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VIDEO: Open, robotic, laparoscopic approaches equally effective in pancreatectomy
WASHINGTON – Minimally invasive surgery – whether robotic or laparoscopic – is just as effective as open surgery in pancreatectomy.
Both minimally invasive approaches had perioperative and oncologic outcomes that were similar to open approaches, as well as to each other, Katelin Mirkin, MD, reported at the annual clinical congress of the American College of Surgeons. And while minimally invasive surgery (MIS) techniques were associated with a slightly faster move to neoadjuvant chemotherapy, survival outcomes in all three surgical approaches were similar.
Dr. Mirkin, a surgery resident at Penn State Milton S. Hershey Medical Center, Hershey, Pa., plumbed the National Cancer Database for patients with stage I-III pancreatic cancer who were treated by surgical resection from 2010 to 2012. Her cohort comprised 9,047 patients; of these, 7,924 were treated with open surgery, 992 with laparoscopic surgery, and 131 with robotic surgery. She examined a number of factors including lymph node harvest and surgical margins, length of stay and time to adjuvant chemotherapy, and survival.
Patients who had MIS were older (67 vs. 66 years) and more often treated at an academic center, but otherwise there were no significant baseline differences.
Dr. Mirkin first compared the open surgeries with MIS. There were no significant associations with surgical approach and cancer stage. However, distal resections were significantly more likely to be dealt with by MIS, and Whipple procedures by open approaches. There were also more open than MIS total resections.
MIS was more likely to conclude with negative surgical margins (79% vs. 75%), and open surgery more likely to end with positive margins (22% vs. 19%).
Perioperative outcomes favored MIS approaches for all types of surgery, with a mean overall stay of 9.5 days vs. 11.3 days for open surgery. The mean length of stay for a distal resection was 7 days for MIS vs. 8 for open. For a Whipple procedure, the mean stay was 10.7 vs. 11.9 days. For a total resection, it was 10 vs. 11.8 days.
MIS was also associated with a significantly shorter time to the initiation of adjuvant chemotherapy overall (56 vs. 59 days). For a Whipple, time to chemotherapy was 58 vs. 60 days, respectively. For a distal resection, it was 52 vs. 56 days, and for a total resection, 52 vs. 58 days.
Neither approach offered a survival benefit over the other, Dr. Mirkin noted. For stage I cancers, less than 50% of MIS patients and less than 25% of open patients were alive by 50 months. For those with stage II tumors, less than 25% of each group was alive by 40 months. For stage III tumors, the 40-month survival rates were about 10% for MIS patients and 15% for open patients.
Dr. Mirkin then examined perioperative, oncologic, and survival outcomes among those who underwent laparoscopic and robotic surgeries. There were no demographic differences between these groups.
Oncologic outcomes were almost identical with regard to the number of positive regional nodes harvested (six), and surgical margins. Nodes were negative in 82% of robotic cases vs. 78% of laparoscopic cases and positive in 17.6% of robotic cases and 19.4% of laparoscopic cases.
Length of stay was significantly shorter for a laparoscopic approach overall (10 vs. 9.4 days) and particularly in distal resection (7 vs. 10 days). However, there were no differences in length of stay in any other surgery type. Nor was there any difference in the time to neoadjuvant chemotherapy.
Survival outcomes were similar as well. For stage I cancers, 40-month survival was about 40% in the laparoscopic group and 25% in the robotic group. For stage II cancers, 40-month survival was about 15% and 25%, respectively. For stage III tumors, 20-month survival in the robotic group was near 0 and 25% in the laparoscopic group. By 40 months almost all patients were deceased.
A multivariate survival analysis controlled for age, sex, race, comorbidities, facility type and location, surgery type, surgical margins, pathologic stage, and systemic therapy. It found only one significant association: Patients with 12 or more lymph nodes harvested were 19% more likely to die than those with fewer than 12 nodes harvested.
Time to chemotherapy (longer or shorter than 57 days) did not significantly impact survival, Dr. Mirkin said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @alz_gal
WASHINGTON – Minimally invasive surgery – whether robotic or laparoscopic – is just as effective as open surgery in pancreatectomy.
