarlane, who is Clinical Chair in Epidemiology at the University of Aberdeen (Scotland), where the BSRBR-AS is run. This is for several reasons: “One is the challenge of identifying patients with axial SpA who have comorbid fibromyalgia.

“The second is the concern that comorbid fibromyalgia may have an effect on disease indices such as BASDAI [Bath Ankylosing Spondylitis Disease Activity Index],” Dr. Macfarlane observed.

This leads to the third issue: “Are patients with comorbid fibromyalgia inappropriately receiving biological therapy, and how do they respond if they do receive it?”

Previous data from the BSRBR-AS have shown that approximately one in five patients with axSpA meet research criteria for fibromyalgia (Arthritis Rheumatol. 2017;69:2144-50) and that the prevalence of the comorbidity was higher in those who met Assessment of SpondyloArthritis International Society imaging criteria and lower in those who only met clinical criteria (25% vs. 10%).

 

 


The current aims of the study presented by Dr. Macfarlane were to first quantify the extent to which meeting fibromyalgia criteria was associated with higher measures of disease activity and impact, and then to see if meeting these criteria was associated with a poorer response to first use of a TNFi.

In order to find out, Dr. Macfarlane and his associates examined data from the prospective BSRBR-AS, which has been running since 2012. The BSRBR-AS recruits patients with ASAS-confirmed axSpA who are newly starting biologics from 83 U.K. centers.



At recruitment and at 3 months, patients starting biologic treatment undergo several assessments, which since 2015 has included research criteria for fibromyalgia (J Rheumatol. 2011;38:1113–22). The latter incorporate a Widespread Pain Index rated 0-19 and a Symptom Severity Scale rated 0-12 and cover items such as fatigue and waking up unrefreshed, and the presence of lower abdominal pain or headaches.

To date, around 1,750 participants in the BSRBR-AS have completed the fibromyalgia criteria, Dr. Macfarlane said.

 

 


Across the board, baseline measures of disease activity were lower in patients who met the fibromyalgia criteria versus those who did not. This included the BASDAI and the Bath Ankylosing Spondylitis Functional Index, where scores were approximately 6.5 and 4.5 for each measure.

“Quality of life was significantly lower in those who were fibromyalgia positive,” Dr. Macfarlane said. Indeed, whatever the measure used, from the disease-specific Ankylosing Spondylitis Quality of Life (ASQoL) Scale to the general EuroQoL Quality of Life Scale, there were significant differences between those who did and did not meet fibromyalgia criteria. There were also higher scores for depression, anxiety, poorer-quality sleep, and higher levels of fatigue.

Patients treated with TNFi therapy showed improvement in both BASDAI and ASQoL scores regardless of whether they met fibromyalgia criteria, but crucially, the responses were still lower and significantly different from those without fibromyalgia.

An ASAS20 response to TNFi therapy was met by “slightly fewer” patients who met the fibromyalgia criteria than by those who did not at all follow-up points: at 3 months (about 35% vs. 45%), 6 months (about 58% vs. 61%), and 12 months (about 60% vs. 62%).

A high score on the Symptom Severity Scale but not the Widespread Pain Index of the fibromyalgia criteria was associated with a lower response to TNFi therapy at 3 months. “Such patients may benefit from the use of TNFi and nonpharmacological therapy,” Dr. Macfarlane said.

 

 


The BSRBR-AS is funded by the British Society for Rheumatology, which in turn receives funding from AbbVie, Pfizer, and UCB. Dr. Macfarlane did not provide any disclosures but has previously acknowledged receiving an honorarium from Pfizer and research funding from AbbVie and Pfizer for the Scotland Registry for Ankylosing Spondylitis study.

SOURCE: Macfarlane GJ et al. Rheumatology. 2018;57(Suppl. 3):key075.183.

 

– Individuals with axial spondyloarthritis (axSpA) who have comorbid fibromyalgia do respond to biologic therapy but at a seemingly lower rate if they have a high symptom score during early assessments.

Data from the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR-AS) showed that participants with axSpA who were starting biologic therapy with a tumor necrosis factor inhibitor (TNFi) for the first time also had worse disease activity at baseline if they met fibromyalgia research criteria than if they did not.

Sara Freeman/MDedge News
Dr. Gary Macfarlane
These findings show that there are “considerable unmet needs” for patients with axSpA and comorbid fibromyalgia, even though they had some improvement, Gary J. Macfarlane, MBChB, PhD, the BSRBR-AS’s chief investigator, reported at the British Society for Rheumatology annual conference.

“The issue of fibromyalgia as a comorbidity in axial SpA has been the subject of current considerable interest,” said Dr. Macfarlane, who is Clinical Chair in Epidemiology at the University of Aberdeen (Scotland), where the BSRBR-AS is run. This is for several reasons: “One is the challenge of identifying patients with axial SpA who have comorbid fibromyalgia.

“The second is the concern that comorbid fibromyalgia may have an effect on disease indices such as BASDAI [Bath Ankylosing Spondylitis Disease Activity Index],” Dr. Macfarlane observed.

This leads to the third issue: “Are patients with comorbid fibromyalgia inappropriately receiving biological therapy, and how do they respond if they do receive it?”

Previous data from the BSRBR-AS have shown that approximately one in five patients with axSpA meet research criteria for fibromyalgia (Arthritis Rheumatol. 2017;69:2144-50) and that the prevalence of the comorbidity was higher in those who met Assessment of SpondyloArthritis International Society imaging criteria and lower in those who only met clinical criteria (25% vs. 10%).

 

 


The current aims of the study presented by Dr. Macfarlane were to first quantify the extent to which meeting fibromyalgia criteria was associated with higher measures of disease activity and impact, and then to see if meeting these criteria was associated with a poorer response to first use of a TNFi.

In order to find out, Dr. Macfarlane and his associates examined data from the prospective BSRBR-AS, which has been running since 2012. The BSRBR-AS recruits patients with ASAS-confirmed axSpA who are newly starting biologics from 83 U.K. centers.



At recruitment and at 3 months, patients starting biologic treatment undergo several assessments, which since 2015 has included research criteria for fibromyalgia (J Rheumatol. 2011;38:1113–22). The latter incorporate a Widespread Pain Index rated 0-19 and a Symptom Severity Scale rated 0-12 and cover items such as fatigue and waking up unrefreshed, and the presence of lower abdominal pain or headaches.

To date, around 1,750 participants in the BSRBR-AS have completed the fibromyalgia criteria, Dr. Macfarlane said.

 

 


Across the board, baseline measures of disease activity were lower in patients who met the fibromyalgia criteria versus those who did not. This included the BASDAI and the Bath Ankylosing Spondylitis Functional Index, where scores were approximately 6.5 and 4.5 for each measure.

“Quality of life was significantly lower in those who were fibromyalgia positive,” Dr. Macfarlane said. Indeed, whatever the measure used, from the disease-specific Ankylosing Spondylitis Quality of Life (ASQoL) Scale to the general EuroQoL Quality of Life Scale, there were significant differences between those who did and did not meet fibromyalgia criteria. There were also higher scores for depression, anxiety, poorer-quality sleep, and higher levels of fatigue.

Patients treated with TNFi therapy showed improvement in both BASDAI and ASQoL scores regardless of whether they met fibromyalgia criteria, but crucially, the responses were still lower and significantly different from those without fibromyalgia.

An ASAS20 response to TNFi therapy was met by “slightly fewer” patients who met the fibromyalgia criteria than by those who did not at all follow-up points: at 3 months (about 35% vs. 45%), 6 months (about 58% vs. 61%), and 12 months (about 60% vs. 62%).

A high score on the Symptom Severity Scale but not the Widespread Pain Index of the fibromyalgia criteria was associated with a lower response to TNFi therapy at 3 months. “Such patients may benefit from the use of TNFi and nonpharmacological therapy,” Dr. Macfarlane said.

 

 


The BSRBR-AS is funded by the British Society for Rheumatology, which in turn receives funding from AbbVie, Pfizer, and UCB. Dr. Macfarlane did not provide any disclosures but has previously acknowledged receiving an honorarium from Pfizer and research funding from AbbVie and Pfizer for the Scotland Registry for Ankylosing Spondylitis study.

SOURCE: Macfarlane GJ et al. Rheumatology. 2018;57(Suppl. 3):key075.183.

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Key clinical point: Comorbid axial spondyloarthritis and fibromyalgia are associated with a lower response to biologic therapy.

Major finding: About 35% vs. 45% of patients who did and did not meet research criteria for fibromyalgia had an ASAS20 response at 3 months.

Study details: Data on 1,750 participants of the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR-AS).

Disclosures: The BSRBR-AS is funded by the British Society for Rheumatology, which in turn receives funding from AbbVie, Pfizer, and UCB. Dr. Macfarlane did not provide any disclosures but has previously acknowledged receiving an honorarium from Pfizer and research funding from AbbVie and Pfizer for the Scotland Registry for Ankylosing Spondylitis study.

Source: Macfarlane GJ et al. Rheumatology. 2018;57(Suppl. 3):key075.183.

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Tailored hemophilia prophylaxis could cut costs

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Fri, 01/04/2019 - 10:25

 

Tailored frequency-escalated prophylaxis produced good outcomes with little arthropathy among boys with hemophilia A, according to findings from a prospective study.

The potential to use smaller amounts of clotting factor concentrates (CFCs) also offers a possible cost savings, Brian M. Feldman, MD, of the Hospital for Sick Children, Toronto, and his colleagues reported in the Lancet Haematology.

finger bleeding
Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

Prophylactic treatment to prevent bleeding episodes and avoid long term complications using regular CFCs is very effective but also very expensive. The Canadian Hemophilia Prophylaxis Study (CHPS) began 2 decades ago with the premise that, since CFC use accounts for most of the financial burden in severe hemophilia and because primary prophylaxis is started at a very young age, the burden on both the patient and the health care system could potentially be reduced by starting prophylaxis with CFC infusions at reduced frequency intervals. The individual’s subsequent bleeding episodes would then determine how the dose and frequency could be tailored.

In the study, 56 boys between the ages of 1 and 2.5 years with severe hemophilia A from 12 Canadian centers were enrolled in the CHPS, with a median time in the study of 10.2 years. Treatment was with standard half-life recombinant factor VIII (SHL-rFVIII), beginning as once weekly prophylaxis with 50 IU/kg and then escalating in frequency with appropriate dose adjustments as needed (step 1). The primary endpoint for this analysis was joint health, as measured by the modified Colorado Child Physical Examination Scores at completion of the study.

Participants were able to stay on once a week prophylaxis, without unacceptable bleeding, until a median age of 4.5 years. At this time, boys who developed unacceptable bleeding were escalated to twice-weekly prophylaxis at 30 IU/kg (step 2). The median age for beginning alternate day prophylaxis at 25 IU/kg (step 3) was 9.9 years of age.

The median annual SHL-rFVIII use was 3,582 IU/kg at age 2 years (n = 56), 4,041 IU/kg at age 6 years (n = 53), 3,638 IU/kg at age 10 years (n = 40), and 3,663 IU/kg at 14 years of age (n = 18). Overall adherence to the tailored regimen was a median of 86%, and no treatment-related safety events were observed during the study, including central venous catheter infections.

The median use of SHL-rFVIII on the tailored frequency-escalated prophylaxis is considerably less than the 6,000 IU/kg per year used in standard prophylaxis regimens, the researchers noted.

 

 


“We have previously shown, with a formal cost-benefit analysis using the value-of-information approach, that tailored frequency escalated prophylaxis provides substantial cost-benefit in a variety of scenarios. Our results from this study lend further support to these findings,” they wrote.

The median annualized index joint bleeding rate was 0.95 per year, but 30% of the boys in the study experienced “unacceptable breakthrough bleeding” during the study.

Overall joint health was “well preserved,” according to the researchers. The median Colorado Child Physical Examination Score at the end of the CHPS was 1 (range 0-12) for the left ankle and 1 for the right ankle, with all other joints having a median score of 0.

Activities of daily living and physical function, as well as health-related quality of life were generally good, the researchers reported.

The study was initially funded by grants from the Medical Research Council of Canada/Pharmaceutical Manufacturers Association of Canada Partnership Fund and by the Bayer/Canadian Blood Services/Héma-Québec Partnership Fund. Subsequent renewals were funded by Bayer. Dr. Feldman reported grants from Bayer during the conduct of the study and grants from Baxter/Baxalta/Shire outside the submitted work. Several coauthors also report multiple relationships with industry.

SOURCE: Feldman BM et al. Lancet Haematol. 2018 May 3. doi: 10.1016/S2352-3026(18)30048-6.

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Tailored frequency-escalated prophylaxis produced good outcomes with little arthropathy among boys with hemophilia A, according to findings from a prospective study.

The potential to use smaller amounts of clotting factor concentrates (CFCs) also offers a possible cost savings, Brian M. Feldman, MD, of the Hospital for Sick Children, Toronto, and his colleagues reported in the Lancet Haematology.

finger bleeding
Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

Prophylactic treatment to prevent bleeding episodes and avoid long term complications using regular CFCs is very effective but also very expensive. The Canadian Hemophilia Prophylaxis Study (CHPS) began 2 decades ago with the premise that, since CFC use accounts for most of the financial burden in severe hemophilia and because primary prophylaxis is started at a very young age, the burden on both the patient and the health care system could potentially be reduced by starting prophylaxis with CFC infusions at reduced frequency intervals. The individual’s subsequent bleeding episodes would then determine how the dose and frequency could be tailored.

In the study, 56 boys between the ages of 1 and 2.5 years with severe hemophilia A from 12 Canadian centers were enrolled in the CHPS, with a median time in the study of 10.2 years. Treatment was with standard half-life recombinant factor VIII (SHL-rFVIII), beginning as once weekly prophylaxis with 50 IU/kg and then escalating in frequency with appropriate dose adjustments as needed (step 1). The primary endpoint for this analysis was joint health, as measured by the modified Colorado Child Physical Examination Scores at completion of the study.

Participants were able to stay on once a week prophylaxis, without unacceptable bleeding, until a median age of 4.5 years. At this time, boys who developed unacceptable bleeding were escalated to twice-weekly prophylaxis at 30 IU/kg (step 2). The median age for beginning alternate day prophylaxis at 25 IU/kg (step 3) was 9.9 years of age.

The median annual SHL-rFVIII use was 3,582 IU/kg at age 2 years (n = 56), 4,041 IU/kg at age 6 years (n = 53), 3,638 IU/kg at age 10 years (n = 40), and 3,663 IU/kg at 14 years of age (n = 18). Overall adherence to the tailored regimen was a median of 86%, and no treatment-related safety events were observed during the study, including central venous catheter infections.

The median use of SHL-rFVIII on the tailored frequency-escalated prophylaxis is considerably less than the 6,000 IU/kg per year used in standard prophylaxis regimens, the researchers noted.

 

 


“We have previously shown, with a formal cost-benefit analysis using the value-of-information approach, that tailored frequency escalated prophylaxis provides substantial cost-benefit in a variety of scenarios. Our results from this study lend further support to these findings,” they wrote.

The median annualized index joint bleeding rate was 0.95 per year, but 30% of the boys in the study experienced “unacceptable breakthrough bleeding” during the study.

Overall joint health was “well preserved,” according to the researchers. The median Colorado Child Physical Examination Score at the end of the CHPS was 1 (range 0-12) for the left ankle and 1 for the right ankle, with all other joints having a median score of 0.

Activities of daily living and physical function, as well as health-related quality of life were generally good, the researchers reported.

The study was initially funded by grants from the Medical Research Council of Canada/Pharmaceutical Manufacturers Association of Canada Partnership Fund and by the Bayer/Canadian Blood Services/Héma-Québec Partnership Fund. Subsequent renewals were funded by Bayer. Dr. Feldman reported grants from Bayer during the conduct of the study and grants from Baxter/Baxalta/Shire outside the submitted work. Several coauthors also report multiple relationships with industry.

SOURCE: Feldman BM et al. Lancet Haematol. 2018 May 3. doi: 10.1016/S2352-3026(18)30048-6.

 

Tailored frequency-escalated prophylaxis produced good outcomes with little arthropathy among boys with hemophilia A, according to findings from a prospective study.

The potential to use smaller amounts of clotting factor concentrates (CFCs) also offers a possible cost savings, Brian M. Feldman, MD, of the Hospital for Sick Children, Toronto, and his colleagues reported in the Lancet Haematology.

finger bleeding
Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

Prophylactic treatment to prevent bleeding episodes and avoid long term complications using regular CFCs is very effective but also very expensive. The Canadian Hemophilia Prophylaxis Study (CHPS) began 2 decades ago with the premise that, since CFC use accounts for most of the financial burden in severe hemophilia and because primary prophylaxis is started at a very young age, the burden on both the patient and the health care system could potentially be reduced by starting prophylaxis with CFC infusions at reduced frequency intervals. The individual’s subsequent bleeding episodes would then determine how the dose and frequency could be tailored.

In the study, 56 boys between the ages of 1 and 2.5 years with severe hemophilia A from 12 Canadian centers were enrolled in the CHPS, with a median time in the study of 10.2 years. Treatment was with standard half-life recombinant factor VIII (SHL-rFVIII), beginning as once weekly prophylaxis with 50 IU/kg and then escalating in frequency with appropriate dose adjustments as needed (step 1). The primary endpoint for this analysis was joint health, as measured by the modified Colorado Child Physical Examination Scores at completion of the study.

Participants were able to stay on once a week prophylaxis, without unacceptable bleeding, until a median age of 4.5 years. At this time, boys who developed unacceptable bleeding were escalated to twice-weekly prophylaxis at 30 IU/kg (step 2). The median age for beginning alternate day prophylaxis at 25 IU/kg (step 3) was 9.9 years of age.

The median annual SHL-rFVIII use was 3,582 IU/kg at age 2 years (n = 56), 4,041 IU/kg at age 6 years (n = 53), 3,638 IU/kg at age 10 years (n = 40), and 3,663 IU/kg at 14 years of age (n = 18). Overall adherence to the tailored regimen was a median of 86%, and no treatment-related safety events were observed during the study, including central venous catheter infections.

The median use of SHL-rFVIII on the tailored frequency-escalated prophylaxis is considerably less than the 6,000 IU/kg per year used in standard prophylaxis regimens, the researchers noted.

 

 


“We have previously shown, with a formal cost-benefit analysis using the value-of-information approach, that tailored frequency escalated prophylaxis provides substantial cost-benefit in a variety of scenarios. Our results from this study lend further support to these findings,” they wrote.

The median annualized index joint bleeding rate was 0.95 per year, but 30% of the boys in the study experienced “unacceptable breakthrough bleeding” during the study.

Overall joint health was “well preserved,” according to the researchers. The median Colorado Child Physical Examination Score at the end of the CHPS was 1 (range 0-12) for the left ankle and 1 for the right ankle, with all other joints having a median score of 0.

Activities of daily living and physical function, as well as health-related quality of life were generally good, the researchers reported.

The study was initially funded by grants from the Medical Research Council of Canada/Pharmaceutical Manufacturers Association of Canada Partnership Fund and by the Bayer/Canadian Blood Services/Héma-Québec Partnership Fund. Subsequent renewals were funded by Bayer. Dr. Feldman reported grants from Bayer during the conduct of the study and grants from Baxter/Baxalta/Shire outside the submitted work. Several coauthors also report multiple relationships with industry.

SOURCE: Feldman BM et al. Lancet Haematol. 2018 May 3. doi: 10.1016/S2352-3026(18)30048-6.

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Key clinical point: Tailored frequency-escalated prophylaxis resulted in good outcomes and potential cost savings in hemophilia A.

Major finding: The median CPPES score at the end of the study was 1 (range 0-12) for the left ankle and 1 for the right ankle, with all other joints having a median score of 0.

Study details: Longitudinal design comprising 56 boys with severe hemophilia A who were followed for up to 16.1 years.

Disclosures: The study was initially funded by grants from the Medical Research Council of Canada/Pharmaceutical Manufacturers Association of Canada Partnership Fund and by the Bayer/Canadian Blood Services/Héma-Québec Partnership Fund. Subsequent renewals were funded by Bayer. Dr. Feldman reported grants from Bayer during the conduct of the study and grants from Baxter/Baxalta/Shire outside the submitted work. Several coauthors also report multiple relationships with industry.

Source: Feldman BM et al. Lancet Haematol. 2018 May 3. doi: 10.1016/S2352-3026(18)30048-6.

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Congress passes ‘right to try’ legislation

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Thu, 03/28/2019 - 14:37

 

Both houses of Congress have now approved a bill to provide terminally ill patients with access to experimental treatments, despite opposition from many Democrats and more than 100 patient and physician groups. President Trump is expected to sign the legislation.