Both minimally invasive approaches had perioperative and oncologic outcomes that were similar to open approaches, as well as to each other, Katelin Mirkin, MD, reported at the annual clinical congress of the American College of Surgeons. And while minimally invasive surgery (MIS) techniques were associated with a slightly faster move to neoadjuvant chemotherapy, survival outcomes in all three surgical approaches were similar.
Dr. Mirkin, a surgery resident at Penn State Milton S. Hershey Medical Center, Hershey, Pa., plumbed the National Cancer Database for patients with stage I-III pancreatic cancer who were treated by surgical resection from 2010 to 2012. Her cohort comprised 9,047 patients; of these, 7,924 were treated with open surgery, 992 with laparoscopic surgery, and 131 with robotic surgery. She examined a number of factors including lymph node harvest and surgical margins, length of stay and time to adjuvant chemotherapy, and survival.
Patients who had MIS were older (67 vs. 66 years) and more often treated at an academic center, but otherwise there were no significant baseline differences.
Dr. Mirkin first compared the open surgeries with MIS. There were no significant associations with surgical approach and cancer stage. However, distal resections were significantly more likely to be dealt with by MIS, and Whipple procedures by open approaches. There were also more open than MIS total resections.
MIS was more likely to conclude with negative surgical margins (79% vs. 75%), and open surgery more likely to end with positive margins (22% vs. 19%).
Perioperative outcomes favored MIS approaches for all types of surgery, with a mean overall stay of 9.5 days vs. 11.3 days for open surgery. The mean length of stay for a distal resection was 7 days for MIS vs. 8 for open. For a Whipple procedure, the mean stay was 10.7 vs. 11.9 days. For a total resection, it was 10 vs. 11.8 days.
MIS was also associated with a significantly shorter time to the initiation of adjuvant chemotherapy overall (56 vs. 59 days). For a Whipple, time to chemotherapy was 58 vs. 60 days, respectively. For a distal resection, it was 52 vs. 56 days, and for a total resection, 52 vs. 58 days.
Neither approach offered a survival benefit over the other, Dr. Mirkin noted. For stage I cancers, less than 50% of MIS patients and less than 25% of open patients were alive by 50 months. For those with stage II tumors, less than 25% of each group was alive by 40 months. For stage III tumors, the 40-month survival rates were about 10% for MIS patients and 15% for open patients.
Dr. Mirkin then examined perioperative, oncologic, and survival outcomes among those who underwent laparoscopic and robotic surgeries. There were no demographic differences between these groups.
Oncologic outcomes were almost identical with regard to the number of positive regional nodes harvested (six), and surgical margins. Nodes were negative in 82% of robotic cases vs. 78% of laparoscopic cases and positive in 17.6% of robotic cases and 19.4% of laparoscopic cases.
Length of stay was significantly shorter for a laparoscopic approach overall (10 vs. 9.4 days) and particularly in distal resection (7 vs. 10 days). However, there were no differences in length of stay in any other surgery type. Nor was there any difference in the time to neoadjuvant chemotherapy.
Survival outcomes were similar as well. For stage I cancers, 40-month survival was about 40% in the laparoscopic group and 25% in the robotic group. For stage II cancers, 40-month survival was about 15% and 25%, respectively. For stage III tumors, 20-month survival in the robotic group was near 0 and 25% in the laparoscopic group. By 40 months almost all patients were deceased.
A multivariate survival analysis controlled for age, sex, race, comorbidities, facility type and location, surgery type, surgical margins, pathologic stage, and systemic therapy. It found only one significant association: Patients with 12 or more lymph nodes harvested were 19% more likely to die than those with fewer than 12 nodes harvested.
Time to chemotherapy (longer or shorter than 57 days) did not significantly impact survival, Dr. Mirkin said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @alz_gal
WASHINGTON – Minimally invasive surgery – whether robotic or laparoscopic – is just as effective as open surgery in pancreatectomy.
Both minimally invasive approaches had perioperative and oncologic outcomes that were similar to open approaches, as well as to each other, Katelin Mirkin, MD, reported at the annual clinical congress of the American College of Surgeons. And while minimally invasive surgery (MIS) techniques were associated with a slightly faster move to neoadjuvant chemotherapy, survival outcomes in all three surgical approaches were similar.
Dr. Mirkin, a surgery resident at Penn State Milton S. Hershey Medical Center, Hershey, Pa., plumbed the National Cancer Database for patients with stage I-III pancreatic cancer who were treated by surgical resection from 2010 to 2012. Her cohort comprised 9,047 patients; of these, 7,924 were treated with open surgery, 992 with laparoscopic surgery, and 131 with robotic surgery. She examined a number of factors including lymph node harvest and surgical margins, length of stay and time to adjuvant chemotherapy, and survival.
Patients who had MIS were older (67 vs. 66 years) and more often treated at an academic center, but otherwise there were no significant baseline differences.
Dr. Mirkin first compared the open surgeries with MIS. There were no significant associations with surgical approach and cancer stage. However, distal resections were significantly more likely to be dealt with by MIS, and Whipple procedures by open approaches. There were also more open than MIS total resections.
MIS was more likely to conclude with negative surgical margins (79% vs. 75%), and open surgery more likely to end with positive margins (22% vs. 19%).
Perioperative outcomes favored MIS approaches for all types of surgery, with a mean overall stay of 9.5 days vs. 11.3 days for open surgery. The mean length of stay for a distal resection was 7 days for MIS vs. 8 for open. For a Whipple procedure, the mean stay was 10.7 vs. 11.9 days. For a total resection, it was 10 vs. 11.8 days.
MIS was also associated with a significantly shorter time to the initiation of adjuvant chemotherapy overall (56 vs. 59 days). For a Whipple, time to chemotherapy was 58 vs. 60 days, respectively. For a distal resection, it was 52 vs. 56 days, and for a total resection, 52 vs. 58 days.
Neither approach offered a survival benefit over the other, Dr. Mirkin noted. For stage I cancers, less than 50% of MIS patients and less than 25% of open patients were alive by 50 months. For those with stage II tumors, less than 25% of each group was alive by 40 months. For stage III tumors, the 40-month survival rates were about 10% for MIS patients and 15% for open patients.
Dr. Mirkin then examined perioperative, oncologic, and survival outcomes among those who underwent laparoscopic and robotic surgeries. There were no demographic differences between these groups.
Oncologic outcomes were almost identical with regard to the number of positive regional nodes harvested (six), and surgical margins. Nodes were negative in 82% of robotic cases vs. 78% of laparoscopic cases and positive in 17.6% of robotic cases and 19.4% of laparoscopic cases.
Length of stay was significantly shorter for a laparoscopic approach overall (10 vs. 9.4 days) and particularly in distal resection (7 vs. 10 days). However, there were no differences in length of stay in any other surgery type. Nor was there any difference in the time to neoadjuvant chemotherapy.
Survival outcomes were similar as well. For stage I cancers, 40-month survival was about 40% in the laparoscopic group and 25% in the robotic group. For stage II cancers, 40-month survival was about 15% and 25%, respectively. For stage III tumors, 20-month survival in the robotic group was near 0 and 25% in the laparoscopic group. By 40 months almost all patients were deceased.
A multivariate survival analysis controlled for age, sex, race, comorbidities, facility type and location, surgery type, surgical margins, pathologic stage, and systemic therapy. It found only one significant association: Patients with 12 or more lymph nodes harvested were 19% more likely to die than those with fewer than 12 nodes harvested.
Time to chemotherapy (longer or shorter than 57 days) did not significantly impact survival, Dr. Mirkin said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @alz_gal
AT THE ACS CLINICAL CONGRESS
Key clinical point:
Major finding: For stage I cancers, less than 50% of minimally invasive surgery patients and less than 25% of open surgery patients were alive by 50 months. For those with stage II tumors, less than 25% of each group was alive by 40 months.