By a vote of 250-169, the House passed S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 on May 22. All Republication House members voted for the bill, as did 22 Democrats. The Senate had passed the bill by unanimous consent in August 2017.

franckreporter/Thinkstock
The law would allow certain terminally ill patients who have unsuccessfully tried approved treatment options and are ineligible for clinical trials to gain access to certain unapproved, investigational drugs.

“This is dangerous legislation that threatens FDA’s [Food and Drug Administration’s] authority over insuring that medical treatments are effective,” Rep. Frank Pallone (D-N.J.), ranking member of the House Energy and Commerce Committee, said during the debate on the bill. “This bill needlessly exposes vulnerable patients to the risk of unproven medications.”

He noted the language will apply broadly to anyone who has been diagnosed with a disease but may not be terminal.

“The term ‘life-threatening disease or condition’ could include chronic and often manageable diseases, such as diabetes or chronic heart failure,” he said. “If all patients with diabetes and other chronic but manageable illnesses were eligible, you have greatly expanded the scope of the legislation well beyond the scope of most state laws and FDA’s expanded access program. This exposes an even greater number of patients to risk and undermines our clinical trial program by diverting patients from trials that could support full approval to the alternate pathway.”

The law notes that the experimental drug must have cleared phase 1 testing and experimentation, and development and testing must be ongoing. Treating physicians will not be compensated for certifying a patient as eligible to gain access to an investigational drug.

 

 


Patient and physician groups, including the American Society of Clinical Oncology, Friends of Cancer Research, American Lung Association, Cystic Fibrosis Foundation, and National Organization for Rare Disorders, voiced their opposition in a May 21 letter to House Republican and Democratic leaders.

“The Senate version of the legislation is less safe than the pathway proposed in the House version and is dangerous compared to the current [FDA] expanded access program,” according to the groups. “Both House and Senate versions would also remove FDA’s consultation on dosing, route of administration, dosing schedule, and other important safety measures available under FDA’s current expanded access program.”

The organizations noted that, while they did not support the House version, it “includes improved patient safeguards compared to the Senate version. The Senate version would negatively impact patient safety substantially, and our collective organizations are strongly opposed.”

President Trump has signaled he will sign the bill.
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Both houses of Congress have now approved a bill to provide terminally ill patients with access to experimental treatments, despite opposition from many Democrats and more than 100 patient and physician groups. President Trump is expected to sign the legislation.

By a vote of 250-169, the House passed S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 on May 22. All Republication House members voted for the bill, as did 22 Democrats. The Senate had passed the bill by unanimous consent in August 2017.

franckreporter/Thinkstock
The law would allow certain terminally ill patients who have unsuccessfully tried approved treatment options and are ineligible for clinical trials to gain access to certain unapproved, investigational drugs.

“This is dangerous legislation that threatens FDA’s [Food and Drug Administration’s] authority over insuring that medical treatments are effective,” Rep. Frank Pallone (D-N.J.), ranking member of the House Energy and Commerce Committee, said during the debate on the bill. “This bill needlessly exposes vulnerable patients to the risk of unproven medications.”

He noted the language will apply broadly to anyone who has been diagnosed with a disease but may not be terminal.

“The term ‘life-threatening disease or condition’ could include chronic and often manageable diseases, such as diabetes or chronic heart failure,” he said. “If all patients with diabetes and other chronic but manageable illnesses were eligible, you have greatly expanded the scope of the legislation well beyond the scope of most state laws and FDA’s expanded access program. This exposes an even greater number of patients to risk and undermines our clinical trial program by diverting patients from trials that could support full approval to the alternate pathway.”

The law notes that the experimental drug must have cleared phase 1 testing and experimentation, and development and testing must be ongoing. Treating physicians will not be compensated for certifying a patient as eligible to gain access to an investigational drug.

 

 


Patient and physician groups, including the American Society of Clinical Oncology, Friends of Cancer Research, American Lung Association, Cystic Fibrosis Foundation, and National Organization for Rare Disorders, voiced their opposition in a May 21 letter to House Republican and Democratic leaders.

“The Senate version of the legislation is less safe than the pathway proposed in the House version and is dangerous compared to the current [FDA] expanded access program,” according to the groups. “Both House and Senate versions would also remove FDA’s consultation on dosing, route of administration, dosing schedule, and other important safety measures available under FDA’s current expanded access program.”

The organizations noted that, while they did not support the House version, it “includes improved patient safeguards compared to the Senate version. The Senate version would negatively impact patient safety substantially, and our collective organizations are strongly opposed.”

President Trump has signaled he will sign the bill.

 

Both houses of Congress have now approved a bill to provide terminally ill patients with access to experimental treatments, despite opposition from many Democrats and more than 100 patient and physician groups. President Trump is expected to sign the legislation.

By a vote of 250-169, the House passed S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 on May 22. All Republication House members voted for the bill, as did 22 Democrats. The Senate had passed the bill by unanimous consent in August 2017.

franckreporter/Thinkstock
The law would allow certain terminally ill patients who have unsuccessfully tried approved treatment options and are ineligible for clinical trials to gain access to certain unapproved, investigational drugs.

“This is dangerous legislation that threatens FDA’s [Food and Drug Administration’s] authority over insuring that medical treatments are effective,” Rep. Frank Pallone (D-N.J.), ranking member of the House Energy and Commerce Committee, said during the debate on the bill. “This bill needlessly exposes vulnerable patients to the risk of unproven medications.”

He noted the language will apply broadly to anyone who has been diagnosed with a disease but may not be terminal.

“The term ‘life-threatening disease or condition’ could include chronic and often manageable diseases, such as diabetes or chronic heart failure,” he said. “If all patients with diabetes and other chronic but manageable illnesses were eligible, you have greatly expanded the scope of the legislation well beyond the scope of most state laws and FDA’s expanded access program. This exposes an even greater number of patients to risk and undermines our clinical trial program by diverting patients from trials that could support full approval to the alternate pathway.”

The law notes that the experimental drug must have cleared phase 1 testing and experimentation, and development and testing must be ongoing. Treating physicians will not be compensated for certifying a patient as eligible to gain access to an investigational drug.

 

 


Patient and physician groups, including the American Society of Clinical Oncology, Friends of Cancer Research, American Lung Association, Cystic Fibrosis Foundation, and National Organization for Rare Disorders, voiced their opposition in a May 21 letter to House Republican and Democratic leaders.

“The Senate version of the legislation is less safe than the pathway proposed in the House version and is dangerous compared to the current [FDA] expanded access program,” according to the groups. “Both House and Senate versions would also remove FDA’s consultation on dosing, route of administration, dosing schedule, and other important safety measures available under FDA’s current expanded access program.”

The organizations noted that, while they did not support the House version, it “includes improved patient safeguards compared to the Senate version. The Senate version would negatively impact patient safety substantially, and our collective organizations are strongly opposed.”

President Trump has signaled he will sign the bill.
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Breakthrough in noninvasive assessment of multivessel CAD

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– A completely noninvasive method of identifying functionally significant lesions in patients with triple-vessel coronary artery disease yielded results comparable to conventional invasive angiographic assessment accompanied by an intracoronary pressure wire, in a prespecified secondary analysis of the SYNTAX II study.

That noninvasive method uses fractional flow reserve calculated from computed tomographic angiography, Carlos Collet, MD, said at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/MDedge News
Dr. Carlos Collet
Moreover, the fully noninvasive evaluation was considerably more informative than was conventional invasive angiography alone, which is the dominant diagnostic strategy utilized in contemporary clinical practice despite persuasive evidence of the added clinical value provided by invasive measurement of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR). Indeed, the noninvasive approach evaluated in SYNTAX II reclassified 30% of patients from the high- and intermediate-risk tertiles based on invasive angiography to the low-risk tertile, a result with important implications for patient management because it renders them stronger candidates for PCI, observed Dr. Collet, a cardiologist at the Academic Medical Center of Amsterdam.

The results were hailed as a harbinger of a coming era in which interventional decision making will be based entirely upon noninvasively acquired anatomic and physiologic data. Conventional diagnostic angiography is predicted to fall by the wayside, with resultant savings in time and cost as well as avoidance of the risks of percutaneous diagnostic angiography, which entails considerably more radiation exposure than does noninvasive CT angiography (CTA).

“We are on the verge of a major change,” said Patrick W. Serruys, MD, PhD, professor of cardiology at Imperial College London, who was the senior coinvestigator in the study. “I think that the next disruptive moment in cardiology will be the introduction of the new generation of multislice CT scans replacing conventional cineangiography in the next 5-10 years. For the interventional cardiologist, to have the results of a multislice CT scan the day before a procedure is a wonderful bonus. You know in advance what you’re going to see, you can develop your treatment strategy, and you can spare contrast.”

Bruce Jancin/MDedge News
Dr. Patrick W. Serruys
This was a relatively small proof-of-concept study involving 77 patients with three-vessel CAD who underwent both CTA with noninvasive calculation of FFR and conventional invasive angiography with invasive physiologic assessment as part of the larger previously reported SYNTAX II (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery II) study.

Compared with conventional invasive angiographic assessment with the use of an intracoronary pressure wire to measure iFR, the noninvasively calculated SYNTAX II score had 95% sensitivity and 61% specificity for detection of functionally significant stenosis, with a positive predictive value of 81% and a negative predictive value of 87%. And this was achieved using older scanners and software considerably less accurate than today’s rapidly evolving state of the art, Dr. Collet noted.

 

 

Background

The original landmark SYNTAX trial led to development of an anatomically based SYNTAX score for use in stratifying risk and guiding treatment planning – coronary artery bypass grafting versus PCI – in patients with multivessel CAD. Both the U.S. and European guidelines recommend the use of this score, based on invasive angiography, giving it a Class IIa and I recommendation, respectively. Patients with a low-risk SYNTAX score of 22 or less were shown to have similar outcomes with PCI and coronary artery bypass grafting, while those with a score of 23 or more had better outcomes at 5-year follow-up with CABG.

Subsequently, incorporation of clinical characteristics formed the basis of the updated SYNTAX II score, with enhanced predictive accuracy allowing for projections of 4-year all-cause mortality with CABG versus PCI in a given patient (www.syntaxscore.com). The new SYNTAX II substudy takes things a giant step further by rendering the coronary imaging and physiology assessment noninvasive.

Simultaneous with Dr. Collet’s presentation at EuroPCR 2018, the study results were published in the Journal of the American College of Cardiology.

In an accompanying editorial, Bjarne L. Norgaard, MD, PhD, of Aarhus (Denmark) University and coauthors enthused, “These data suggest that we may be entering a new era in the management of CAD. The days of having patients entering the catheterization laboratory with nothing more than symptoms and a positive stress test result may be coming to an end. This study may be signaling a shifting paradigm in which CAD is diagnosed and thoroughly characterized noninvasively, and revascularization planning made in a collaborative fashion integrating the heart team, and a wealth of noninvasive data that will hopefully lead to more effective and cost-efficient revascularization strategies.”

 

 


What’s next

Elsewhere at EuroPCR 2018, Dr. Serruys presented the results of the SYNTAX III Revolution Trial, which randomized six pairs of heart teams – each comprising an interventional cardiologist, surgeon, and radiologist – to collectively assess and plan revascularization strategies for 223 patients with left main or triple-vessel CAD. One heart team in each pair was provided with a patient’s noninvasive CTA and FFR results, while the other team was given only the results of conventional angiography.

“There was almost perfect agreement between the heart teams on their decisions,” according to Dr. Serruys. “We were impressed that the surgeons were enthusiastic about the prospect of operating based on multislice CT alone.

On the basis of this evidence that heart teams found, the noninvasive assessment to be acceptable, he and his coinvestigators are organizing a multicenter trial to assess the feasibility and safety of the fully noninvasive stratification, compared with conventional angiography and invasive physiologic assessment of lesions. The primary safety endpoint will be the 1-month patency of bypass grafts.

The multislice scanner used in the SYNTAX III Revolution trial was the General Electric Revolution CT scanner, which enables imaging of the heart during a single heart beat. But Dr. Serruys said most of the big medical imaging companies with an eye to the near future are now developing multislice scanners specifically for the heart.

 

 


“They cost half the price and take only half the space of conventional scanners. I think these small units – which are not used for the brain, the abdomen, and all the rest – are going to play a big role in cardiology,” he predicted.

William Wijns, MD, codirector of EuroPCR, called the results of the SYNTAX II and SYNTAX III Revolution studies “transformative.” He and the other meeting organizers highlighted the studies in a special “deep-dive” session, which he urged younger interventionalists in particular to attend because he believes it’s likely they will be relying on these noninvasive assessments in the near future.

The SYNTAX III Revolution trial was sponsored by the European Cardiovascular Research Institute with support from GE Healthcare and HeartFlow. Dr. Serruys reported having no financial relationship with either company.

SOURCE: Collet C. EuroPCR 2018, Simultaneous publication (J Am Coll Cardiol 2018;71:40-53).

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– A completely noninvasive method of identifying functionally significant lesions in patients with triple-vessel coronary artery disease yielded results comparable to conventional invasive angiographic assessment accompanied by an intracoronary pressure wire, in a prespecified secondary analysis of the SYNTAX II study.

That noninvasive method uses fractional flow reserve calculated from computed tomographic angiography, Carlos Collet, MD, said at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/MDedge News
Dr. Carlos Collet
Moreover, the fully noninvasive evaluation was considerably more informative than was conventional invasive angiography alone, which is the dominant diagnostic strategy utilized in contemporary clinical practice despite persuasive evidence of the added clinical value provided by invasive measurement of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR). Indeed, the noninvasive approach evaluated in SYNTAX II reclassified 30% of patients from the high- and intermediate-risk tertiles based on invasive angiography to the low-risk tertile, a result with important implications for patient management because it renders them stronger candidates for PCI, observed Dr. Collet, a cardiologist at the Academic Medical Center of Amsterdam.

The results were hailed as a harbinger of a coming era in which interventional decision making will be based entirely upon noninvasively acquired anatomic and physiologic data. Conventional diagnostic angiography is predicted to fall by the wayside, with resultant savings in time and cost as well as avoidance of the risks of percutaneous diagnostic angiography, which entails considerably more radiation exposure than does noninvasive CT angiography (CTA).

“We are on the verge of a major change,” said Patrick W. Serruys, MD, PhD, professor of cardiology at Imperial College London, who was the senior coinvestigator in the study. “I think that the next disruptive moment in cardiology will be the introduction of the new generation of multislice CT scans replacing conventional cineangiography in the next 5-10 years. For the interventional cardiologist, to have the results of a multislice CT scan the day before a procedure is a wonderful bonus. You know in advance what you’re going to see, you can develop your treatment strategy, and you can spare contrast.”

Bruce Jancin/MDedge News
Dr. Patrick W. Serruys
This was a relatively small proof-of-concept study involving 77 patients with three-vessel CAD who underwent both CTA with noninvasive calculation of FFR and conventional invasive angiography with invasive physiologic assessment as part of the larger previously reported SYNTAX II (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery II) study.

Compared with conventional invasive angiographic assessment with the use of an intracoronary pressure wire to measure iFR, the noninvasively calculated SYNTAX II score had 95% sensitivity and 61% specificity for detection of functionally significant stenosis, with a positive predictive value of 81% and a negative predictive value of 87%. And this was achieved using older scanners and software considerably less accurate than today’s rapidly evolving state of the art, Dr. Collet noted.

 

 

Background

The original landmark SYNTAX trial led to development of an anatomically based SYNTAX score for use in stratifying risk and guiding treatment planning – coronary artery bypass grafting versus PCI – in patients with multivessel CAD. Both the U.S. and European guidelines recommend the use of this score, based on invasive angiography, giving it a Class IIa and I recommendation, respectively. Patients with a low-risk SYNTAX score of 22 or less were shown to have similar outcomes with PCI and coronary artery bypass grafting, while those with a score of 23 or more had better outcomes at 5-year follow-up with CABG.

Subsequently, incorporation of clinical characteristics formed the basis of the updated SYNTAX II score, with enhanced predictive accuracy allowing for projections of 4-year all-cause mortality with CABG versus PCI in a given patient (www.syntaxscore.com). The new SYNTAX II substudy takes things a giant step further by rendering the coronary imaging and physiology assessment noninvasive.

Simultaneous with Dr. Collet’s presentation at EuroPCR 2018, the study results were published in the Journal of the American College of Cardiology.

In an accompanying editorial, Bjarne L. Norgaard, MD, PhD, of Aarhus (Denmark) University and coauthors enthused, “These data suggest that we may be entering a new era in the management of CAD. The days of having patients entering the catheterization laboratory with nothing more than symptoms and a positive stress test result may be coming to an end. This study may be signaling a shifting paradigm in which CAD is diagnosed and thoroughly characterized noninvasively, and revascularization planning made in a collaborative fashion integrating the heart team, and a wealth of noninvasive data that will hopefully lead to more effective and cost-efficient revascularization strategies.”

 

 


What’s next

Elsewhere at EuroPCR 2018, Dr. Serruys presented the results of the SYNTAX III Revolution Trial, which randomized six pairs of heart teams – each comprising an interventional cardiologist, surgeon, and radiologist – to collectively assess and plan revascularization strategies for 223 patients with left main or triple-vessel CAD. One heart team in each pair was provided with a patient’s noninvasive CTA and FFR results, while the other team was given only the results of conventional angiography.

“There was almost perfect agreement between the heart teams on their decisions,” according to Dr. Serruys. “We were impressed that the surgeons were enthusiastic about the prospect of operating based on multislice CT alone.

On the basis of this evidence that heart teams found, the noninvasive assessment to be acceptable, he and his coinvestigators are organizing a multicenter trial to assess the feasibility and safety of the fully noninvasive stratification, compared with conventional angiography and invasive physiologic assessment of lesions. The primary safety endpoint will be the 1-month patency of bypass grafts.

The multislice scanner used in the SYNTAX III Revolution trial was the General Electric Revolution CT scanner, which enables imaging of the heart during a single heart beat. But Dr. Serruys said most of the big medical imaging companies with an eye to the near future are now developing multislice scanners specifically for the heart.

 

 


“They cost half the price and take only half the space of conventional scanners. I think these small units – which are not used for the brain, the abdomen, and all the rest – are going to play a big role in cardiology,” he predicted.

William Wijns, MD, codirector of EuroPCR, called the results of the SYNTAX II and SYNTAX III Revolution studies “transformative.” He and the other meeting organizers highlighted the studies in a special “deep-dive” session, which he urged younger interventionalists in particular to attend because he believes it’s likely they will be relying on these noninvasive assessments in the near future.

The SYNTAX III Revolution trial was sponsored by the European Cardiovascular Research Institute with support from GE Healthcare and HeartFlow. Dr. Serruys reported having no financial relationship with either company.

SOURCE: Collet C. EuroPCR 2018, Simultaneous publication (J Am Coll Cardiol 2018;71:40-53).

 

– A completely noninvasive method of identifying functionally significant lesions in patients with triple-vessel coronary artery disease yielded results comparable to conventional invasive angiographic assessment accompanied by an intracoronary pressure wire, in a prespecified secondary analysis of the SYNTAX II study.

That noninvasive method uses fractional flow reserve calculated from computed tomographic angiography, Carlos Collet, MD, said at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/MDedge News
Dr. Carlos Collet
Moreover, the fully noninvasive evaluation was considerably more informative than was conventional invasive angiography alone, which is the dominant diagnostic strategy utilized in contemporary clinical practice despite persuasive evidence of the added clinical value provided by invasive measurement of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR). Indeed, the noninvasive approach evaluated in SYNTAX II reclassified 30% of patients from the high- and intermediate-risk tertiles based on invasive angiography to the low-risk tertile, a result with important implications for patient management because it renders them stronger candidates for PCI, observed Dr. Collet, a cardiologist at the Academic Medical Center of Amsterdam.

The results were hailed as a harbinger of a coming era in which interventional decision making will be based entirely upon noninvasively acquired anatomic and physiologic data. Conventional diagnostic angiography is predicted to fall by the wayside, with resultant savings in time and cost as well as avoidance of the risks of percutaneous diagnostic angiography, which entails considerably more radiation exposure than does noninvasive CT angiography (CTA).

“We are on the verge of a major change,” said Patrick W. Serruys, MD, PhD, professor of cardiology at Imperial College London, who was the senior coinvestigator in the study. “I think that the next disruptive moment in cardiology will be the introduction of the new generation of multislice CT scans replacing conventional cineangiography in the next 5-10 years. For the interventional cardiologist, to have the results of a multislice CT scan the day before a procedure is a wonderful bonus. You know in advance what you’re going to see, you can develop your treatment strategy, and you can spare contrast.”