Data source: The database review comprised 9,047 cases.
Disclosures: Dr. Mirkin had no financial disclosures.
The mesh tradeoff: Lower recurrence risk vs. complicaitons
Among patients undergoing elective incisional repair of abdominal wall hernias, the use of mesh reinforcement decreases the short-term recurrence rate by 5% but increases major complications by approximately the same amount over the subsequent 5 years, Dunja Kokotovic, MB, reported at the annual clinical congress of the American College of Surgeons.
“Given the continuously increasing incidence of mesh-related complications with time, it is expected that, with even longer follow-up up than the 5 years observed in this study, mesh-related complications continue to accrue,” said Dr. Kokotovic of the Center for Surgical Science, Zealand University Hospital, Koge, Denmark. The findings of this observational registry-based cohort study were presented at the congress and simultaneously published online in JAMA (2016 Oct 17. doi: 10.1001/jama.2016.15217).
These results highlight the need to assess the long-term safety of interventions before making definitive conclusions about their benefits and widely adopting them. In the United States, manufacturers are required to demonstrate the long-term safety of drugs but not of some devices, including hernia meshes. There were approximately 190,000 such hernia repairs performed in the United States alone during the most recent year for which data are available, and mesh is estimated to have been used in at least half, Dr. Kokotovic noted.
She and her associates analyzed the 5-year outcomes for virtually all incisional hernia repairs performed in Denmark from 2007 through 2010 using data in a mandatory national registry. Their analysis included 3,242 patients (mean age, 58 years): 1,119 (34.5%) who had open mesh repair, 1,757 (54.2%) who had laparoscopic mesh repair, and 366 (11.3%) who had nonmesh repair.
The cumulative risk of reoperation for hernia recurrence was significantly lower for patients who had open mesh repair (12.3%) or laparoscopic mesh repair (10.6%) than for those who had nonmesh repair (17.1%). However, this benefit was offset by the rate of major mesh-related complications requiring surgical intervention – including surgical site infection, formation of a chronic sinus tract, late-onset intra-abdominal abscess, enterocutaneous fistula, bowel obstruction, and bowel perforation – which progressively increased over time. The cumulative incidence of such complications was 5.6% for open mesh repair and 3.7% for laparoscopic mesh repair.
This study was limited in that it was observational rather than being based on randomized data, so selection bias and imbalances among the study groups couldn’t be fully controlled for. However, two strengths of this study were that it reflects the real-world experience of an entire country and all the surgeons performing hernia repairs there, and it had 100% follow-up, the researchers said.
This study was partly funded by the Edgar Schnohr and Wife Gilberte Schnohr’s Foundation supporting independent surgical and anesthesiological research. Dr. Kokotovic reported having no relevant financial disclosures; one investigator reported receiving personal fees from Bard and Etichon for educational presentations.
These study findings suggest that the risk-benefit ratio of mesh reinforcement is not as clear as previously thought and call into question the current widespread use of mesh, even for repair of small hernias, when mesh is the norm for all incisional hernia repairs of any size.
Although the study by Kokotovic and colleagues is one of the most comprehensive long-term studies in hernia surgery, many questions remain about the optimal approach for repairing ventral hernia. To provide more rigorous data to better understand optimal approaches to this common clinical problem, surgeons will need to design large multicenter pragmatic trials with long-term follow-up.
Kamal M. F. Itani, MD, is at the VA Boston Health Care System, Boston University, West Roxbury, Mass., and Harvard Medical School in Boston. He reported having served as a research consultant to Davol 4 years ago regarding an antibiotic-coated mesh product. These remarks are excerpted from an editorial accompanying Dr. Kokotovic’s report (JAMA 2016 Oct 17. doi: 10.1001/jama.2016.15722).
These study findings suggest that the risk-benefit ratio of mesh reinforcement is not as clear as previously thought and call into question the current widespread use of mesh, even for repair of small hernias, when mesh is the norm for all incisional hernia repairs of any size.
Although the study by Kokotovic and colleagues is one of the most comprehensive long-term studies in hernia surgery, many questions remain about the optimal approach for repairing ventral hernia. To provide more rigorous data to better understand optimal approaches to this common clinical problem, surgeons will need to design large multicenter pragmatic trials with long-term follow-up.
Kamal M. F. Itani, MD, is at the VA Boston Health Care System, Boston University, West Roxbury, Mass., and Harvard Medical School in Boston. He reported having served as a research consultant to Davol 4 years ago regarding an antibiotic-coated mesh product. These remarks are excerpted from an editorial accompanying Dr. Kokotovic’s report (JAMA 2016 Oct 17. doi: 10.1001/jama.2016.15722).
These study findings suggest that the risk-benefit ratio of mesh reinforcement is not as clear as previously thought and call into question the current widespread use of mesh, even for repair of small hernias, when mesh is the norm for all incisional hernia repairs of any size.
Although the study by Kokotovic and colleagues is one of the most comprehensive long-term studies in hernia surgery, many questions remain about the optimal approach for repairing ventral hernia. To provide more rigorous data to better understand optimal approaches to this common clinical problem, surgeons will need to design large multicenter pragmatic trials with long-term follow-up.
Kamal M. F. Itani, MD, is at the VA Boston Health Care System, Boston University, West Roxbury, Mass., and Harvard Medical School in Boston. He reported having served as a research consultant to Davol 4 years ago regarding an antibiotic-coated mesh product. These remarks are excerpted from an editorial accompanying Dr. Kokotovic’s report (JAMA 2016 Oct 17. doi: 10.1001/jama.2016.15722).
Among patients undergoing elective incisional repair of abdominal wall hernias, the use of mesh reinforcement decreases the short-term recurrence rate by 5% but increases major complications by approximately the same amount over the subsequent 5 years, Dunja Kokotovic, MB, reported at the annual clinical congress of the American College of Surgeons.
“Given the continuously increasing incidence of mesh-related complications with time, it is expected that, with even longer follow-up up than the 5 years observed in this study, mesh-related complications continue to accrue,” said Dr. Kokotovic of the Center for Surgical Science, Zealand University Hospital, Koge, Denmark. The findings of this observational registry-based cohort study were presented at the congress and simultaneously published online in JAMA (2016 Oct 17. doi: 10.1001/jama.2016.15217).
These results highlight the need to assess the long-term safety of interventions before making definitive conclusions about their benefits and widely adopting them. In the United States, manufacturers are required to demonstrate the long-term safety of drugs but not of some devices, including hernia meshes. There were approximately 190,000 such hernia repairs performed in the United States alone during the most recent year for which data are available, and mesh is estimated to have been used in at least half, Dr. Kokotovic noted.
She and her associates analyzed the 5-year outcomes for virtually all incisional hernia repairs performed in Denmark from 2007 through 2010 using data in a mandatory national registry. Their analysis included 3,242 patients (mean age, 58 years): 1,119 (34.5%) who had open mesh repair, 1,757 (54.2%) who had laparoscopic mesh repair, and 366 (11.3%) who had nonmesh repair.
The cumulative risk of reoperation for hernia recurrence was significantly lower for patients who had open mesh repair (12.3%) or laparoscopic mesh repair (10.6%) than for those who had nonmesh repair (17.1%). However, this benefit was offset by the rate of major mesh-related complications requiring surgical intervention – including surgical site infection, formation of a chronic sinus tract, late-onset intra-abdominal abscess, enterocutaneous fistula, bowel obstruction, and bowel perforation – which progressively increased over time. The cumulative incidence of such complications was 5.6% for open mesh repair and 3.7% for laparoscopic mesh repair.
This study was limited in that it was observational rather than being based on randomized data, so selection bias and imbalances among the study groups couldn’t be fully controlled for. However, two strengths of this study were that it reflects the real-world experience of an entire country and all the surgeons performing hernia repairs there, and it had 100% follow-up, the researchers said.