Bruce Jancin/MDedge News
Dr. Patrick W. Serruys
This was a relatively small proof-of-concept study involving 77 patients with three-vessel CAD who underwent both CTA with noninvasive calculation of FFR and conventional invasive angiography with invasive physiologic assessment as part of the larger previously reported SYNTAX II (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery II) study.

Compared with conventional invasive angiographic assessment with the use of an intracoronary pressure wire to measure iFR, the noninvasively calculated SYNTAX II score had 95% sensitivity and 61% specificity for detection of functionally significant stenosis, with a positive predictive value of 81% and a negative predictive value of 87%. And this was achieved using older scanners and software considerably less accurate than today’s rapidly evolving state of the art, Dr. Collet noted.

 

 

Background

The original landmark SYNTAX trial led to development of an anatomically based SYNTAX score for use in stratifying risk and guiding treatment planning – coronary artery bypass grafting versus PCI – in patients with multivessel CAD. Both the U.S. and European guidelines recommend the use of this score, based on invasive angiography, giving it a Class IIa and I recommendation, respectively. Patients with a low-risk SYNTAX score of 22 or less were shown to have similar outcomes with PCI and coronary artery bypass grafting, while those with a score of 23 or more had better outcomes at 5-year follow-up with CABG.

Subsequently, incorporation of clinical characteristics formed the basis of the updated SYNTAX II score, with enhanced predictive accuracy allowing for projections of 4-year all-cause mortality with CABG versus PCI in a given patient (www.syntaxscore.com). The new SYNTAX II substudy takes things a giant step further by rendering the coronary imaging and physiology assessment noninvasive.

Simultaneous with Dr. Collet’s presentation at EuroPCR 2018, the study results were published in the Journal of the American College of Cardiology.

In an accompanying editorial, Bjarne L. Norgaard, MD, PhD, of Aarhus (Denmark) University and coauthors enthused, “These data suggest that we may be entering a new era in the management of CAD. The days of having patients entering the catheterization laboratory with nothing more than symptoms and a positive stress test result may be coming to an end. This study may be signaling a shifting paradigm in which CAD is diagnosed and thoroughly characterized noninvasively, and revascularization planning made in a collaborative fashion integrating the heart team, and a wealth of noninvasive data that will hopefully lead to more effective and cost-efficient revascularization strategies.”

 

 


What’s next

Elsewhere at EuroPCR 2018, Dr. Serruys presented the results of the SYNTAX III Revolution Trial, which randomized six pairs of heart teams – each comprising an interventional cardiologist, surgeon, and radiologist – to collectively assess and plan revascularization strategies for 223 patients with left main or triple-vessel CAD. One heart team in each pair was provided with a patient’s noninvasive CTA and FFR results, while the other team was given only the results of conventional angiography.

“There was almost perfect agreement between the heart teams on their decisions,” according to Dr. Serruys. “We were impressed that the surgeons were enthusiastic about the prospect of operating based on multislice CT alone.

On the basis of this evidence that heart teams found, the noninvasive assessment to be acceptable, he and his coinvestigators are organizing a multicenter trial to assess the feasibility and safety of the fully noninvasive stratification, compared with conventional angiography and invasive physiologic assessment of lesions. The primary safety endpoint will be the 1-month patency of bypass grafts.

The multislice scanner used in the SYNTAX III Revolution trial was the General Electric Revolution CT scanner, which enables imaging of the heart during a single heart beat. But Dr. Serruys said most of the big medical imaging companies with an eye to the near future are now developing multislice scanners specifically for the heart.

 

 


“They cost half the price and take only half the space of conventional scanners. I think these small units – which are not used for the brain, the abdomen, and all the rest – are going to play a big role in cardiology,” he predicted.

William Wijns, MD, codirector of EuroPCR, called the results of the SYNTAX II and SYNTAX III Revolution studies “transformative.” He and the other meeting organizers highlighted the studies in a special “deep-dive” session, which he urged younger interventionalists in particular to attend because he believes it’s likely they will be relying on these noninvasive assessments in the near future.

The SYNTAX III Revolution trial was sponsored by the European Cardiovascular Research Institute with support from GE Healthcare and HeartFlow. Dr. Serruys reported having no financial relationship with either company.

SOURCE: Collet C. EuroPCR 2018, Simultaneous publication (J Am Coll Cardiol 2018;71:40-53).

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REPORTING FROM EUROPCR 2018

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Key clinical point: Noninvasive assessment of lesions in triple-vessel CAD may replace invasive diagnostic coronary angiography.

Major finding: A completely noninvasive method of identifying functionally significant lesions in patients with triple-vessel CAD by means of fractional flow reserve calculated from CT angiography yielded results comparable to conventional pressure-wire-based invasive angiographic assessment.

Study details: This prespecified secondary analysis of the SYNTAX II trial compared the results of noninvasive assessment of patients with triple-vessel CAD using FFR calculated from CT angiography with conventional angiography plus an invasive pressure wire.

Disclosures: The study was sponsored by the European Cardiovascular Research Institute with research grant support from Volcano and Boston Scientific. The presenter reported financial relationships with half a dozen medical device companies, but neither of those two.

Source: Collet C. EuroPCR 2018, simultaneous publication (J Am Coll Cardiol 2018;71:40-53).
 

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A fib ablation in HFrEF patients gains momentum

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– Results from two recent trials suggest that cardiologists may have a new way to improve outcomes in patients with heart failure with reduced ejection fraction if they also have atrial fibrillation: Cut the patient’s atrial fibrillation burden with catheter ablation.

This seemingly off-target approach to improving survival, avoiding heart failure hospitalizations, and possibly reducing other adverse events first gained attention with results from the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) randomized trial, first reported in 2017. The study showed in 363 patients that atrial fibrillation (AF) ablation in patients with heart failure with reduced ejection fraction (HFrEF) led to a statistically significant 38% relative reduction in the primary endpoint of mortality or heart failure hospitalization during a median 38 months of follow-up (N Engl J Med. 2018 Feb 1;378[5]:417-27).

This groundbreaking finding then received some degree of confirmation when Douglas L. Packer, MD, reported primary results from CABANA (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) at the annual scientific sessions of the Heart Rhythm Society. CABANA compared upfront ablation against first-line medical management of AF in 2,203 patients. While the primary endpoint of the cumulative rate of all-cause death, disabling stroke, serious bleeding, or cardiac arrest over a median follow-up of just over 4 years was neutral, with no statistically significant difference between the two treatment arms, a subgroup analysis showed a tantalizing suggestion of benefit in the 337 enrolled patients with a history of congestive heart failure (15% of the total study group).

In this subgroup, treatment with ablation cut the primary endpoint by 39% relative to those treated upfront with medical management, an effect that came close to statistical significance. In addition, Dr. Packer took special note of the per-protocol analysis, which censored out the crossover patients who constituted roughly a fifth of all enrolled patients. In the subgroup analysis using the per-protocol data, ablation was linked with a statistically significant 49% relative reduction in the primary endpoint among patients with a history of heart failure.

The patients for whom there may be the quickest shift to upfront ablation to treat AF based on the CABANA results will be those with heart failure and others with high underlying risk, Dr. Packer predicted at the meeting.

“The CASTLE-AF results were interesting, but in fewer than 400 patients. Now we’ve basically seen the same thing” in CABANA, said Dr. Packer, professor and a cardiac electrophysiologist at the Mayo Clinic in Rochester, Minn.

Notably however, the results Dr. Packer reported on the heart failure subgroup did not include any information on how many of these were patients who had HFrEF or heart failure with preserved ejection fraction and how the apparent benefit from AF ablation affected each of these two heart failure types. In addition, the reported CABANA results did not have an endpoint result that completely matched the mortality and heart failure hospitalization composite endpoint used in CASTLE-AF. The closest endpoint that Dr. Packer reported from CABANA was a composite of mortality and cardiovascular hospitalization that showed, for the entire CABANA cohort, a statistically significant 17% relative reduction with ablation in the intention-to-treat analysis. Dr. Packer gave no data on how this outcome shook out in the subgroup of heart failure patients.

 

 


Despite these limitations, in trying to synthesize the CABANA and CASTLE-AF results, several electrophysiologists who heard the results agreed with Dr. Packer that the CABANA results confirmed the CASTLE-AF findings and helped strengthen the case for strongly considering AF ablation as first-line treatment in patients with heart failure.

“It’s clear that sinus rhythm is important in patients with heart failure. CASTLE-AF and now these results; that’s very strong to me,” said Eric N. Prystowsky, MD, a cardiac electrophysiologist with the St. Vincent Medical Group in Indianapolis and designated discussant for CABANA at the meeting.
Mitchel L. Zoler/MDedge News
Dr. Eric N. Pryskowsky


“It’s confirmatory,” said Nassir F. Marrouche, MD, lead investigator for CASTLE-AF, and professor and director of the electrophysiology laboratory at the University of Utah in Salt Lake City.
Mitchel L. Zoler/MDedge News
Dr. Nassir F. Marrouche

 

 


The “signal” of benefit from AF ablation in heart failure patients in CABANA “replicates what was seen in CASTLE-AF. The results are highly consistent and very important regarding how to treat patients with AF and heart failure,” said Jeremy N. Ruskin, MD, professor of medicine at Harvard Medical School and director of the cardiac arrhythmia service at Massachusetts General Hospital, both in Boston. “The data strongly suggest that catheter ablation is helpful for restoring and preserving [heart] muscle function,” Dr. Ruskin said in a video interview. He noted that AF occurs in at least about a quarter of heart failure patients.

Other cardiologists at the meeting noted that, on the basis of the CASTLE-AF results alone, they have already become more aggressive about treating AF with ablation in patients with heart failure in routine practice.

Mitchel L. Zoler/MDedge News
Dr. Andrea M. Russo
“The CASTLE-AF data confirmed that I can improve heart failure outcomes in patients with AF. You might think that the heart failure patients are too sick, but ablation is the appropriate treatment; you make their heart failure better,” said Andrea M. Russo, MD, professor and director of the electrophysiology and arrhythmia service at Cooper University Health Care in Camden, N.J.

“It adds to the armamentarium for treatment of patients with heart failure,” said Johannes Brachmann, MD, professor and chief of cardiology at the Coburg (Germany) Clinic and a senior coinvestigator for CASTLE-AF.
Mitchel L. Zoler/MDedge News
Dr. Johannes Brachmann

 

 


William T. Abraham, MD, a heart failure specialist at The Ohio State University in Columbus, offered a broader perspective on where AF diagnosis, treatment, and ablation currently stand in U.S. heart failure practice.

“There is a very tight link between AF burden and worse outcomes in heart failure, so there is something intuitively appealing about restoring sinus rhythm in heart failure patients. I think most heart failure clinicians believe, like me, that heart failure patients with AF benefit from restoration of normal sinus rhythm. But I don’t believe that the CASTLE-AF results have so far had much impact on practice, in part because it was a relatively small study. The heart failure community is looking for some confirmation,” said Dr. Abraham, professor and director of cardiovascular medicine at Ohio State.

“I think the CABANA results are encouraging, but they came from only 15% of the enrolled patients who also had heart failure. CABANA adds to our knowledge, but I’m not sure it’s definitive for the heart failure population. I’m not sure it tells us if you treat patients with heart failure with anti-arrhythmia drugs and successfully maintain sinus rhythm do those patients do just as well as those who get ablated,” he said in an interview. “I’d love to see a study of heart failure patients maintained in sinus rhythm with drugs compared with those treated with ablation.”
Mitchel L. Zoler/MDedge News
Dr. William T. Abraham


For most patients with heart failure, the coexistence of AF is identified because of AF symptoms, or when asymptomatic AF is found in recordings made by an implanted cardiac device. “I’m more aggressive about addressing asymptomatic AF in my heart failure patients, and I believe the heart failure community is moving rapidly in that direction because of the association between higher AF burden and worse heart failure outcomes,” Dr. Abraham said.
 

 


A more cautious view came from another heart failure specialist, Clyde Yancy, MD, professor and chief of cardiology at Northwestern University in Chicago. “It’s pretty evident that in certain patients with heart failure AF ablation might be the right treatment, but is it every HFrEF patient with AF?” he wondered. “It’s nice to have more evidence so we can be more comfortable sending heart failure patients for ablation, but I want to see more information about the risk” from ablation in heart failure patients, “the sustainability of the effect, and the consequences of ablation.”
Mitchel L. Zoler/MDedge News
Dr. Clyde Yancy


But the reservations expressed by cardiologists like Dr. Yancy contrasted with the views of colleagues who consider the current evidence much more convincing.

“It seems logical to look harder for AF” in heart failure patients, based on the accumulated evidence from CASTLE-AF and CABANA, said Dr. Ruskin. “I don’t think we can offer advice to heart failure physicians to screen their heart failure patients for AF, but if it’s seen I think we have some useful information on how to address it.”

CASTLE-AF was funded by Biotronik. CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and has received research funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude, and also from several other companies. Dr. Prystowsky as been a consultant to CardioNet and Medtronic, he has an equity interest in Stereotaxis, and he receives fellowship support from Medtronic and St. Jude. Dr. Marrouche has been a consultant to Biosense Webster, Biotronik, Boston Scientific, and St. Jude. He has received research support from Medtronic, and he has had financial relationships with several other companies. Dr. Ruskin has been a consultant to Biosense Webster and Medtronic and several other companies, has an ownership interest in Amgen, Cameron Health, InfoBionic, Newpace, Portola, and Regeneron, and has a fiduciary role in Pharmaco-Kinesis. Dr. Russo and Dr. Yancy had no disclosures. Dr. Brachmann has been a consultant to and has received research funding from Biotronik, Boston Scientific, St. Jude, and several other companies. Dr. Abraham has been a consultant to Abbott Vascular, Medtronic, Novartis, and St. Jude.
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The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

– Results from two recent trials suggest that cardiologists may have a new way to improve outcomes in patients with heart failure with reduced ejection fraction if they also have atrial fibrillation: Cut the patient’s atrial fibrillation burden with catheter ablation.

This seemingly off-target approach to improving survival, avoiding heart failure hospitalizations, and possibly reducing other adverse events first gained attention with results from the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) randomized trial, first reported in 2017. The study showed in 363 patients that atrial fibrillation (AF) ablation in patients with heart failure with reduced ejection fraction (HFrEF) led to a statistically significant 38% relative reduction in the primary endpoint of mortality or heart failure hospitalization during a median 38 months of follow-up (N Engl J Med. 2018 Feb 1;378[5]:417-27).

This groundbreaking finding then received some degree of confirmation when Douglas L. Packer, MD, reported primary results from CABANA (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) at the annual scientific sessions of the Heart Rhythm Society. CABANA compared upfront ablation against first-line medical management of AF in 2,203 patients. While the primary endpoint of the cumulative rate of all-cause death, disabling stroke, serious bleeding, or cardiac arrest over a median follow-up of just over 4 years was neutral, with no statistically significant difference between the two treatment arms, a subgroup analysis showed a tantalizing suggestion of benefit in the 337 enrolled patients with a history of congestive heart failure (15% of the total study group).

In this subgroup, treatment with ablation cut the primary endpoint by 39% relative to those treated upfront with medical management, an effect that came close to statistical significance. In addition, Dr. Packer took special note of the per-protocol analysis, which censored out the crossover patients who constituted roughly a fifth of all enrolled patients. In the subgroup analysis using the per-protocol data, ablation was linked with a statistically significant 49% relative reduction in the primary endpoint among patients with a history of heart failure.

The patients for whom there may be the quickest shift to upfront ablation to treat AF based on the CABANA results will be those with heart failure and others with high underlying risk, Dr. Packer predicted at the meeting.

“The CASTLE-AF results were interesting, but in fewer than 400 patients. Now we’ve basically seen the same thing” in CABANA, said Dr. Packer, professor and a cardiac electrophysiologist at the Mayo Clinic in Rochester, Minn.

Notably however, the results Dr. Packer reported on the heart failure subgroup did not include any information on how many of these were patients who had HFrEF or heart failure with preserved ejection fraction and how the apparent benefit from AF ablation affected each of these two heart failure types. In addition, the reported CABANA results did not have an endpoint result that completely matched the mortality and heart failure hospitalization composite endpoint used in CASTLE-AF. The closest endpoint that Dr. Packer reported from CABANA was a composite of mortality and cardiovascular hospitalization that showed, for the entire CABANA cohort, a statistically significant 17% relative reduction with ablation in the intention-to-treat analysis. Dr. Packer gave no data on how this outcome shook out in the subgroup of heart failure patients.

 

 


Despite these limitations, in trying to synthesize the CABANA and CASTLE-AF results, several electrophysiologists who heard the results agreed with Dr. Packer that the CABANA results confirmed the CASTLE-AF findings and helped strengthen the case for strongly considering AF ablation as first-line treatment in patients with heart failure.

“It’s clear that sinus rhythm is important in patients with heart failure. CASTLE-AF and now these results; that’s very strong to me,” said Eric N. Prystowsky, MD, a cardiac electrophysiologist with the St. Vincent Medical Group in Indianapolis and designated discussant for CABANA at the meeting.
Mitchel L. Zoler/MDedge News
Dr. Eric N. Pryskowsky


“It’s confirmatory,” said Nassir F. Marrouche, MD, lead investigator for CASTLE-AF, and professor and director of the electrophysiology laboratory at the University of Utah in Salt Lake City.
Mitchel L. Zoler/MDedge News
Dr. Nassir F. Marrouche

 

 


The “signal” of benefit from AF ablation in heart failure patients in CABANA “replicates what was seen in CASTLE-AF. The results are highly consistent and very important regarding how to treat patients with AF and heart failure,” said Jeremy N. Ruskin, MD, professor of medicine at Harvard Medical School and director of the cardiac arrhythmia service at Massachusetts General Hospital, both in Boston. “The data strongly suggest that catheter ablation is helpful for restoring and preserving [heart] muscle function,” Dr. Ruskin said in a video interview. He noted that AF occurs in at least about a quarter of heart failure patients.

Other cardiologists at the meeting noted that, on the basis of the CASTLE-AF results alone, they have already become more aggressive about treating AF with ablation in patients with heart failure in routine practice.

Mitchel L. Zoler/MDedge News
Dr. Andrea M. Russo
“The CASTLE-AF data confirmed that I can improve heart failure outcomes in patients with AF. You might think that the heart failure patients are too sick, but ablation is the appropriate treatment; you make their heart failure better,” said Andrea M. Russo, MD, professor and director of the electrophysiology and arrhythmia service at Cooper University Health Care in Camden, N.J.

“It adds to the armamentarium for treatment of patients with heart failure,” said Johannes Brachmann, MD, professor and chief of cardiology at the Coburg (Germany) Clinic and a senior coinvestigator for CASTLE-AF.
Mitchel L. Zoler/MDedge News
Dr. Johannes Brachmann

 

 


William T. Abraham, MD, a heart failure specialist at The Ohio State University in Columbus, offered a broader perspective on where AF diagnosis, treatment, and ablation currently stand in U.S. heart failure practice.

“There is a very tight link between AF burden and worse outcomes in heart failure, so there is something intuitively appealing about restoring sinus rhythm in heart failure patients. I think most heart failure clinicians believe, like me, that heart failure patients with AF benefit from restoration of normal sinus rhythm. But I don’t believe that the CASTLE-AF results have so far had much impact on practice, in part because it was a relatively small study. The heart failure community is looking for some confirmation,” said Dr. Abraham, professor and director of cardiovascular medicine at Ohio State.

“I think the CABANA results are encouraging, but they came from only 15% of the enrolled patients who also had heart failure. CABANA adds to our knowledge, but I’m not sure it’s definitive for the heart failure population. I’m not sure it tells us if you treat patients with heart failure with anti-arrhythmia drugs and successfully maintain sinus rhythm do those patients do just as well as those who get ablated,” he said in an interview. “I’d love to see a study of heart failure patients maintained in sinus rhythm with drugs compared with those treated with ablation.”
Mitchel L. Zoler/MDedge News
Dr. William T. Abraham


For most patients with heart failure, the coexistence of AF is identified because of AF symptoms, or when asymptomatic AF is found in recordings made by an implanted cardiac device. “I’m more aggressive about addressing asymptomatic AF in my heart failure patients, and I believe the heart failure community is moving rapidly in that direction because of the association between higher AF burden and worse heart failure outcomes,” Dr. Abraham said.
 

 


A more cautious view came from another heart failure specialist, Clyde Yancy, MD, professor and chief of cardiology at Northwestern University in Chicago. “It’s pretty evident that in certain patients with heart failure AF ablation might be the right treatment, but is it every HFrEF patient with AF?” he wondered. “It’s nice to have more evidence so we can be more comfortable sending heart failure patients for ablation, but I want to see more information about the risk” from ablation in heart failure patients, “the sustainability of the effect, and the consequences of ablation.”
Mitchel L. Zoler/MDedge News
Dr. Clyde Yancy


But the reservations expressed by cardiologists like Dr. Yancy contrasted with the views of colleagues who consider the current evidence much more convincing.

“It seems logical to look harder for AF” in heart failure patients, based on the accumulated evidence from CASTLE-AF and CABANA, said Dr. Ruskin. “I don’t think we can offer advice to heart failure physicians to screen their heart failure patients for AF, but if it’s seen I think we have some useful information on how to address it.”

CASTLE-AF was funded by Biotronik. CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and has received research funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude, and also from several other companies. Dr. Prystowsky as been a consultant to CardioNet and Medtronic, he has an equity interest in Stereotaxis, and he receives fellowship support from Medtronic and St. Jude. Dr. Marrouche has been a consultant to Biosense Webster, Biotronik, Boston Scientific, and St. Jude. He has received research support from Medtronic, and he has had financial relationships with several other companies. Dr. Ruskin has been a consultant to Biosense Webster and Medtronic and several other companies, has an ownership interest in Amgen, Cameron Health, InfoBionic, Newpace, Portola, and Regeneron, and has a fiduciary role in Pharmaco-Kinesis. Dr. Russo and Dr. Yancy had no disclosures. Dr. Brachmann has been a consultant to and has received research funding from Biotronik, Boston Scientific, St. Jude, and several other companies. Dr. Abraham has been a consultant to Abbott Vascular, Medtronic, Novartis, and St. Jude.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

– Results from two recent trials suggest that cardiologists may have a new way to improve outcomes in patients with heart failure with reduced ejection fraction if they also have atrial fibrillation: Cut the patient’s atrial fibrillation burden with catheter ablation.

This seemingly off-target approach to improving survival, avoiding heart failure hospitalizations, and possibly reducing other adverse events first gained attention with results from the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) randomized trial, first reported in 2017. The study showed in 363 patients that atrial fibrillation (AF) ablation in patients with heart failure with reduced ejection fraction (HFrEF) led to a statistically significant 38% relative reduction in the primary endpoint of mortality or heart failure hospitalization during a median 38 months of follow-up (N Engl J Med. 2018 Feb 1;378[5]:417-27).

This groundbreaking finding then received some degree of confirmation when Douglas L. Packer, MD, reported primary results from CABANA (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) at the annual scientific sessions of the Heart Rhythm Society. CABANA compared upfront ablation against first-line medical management of AF in 2,203 patients. While the primary endpoint of the cumulative rate of all-cause death, disabling stroke, serious bleeding, or cardiac arrest over a median follow-up of just over 4 years was neutral, with no statistically significant difference between the two treatment arms, a subgroup analysis showed a tantalizing suggestion of benefit in the 337 enrolled patients with a history of congestive heart failure (15% of the total study group).

In this subgroup, treatment with ablation cut the primary endpoint by 39% relative to those treated upfront with medical management, an effect that came close to statistical significance. In addition, Dr. Packer took special note of the per-protocol analysis, which censored out the crossover patients who constituted roughly a fifth of all enrolled patients. In the subgroup analysis using the per-protocol data, ablation was linked with a statistically significant 49% relative reduction in the primary endpoint among patients with a history of heart failure.

The patients for whom there may be the quickest shift to upfront ablation to treat AF based on the CABANA results will be those with heart failure and others with high underlying risk, Dr. Packer predicted at the meeting.

“The CASTLE-AF results were interesting, but in fewer than 400 patients. Now we’ve basically seen the same thing” in CABANA, said Dr. Packer, professor and a cardiac electrophysiologist at the Mayo Clinic in Rochester, Minn.

Notably however, the results Dr. Packer reported on the heart failure subgroup did not include any information on how many of these were patients who had HFrEF or heart failure with preserved ejection fraction and how the apparent benefit from AF ablation affected each of these two heart failure types. In addition, the reported CABANA results did not have an endpoint result that completely matched the mortality and heart failure hospitalization composite endpoint used in CASTLE-AF. The closest endpoint that Dr. Packer reported from CABANA was a composite of mortality and cardiovascular hospitalization that showed, for the entire CABANA cohort, a statistically significant 17% relative reduction with ablation in the intention-to-treat analysis. Dr. Packer gave no data on how this outcome shook out in the subgroup of heart failure patients.

 

 


Despite these limitations, in trying to synthesize the CABANA and CASTLE-AF results, several electrophysiologists who heard the results agreed with Dr. Packer that the CABANA results confirmed the CASTLE-AF findings and helped strengthen the case for strongly considering AF ablation as first-line treatment in patients with heart failure.

“It’s clear that sinus rhythm is important in patients with heart failure. CASTLE-AF and now these results; that’s very strong to me,” said Eric N. Prystowsky, MD, a cardiac electrophysiologist with the St. Vincent Medical Group in Indianapolis and designated discussant for CABANA at the meeting.
Mitchel L. Zoler/MDedge News
Dr. Eric N. Pryskowsky


“It’s confirmatory,” said Nassir F. Marrouche, MD, lead investigator for CASTLE-AF, and professor and director of the electrophysiology laboratory at the University of Utah in Salt Lake City.
Mitchel L. Zoler/MDedge News
Dr. Nassir F. Marrouche

 

 


The “signal” of benefit from AF ablation in heart failure patients in CABANA “replicates what was seen in CASTLE-AF. The results are highly consistent and very important regarding how to treat patients with AF and heart failure,” said Jeremy N. Ruskin, MD, professor of medicine at Harvard Medical School and director of the cardiac arrhythmia service at Massachusetts General Hospital, both in Boston. “The data strongly suggest that catheter ablation is helpful for restoring and preserving [heart] muscle function,” Dr. Ruskin said in a video interview. He noted that AF occurs in at least about a quarter of heart failure patients.

Other cardiologists at the meeting noted that, on the basis of the CASTLE-AF results alone, they have already become more aggressive about treating AF with ablation in patients with heart failure in routine practice.

Mitchel L. Zoler/MDedge News
Dr. Andrea M. Russo
“The CASTLE-AF data confirmed that I can improve heart failure outcomes in patients with AF. You might think that the heart failure patients are too sick, but ablation is the appropriate treatment; you make their heart failure better,” said Andrea M. Russo, MD, professor and director of the electrophysiology and arrhythmia service at Cooper University Health Care in Camden, N.J.

“It adds to the armamentarium for treatment of patients with heart failure,” said Johannes Brachmann, MD, professor and chief of cardiology at the Coburg (Germany) Clinic and a senior coinvestigator for CASTLE-AF.
Mitchel L. Zoler/MDedge News
Dr. Johannes Brachmann

 

 


William T. Abraham, MD, a heart failure specialist at The Ohio State University in Columbus, offered a broader perspective on where AF diagnosis, treatment, and ablation currently stand in U.S. heart failure practice.

“There is a very tight link between AF burden and worse outcomes in heart failure, so there is something intuitively appealing about restoring sinus rhythm in heart failure patients. I think most heart failure clinicians believe, like me, that heart failure patients with AF benefit from restoration of normal sinus rhythm. But I don’t believe that the CASTLE-AF results have so far had much impact on practice, in part because it was a relatively small study. The heart failure community is looking for some confirmation,” said Dr. Abraham, professor and director of cardiovascular medicine at Ohio State.

“I think the CABANA results are encouraging, but they came from only 15% of the enrolled patients who also had heart failure. CABANA adds to our knowledge, but I’m not sure it’s definitive for the heart failure population. I’m not sure it tells us if you treat patients with heart failure with anti-arrhythmia drugs and successfully maintain sinus rhythm do those patients do just as well as those who get ablated,” he said in an interview. “I’d love to see a study of heart failure patients maintained in sinus rhythm with drugs compared with those treated with ablation.”
Mitchel L. Zoler/MDedge News
Dr. William T. Abraham


For most patients with heart failure, the coexistence of AF is identified because of AF symptoms, or when asymptomatic AF is found in recordings made by an implanted cardiac device. “I’m more aggressive about addressing asymptomatic AF in my heart failure patients, and I believe the heart failure community is moving rapidly in that direction because of the association between higher AF burden and worse heart failure outcomes,” Dr. Abraham said.
 

 


A more cautious view came from another heart failure specialist, Clyde Yancy, MD, professor and chief of cardiology at Northwestern University in Chicago. “It’s pretty evident that in certain patients with heart failure AF ablation might be the right treatment, but is it every HFrEF patient with AF?” he wondered. “It’s nice to have more evidence so we can be more comfortable sending heart failure patients for ablation, but I want to see more information about the risk” from ablation in heart failure patients, “the sustainability of the effect, and the consequences of ablation.”
Mitchel L. Zoler/MDedge News
Dr. Clyde Yancy


But the reservations expressed by cardiologists like Dr. Yancy contrasted with the views of colleagues who consider the current evidence much more convincing.

“It seems logical to look harder for AF” in heart failure patients, based on the accumulated evidence from CASTLE-AF and CABANA, said Dr. Ruskin. “I don’t think we can offer advice to heart failure physicians to screen their heart failure patients for AF, but if it’s seen I think we have some useful information on how to address it.”

CASTLE-AF was funded by Biotronik. CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and has received research funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude, and also from several other companies. Dr. Prystowsky as been a consultant to CardioNet and Medtronic, he has an equity interest in Stereotaxis, and he receives fellowship support from Medtronic and St. Jude. Dr. Marrouche has been a consultant to Biosense Webster, Biotronik, Boston Scientific, and St. Jude. He has received research support from Medtronic, and he has had financial relationships with several other companies. Dr. Ruskin has been a consultant to Biosense Webster and Medtronic and several other companies, has an ownership interest in Amgen, Cameron Health, InfoBionic, Newpace, Portola, and Regeneron, and has a fiduciary role in Pharmaco-Kinesis. Dr. Russo and Dr. Yancy had no disclosures. Dr. Brachmann has been a consultant to and has received research funding from Biotronik, Boston Scientific, St. Jude, and several other companies. Dr. Abraham has been a consultant to Abbott Vascular, Medtronic, Novartis, and St. Jude.
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Establishing Financial Literacy: What Every Resident Needs to Know

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Establishing Financial Literacy: What Every Resident Needs to Know

The average debt of graduating medical students today is $190,000, which has increased from $32,000 since 1986 (or the equivalent of $70,000 in 2017 dollars when adjusted for inflation).1 This fact is especially disconcerting given that medical trainees and professionals are not known for being financially sophisticated, and rising levels of high-interest educational debt, increasing years of training, and stagnant or decreasing physician salaries make this status quo untenable.2 Building foundational financial literacy and establishing good financial practices should start during medical school and residency; these basics are a crucial component of long-term job satisfaction and professional resilience.

One prominent physician finance writer advocates that residents should consider the following 5 big-ticket financial steps: acquire life and disability insurance, open a Roth IRA, engage yearly in some type of financial education, and learn about billing and coding in your specialty.3 These exercises, except life insurance for a resident without dependents, are all nonnegotiable, yet alone are insufficient actions to build a solid financial foundation. The purpose of this article is to address additional steps every resident should take, including establishing a workable budget, learning how and why to calculate net worth yearly, determining what percentage of income to save for retirement and basic investing strategies, and managing student loans.

Establish a Workable Budget

Living on a budget is a form of reality acceptance. It may feel impossible to save or budget on a resident salary, but residents earn approximately the median US household income of $59,039, according to the US Census Bureau from September 2017.4,5 There are many tools that can be used to create a budget and to track monthly expenses. However, the simplest way to budget is to pay yourself first with automatic deductions to retirement and savings accounts as well as automated bill payments. Making a habit of reviewing all expenses at the end of every month allows you to see if expenditures remain aligned to your personal values and to reallocate funds for the upcoming month if they are not.

Calculate Net Worth Yearly

Calculating personal net worth may appear to be a discouraging activity to advocate for residents, as many will have a negative 6-figure net worth. The purpose is two-fold: Firstly, to compel you to become well acquainted with your varying types of debt and their respective interest rates. Secondly, similar to taking serial photographs of vitiligo patients to monitor for improvement, it may be the only thing in a long slow slog that indicates beneficial change is occurring because small daily efforts over time yield surprisingly impressive results and the calculation factors in both debt repayment and contributions to all savings vehicles. An example of a simplified method to calculate net worth is demonstrated in the Table.

 

 

Understand Your Retirement Account and Asset Distribution

Contributing to a retirement account should start day 1 of intern year. A simple rule of thumb to estimate how much money you need to save for retirement is to divide how much you expect to spend on a yearly basis by 4%. For example, if you anticipate spending $80,000 per year during retirement, you will need $2 million in savings (0.04×$2,000,000=$80,000). The amount saved depends on the aggressiveness of your financial goals, but it should be a minimum of 10% to 15% of income during residency and at least 20% afterwards. This strategy allows even a resident to save $25,000 to $50,000 over a 4-year period (depending on employer match), which can accrue additional value in the stock market. One advantage of contributing to an employer-based retirement account, which usually is a 403(b) plan for residents, is that it lowers your tax burden for the year because the savings are tax deferred, in contrast to a Roth IRA, which is funded with posttax dollars. Roth accounts often are recommended for residents because contributions are made during a period in which the physician is presumably in the lowest tax bracket, as account earnings and withdrawals from a Roth IRA after 59.5 years of age, when most physicians expect to be in a higher tax bracket, are tax free. Another advantage of contributing to a 403(b) account is that many residency programs offer a match, which provides for an immediate and substantial return on invested money. Because most residents do not have the cash flow to fully fund both a Roth IRA and 403(b) account (2018 contribution limits are $5500 and $18,500, respectively),6,7 one strategy to utilize both is to save enough to the 403(b) to capture the employer match and place whatever additional savings you can afford into the Roth IRA.

Many different investment strategies exist, and a thorough discussion of them is beyond the scope of this article. Simply speaking, there are 4 major asset classes in which to invest: US stocks, foreign stocks, real estate, and bonds. The variation of recommended contributions to each asset is limitless, and every resident should spend time considering the best strategy for his/her goals. One example of a simple effective investing strategy is to utilize index funds, which track the market and therefore rise with the market, as they tend to go up (at least historically, though temporary setbacks occur).8 If you are investing in funds available through your employer-sponsored retirement account, examine the funds you are automatically assigned and their associated fee and expense ratio (ER) disclosures, which are typically available through the online portal. A general rule of thumb is that good funds have ERs of less than 0.5% and bad funds have ERs greater than 1% and additional associated fees. The funds available to you also can be researched on the Morningstar, Inc, website (www.morningstar.com). My institution (University of Texas Dell Medical School, Austin) offers a variety of options with ERs varying from 0.02% to 1.02%. The difference in the costs associated with these funds over decades is notable, and it pays (literally) to understand the nuances. Reallocation of funds usually can be done easily online and are effective within 24 hours.

Student Loans

Although many residents agonize most over management of student loans, the simple solution is do not defer them. Refinancing federal loans with a private company versus enrolling in an income-based repayment program depends on many factors, including whether you have a high-earning spouse, how many dependents you have, and whether you expect to stay in academia and will be eligible for Public Service Loan Forgiveness, among others. Look critically at your situation and likely future employment to decide what is most appropriate for you; doing so can save you thousands of dollars in interest over the course of your residency.

Final Thoughts

To the detriment of residents and the attending physicians they will become, discussing financial matters in medicine remains rare, perhaps because it seems to shift what should be the singular focus of our profession, namely to help the sick, to thoughts of personal gain, which is a false dichotomy. Unquestionably, the physician’s role that supersedes all others is to care for the patient and to honor the oath we all took: “Into whatsoever houses I enter, I will enter to help the sick.” But this commitment should not preclude the mastery of financial concepts that promote personal and professional health and well-being. After all, the joy in work is maximized when you are not enslaved to it.

Your reading assignment, paper revision, or presentation can wait. Making time to understand your current financial health, to build your own financial literacy, and to plan for your future is an important component of a long satisfying career. Start now.

References
  1. Grischkan J, George BP, Chaiyachati K, et al. Distribution of medical education debt by specialty, 2010-2016. JAMA Intern Med. 2017;177:1532-1535.
  2. Ahmad FA, White AJ, Hiller KM, et al. An assessment of residents’ and fellows’ personal finance literacy: an unmet medical education need. Int J Med Educ. 2017;8:192-204.
  3. The five big money items you should do as a resident. The White Coat Investor website. https://www.whitecoatinvestor.com/the-five-big-money-items-you-should-do-as-a-resident. Published July 7, 2011. Accessed May 14, 2018.
  4. Income, poverty and health insurance coverage in the United States: 2016. United States Census Bureau website. https://www.census.gov/newsroom/press-releases/2017/income-povery.html. Published September 12, 2017. Accessed May 14, 2018.
  5. Levy S. Residents salary and debt report 2017. Medscape website. https://www.medscape.com/slideshow/residents-salary-and-debt-report-2017-6008931. Published July 26, 2017. Accessed May 22, 2018.
  6. Retirement topics - IRA contribution limits. Internal Revenue Service website. https://www.irs.gov/retirement-plans/plan-participant-employee/retirement-topics-ira-contribution-limits. Updated October 20, 2017. Accessed May 22, 2018.
  7. Retirement plan FAQs regarding 403(b) tax-sheltered annuity plans. Internal Revenue Service website. https://www.irs.gov/retirement-plans/retirement-plans-faqs-regarding-403b-tax-sheltered-annuity-plans#conts. Updated November 14, 2017. Accessed May 22, 2018.
  8. Collins JL. Stock series. JLCollins website. http://jlcollinsnh.com/stock-series/. Accessed May 14, 2018.
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From the Division of Dermatology, University of Texas Dell Medical School, Austin.

The author reports no conflict of interest.

Correspondence: Ashley D. Lundgren, MD, 313 E 12th St, Ste 103, Austin, TX 78701 ([email protected]).

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The average debt of graduating medical students today is $190,000, which has increased from $32,000 since 1986 (or the equivalent of $70,000 in 2017 dollars when adjusted for inflation).1 This fact is especially disconcerting given that medical trainees and professionals are not known for being financially sophisticated, and rising levels of high-interest educational debt, increasing years of training, and stagnant or decreasing physician salaries make this status quo untenable.2 Building foundational financial literacy and establishing good financial practices should start during medical school and residency; these basics are a crucial component of long-term job satisfaction and professional resilience.

One prominent physician finance writer advocates that residents should consider the following 5 big-ticket financial steps: acquire life and disability insurance, open a Roth IRA, engage yearly in some type of financial education, and learn about billing and coding in your specialty.3 These exercises, except life insurance for a resident without dependents, are all nonnegotiable, yet alone are insufficient actions to build a solid financial foundation. The purpose of this article is to address additional steps every resident should take, including establishing a workable budget, learning how and why to calculate net worth yearly, determining what percentage of income to save for retirement and basic investing strategies, and managing student loans.

Establish a Workable Budget

Living on a budget is a form of reality acceptance. It may feel impossible to save or budget on a resident salary, but residents earn approximately the median US household income of $59,039, according to the US Census Bureau from September 2017.4,5 There are many tools that can be used to create a budget and to track monthly expenses. However, the simplest way to budget is to pay yourself first with automatic deductions to retirement and savings accounts as well as automated bill payments. Making a habit of reviewing all expenses at the end of every month allows you to see if expenditures remain aligned to your personal values and to reallocate funds for the upcoming month if they are not.

Calculate Net Worth Yearly

Calculating personal net worth may appear to be a discouraging activity to advocate for residents, as many will have a negative 6-figure net worth. The purpose is two-fold: Firstly, to compel you to become well acquainted with your varying types of debt and their respective interest rates. Secondly, similar to taking serial photographs of vitiligo patients to monitor for improvement, it may be the only thing in a long slow slog that indicates beneficial change is occurring because small daily efforts over time yield surprisingly impressive results and the calculation factors in both debt repayment and contributions to all savings vehicles. An example of a simplified method to calculate net worth is demonstrated in the Table.