This study was partly funded by the Edgar Schnohr and Wife Gilberte Schnohr’s Foundation supporting independent surgical and anesthesiological research. Dr. Kokotovic reported having no relevant financial disclosures; one investigator reported receiving personal fees from Bard and Etichon for educational presentations.
Among patients undergoing elective incisional repair of abdominal wall hernias, the use of mesh reinforcement decreases the short-term recurrence rate by 5% but increases major complications by approximately the same amount over the subsequent 5 years, Dunja Kokotovic, MB, reported at the annual clinical congress of the American College of Surgeons.
“Given the continuously increasing incidence of mesh-related complications with time, it is expected that, with even longer follow-up up than the 5 years observed in this study, mesh-related complications continue to accrue,” said Dr. Kokotovic of the Center for Surgical Science, Zealand University Hospital, Koge, Denmark. The findings of this observational registry-based cohort study were presented at the congress and simultaneously published online in JAMA (2016 Oct 17. doi: 10.1001/jama.2016.15217).
These results highlight the need to assess the long-term safety of interventions before making definitive conclusions about their benefits and widely adopting them. In the United States, manufacturers are required to demonstrate the long-term safety of drugs but not of some devices, including hernia meshes. There were approximately 190,000 such hernia repairs performed in the United States alone during the most recent year for which data are available, and mesh is estimated to have been used in at least half, Dr. Kokotovic noted.
She and her associates analyzed the 5-year outcomes for virtually all incisional hernia repairs performed in Denmark from 2007 through 2010 using data in a mandatory national registry. Their analysis included 3,242 patients (mean age, 58 years): 1,119 (34.5%) who had open mesh repair, 1,757 (54.2%) who had laparoscopic mesh repair, and 366 (11.3%) who had nonmesh repair.
The cumulative risk of reoperation for hernia recurrence was significantly lower for patients who had open mesh repair (12.3%) or laparoscopic mesh repair (10.6%) than for those who had nonmesh repair (17.1%). However, this benefit was offset by the rate of major mesh-related complications requiring surgical intervention – including surgical site infection, formation of a chronic sinus tract, late-onset intra-abdominal abscess, enterocutaneous fistula, bowel obstruction, and bowel perforation – which progressively increased over time. The cumulative incidence of such complications was 5.6% for open mesh repair and 3.7% for laparoscopic mesh repair.
This study was limited in that it was observational rather than being based on randomized data, so selection bias and imbalances among the study groups couldn’t be fully controlled for. However, two strengths of this study were that it reflects the real-world experience of an entire country and all the surgeons performing hernia repairs there, and it had 100% follow-up, the researchers said.
This study was partly funded by the Edgar Schnohr and Wife Gilberte Schnohr’s Foundation supporting independent surgical and anesthesiological research. Dr. Kokotovic reported having no relevant financial disclosures; one investigator reported receiving personal fees from Bard and Etichon for educational presentations.
FROM THE ACS CLINICAL CONGRESS
Key clinical point: Among patients undergoing elective incisional repair of abdominal wall hernias, the use of mesh reinforcement decreases the short-term recurrence rate by 5% but increases major complications by 5.6% over the subsequent 5 years.
Major finding: The cumulative rate of major mesh-related complications requiring surgical intervention was 5.6% for open mesh repair and 3.7% for laparoscopic mesh repair, compared with 0% for nonmesh repair.
Data source: A nationwide observational registry-based cohort study involving virtually all incisional hernia repairs (3,242) performed in Denmark from 2007 through 2010.
Disclosures: This study was partly funded by the Edgar Schnohr and Wife Gilberte Schnohr’s Foundation supporting independent surgical and anesthesiological research. Dr. Kokotovic reported having no relevant financial disclosures; one investigator reported receiving personal fees from Bard and Etichon for educational presentations.
MACRA final rule exempts many more doctors
Physicians who do not have a large Medicare population or who do not bill much to Medicare Part B will get a bit more breathing room to avoid having to participate in MACRA’s Quality Payment Program.