 

 

Understand Your Retirement Account and Asset Distribution

Contributing to a retirement account should start day 1 of intern year. A simple rule of thumb to estimate how much money you need to save for retirement is to divide how much you expect to spend on a yearly basis by 4%. For example, if you anticipate spending $80,000 per year during retirement, you will need $2 million in savings (0.04×$2,000,000=$80,000). The amount saved depends on the aggressiveness of your financial goals, but it should be a minimum of 10% to 15% of income during residency and at least 20% afterwards. This strategy allows even a resident to save $25,000 to $50,000 over a 4-year period (depending on employer match), which can accrue additional value in the stock market. One advantage of contributing to an employer-based retirement account, which usually is a 403(b) plan for residents, is that it lowers your tax burden for the year because the savings are tax deferred, in contrast to a Roth IRA, which is funded with posttax dollars. Roth accounts often are recommended for residents because contributions are made during a period in which the physician is presumably in the lowest tax bracket, as account earnings and withdrawals from a Roth IRA after 59.5 years of age, when most physicians expect to be in a higher tax bracket, are tax free. Another advantage of contributing to a 403(b) account is that many residency programs offer a match, which provides for an immediate and substantial return on invested money. Because most residents do not have the cash flow to fully fund both a Roth IRA and 403(b) account (2018 contribution limits are $5500 and $18,500, respectively),6,7 one strategy to utilize both is to save enough to the 403(b) to capture the employer match and place whatever additional savings you can afford into the Roth IRA.

Many different investment strategies exist, and a thorough discussion of them is beyond the scope of this article. Simply speaking, there are 4 major asset classes in which to invest: US stocks, foreign stocks, real estate, and bonds. The variation of recommended contributions to each asset is limitless, and every resident should spend time considering the best strategy for his/her goals. One example of a simple effective investing strategy is to utilize index funds, which track the market and therefore rise with the market, as they tend to go up (at least historically, though temporary setbacks occur).8 If you are investing in funds available through your employer-sponsored retirement account, examine the funds you are automatically assigned and their associated fee and expense ratio (ER) disclosures, which are typically available through the online portal. A general rule of thumb is that good funds have ERs of less than 0.5% and bad funds have ERs greater than 1% and additional associated fees. The funds available to you also can be researched on the Morningstar, Inc, website (www.morningstar.com). My institution (University of Texas Dell Medical School, Austin) offers a variety of options with ERs varying from 0.02% to 1.02%. The difference in the costs associated with these funds over decades is notable, and it pays (literally) to understand the nuances. Reallocation of funds usually can be done easily online and are effective within 24 hours.

Student Loans

Although many residents agonize most over management of student loans, the simple solution is do not defer them. Refinancing federal loans with a private company versus enrolling in an income-based repayment program depends on many factors, including whether you have a high-earning spouse, how many dependents you have, and whether you expect to stay in academia and will be eligible for Public Service Loan Forgiveness, among others. Look critically at your situation and likely future employment to decide what is most appropriate for you; doing so can save you thousands of dollars in interest over the course of your residency.

Final Thoughts

To the detriment of residents and the attending physicians they will become, discussing financial matters in medicine remains rare, perhaps because it seems to shift what should be the singular focus of our profession, namely to help the sick, to thoughts of personal gain, which is a false dichotomy. Unquestionably, the physician’s role that supersedes all others is to care for the patient and to honor the oath we all took: “Into whatsoever houses I enter, I will enter to help the sick.” But this commitment should not preclude the mastery of financial concepts that promote personal and professional health and well-being. After all, the joy in work is maximized when you are not enslaved to it.

Your reading assignment, paper revision, or presentation can wait. Making time to understand your current financial health, to build your own financial literacy, and to plan for your future is an important component of a long satisfying career. Start now.

The average debt of graduating medical students today is $190,000, which has increased from $32,000 since 1986 (or the equivalent of $70,000 in 2017 dollars when adjusted for inflation).1 This fact is especially disconcerting given that medical trainees and professionals are not known for being financially sophisticated, and rising levels of high-interest educational debt, increasing years of training, and stagnant or decreasing physician salaries make this status quo untenable.2 Building foundational financial literacy and establishing good financial practices should start during medical school and residency; these basics are a crucial component of long-term job satisfaction and professional resilience.

One prominent physician finance writer advocates that residents should consider the following 5 big-ticket financial steps: acquire life and disability insurance, open a Roth IRA, engage yearly in some type of financial education, and learn about billing and coding in your specialty.3 These exercises, except life insurance for a resident without dependents, are all nonnegotiable, yet alone are insufficient actions to build a solid financial foundation. The purpose of this article is to address additional steps every resident should take, including establishing a workable budget, learning how and why to calculate net worth yearly, determining what percentage of income to save for retirement and basic investing strategies, and managing student loans.

Establish a Workable Budget

Living on a budget is a form of reality acceptance. It may feel impossible to save or budget on a resident salary, but residents earn approximately the median US household income of $59,039, according to the US Census Bureau from September 2017.4,5 There are many tools that can be used to create a budget and to track monthly expenses. However, the simplest way to budget is to pay yourself first with automatic deductions to retirement and savings accounts as well as automated bill payments. Making a habit of reviewing all expenses at the end of every month allows you to see if expenditures remain aligned to your personal values and to reallocate funds for the upcoming month if they are not.

Calculate Net Worth Yearly

Calculating personal net worth may appear to be a discouraging activity to advocate for residents, as many will have a negative 6-figure net worth. The purpose is two-fold: Firstly, to compel you to become well acquainted with your varying types of debt and their respective interest rates. Secondly, similar to taking serial photographs of vitiligo patients to monitor for improvement, it may be the only thing in a long slow slog that indicates beneficial change is occurring because small daily efforts over time yield surprisingly impressive results and the calculation factors in both debt repayment and contributions to all savings vehicles. An example of a simplified method to calculate net worth is demonstrated in the Table.

 

 

Understand Your Retirement Account and Asset Distribution

Contributing to a retirement account should start day 1 of intern year. A simple rule of thumb to estimate how much money you need to save for retirement is to divide how much you expect to spend on a yearly basis by 4%. For example, if you anticipate spending $80,000 per year during retirement, you will need $2 million in savings (0.04×$2,000,000=$80,000). The amount saved depends on the aggressiveness of your financial goals, but it should be a minimum of 10% to 15% of income during residency and at least 20% afterwards. This strategy allows even a resident to save $25,000 to $50,000 over a 4-year period (depending on employer match), which can accrue additional value in the stock market. One advantage of contributing to an employer-based retirement account, which usually is a 403(b) plan for residents, is that it lowers your tax burden for the year because the savings are tax deferred, in contrast to a Roth IRA, which is funded with posttax dollars. Roth accounts often are recommended for residents because contributions are made during a period in which the physician is presumably in the lowest tax bracket, as account earnings and withdrawals from a Roth IRA after 59.5 years of age, when most physicians expect to be in a higher tax bracket, are tax free. Another advantage of contributing to a 403(b) account is that many residency programs offer a match, which provides for an immediate and substantial return on invested money. Because most residents do not have the cash flow to fully fund both a Roth IRA and 403(b) account (2018 contribution limits are $5500 and $18,500, respectively),6,7 one strategy to utilize both is to save enough to the 403(b) to capture the employer match and place whatever additional savings you can afford into the Roth IRA.

Many different investment strategies exist, and a thorough discussion of them is beyond the scope of this article. Simply speaking, there are 4 major asset classes in which to invest: US stocks, foreign stocks, real estate, and bonds. The variation of recommended contributions to each asset is limitless, and every resident should spend time considering the best strategy for his/her goals. One example of a simple effective investing strategy is to utilize index funds, which track the market and therefore rise with the market, as they tend to go up (at least historically, though temporary setbacks occur).8 If you are investing in funds available through your employer-sponsored retirement account, examine the funds you are automatically assigned and their associated fee and expense ratio (ER) disclosures, which are typically available through the online portal. A general rule of thumb is that good funds have ERs of less than 0.5% and bad funds have ERs greater than 1% and additional associated fees. The funds available to you also can be researched on the Morningstar, Inc, website (www.morningstar.com). My institution (University of Texas Dell Medical School, Austin) offers a variety of options with ERs varying from 0.02% to 1.02%. The difference in the costs associated with these funds over decades is notable, and it pays (literally) to understand the nuances. Reallocation of funds usually can be done easily online and are effective within 24 hours.

Student Loans

Although many residents agonize most over management of student loans, the simple solution is do not defer them. Refinancing federal loans with a private company versus enrolling in an income-based repayment program depends on many factors, including whether you have a high-earning spouse, how many dependents you have, and whether you expect to stay in academia and will be eligible for Public Service Loan Forgiveness, among others. Look critically at your situation and likely future employment to decide what is most appropriate for you; doing so can save you thousands of dollars in interest over the course of your residency.

Final Thoughts

To the detriment of residents and the attending physicians they will become, discussing financial matters in medicine remains rare, perhaps because it seems to shift what should be the singular focus of our profession, namely to help the sick, to thoughts of personal gain, which is a false dichotomy. Unquestionably, the physician’s role that supersedes all others is to care for the patient and to honor the oath we all took: “Into whatsoever houses I enter, I will enter to help the sick.” But this commitment should not preclude the mastery of financial concepts that promote personal and professional health and well-being. After all, the joy in work is maximized when you are not enslaved to it.

Your reading assignment, paper revision, or presentation can wait. Making time to understand your current financial health, to build your own financial literacy, and to plan for your future is an important component of a long satisfying career. Start now.

References
  1. Grischkan J, George BP, Chaiyachati K, et al. Distribution of medical education debt by specialty, 2010-2016. JAMA Intern Med. 2017;177:1532-1535.
  2. Ahmad FA, White AJ, Hiller KM, et al. An assessment of residents’ and fellows’ personal finance literacy: an unmet medical education need. Int J Med Educ. 2017;8:192-204.
  3. The five big money items you should do as a resident. The White Coat Investor website. https://www.whitecoatinvestor.com/the-five-big-money-items-you-should-do-as-a-resident. Published July 7, 2011. Accessed May 14, 2018.
  4. Income, poverty and health insurance coverage in the United States: 2016. United States Census Bureau website. https://www.census.gov/newsroom/press-releases/2017/income-povery.html. Published September 12, 2017. Accessed May 14, 2018.
  5. Levy S. Residents salary and debt report 2017. Medscape website. https://www.medscape.com/slideshow/residents-salary-and-debt-report-2017-6008931. Published July 26, 2017. Accessed May 22, 2018.
  6. Retirement topics - IRA contribution limits. Internal Revenue Service website. https://www.irs.gov/retirement-plans/plan-participant-employee/retirement-topics-ira-contribution-limits. Updated October 20, 2017. Accessed May 22, 2018.
  7. Retirement plan FAQs regarding 403(b) tax-sheltered annuity plans. Internal Revenue Service website. https://www.irs.gov/retirement-plans/retirement-plans-faqs-regarding-403b-tax-sheltered-annuity-plans#conts. Updated November 14, 2017. Accessed May 22, 2018.
  8. Collins JL. Stock series. JLCollins website. http://jlcollinsnh.com/stock-series/. Accessed May 14, 2018.
References
  1. Grischkan J, George BP, Chaiyachati K, et al. Distribution of medical education debt by specialty, 2010-2016. JAMA Intern Med. 2017;177:1532-1535.
  2. Ahmad FA, White AJ, Hiller KM, et al. An assessment of residents’ and fellows’ personal finance literacy: an unmet medical education need. Int J Med Educ. 2017;8:192-204.
  3. The five big money items you should do as a resident. The White Coat Investor website. https://www.whitecoatinvestor.com/the-five-big-money-items-you-should-do-as-a-resident. Published July 7, 2011. Accessed May 14, 2018.
  4. Income, poverty and health insurance coverage in the United States: 2016. United States Census Bureau website. https://www.census.gov/newsroom/press-releases/2017/income-povery.html. Published September 12, 2017. Accessed May 14, 2018.
  5. Levy S. Residents salary and debt report 2017. Medscape website. https://www.medscape.com/slideshow/residents-salary-and-debt-report-2017-6008931. Published July 26, 2017. Accessed May 22, 2018.
  6. Retirement topics - IRA contribution limits. Internal Revenue Service website. https://www.irs.gov/retirement-plans/plan-participant-employee/retirement-topics-ira-contribution-limits. Updated October 20, 2017. Accessed May 22, 2018.
  7. Retirement plan FAQs regarding 403(b) tax-sheltered annuity plans. Internal Revenue Service website. https://www.irs.gov/retirement-plans/retirement-plans-faqs-regarding-403b-tax-sheltered-annuity-plans#conts. Updated November 14, 2017. Accessed May 22, 2018.
  8. Collins JL. Stock series. JLCollins website. http://jlcollinsnh.com/stock-series/. Accessed May 14, 2018.
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Participation in Work and Sport Following Reverse and Total Shoulder Arthroplasty

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Participation in Work and Sport Following Reverse and Total Shoulder Arthroplasty

ABSTRACT

Both anatomical total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA) are routinely performed for patients who desire to continuously work or participate in sports. This study analyzes and compares the ability of patients to work and partake in sports following shoulder arthroplasty based on responses to clinical outcome surveys.

A retrospective review of the shoulder surgery repository was performed for all patients treated with TSA and RSA and who completed questions 9 and 10 on the activity patient self-evaluation portion of the American Shoulder and Elbow Surgeons (ASES) Assessment Form. Patients with a minimum of 1-year follow-up were included if a sport or work was identified. The analysis included 162 patients with TSA and 114 patients with RSA. Comparisons were made between TSA and RSA in terms of the specific ASES scores (rated 0-3) reported for ability to work and participate in sports and total ASES scores, and scores based on specific sports or line of work reported. Comparisons were also made between sports predominantly using shoulder function and those that do not.

TSA patients had a 27% higher ability to participate in sports (average specific ASES score: 2.5 vs 1.9, P < .001) than RSA patients and presented significantly higher scores for swimming and golf. Compared with RSA patients, TSA patients demonstrated more ability to participate in sports requiring shoulder function without difficulty, as 63% reported maximal scores (P = .003). Total shoulder arthroplasty patients also demonstrated a 21% higher ability to work than RSA patients (average specific ASES scores: 2.6 vs 2.1, P < .001), yielding significantly higher scores for housework and gardening.

Both TSA and RSA allow for participation in work and sports, with TSA patients reporting better overall ability to participate. For sports involving shoulder function, TSA patients more commonly report maximal ability to participate than RSA patients.

End-stage shoulder arthritis has been successfully treated with anatomical total shoulder arthroplasty (TSA) with high rates of functional recovery.1 With the introduction of reverse shoulder arthroplasty (RSA), indications for TSA have expanded.2-6 With continuing expansion of surgical indications, a more diverse and potentially active patient population is now being treated. As patients exhibit increased awareness of health and wellness, they demonstrate significant interest in understanding their ability to work or participate in sports after surgery.7 Patients no longer focus on pain relief as the only goal of surgery. A recent study of patients aged 65 years and undergoing shoulder arthroplasty revealed that 64% of the patients listed the ability to return to sports as the main reason for undergoing surgery,8 highlighting the significance of sports play in a patient’s life. Prior to surgery, shoulder pathologies lead to impairment in function, range of motion, and pain,9 hindering a patient to participate in both work and sports. With the intervention yielding improvement to these areas6,9-13 with increased patient satisfaction,10,13 accurately tailoring patient expectations for participation in sports and work postoperatively becomes increasingly important.

Continue to: Although several studies...

 

 

Although several studies have demonstrated the ability of patients to return to sports following TSA,8,14-18 a limited number of studies discuss the return to sports following RSA.19-21 Despite known postoperative improvements, no clear consensus is reached as to which specific sports patients can return to and at what level of participation is to be expected. Surveyed members of the American Shoulder and Elbow Surgeons (ASES) universally favored full return to sports, except for contact sports for TSA patients, whereas other surgeons are more conservative to allow RSA patients to return to activities.22 To our knowledge, no other study has investigated the ability to work following RSA. Furthermore, no other study has used patient-reported outcomes to compare the quality of participation in sports or work between TSA and RSA patients following surgery. This study reports the ability of patients treated with TSA and RSA to work and participate in sports based on clinical outcome surveys. We hypothesize that TSA patients will be allowed to work and participate in sports with less difficulty than RSA patients.

MATERIALS AND METHODS

Following Institutional Review Board approval, a retrospective review was performed on all patients treated with TSA or RSA and who completed questions 9 and/or 10 (by score and named usual sport and/or work) on the activity patient self-evaluation portion of the ASES23 Assessment Form between 2007 to 2014; queries were made via the Shoulder Outcomes Repository. A minimum of 12-month follow-up was required, as functional recovery has been shown to plateau or nearly plateau by 12 months.11 Patients were excluded if <12 months of follow-up was available, if they failed to provide a written answer for questions 9 or 10 on the activity patient self-evaluation portion of the ASES Assessment Form, or if they required a revision shoulder arthroplasty. A single fellowship-trained shoulder and elbow surgeon performed all procedures via the same deltopectoral approach and prescribed identical postoperative rehabilitation for both TSA and RSA patients. The database query yielded 162 TSA and 114 RSA patients, for a total of 276 patients eligible for the study.

For all patients, the most recent follow-up ASES score was used. Comparisons were made between TSA and RSA for total ASES scores and response groups for usual sport (ASES question 9) and usual work (ASES question 10). The ASES questionnaire provides patients with 4 choices for each question based on the ability to perform each activity: 0, unable to do; 1, very difficult; 2, somewhat difficult; and 3, not difficult. The questionnaire also allows the patients to identify their usual work and sports. If patients noted >1 sport or work activity, they were included within multiple subgroups. Patients were further compared by age and gender.

Work was subdivided to include retired, housework, desk jobs, prolonged standing, gardening/yard work, jobs requiring lifting, carpenter/construction, cook/food preparation, and creative jobs (Table 1). 

Sports were subdivided to include golf, swimming, walking, gym exercises, racquet sports, group fitness, sedentary sports, fishing and target shooting, adventure sports, team sports, bowling, biking, hiking/jogging/rollerblading, and motorcycle riding (Table 2). 
Sports were further subdivided into those which predominately use shoulder function and those requiring minimal shoulder function (Table 3).

Statistical analysis was performed with SPSS Version 21 (IBM). Unpaired t tests were used to determine differences between groups. A P-value of <.05 was deemed significant.

Continue to: A total of 276 patients...

 

 

RESULTS

A total of 276 patients that met the inclusion criteria were eligible for the study, with 162 having undergone TSA and 114 with RSA. Overall average follow-up totaled 29 months (range, 12-91 months). RSA patients (average age, 75 years old; range, 46-88 years) were significantly older than TSA patients (average age, 69 years old; range, 32-89 years; P = .001). Significantly more women were treated with TSA (52% TSA; 48% RSA; P = .012), whereas significantly more men were treated with TSA (67% TSA; 33% RSA, P = .012). Total ASES scores were significantly higher for TSA patients than RSA patients in work (P = .012) (Table 4) but not in sports (P = .063) (Table 5) categories.

 

SPORTS

A total of 186 patients, comprising of 71 RSA and 115 TSA individuals, responded to question 9 of the ASES questionnaire (Table 5). Among usually reported sports, golf (25%), swimming (17%), and walking (18%) were the most commonly cited. RSA patients indicating a sport were significantly older than TSA patients (74 years vs 69 years, P < .001). TSA patients reported a 27% higher difference in overall ability to participate in sports, with an average ASES sport-specific score of 2.5 compared with the 1.9 for RSA patients (P < .001).

Among specific sports, TSA patients reported significantly higher scores for swimming (2.6 vs 1.8, P = .007) and golf (2.5 vs 1.8, P = .050). However, no significant differences were observed for walking, gym exercises, and racquet sports (Table 5). Among sport subsets, RSA patients were significantly older for golf (77 years vs 70 years, P = .006) and bowling (80 years vs 68 years, P = .005). Five TSA patients reported biking as their sport, whereas no RSA patient reported such activity. Within each subset of sports, no significant differences were noted in average ASES total scores.

TSA patients demonstrated a more significant ability to perform usual sports that involve shoulder function without difficulty (score of 3). In shoulder dominant sports, a total of 63% of TSA patients reported a score of 3 compared with the 39% of RSA patients (P = .003). RSA patients more often reported an inability to perform shoulder specific sports, as proven by 20% of RSA patients reporting a score of 0 compared with 4% of TSA patients (P < .001) (Table 6).

WORK

A total of 265 patients, including 106 RSA and 159 TSA patients, responded to question 10 of the ASES questionnaire. Among usually reported work, retirement (43%), housework (27%), and desk jobs (18%) were the most commonly cited. RSA patients denoting a work were significantly older than TSA patients (75 years vs 69 years, P < .001). Patients with TSA presented a 21% higher difference in the overall ability to work, featuring an average ASES work-specific score of 2.6 compared with the 2.1 for RSA patients (P < .001) (Table 4).

Continue to: Among specific work activities...

 

 

Among specific work activities, TSA patients reported significantly higher scores for housework (2.7 vs 2; 34% difference; P = .001) and gardening (2.8 vs 1.7; 65% difference; P = .009) in comparison with RSA patients. However, no significant differences were observed for other work activities, including retirement, desk job, prolonged standing, creative jobs, lifting jobs, or construction (Table 4). Among the work subgroups, RSA patients were older than TSA patients for the retired group (77 years vs 72 years; P < .001) and gardening (81 years vs 68 years; P = .002).

DISCUSSION

The ability to participate in sports and work is a common goal for shoulder arthroplasty patients. However, the ability at which participation occurs has not been examined. This study illustrates not only the ability to engage in usual work or sport, but provides some insights into patient-reported quality of participation. Overall, TSA patients featured 27% higher sport-specific ASES scores and 21% higher work-specific ASES scores than RSA patients, confirming our hypothesis that TSA patients can participate in work or sports with less difficulty in general. This study is the first to stratify the difficulty of participating in sports in general and in specific sports identified by patients. Although statistical analysis was performed for individual sports and work reported, the use of small cohorts possibly affected the ability to detect significant differences. The data presented in this study can thus be used as descriptive evidence of what a patient may expect to be able to do following surgery, helping to define patient expectations prior to electing to undergo shoulder arthroplasty.

Among specific sports identified by patients, a few significant differences were observed between RSA and TSA patients. However, ASES-specific scores almost universally favored TSA. Of the sport subgroups, swimming and golf showed significant differences. For swimming, this difference was fairly significant, as TSA patients demonstrated a 49% higher score than their RSA counterparts, but without differences in age or total ASES score (Table 5). Alteration in shoulder mechanics after RSA may be used to explain the difficulty in returning to swimming, as additional time may be needed to adapt to new mechanics.24 McCarty and colleagues8 demonstrated that 90% of patients following TSA fully resumed participation in swimming within 6 months of surgery, and further stated that repetitive motions of swimming caused no effects on short-term outcomes. No similar analysis of swimming has been reported for RSA patients. Based upon our findings, the average RSA patient can experience some difficulties when returning to swimming after surgery (average specific ASES score, 1.8).

Jensen and Rockwood16 were among the first to demonstrate successful return to golf of 24 patients who had undergone either TSA or hemiarthroplasty (HA), showing a 5-stroke improvement in their game. A recent study investigating patient-reported activity in patients aged 75 years and undergoing RSA showed that 23% of patients returned to high-level activity sports, such as golf, motorcycle riding, or free weights.19 All patients who participated in golf before surgery resumed playing following surgery; however, golf was listed among the top activities that patients wanted to participate in but could not for any reason.19 Our data suggest that golfers with TSA will face less difficulty returning to sports compared with their RSA counterparts (average specific ASES score, 2.5 vs 1.8, who might find golf somewhat difficult.

Although no study has provided a clear consensus as to which activities are safe to perform following shoulder arthroplasty, experts have suggested that activities that impart high loads on the glenohumeral joint should be avoided.15 Among TSA patients, McCarty and colleagues8 reported high rates of return for swimmers, golfers, and tennis players; however, relatively low rates were reported for weight lifting, bowling, and softball (20%). Within our study group, golf, swimming, and walking were listed among the most popular sports performed. Although weight lifting, bowling, and softball were less commonly identified as usual sports within our study, patients treated with TSA demonstrated more ease to participate than RSA patients. This result was observed with ASES-specific scores noted for weight lifting and gym exercises (TSA, 2.5; RSA, 2.3) and team sports, such as softball (TSA, 2; RSA, 1.3). However, for bowling, RSA patients showed a trend toward more ability (RSA, 2.7; TSA, 1.7).

Continue to: Among specific work activities...

 

 

Successful return to sports that involve shoulder function, such as golf and swimming, has been demonstrated for TSA.8,14,16,17 However, studies have reported that return to these sports can be difficult for RSA patients.20 Fink and colleagues19 reported that following RSA, 48.7% of patients returned to moderate-intensity sports, such as swimming and golf. Consistent with these findings, in our study, TSA patients demonstrated a significantly higher ability to participate in their usual sports without difficulty (ASES-specific score of 3). This observation may relate to lower ultimate achievements in range of motion and strength in patients treated with RSA, when compared with TSA patients,24,25 and the generalized practice of utilizing RSA for lower-demand patients (RSA patients in this study were older).

Overall, participation in work was 21% easier for TSA patients than RSA patients. Although the majority of our patients cited retirement as their primary work, which is consistent with what one would expect with the mean age of this study’s cohorts (RSA, 75 years; TSA, 69 years), housework and gardening were the only specifically identified forms of work that demonstrated significant differences between RSA and TSA patients. A few reports in the literature documented the ability to return to work after shoulder arthroplasty. In a recent report on 13 workers’ compensation patients treated with TSA, only 1 patient returned to the same job, and 54% did not return to work.26 In a study comparing 14 workers’ compensation to a matched group of controls with all members treated with RSA, the workers’ compensation group yielded a lower return-to-work rate (14.2%) than the controls (41.7%).27 In a large study of 154 TSA patients, 14% returned to work, but specific jobs were not described in this analysis.14

The results of this study suggest that more TSA patients successfully participate in low-demand activities, such as gardening or housework. Zarkadas and colleagues18 reported that 65% of TSA and 47% of HA patients successfully returned to gardening compared with 42% of RSA patients observed in a continuation study.20 This study showed that TSA patients yielded a 65% difference in ability to work in gardening and 34% difference in ability to perform housework compared with RSA patients. Based on these findings, TSA patients can expect to experience no difficulty in performing housework or gardening, whereas RSA patients may find these tasks difficult to a certain degree.

The main limitation of this study is the reporting bias that results from survey-based studies. Possibly, more people engage in specific sports or work than what were reported. This type of study also features an inherent selection bias, as patients with highly and physically demanding jobs or usual sports were less likely to have been offered either TSA or RSA. An additional important limitation is the relatively small cohorts within sport and work subgroups; the small cohorts probably underpowered the statistical results of this study and made these findings valuable mostly as descriptive observations. Larger studies focusing on each subgroup will further clarify the ability of shoulder arthroplasty to perform individual sports or work. Further studies evaluating preoperative to postoperative sports- and work-specific ASES scores would provide notable insights into the functional improvements observed within each sport or work following surgery. The relatively large study population of 276 patients strengthened the findings, which relate to the overall ability to participate in sports and work for TSA and RSA patients. Finally, the evaluated TSA and RSA patients possibly represent different groups (significant difference in age and gender) with different underlying pathologies and potentially different demands and expectations. However, comparisons among these groups of patients bear importance in defining patient expectations related to surgery. Still, the ability to participate in sport or work possibly relates more to the limitations of the implant used than patient pathology. This possibility warrants further investigation.

CONCLUSION

Both TSA and RSA allow for participation in work and sports, with TSA patients reporting easier overall ability to participate. For sports involving shoulder function, TSA patients more commonly report maximal ability to participate than RSA patients.

References

1. Fehringer EV, Kopjar B, Boorman RS, Churchill RS, Smith KL, Matsen FA 3rd. Characterizing the functional improvement after total shoulder arthroplasty for osteoarthritis. J Bone Joint Surg Am. 2002;84-A(8):1349-1353.

2. Cuff DJ, Pupello DR. Comparison of hemiarthroplasty and reverse shoulder arthroplasty for the treatment of proximal humeral fractures in elderly patients. J Bone Joint Surg Am. 2013;95(22):2050-2055. doi:10.2106/JBJS.L.01637.

3. Guery J, Favard L, Sirveaux F, Oudet D, Mole D, Walch G. Reverse total shoulder arthroplasty. Survivorship analysis of eighty replacements followed for five to ten years. J Bone Joint Surg Am. 2006;88(8):1742-1747.

4. Levy JC, Virani N, Pupello D, Frankle M. Use of the reverse shoulder prosthesis for the treatment of failed hemiarthroplasty in patients with glenohumeral arthritis and rotator cuff deficiency. J Bone Joint Surg Br. 2007;89(2):189-195.

5. Patel DN, Young B, Onyekwelu I, Zuckerman JD, Kwon YW. Reverse total shoulder arthroplasty for failed shoulder arthroplasty. J Shoulder Elbow Surg. 2012;21(11):1478-1483. doi:10.1016/j.jse.2011.11.004.

6. Sebastia-Forcada E, Cebrian-Gomez R, Lizaur-Utrilla A, Gil-Guillen V. Reverse shoulder arthroplasty versus hemiarthroplasty for acute proximal humeral fractures. A blinded, randomized, controlled, prospective study. J Shoulder Elbow Surg. 2014;23(10):1419-1426. doi:10.1016/j.jse.2014.06.035.

7. Henn RF 3rd, Ghomrawi H, Rutledge JR, Mazumdar M, Mancuso CA, Marx RG. Preoperative patient expectations of total shoulder arthroplasty. J Bone Joint Surg Am. 2011;93(22):2110-2115. doi:10.2106/JBJS.J.01114.

8. McCarty EC, Marx RG, Maerz D, Altchek D, Warren RF. Sports participation after shoulder replacement surgery. Am J Sports Med. 2008;36(8):1577-1581. doi:10.1177/0363546508317126.

9. Puskas B, Harreld K, Clark R, Downes K, Virani NA, Frankle M. Isometric strength, range of motion, and impairment before and after total and reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(7):869-876. doi:10.1016/j.jse.2012.09.004.

10. Deshmukh AV, Koris M, Zurakowski D, Thornhill TS. Total shoulder arthroplasty: long-term survivorship, functional outcome, and quality of life. J Shoulder Elbow Surg. 2005;14(5):471-479.

11. Levy JC, Everding NG, Gil CC Jr., Stephens S, Giveans MR. Speed of recovery after shoulder arthroplasty: a comparison of reverse and anatomic total shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(12):1872-1881. doi:10.1016/j.jse.2014.04.014.

12. Nolan BM, Ankerson E, Wiater JM. Reverse total shoulder arthroplasty improves function in cuff tear arthropathy. Clin Orthop Relat Res. 2011;469(9):2476-2482. doi:10.1007/s11999-010-1683-z.

13. Norris TR, Iannotti JP. Functional outcome after shoulder arthroplasty for primary osteoarthritis: a multicenter study. J Shoulder Elbow Surg. 2002;11(2):130-135.

14. Bulhoff M, Sattler P, Bruckner T, Loew M, Zeifang F, Raiss P. Do patients return to sports and work after total shoulder replacement surgery? Am J Sports Med. 2015;43(2):423-427. doi:10.1177/0363546514557940.

15. Healy WL, Iorio R, Lemos MJ. Athletic activity after joint replacement. Am J Sports Med. 2001;29(3):377-388.

16. Jensen KL, Rockwood CA Jr. Shoulder arthroplasty in recreational golfers. J Shoulder Elbow Surg. 1998;7(4):362-367.

17. Schumann K, Flury MP, Schwyzer HK, Simmen BR, Drerup S, Goldhahn J. Sports activity after anatomical total shoulder arthroplasty. Am J Sports Med. 2010;38(10):2097-2105. doi:10.1177/0363546510371368.

18. Zarkadas PC, Throckmorton TQ, Dahm DL, Sperling J, Schleck CD, Cofield R. Patient reported activities after shoulder replacement: total and hemiarthroplasty. J Shoulder Elbow Surg. 2011;20(2):273-280. doi:10.1016/j.jse.2010.06.007.

19. Fink Barnes LA, Grantham WJ, Meadows MC, Bigliani LU, Levine WN, Ahmad CS. Sports activity after reverse total shoulder arthroplasty with minimum 2-year follow-up. Am J Orthop. 2015;44(2):68-72.

20. Lawrence TM, Ahmadi S, Sanchez-Sotelo J, Sperling JW, Cofield RH. Patient reported activities after reverse shoulder arthroplasty: part II. J Shoulder Elbow Surg. 2012;21(11):1464-1469. doi:10.1016/j.jse.2011.11.012.

21. Simovitch RW, Gerard BK, Brees JA, Fullick R, Kearse JC. Outcomes of reverse total shoulder arthroplasty in a senior athletic population. J Shoulder Elbow Surg. 2015;24(9):1481-1485. doi:10.1016/j.jse.2015.03.011.

22. Golant A, Christoforou D, Zuckerman JD, Kwon YW. Return to sports after shoulder arthroplasty: a survey of surgeons' preferences. J Shoulder Elbow Surg. 2012;21(4):554-560. doi:10.1016/j.jse.2010.11.021.

23. Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587-594.

24. Alta TD, de Toledo JM, Veeger HE, Janssen TW, Willems WJ. The active and passive kinematic difference between primary reverse and total shoulder prostheses. J Shoulder Elbow Surg. 2014;23(9):1395-1402. doi:10.1016/j.jse.2014.01.040.

25. Alta TD, Veeger DH, de Toledo JM, Janssen TW, Willems WJ. Isokinetic strength differences between patients with primary reverse and total shoulder prostheses: muscle strength quantified with a dynamometer. Clin Biomech (Bristol, Avon). 2014;29(9):965-970. doi:10.1016/j.clinbiomech.2014.08.018.

26. Jawa A, Dasti UR, Fasulo SM, Vaickus MH, Curtis AS, Miller SL. Anatomic total shoulder arthroplasty for patients receiving workers' compensation. J Shoulder Elbow Surg. 2015;24(11):1694-1697. doi:10.1016/j.jse.2015.04.017.

27. Morris BJ, Haigler RE, Laughlin MS, Elkousy HA, Gartsman GM, Edwards TB. Workers' compensation claims and outcomes after reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(3):453-459. doi:10.1016/j.jse.2014.07.009.

Author and Disclosure Information

Authors’ Disclosure Statement: Dr. Levy reports that he is a paid consultant of Globus Medical and DJO Orthopaedics; receives research grant funding from DJO Orthopaedics, Zimmer Biomet, Wright Medical, Rotation Medical, and OrthoSpace; and receives royalties from Innomed and DJO Orthopaedics. The other authors report no actual or potential conflict of interest in relation to this article.

Dr. Kurowicki is an Orthopaedic Research Fellow, Department of Orthopaedic Surgery, Seton Hall University, School of Health and Medical Sciences, South Orange, New Jersey. Dr. Rosas is a Physician Scientist, Department of Orthopaedic Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina. Dr. Law is an Orthopaedic Research Fellow, Department of Orthopaedic Research, Holy Cross Orthopaedic Research Institute, Fort Lauderdale, Florida. Dr. Levy is Chief of Orthopaedic Surgery, Department of Orthopaedic Surgery, Division of Shoulder and Elbow Surgery, Holy Cross Hospital, Fort Lauderdale, Florida.

Address correspondence to: Jennifer Kurowicki, MD, Seton Hall University, School of Health and Medical Sciences, 400 S Orange Ave, South Orange, NJ 07079 (email, [email protected]).

Am J Orthop. 2018;47(5). Copyright Frontline Medical Communications Inc. 2018. All rights reserved.

. Participation in Work and Sport Following Reverse and Total Shoulder Arthroplasty. Am J Orthop.

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Author and Disclosure Information

Authors’ Disclosure Statement: Dr. Levy reports that he is a paid consultant of Globus Medical and DJO Orthopaedics; receives research grant funding from DJO Orthopaedics, Zimmer Biomet, Wright Medical, Rotation Medical, and OrthoSpace; and receives royalties from Innomed and DJO Orthopaedics. The other authors report no actual or potential conflict of interest in relation to this article.

Dr. Kurowicki is an Orthopaedic Research Fellow, Department of Orthopaedic Surgery, Seton Hall University, School of Health and Medical Sciences, South Orange, New Jersey. Dr. Rosas is a Physician Scientist, Department of Orthopaedic Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina. Dr. Law is an Orthopaedic Research Fellow, Department of Orthopaedic Research, Holy Cross Orthopaedic Research Institute, Fort Lauderdale, Florida. Dr. Levy is Chief of Orthopaedic Surgery, Department of Orthopaedic Surgery, Division of Shoulder and Elbow Surgery, Holy Cross Hospital, Fort Lauderdale, Florida.

Address correspondence to: Jennifer Kurowicki, MD, Seton Hall University, School of Health and Medical Sciences, 400 S Orange Ave, South Orange, NJ 07079 (email, [email protected]).

Am J Orthop. 2018;47(5). Copyright Frontline Medical Communications Inc. 2018. All rights reserved.

. Participation in Work and Sport Following Reverse and Total Shoulder Arthroplasty. Am J Orthop.

Author and Disclosure Information

Authors’ Disclosure Statement: Dr. Levy reports that he is a paid consultant of Globus Medical and DJO Orthopaedics; receives research grant funding from DJO Orthopaedics, Zimmer Biomet, Wright Medical, Rotation Medical, and OrthoSpace; and receives royalties from Innomed and DJO Orthopaedics. The other authors report no actual or potential conflict of interest in relation to this article.

Dr. Kurowicki is an Orthopaedic Research Fellow, Department of Orthopaedic Surgery, Seton Hall University, School of Health and Medical Sciences, South Orange, New Jersey. Dr. Rosas is a Physician Scientist, Department of Orthopaedic Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina. Dr. Law is an Orthopaedic Research Fellow, Department of Orthopaedic Research, Holy Cross Orthopaedic Research Institute, Fort Lauderdale, Florida. Dr. Levy is Chief of Orthopaedic Surgery, Department of Orthopaedic Surgery, Division of Shoulder and Elbow Surgery, Holy Cross Hospital, Fort Lauderdale, Florida.

Address correspondence to: Jennifer Kurowicki, MD, Seton Hall University, School of Health and Medical Sciences, 400 S Orange Ave, South Orange, NJ 07079 (email, [email protected]).

Am J Orthop. 2018;47(5). Copyright Frontline Medical Communications Inc. 2018. All rights reserved.

. Participation in Work and Sport Following Reverse and Total Shoulder Arthroplasty. Am J Orthop.

ABSTRACT

Both anatomical total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA) are routinely performed for patients who desire to continuously work or participate in sports. This study analyzes and compares the ability of patients to work and partake in sports following shoulder arthroplasty based on responses to clinical outcome surveys.

A retrospective review of the shoulder surgery repository was performed for all patients treated with TSA and RSA and who completed questions 9 and 10 on the activity patient self-evaluation portion of the American Shoulder and Elbow Surgeons (ASES) Assessment Form. Patients with a minimum of 1-year follow-up were included if a sport or work was identified. The analysis included 162 patients with TSA and 114 patients with RSA. Comparisons were made between TSA and RSA in terms of the specific ASES scores (rated 0-3) reported for ability to work and participate in sports and total ASES scores, and scores based on specific sports or line of work reported. Comparisons were also made between sports predominantly using shoulder function and those that do not.

TSA patients had a 27% higher ability to participate in sports (average specific ASES score: 2.5 vs 1.9, P < .001) than RSA patients and presented significantly higher scores for swimming and golf. Compared with RSA patients, TSA patients demonstrated more ability to participate in sports requiring shoulder function without difficulty, as 63% reported maximal scores (P = .003). Total shoulder arthroplasty patients also demonstrated a 21% higher ability to work than RSA patients (average specific ASES scores: 2.6 vs 2.1, P < .001), yielding significantly higher scores for housework and gardening.

Both TSA and RSA allow for participation in work and sports, with TSA patients reporting better overall ability to participate. For sports involving shoulder function, TSA patients more commonly report maximal ability to participate than RSA patients.

End-stage shoulder arthritis has been successfully treated with anatomical total shoulder arthroplasty (TSA) with high rates of functional recovery.1 With the introduction of reverse shoulder arthroplasty (RSA), indications for TSA have expanded.2-6 With continuing expansion of surgical indications, a more diverse and potentially active patient population is now being treated. As patients exhibit increased awareness of health and wellness, they demonstrate significant interest in understanding their ability to work or participate in sports after surgery.7 Patients no longer focus on pain relief as the only goal of surgery. A recent study of patients aged 65 years and undergoing shoulder arthroplasty revealed that 64% of the patients listed the ability to return to sports as the main reason for undergoing surgery,8 highlighting the significance of sports play in a patient’s life. Prior to surgery, shoulder pathologies lead to impairment in function, range of motion, and pain,9 hindering a patient to participate in both work and sports. With the intervention yielding improvement to these areas6,9-13 with increased patient satisfaction,10,13 accurately tailoring patient expectations for participation in sports and work postoperatively becomes increasingly important.

Continue to: Although several studies...