In a final rule posted Oct. 14 that sets out how the Medicare Access and CHIP Reauthorization Act (MACRA) will work, the Centers for Medicare & Medicaid Services increased the threshold for inclusion in the new value-based payment program from the initial proposal of physicians who bill Medicare more than $10,000 per year or treat more than 100 Medicare patients per year to those who bill more than $30,000 per year or provide care to more than 100 Medicare patients per year.
However, agency officials noted that it is committed to helping these small and solo practices become active participants in the Quality Payment Program.
“We heard these concerns and are taking additional steps to aid small practices, including reducing the time and cost to participate, excluding more small practices, increasing the availability of Advanced APMs [Alternative Payment Models] to small practices, allowing practices to begin participation at their own pace, changing one of the qualifications for participation in Advanced APMs to be practice-based as an alternative to total cost–based, and conducting significant technical support and outreach to small practices using $20 million a year over the next 5 years.”
CMS officials estimate that the new threshold will exclude an estimated 380,000 physicians and health care providers, up from about 225,000 under the initially proposed threshold.
Mr. Slavitt added that with these changes, “we estimate that small physicians will have the same level of participation as that of other practice sizes.”
The flexibility of participation was first announced Sept. 8, in a blog post outlining four options for participation in the Quality Payment Program:
• Option 1: Test the quality payment program in 2017 by submitting data without facing any negative payment adjustments. This will give physicians the year to make sure their processes are in place and ready for broader participation in 2018 and beyond.
• Option 2: Delay the start of the performance period and participate for just part of 2017. Depending on how long a physician delays reporting quality information back to CMS, they could still qualify for a smaller bonus payment.
• Option 3: Participate for the entire calendar year as called for by the law and be eligible for the full participation bonuses.
• Option 4: For those who qualify, participate in an Advanced Alternative Payment Model beginning next year.
That said, under the final rule, those who fail to do the bare minimum and report no data in 2017 will face a 4% pay cut in 2019.
“I am sure that is going to impact some providers,” John Feore, director at Avalere Health, said in an interview. “But with the options, you can report on a very small number of measures, one for each of the categories, for a continuous 90-day period and you will be sort of held harmless [and able] to transition over time into the program.”
Mr. Feore said that did not see any surprises in his initial quick scan of the final rule and that he views the increased flexibility as positive.
“CMS is understanding that MACRA is a pretty substantial change,” he said. “They are calling [2017] a transition year. They are even referring to 2018 as a transition year with more details to come. They are responding to stakeholder concerns that it was a little too much too soon and there is varying degrees of readiness.”
Physician organizations were supportive of the final rule, particularly regarding how it addresses the concerns of small/solo practices.
CMS officials “took a significant step last month to address AMA concerns about the original proposal,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “The final rule includes additional steps to help small and rural practices by raising the low-volume threshold exemption, and practices of all sizes will benefit from reduced MIPS reporting requirements. Our initial review indicates that CMS has been responsive to many concerns raised by the AMA.”
American College of Cardiology President Richard A. Chazal, MD, said in a statement that the organization is “encouraged to see that CMS has made several changes in the final rule based on comments by the clinician community.”
The American College of Rheumatology also expressed support.
“Giving providers the flexibility of multiple options for participation in the first and second years will help ensure a smooth transition to the new payment system, and the continued delivery of quality care to Medicare patients living with rheumatic diseases,” the organization said in a statement. “We also appreciated the broadening of exemptions from the program, which will help to protect small practices that already struggle to keep up with administrative burdens, along with the reduction in the number of required measures to be reported.”
The American Osteopathic Association applauded the flexibility being offered, but found it “disappointing that many of those currently in patient-centered medical homes will still not qualify for [APMs] and opportunities to enter other such value-based models remain limited.”