 

 

Although several studies have demonstrated the ability of patients to return to sports following TSA,8,14-18 a limited number of studies discuss the return to sports following RSA.19-21 Despite known postoperative improvements, no clear consensus is reached as to which specific sports patients can return to and at what level of participation is to be expected. Surveyed members of the American Shoulder and Elbow Surgeons (ASES) universally favored full return to sports, except for contact sports for TSA patients, whereas other surgeons are more conservative to allow RSA patients to return to activities.22 To our knowledge, no other study has investigated the ability to work following RSA. Furthermore, no other study has used patient-reported outcomes to compare the quality of participation in sports or work between TSA and RSA patients following surgery. This study reports the ability of patients treated with TSA and RSA to work and participate in sports based on clinical outcome surveys. We hypothesize that TSA patients will be allowed to work and participate in sports with less difficulty than RSA patients.

MATERIALS AND METHODS

Following Institutional Review Board approval, a retrospective review was performed on all patients treated with TSA or RSA and who completed questions 9 and/or 10 (by score and named usual sport and/or work) on the activity patient self-evaluation portion of the ASES23 Assessment Form between 2007 to 2014; queries were made via the Shoulder Outcomes Repository. A minimum of 12-month follow-up was required, as functional recovery has been shown to plateau or nearly plateau by 12 months.11 Patients were excluded if <12 months of follow-up was available, if they failed to provide a written answer for questions 9 or 10 on the activity patient self-evaluation portion of the ASES Assessment Form, or if they required a revision shoulder arthroplasty. A single fellowship-trained shoulder and elbow surgeon performed all procedures via the same deltopectoral approach and prescribed identical postoperative rehabilitation for both TSA and RSA patients. The database query yielded 162 TSA and 114 RSA patients, for a total of 276 patients eligible for the study.

For all patients, the most recent follow-up ASES score was used. Comparisons were made between TSA and RSA for total ASES scores and response groups for usual sport (ASES question 9) and usual work (ASES question 10). The ASES questionnaire provides patients with 4 choices for each question based on the ability to perform each activity: 0, unable to do; 1, very difficult; 2, somewhat difficult; and 3, not difficult. The questionnaire also allows the patients to identify their usual work and sports. If patients noted >1 sport or work activity, they were included within multiple subgroups. Patients were further compared by age and gender.

Work was subdivided to include retired, housework, desk jobs, prolonged standing, gardening/yard work, jobs requiring lifting, carpenter/construction, cook/food preparation, and creative jobs (Table 1). 

Sports were subdivided to include golf, swimming, walking, gym exercises, racquet sports, group fitness, sedentary sports, fishing and target shooting, adventure sports, team sports, bowling, biking, hiking/jogging/rollerblading, and motorcycle riding (Table 2). 
Sports were further subdivided into those which predominately use shoulder function and those requiring minimal shoulder function (Table 3).

Statistical analysis was performed with SPSS Version 21 (IBM). Unpaired t tests were used to determine differences between groups. A P-value of <.05 was deemed significant.

Continue to: A total of 276 patients...

 

 

RESULTS

A total of 276 patients that met the inclusion criteria were eligible for the study, with 162 having undergone TSA and 114 with RSA. Overall average follow-up totaled 29 months (range, 12-91 months). RSA patients (average age, 75 years old; range, 46-88 years) were significantly older than TSA patients (average age, 69 years old; range, 32-89 years; P = .001). Significantly more women were treated with TSA (52% TSA; 48% RSA; P = .012), whereas significantly more men were treated with TSA (67% TSA; 33% RSA, P = .012). Total ASES scores were significantly higher for TSA patients than RSA patients in work (P = .012) (Table 4) but not in sports (P = .063) (Table 5) categories.

 

SPORTS

A total of 186 patients, comprising of 71 RSA and 115 TSA individuals, responded to question 9 of the ASES questionnaire (Table 5). Among usually reported sports, golf (25%), swimming (17%), and walking (18%) were the most commonly cited. RSA patients indicating a sport were significantly older than TSA patients (74 years vs 69 years, P < .001). TSA patients reported a 27% higher difference in overall ability to participate in sports, with an average ASES sport-specific score of 2.5 compared with the 1.9 for RSA patients (P < .001).

Among specific sports, TSA patients reported significantly higher scores for swimming (2.6 vs 1.8, P = .007) and golf (2.5 vs 1.8, P = .050). However, no significant differences were observed for walking, gym exercises, and racquet sports (Table 5). Among sport subsets, RSA patients were significantly older for golf (77 years vs 70 years, P = .006) and bowling (80 years vs 68 years, P = .005). Five TSA patients reported biking as their sport, whereas no RSA patient reported such activity. Within each subset of sports, no significant differences were noted in average ASES total scores.

TSA patients demonstrated a more significant ability to perform usual sports that involve shoulder function without difficulty (score of 3). In shoulder dominant sports, a total of 63% of TSA patients reported a score of 3 compared with the 39% of RSA patients (P = .003). RSA patients more often reported an inability to perform shoulder specific sports, as proven by 20% of RSA patients reporting a score of 0 compared with 4% of TSA patients (P < .001) (Table 6).

WORK

A total of 265 patients, including 106 RSA and 159 TSA patients, responded to question 10 of the ASES questionnaire. Among usually reported work, retirement (43%), housework (27%), and desk jobs (18%) were the most commonly cited. RSA patients denoting a work were significantly older than TSA patients (75 years vs 69 years, P < .001). Patients with TSA presented a 21% higher difference in the overall ability to work, featuring an average ASES work-specific score of 2.6 compared with the 2.1 for RSA patients (P < .001) (Table 4).

Continue to: Among specific work activities...

 

 

Among specific work activities, TSA patients reported significantly higher scores for housework (2.7 vs 2; 34% difference; P = .001) and gardening (2.8 vs 1.7; 65% difference; P = .009) in comparison with RSA patients. However, no significant differences were observed for other work activities, including retirement, desk job, prolonged standing, creative jobs, lifting jobs, or construction (Table 4). Among the work subgroups, RSA patients were older than TSA patients for the retired group (77 years vs 72 years; P < .001) and gardening (81 years vs 68 years; P = .002).

DISCUSSION

The ability to participate in sports and work is a common goal for shoulder arthroplasty patients. However, the ability at which participation occurs has not been examined. This study illustrates not only the ability to engage in usual work or sport, but provides some insights into patient-reported quality of participation. Overall, TSA patients featured 27% higher sport-specific ASES scores and 21% higher work-specific ASES scores than RSA patients, confirming our hypothesis that TSA patients can participate in work or sports with less difficulty in general. This study is the first to stratify the difficulty of participating in sports in general and in specific sports identified by patients. Although statistical analysis was performed for individual sports and work reported, the use of small cohorts possibly affected the ability to detect significant differences. The data presented in this study can thus be used as descriptive evidence of what a patient may expect to be able to do following surgery, helping to define patient expectations prior to electing to undergo shoulder arthroplasty.

Among specific sports identified by patients, a few significant differences were observed between RSA and TSA patients. However, ASES-specific scores almost universally favored TSA. Of the sport subgroups, swimming and golf showed significant differences. For swimming, this difference was fairly significant, as TSA patients demonstrated a 49% higher score than their RSA counterparts, but without differences in age or total ASES score (Table 5). Alteration in shoulder mechanics after RSA may be used to explain the difficulty in returning to swimming, as additional time may be needed to adapt to new mechanics.24 McCarty and colleagues8 demonstrated that 90% of patients following TSA fully resumed participation in swimming within 6 months of surgery, and further stated that repetitive motions of swimming caused no effects on short-term outcomes. No similar analysis of swimming has been reported for RSA patients. Based upon our findings, the average RSA patient can experience some difficulties when returning to swimming after surgery (average specific ASES score, 1.8).

Jensen and Rockwood16 were among the first to demonstrate successful return to golf of 24 patients who had undergone either TSA or hemiarthroplasty (HA), showing a 5-stroke improvement in their game. A recent study investigating patient-reported activity in patients aged 75 years and undergoing RSA showed that 23% of patients returned to high-level activity sports, such as golf, motorcycle riding, or free weights.19 All patients who participated in golf before surgery resumed playing following surgery; however, golf was listed among the top activities that patients wanted to participate in but could not for any reason.19 Our data suggest that golfers with TSA will face less difficulty returning to sports compared with their RSA counterparts (average specific ASES score, 2.5 vs 1.8, who might find golf somewhat difficult.

Although no study has provided a clear consensus as to which activities are safe to perform following shoulder arthroplasty, experts have suggested that activities that impart high loads on the glenohumeral joint should be avoided.15 Among TSA patients, McCarty and colleagues8 reported high rates of return for swimmers, golfers, and tennis players; however, relatively low rates were reported for weight lifting, bowling, and softball (20%). Within our study group, golf, swimming, and walking were listed among the most popular sports performed. Although weight lifting, bowling, and softball were less commonly identified as usual sports within our study, patients treated with TSA demonstrated more ease to participate than RSA patients. This result was observed with ASES-specific scores noted for weight lifting and gym exercises (TSA, 2.5; RSA, 2.3) and team sports, such as softball (TSA, 2; RSA, 1.3). However, for bowling, RSA patients showed a trend toward more ability (RSA, 2.7; TSA, 1.7).

Continue to: Among specific work activities...

 

 

Successful return to sports that involve shoulder function, such as golf and swimming, has been demonstrated for TSA.8,14,16,17 However, studies have reported that return to these sports can be difficult for RSA patients.20 Fink and colleagues19 reported that following RSA, 48.7% of patients returned to moderate-intensity sports, such as swimming and golf. Consistent with these findings, in our study, TSA patients demonstrated a significantly higher ability to participate in their usual sports without difficulty (ASES-specific score of 3). This observation may relate to lower ultimate achievements in range of motion and strength in patients treated with RSA, when compared with TSA patients,24,25 and the generalized practice of utilizing RSA for lower-demand patients (RSA patients in this study were older).

Overall, participation in work was 21% easier for TSA patients than RSA patients. Although the majority of our patients cited retirement as their primary work, which is consistent with what one would expect with the mean age of this study’s cohorts (RSA, 75 years; TSA, 69 years), housework and gardening were the only specifically identified forms of work that demonstrated significant differences between RSA and TSA patients. A few reports in the literature documented the ability to return to work after shoulder arthroplasty. In a recent report on 13 workers’ compensation patients treated with TSA, only 1 patient returned to the same job, and 54% did not return to work.26 In a study comparing 14 workers’ compensation to a matched group of controls with all members treated with RSA, the workers’ compensation group yielded a lower return-to-work rate (14.2%) than the controls (41.7%).27 In a large study of 154 TSA patients, 14% returned to work, but specific jobs were not described in this analysis.14

The results of this study suggest that more TSA patients successfully participate in low-demand activities, such as gardening or housework. Zarkadas and colleagues18 reported that 65% of TSA and 47% of HA patients successfully returned to gardening compared with 42% of RSA patients observed in a continuation study.20 This study showed that TSA patients yielded a 65% difference in ability to work in gardening and 34% difference in ability to perform housework compared with RSA patients. Based on these findings, TSA patients can expect to experience no difficulty in performing housework or gardening, whereas RSA patients may find these tasks difficult to a certain degree.

The main limitation of this study is the reporting bias that results from survey-based studies. Possibly, more people engage in specific sports or work than what were reported. This type of study also features an inherent selection bias, as patients with highly and physically demanding jobs or usual sports were less likely to have been offered either TSA or RSA. An additional important limitation is the relatively small cohorts within sport and work subgroups; the small cohorts probably underpowered the statistical results of this study and made these findings valuable mostly as descriptive observations. Larger studies focusing on each subgroup will further clarify the ability of shoulder arthroplasty to perform individual sports or work. Further studies evaluating preoperative to postoperative sports- and work-specific ASES scores would provide notable insights into the functional improvements observed within each sport or work following surgery. The relatively large study population of 276 patients strengthened the findings, which relate to the overall ability to participate in sports and work for TSA and RSA patients. Finally, the evaluated TSA and RSA patients possibly represent different groups (significant difference in age and gender) with different underlying pathologies and potentially different demands and expectations. However, comparisons among these groups of patients bear importance in defining patient expectations related to surgery. Still, the ability to participate in sport or work possibly relates more to the limitations of the implant used than patient pathology. This possibility warrants further investigation.

CONCLUSION

Both TSA and RSA allow for participation in work and sports, with TSA patients reporting easier overall ability to participate. For sports involving shoulder function, TSA patients more commonly report maximal ability to participate than RSA patients.

ABSTRACT

Both anatomical total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA) are routinely performed for patients who desire to continuously work or participate in sports. This study analyzes and compares the ability of patients to work and partake in sports following shoulder arthroplasty based on responses to clinical outcome surveys.

A retrospective review of the shoulder surgery repository was performed for all patients treated with TSA and RSA and who completed questions 9 and 10 on the activity patient self-evaluation portion of the American Shoulder and Elbow Surgeons (ASES) Assessment Form. Patients with a minimum of 1-year follow-up were included if a sport or work was identified. The analysis included 162 patients with TSA and 114 patients with RSA. Comparisons were made between TSA and RSA in terms of the specific ASES scores (rated 0-3) reported for ability to work and participate in sports and total ASES scores, and scores based on specific sports or line of work reported. Comparisons were also made between sports predominantly using shoulder function and those that do not.

TSA patients had a 27% higher ability to participate in sports (average specific ASES score: 2.5 vs 1.9, P < .001) than RSA patients and presented significantly higher scores for swimming and golf. Compared with RSA patients, TSA patients demonstrated more ability to participate in sports requiring shoulder function without difficulty, as 63% reported maximal scores (P = .003). Total shoulder arthroplasty patients also demonstrated a 21% higher ability to work than RSA patients (average specific ASES scores: 2.6 vs 2.1, P < .001), yielding significantly higher scores for housework and gardening.

Both TSA and RSA allow for participation in work and sports, with TSA patients reporting better overall ability to participate. For sports involving shoulder function, TSA patients more commonly report maximal ability to participate than RSA patients.

End-stage shoulder arthritis has been successfully treated with anatomical total shoulder arthroplasty (TSA) with high rates of functional recovery.1 With the introduction of reverse shoulder arthroplasty (RSA), indications for TSA have expanded.2-6 With continuing expansion of surgical indications, a more diverse and potentially active patient population is now being treated. As patients exhibit increased awareness of health and wellness, they demonstrate significant interest in understanding their ability to work or participate in sports after surgery.7 Patients no longer focus on pain relief as the only goal of surgery. A recent study of patients aged 65 years and undergoing shoulder arthroplasty revealed that 64% of the patients listed the ability to return to sports as the main reason for undergoing surgery,8 highlighting the significance of sports play in a patient’s life. Prior to surgery, shoulder pathologies lead to impairment in function, range of motion, and pain,9 hindering a patient to participate in both work and sports. With the intervention yielding improvement to these areas6,9-13 with increased patient satisfaction,10,13 accurately tailoring patient expectations for participation in sports and work postoperatively becomes increasingly important.

Continue to: Although several studies...

 

 

Although several studies have demonstrated the ability of patients to return to sports following TSA,8,14-18 a limited number of studies discuss the return to sports following RSA.19-21 Despite known postoperative improvements, no clear consensus is reached as to which specific sports patients can return to and at what level of participation is to be expected. Surveyed members of the American Shoulder and Elbow Surgeons (ASES) universally favored full return to sports, except for contact sports for TSA patients, whereas other surgeons are more conservative to allow RSA patients to return to activities.22 To our knowledge, no other study has investigated the ability to work following RSA. Furthermore, no other study has used patient-reported outcomes to compare the quality of participation in sports or work between TSA and RSA patients following surgery. This study reports the ability of patients treated with TSA and RSA to work and participate in sports based on clinical outcome surveys. We hypothesize that TSA patients will be allowed to work and participate in sports with less difficulty than RSA patients.

MATERIALS AND METHODS

Following Institutional Review Board approval, a retrospective review was performed on all patients treated with TSA or RSA and who completed questions 9 and/or 10 (by score and named usual sport and/or work) on the activity patient self-evaluation portion of the ASES23 Assessment Form between 2007 to 2014; queries were made via the Shoulder Outcomes Repository. A minimum of 12-month follow-up was required, as functional recovery has been shown to plateau or nearly plateau by 12 months.11 Patients were excluded if <12 months of follow-up was available, if they failed to provide a written answer for questions 9 or 10 on the activity patient self-evaluation portion of the ASES Assessment Form, or if they required a revision shoulder arthroplasty. A single fellowship-trained shoulder and elbow surgeon performed all procedures via the same deltopectoral approach and prescribed identical postoperative rehabilitation for both TSA and RSA patients. The database query yielded 162 TSA and 114 RSA patients, for a total of 276 patients eligible for the study.

For all patients, the most recent follow-up ASES score was used. Comparisons were made between TSA and RSA for total ASES scores and response groups for usual sport (ASES question 9) and usual work (ASES question 10). The ASES questionnaire provides patients with 4 choices for each question based on the ability to perform each activity: 0, unable to do; 1, very difficult; 2, somewhat difficult; and 3, not difficult. The questionnaire also allows the patients to identify their usual work and sports. If patients noted >1 sport or work activity, they were included within multiple subgroups. Patients were further compared by age and gender.

Work was subdivided to include retired, housework, desk jobs, prolonged standing, gardening/yard work, jobs requiring lifting, carpenter/construction, cook/food preparation, and creative jobs (Table 1). 

Sports were subdivided to include golf, swimming, walking, gym exercises, racquet sports, group fitness, sedentary sports, fishing and target shooting, adventure sports, team sports, bowling, biking, hiking/jogging/rollerblading, and motorcycle riding (Table 2). 
Sports were further subdivided into those which predominately use shoulder function and those requiring minimal shoulder function (Table 3).

Statistical analysis was performed with SPSS Version 21 (IBM). Unpaired t tests were used to determine differences between groups. A P-value of <.05 was deemed significant.

Continue to: A total of 276 patients...

 

 

RESULTS

A total of 276 patients that met the inclusion criteria were eligible for the study, with 162 having undergone TSA and 114 with RSA. Overall average follow-up totaled 29 months (range, 12-91 months). RSA patients (average age, 75 years old; range, 46-88 years) were significantly older than TSA patients (average age, 69 years old; range, 32-89 years; P = .001). Significantly more women were treated with TSA (52% TSA; 48% RSA; P = .012), whereas significantly more men were treated with TSA (67% TSA; 33% RSA, P = .012). Total ASES scores were significantly higher for TSA patients than RSA patients in work (P = .012) (Table 4) but not in sports (P = .063) (Table 5) categories.

 

SPORTS

A total of 186 patients, comprising of 71 RSA and 115 TSA individuals, responded to question 9 of the ASES questionnaire (Table 5). Among usually reported sports, golf (25%), swimming (17%), and walking (18%) were the most commonly cited. RSA patients indicating a sport were significantly older than TSA patients (74 years vs 69 years, P < .001). TSA patients reported a 27% higher difference in overall ability to participate in sports, with an average ASES sport-specific score of 2.5 compared with the 1.9 for RSA patients (P < .001).

Among specific sports, TSA patients reported significantly higher scores for swimming (2.6 vs 1.8, P = .007) and golf (2.5 vs 1.8, P = .050). However, no significant differences were observed for walking, gym exercises, and racquet sports (Table 5). Among sport subsets, RSA patients were significantly older for golf (77 years vs 70 years, P = .006) and bowling (80 years vs 68 years, P = .005). Five TSA patients reported biking as their sport, whereas no RSA patient reported such activity. Within each subset of sports, no significant differences were noted in average ASES total scores.

TSA patients demonstrated a more significant ability to perform usual sports that involve shoulder function without difficulty (score of 3). In shoulder dominant sports, a total of 63% of TSA patients reported a score of 3 compared with the 39% of RSA patients (P = .003). RSA patients more often reported an inability to perform shoulder specific sports, as proven by 20% of RSA patients reporting a score of 0 compared with 4% of TSA patients (P < .001) (Table 6).

WORK

A total of 265 patients, including 106 RSA and 159 TSA patients, responded to question 10 of the ASES questionnaire. Among usually reported work, retirement (43%), housework (27%), and desk jobs (18%) were the most commonly cited. RSA patients denoting a work were significantly older than TSA patients (75 years vs 69 years, P < .001). Patients with TSA presented a 21% higher difference in the overall ability to work, featuring an average ASES work-specific score of 2.6 compared with the 2.1 for RSA patients (P < .001) (Table 4).

Continue to: Among specific work activities...

 

 

Among specific work activities, TSA patients reported significantly higher scores for housework (2.7 vs 2; 34% difference; P = .001) and gardening (2.8 vs 1.7; 65% difference; P = .009) in comparison with RSA patients. However, no significant differences were observed for other work activities, including retirement, desk job, prolonged standing, creative jobs, lifting jobs, or construction (Table 4). Among the work subgroups, RSA patients were older than TSA patients for the retired group (77 years vs 72 years; P < .001) and gardening (81 years vs 68 years; P = .002).

DISCUSSION

The ability to participate in sports and work is a common goal for shoulder arthroplasty patients. However, the ability at which participation occurs has not been examined. This study illustrates not only the ability to engage in usual work or sport, but provides some insights into patient-reported quality of participation. Overall, TSA patients featured 27% higher sport-specific ASES scores and 21% higher work-specific ASES scores than RSA patients, confirming our hypothesis that TSA patients can participate in work or sports with less difficulty in general. This study is the first to stratify the difficulty of participating in sports in general and in specific sports identified by patients. Although statistical analysis was performed for individual sports and work reported, the use of small cohorts possibly affected the ability to detect significant differences. The data presented in this study can thus be used as descriptive evidence of what a patient may expect to be able to do following surgery, helping to define patient expectations prior to electing to undergo shoulder arthroplasty.

Among specific sports identified by patients, a few significant differences were observed between RSA and TSA patients. However, ASES-specific scores almost universally favored TSA. Of the sport subgroups, swimming and golf showed significant differences. For swimming, this difference was fairly significant, as TSA patients demonstrated a 49% higher score than their RSA counterparts, but without differences in age or total ASES score (Table 5). Alteration in shoulder mechanics after RSA may be used to explain the difficulty in returning to swimming, as additional time may be needed to adapt to new mechanics.24 McCarty and colleagues8 demonstrated that 90% of patients following TSA fully resumed participation in swimming within 6 months of surgery, and further stated that repetitive motions of swimming caused no effects on short-term outcomes. No similar analysis of swimming has been reported for RSA patients. Based upon our findings, the average RSA patient can experience some difficulties when returning to swimming after surgery (average specific ASES score, 1.8).

Jensen and Rockwood16 were among the first to demonstrate successful return to golf of 24 patients who had undergone either TSA or hemiarthroplasty (HA), showing a 5-stroke improvement in their game. A recent study investigating patient-reported activity in patients aged 75 years and undergoing RSA showed that 23% of patients returned to high-level activity sports, such as golf, motorcycle riding, or free weights.19 All patients who participated in golf before surgery resumed playing following surgery; however, golf was listed among the top activities that patients wanted to participate in but could not for any reason.19 Our data suggest that golfers with TSA will face less difficulty returning to sports compared with their RSA counterparts (average specific ASES score, 2.5 vs 1.8, who might find golf somewhat difficult.

Although no study has provided a clear consensus as to which activities are safe to perform following shoulder arthroplasty, experts have suggested that activities that impart high loads on the glenohumeral joint should be avoided.15 Among TSA patients, McCarty and colleagues8 reported high rates of return for swimmers, golfers, and tennis players; however, relatively low rates were reported for weight lifting, bowling, and softball (20%). Within our study group, golf, swimming, and walking were listed among the most popular sports performed. Although weight lifting, bowling, and softball were less commonly identified as usual sports within our study, patients treated with TSA demonstrated more ease to participate than RSA patients. This result was observed with ASES-specific scores noted for weight lifting and gym exercises (TSA, 2.5; RSA, 2.3) and team sports, such as softball (TSA, 2; RSA, 1.3). However, for bowling, RSA patients showed a trend toward more ability (RSA, 2.7; TSA, 1.7).

Continue to: Among specific work activities...

 

 

Successful return to sports that involve shoulder function, such as golf and swimming, has been demonstrated for TSA.8,14,16,17 However, studies have reported that return to these sports can be difficult for RSA patients.20 Fink and colleagues19 reported that following RSA, 48.7% of patients returned to moderate-intensity sports, such as swimming and golf. Consistent with these findings, in our study, TSA patients demonstrated a significantly higher ability to participate in their usual sports without difficulty (ASES-specific score of 3). This observation may relate to lower ultimate achievements in range of motion and strength in patients treated with RSA, when compared with TSA patients,24,25 and the generalized practice of utilizing RSA for lower-demand patients (RSA patients in this study were older).

Overall, participation in work was 21% easier for TSA patients than RSA patients. Although the majority of our patients cited retirement as their primary work, which is consistent with what one would expect with the mean age of this study’s cohorts (RSA, 75 years; TSA, 69 years), housework and gardening were the only specifically identified forms of work that demonstrated significant differences between RSA and TSA patients. A few reports in the literature documented the ability to return to work after shoulder arthroplasty. In a recent report on 13 workers’ compensation patients treated with TSA, only 1 patient returned to the same job, and 54% did not return to work.26 In a study comparing 14 workers’ compensation to a matched group of controls with all members treated with RSA, the workers’ compensation group yielded a lower return-to-work rate (14.2%) than the controls (41.7%).27 In a large study of 154 TSA patients, 14% returned to work, but specific jobs were not described in this analysis.14

The results of this study suggest that more TSA patients successfully participate in low-demand activities, such as gardening or housework. Zarkadas and colleagues18 reported that 65% of TSA and 47% of HA patients successfully returned to gardening compared with 42% of RSA patients observed in a continuation study.20 This study showed that TSA patients yielded a 65% difference in ability to work in gardening and 34% difference in ability to perform housework compared with RSA patients. Based on these findings, TSA patients can expect to experience no difficulty in performing housework or gardening, whereas RSA patients may find these tasks difficult to a certain degree.

The main limitation of this study is the reporting bias that results from survey-based studies. Possibly, more people engage in specific sports or work than what were reported. This type of study also features an inherent selection bias, as patients with highly and physically demanding jobs or usual sports were less likely to have been offered either TSA or RSA. An additional important limitation is the relatively small cohorts within sport and work subgroups; the small cohorts probably underpowered the statistical results of this study and made these findings valuable mostly as descriptive observations. Larger studies focusing on each subgroup will further clarify the ability of shoulder arthroplasty to perform individual sports or work. Further studies evaluating preoperative to postoperative sports- and work-specific ASES scores would provide notable insights into the functional improvements observed within each sport or work following surgery. The relatively large study population of 276 patients strengthened the findings, which relate to the overall ability to participate in sports and work for TSA and RSA patients. Finally, the evaluated TSA and RSA patients possibly represent different groups (significant difference in age and gender) with different underlying pathologies and potentially different demands and expectations. However, comparisons among these groups of patients bear importance in defining patient expectations related to surgery. Still, the ability to participate in sport or work possibly relates more to the limitations of the implant used than patient pathology. This possibility warrants further investigation.

CONCLUSION

Both TSA and RSA allow for participation in work and sports, with TSA patients reporting easier overall ability to participate. For sports involving shoulder function, TSA patients more commonly report maximal ability to participate than RSA patients.

References

1. Fehringer EV, Kopjar B, Boorman RS, Churchill RS, Smith KL, Matsen FA 3rd. Characterizing the functional improvement after total shoulder arthroplasty for osteoarthritis. J Bone Joint Surg Am. 2002;84-A(8):1349-1353.

2. Cuff DJ, Pupello DR. Comparison of hemiarthroplasty and reverse shoulder arthroplasty for the treatment of proximal humeral fractures in elderly patients. J Bone Joint Surg Am. 2013;95(22):2050-2055. doi:10.2106/JBJS.L.01637.

3. Guery J, Favard L, Sirveaux F, Oudet D, Mole D, Walch G. Reverse total shoulder arthroplasty. Survivorship analysis of eighty replacements followed for five to ten years. J Bone Joint Surg Am. 2006;88(8):1742-1747.

4. Levy JC, Virani N, Pupello D, Frankle M. Use of the reverse shoulder prosthesis for the treatment of failed hemiarthroplasty in patients with glenohumeral arthritis and rotator cuff deficiency. J Bone Joint Surg Br. 2007;89(2):189-195.

5. Patel DN, Young B, Onyekwelu I, Zuckerman JD, Kwon YW. Reverse total shoulder arthroplasty for failed shoulder arthroplasty. J Shoulder Elbow Surg. 2012;21(11):1478-1483. doi:10.1016/j.jse.2011.11.004.

6. Sebastia-Forcada E, Cebrian-Gomez R, Lizaur-Utrilla A, Gil-Guillen V. Reverse shoulder arthroplasty versus hemiarthroplasty for acute proximal humeral fractures. A blinded, randomized, controlled, prospective study. J Shoulder Elbow Surg. 2014;23(10):1419-1426. doi:10.1016/j.jse.2014.06.035.

7. Henn RF 3rd, Ghomrawi H, Rutledge JR, Mazumdar M, Mancuso CA, Marx RG. Preoperative patient expectations of total shoulder arthroplasty. J Bone Joint Surg Am. 2011;93(22):2110-2115. doi:10.2106/JBJS.J.01114.

8. McCarty EC, Marx RG, Maerz D, Altchek D, Warren RF. Sports participation after shoulder replacement surgery. Am J Sports Med. 2008;36(8):1577-1581. doi:10.1177/0363546508317126.

9. Puskas B, Harreld K, Clark R, Downes K, Virani NA, Frankle M. Isometric strength, range of motion, and impairment before and after total and reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(7):869-876. doi:10.1016/j.jse.2012.09.004.

10. Deshmukh AV, Koris M, Zurakowski D, Thornhill TS. Total shoulder arthroplasty: long-term survivorship, functional outcome, and quality of life. J Shoulder Elbow Surg. 2005;14(5):471-479.

11. Levy JC, Everding NG, Gil CC Jr., Stephens S, Giveans MR. Speed of recovery after shoulder arthroplasty: a comparison of reverse and anatomic total shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(12):1872-1881. doi:10.1016/j.jse.2014.04.014.

12. Nolan BM, Ankerson E, Wiater JM. Reverse total shoulder arthroplasty improves function in cuff tear arthropathy. Clin Orthop Relat Res. 2011;469(9):2476-2482. doi:10.1007/s11999-010-1683-z.

13. Norris TR, Iannotti JP. Functional outcome after shoulder arthroplasty for primary osteoarthritis: a multicenter study. J Shoulder Elbow Surg. 2002;11(2):130-135.

14. Bulhoff M, Sattler P, Bruckner T, Loew M, Zeifang F, Raiss P. Do patients return to sports and work after total shoulder replacement surgery? Am J Sports Med. 2015;43(2):423-427. doi:10.1177/0363546514557940.

15. Healy WL, Iorio R, Lemos MJ. Athletic activity after joint replacement. Am J Sports Med. 2001;29(3):377-388.

16. Jensen KL, Rockwood CA Jr. Shoulder arthroplasty in recreational golfers. J Shoulder Elbow Surg. 1998;7(4):362-367.

17. Schumann K, Flury MP, Schwyzer HK, Simmen BR, Drerup S, Goldhahn J. Sports activity after anatomical total shoulder arthroplasty. Am J Sports Med. 2010;38(10):2097-2105. doi:10.1177/0363546510371368.

18. Zarkadas PC, Throckmorton TQ, Dahm DL, Sperling J, Schleck CD, Cofield R. Patient reported activities after shoulder replacement: total and hemiarthroplasty. J Shoulder Elbow Surg. 2011;20(2):273-280. doi:10.1016/j.jse.2010.06.007.

19. Fink Barnes LA, Grantham WJ, Meadows MC, Bigliani LU, Levine WN, Ahmad CS. Sports activity after reverse total shoulder arthroplasty with minimum 2-year follow-up. Am J Orthop. 2015;44(2):68-72.

20. Lawrence TM, Ahmadi S, Sanchez-Sotelo J, Sperling JW, Cofield RH. Patient reported activities after reverse shoulder arthroplasty: part II. J Shoulder Elbow Surg. 2012;21(11):1464-1469. doi:10.1016/j.jse.2011.11.012.

21. Simovitch RW, Gerard BK, Brees JA, Fullick R, Kearse JC. Outcomes of reverse total shoulder arthroplasty in a senior athletic population. J Shoulder Elbow Surg. 2015;24(9):1481-1485. doi:10.1016/j.jse.2015.03.011.

22. Golant A, Christoforou D, Zuckerman JD, Kwon YW. Return to sports after shoulder arthroplasty: a survey of surgeons' preferences. J Shoulder Elbow Surg. 2012;21(4):554-560. doi:10.1016/j.jse.2010.11.021.

23. Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587-594.

24. Alta TD, de Toledo JM, Veeger HE, Janssen TW, Willems WJ. The active and passive kinematic difference between primary reverse and total shoulder prostheses. J Shoulder Elbow Surg. 2014;23(9):1395-1402. doi:10.1016/j.jse.2014.01.040.

25. Alta TD, Veeger DH, de Toledo JM, Janssen TW, Willems WJ. Isokinetic strength differences between patients with primary reverse and total shoulder prostheses: muscle strength quantified with a dynamometer. Clin Biomech (Bristol, Avon). 2014;29(9):965-970. doi:10.1016/j.clinbiomech.2014.08.018.

26. Jawa A, Dasti UR, Fasulo SM, Vaickus MH, Curtis AS, Miller SL. Anatomic total shoulder arthroplasty for patients receiving workers' compensation. J Shoulder Elbow Surg. 2015;24(11):1694-1697. doi:10.1016/j.jse.2015.04.017.

27. Morris BJ, Haigler RE, Laughlin MS, Elkousy HA, Gartsman GM, Edwards TB. Workers' compensation claims and outcomes after reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(3):453-459. doi:10.1016/j.jse.2014.07.009.

References

1. Fehringer EV, Kopjar B, Boorman RS, Churchill RS, Smith KL, Matsen FA 3rd. Characterizing the functional improvement after total shoulder arthroplasty for osteoarthritis. J Bone Joint Surg Am. 2002;84-A(8):1349-1353.

2. Cuff DJ, Pupello DR. Comparison of hemiarthroplasty and reverse shoulder arthroplasty for the treatment of proximal humeral fractures in elderly patients. J Bone Joint Surg Am. 2013;95(22):2050-2055. doi:10.2106/JBJS.L.01637.

3. Guery J, Favard L, Sirveaux F, Oudet D, Mole D, Walch G. Reverse total shoulder arthroplasty. Survivorship analysis of eighty replacements followed for five to ten years. J Bone Joint Surg Am. 2006;88(8):1742-1747.

4. Levy JC, Virani N, Pupello D, Frankle M. Use of the reverse shoulder prosthesis for the treatment of failed hemiarthroplasty in patients with glenohumeral arthritis and rotator cuff deficiency. J Bone Joint Surg Br. 2007;89(2):189-195.

5. Patel DN, Young B, Onyekwelu I, Zuckerman JD, Kwon YW. Reverse total shoulder arthroplasty for failed shoulder arthroplasty. J Shoulder Elbow Surg. 2012;21(11):1478-1483. doi:10.1016/j.jse.2011.11.004.

6. Sebastia-Forcada E, Cebrian-Gomez R, Lizaur-Utrilla A, Gil-Guillen V. Reverse shoulder arthroplasty versus hemiarthroplasty for acute proximal humeral fractures. A blinded, randomized, controlled, prospective study. J Shoulder Elbow Surg. 2014;23(10):1419-1426. doi:10.1016/j.jse.2014.06.035.

7. Henn RF 3rd, Ghomrawi H, Rutledge JR, Mazumdar M, Mancuso CA, Marx RG. Preoperative patient expectations of total shoulder arthroplasty. J Bone Joint Surg Am. 2011;93(22):2110-2115. doi:10.2106/JBJS.J.01114.

8. McCarty EC, Marx RG, Maerz D, Altchek D, Warren RF. Sports participation after shoulder replacement surgery. Am J Sports Med. 2008;36(8):1577-1581. doi:10.1177/0363546508317126.

9. Puskas B, Harreld K, Clark R, Downes K, Virani NA, Frankle M. Isometric strength, range of motion, and impairment before and after total and reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(7):869-876. doi:10.1016/j.jse.2012.09.004.

10. Deshmukh AV, Koris M, Zurakowski D, Thornhill TS. Total shoulder arthroplasty: long-term survivorship, functional outcome, and quality of life. J Shoulder Elbow Surg. 2005;14(5):471-479.

11. Levy JC, Everding NG, Gil CC Jr., Stephens S, Giveans MR. Speed of recovery after shoulder arthroplasty: a comparison of reverse and anatomic total shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(12):1872-1881. doi:10.1016/j.jse.2014.04.014.

12. Nolan BM, Ankerson E, Wiater JM. Reverse total shoulder arthroplasty improves function in cuff tear arthropathy. Clin Orthop Relat Res. 2011;469(9):2476-2482. doi:10.1007/s11999-010-1683-z.

13. Norris TR, Iannotti JP. Functional outcome after shoulder arthroplasty for primary osteoarthritis: a multicenter study. J Shoulder Elbow Surg. 2002;11(2):130-135.

14. Bulhoff M, Sattler P, Bruckner T, Loew M, Zeifang F, Raiss P. Do patients return to sports and work after total shoulder replacement surgery? Am J Sports Med. 2015;43(2):423-427. doi:10.1177/0363546514557940.

15. Healy WL, Iorio R, Lemos MJ. Athletic activity after joint replacement. Am J Sports Med. 2001;29(3):377-388.

16. Jensen KL, Rockwood CA Jr. Shoulder arthroplasty in recreational golfers. J Shoulder Elbow Surg. 1998;7(4):362-367.

17. Schumann K, Flury MP, Schwyzer HK, Simmen BR, Drerup S, Goldhahn J. Sports activity after anatomical total shoulder arthroplasty. Am J Sports Med. 2010;38(10):2097-2105. doi:10.1177/0363546510371368.

18. Zarkadas PC, Throckmorton TQ, Dahm DL, Sperling J, Schleck CD, Cofield R. Patient reported activities after shoulder replacement: total and hemiarthroplasty. J Shoulder Elbow Surg. 2011;20(2):273-280. doi:10.1016/j.jse.2010.06.007.

19. Fink Barnes LA, Grantham WJ, Meadows MC, Bigliani LU, Levine WN, Ahmad CS. Sports activity after reverse total shoulder arthroplasty with minimum 2-year follow-up. Am J Orthop. 2015;44(2):68-72.

20. Lawrence TM, Ahmadi S, Sanchez-Sotelo J, Sperling JW, Cofield RH. Patient reported activities after reverse shoulder arthroplasty: part II. J Shoulder Elbow Surg. 2012;21(11):1464-1469. doi:10.1016/j.jse.2011.11.012.

21. Simovitch RW, Gerard BK, Brees JA, Fullick R, Kearse JC. Outcomes of reverse total shoulder arthroplasty in a senior athletic population. J Shoulder Elbow Surg. 2015;24(9):1481-1485. doi:10.1016/j.jse.2015.03.011.

22. Golant A, Christoforou D, Zuckerman JD, Kwon YW. Return to sports after shoulder arthroplasty: a survey of surgeons' preferences. J Shoulder Elbow Surg. 2012;21(4):554-560. doi:10.1016/j.jse.2010.11.021.

23. Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587-594.

24. Alta TD, de Toledo JM, Veeger HE, Janssen TW, Willems WJ. The active and passive kinematic difference between primary reverse and total shoulder prostheses. J Shoulder Elbow Surg. 2014;23(9):1395-1402. doi:10.1016/j.jse.2014.01.040.

25. Alta TD, Veeger DH, de Toledo JM, Janssen TW, Willems WJ. Isokinetic strength differences between patients with primary reverse and total shoulder prostheses: muscle strength quantified with a dynamometer. Clin Biomech (Bristol, Avon). 2014;29(9):965-970. doi:10.1016/j.clinbiomech.2014.08.018.

26. Jawa A, Dasti UR, Fasulo SM, Vaickus MH, Curtis AS, Miller SL. Anatomic total shoulder arthroplasty for patients receiving workers' compensation. J Shoulder Elbow Surg. 2015;24(11):1694-1697. doi:10.1016/j.jse.2015.04.017.

27. Morris BJ, Haigler RE, Laughlin MS, Elkousy HA, Gartsman GM, Edwards TB. Workers' compensation claims and outcomes after reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(3):453-459. doi:10.1016/j.jse.2014.07.009.

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TAKE-HOME POINTS

  • Both anatomic (TSA) and reverse shoulder arthroplasty (RSA) allow for the participation in work and sports.
  • TSA patients report easier overall ability to participate in sports, specifically golf and swimming.
  • For sports involving shoulder function, TSA patients more commonly report maximal ability to participate than RSA patients.
  • TSA patients report easier overall ability to return to work-related activities, specifically housework and gardening.
  • TSA patients featured 27% higher sport-specific ASES scores and 21% higher work-specific ASES scores than RSA patients.
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