To that end, CMS officials said that the agency is looking into creating an accountable care organization (ACO) “Track 1 Plus” model that would qualify for as an APM. Currently, ACOs that are in Track 1 share savings but do not assume risk. The agency said that the Track 1 Plus model would have organizations assuming some nominal level of risk that would be smaller, compared with those in the Medicare Shared Savings Program (MSSP) Track 2 and Track 3, as well as those that qualify as Next Generation ACOs. CMS plans to have the ACO Track 1 Plus Model ready for the 2018 reporting year.
The National Association of ACOs expressed disappointment that those ACOs that fall in the Track 1 of the MSSP do not qualify as an APM, but it is “incredibly pleased that CMS recognizes the need for a new model and is taking steps to develop a new MSSP Track 1 Plus,” President and CEO Clif Gaus said in a statement.
More CMS-issued information and educational material about the MACRA final rule can be found here.
Physicians who do not have a large Medicare population or who do not bill much to Medicare Part B will get a bit more breathing room to avoid having to participate in MACRA’s Quality Payment Program.
In a final rule posted Oct. 14 that sets out how the Medicare Access and CHIP Reauthorization Act (MACRA) will work, the Centers for Medicare & Medicaid Services increased the threshold for inclusion in the new value-based payment program from the initial proposal of physicians who bill Medicare more than $10,000 per year or treat more than 100 Medicare patients per year to those who bill more than $30,000 per year or provide care to more than 100 Medicare patients per year.
However, agency officials noted that it is committed to helping these small and solo practices become active participants in the Quality Payment Program.
“We heard these concerns and are taking additional steps to aid small practices, including reducing the time and cost to participate, excluding more small practices, increasing the availability of Advanced APMs [Alternative Payment Models] to small practices, allowing practices to begin participation at their own pace, changing one of the qualifications for participation in Advanced APMs to be practice-based as an alternative to total cost–based, and conducting significant technical support and outreach to small practices using $20 million a year over the next 5 years.”
CMS officials estimate that the new threshold will exclude an estimated 380,000 physicians and health care providers, up from about 225,000 under the initially proposed threshold.
Mr. Slavitt added that with these changes, “we estimate that small physicians will have the same level of participation as that of other practice sizes.”
The flexibility of participation was first announced Sept. 8, in a blog post outlining four options for participation in the Quality Payment Program:
• Option 1: Test the quality payment program in 2017 by submitting data without facing any negative payment adjustments. This will give physicians the year to make sure their processes are in place and ready for broader participation in 2018 and beyond.
• Option 2: Delay the start of the performance period and participate for just part of 2017. Depending on how long a physician delays reporting quality information back to CMS, they could still qualify for a smaller bonus payment.
• Option 3: Participate for the entire calendar year as called for by the law and be eligible for the full participation bonuses.
• Option 4: For those who qualify, participate in an Advanced Alternative Payment Model beginning next year.
That said, under the final rule, those who fail to do the bare minimum and report no data in 2017 will face a 4% pay cut in 2019.
“I am sure that is going to impact some providers,” John Feore, director at Avalere Health, said in an interview. “But with the options, you can report on a very small number of measures, one for each of the categories, for a continuous 90-day period and you will be sort of held harmless [and able] to transition over time into the program.”
Mr. Feore said that did not see any surprises in his initial quick scan of the final rule and that he views the increased flexibility as positive.
“CMS is understanding that MACRA is a pretty substantial change,” he said. “They are calling [2017] a transition year. They are even referring to 2018 as a transition year with more details to come. They are responding to stakeholder concerns that it was a little too much too soon and there is varying degrees of readiness.”
Physician organizations were supportive of the final rule, particularly regarding how it addresses the concerns of small/solo practices.
CMS officials “took a significant step last month to address AMA concerns about the original proposal,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “The final rule includes additional steps to help small and rural practices by raising the low-volume threshold exemption, and practices of all sizes will benefit from reduced MIPS reporting requirements. Our initial review indicates that CMS has been responsive to many concerns raised by the AMA.”
American College of Cardiology President Richard A. Chazal, MD, said in a statement that the organization is “encouraged to see that CMS has made several changes in the final rule based on comments by the clinician community.”
The American College of Rheumatology also expressed support.
“Giving providers the flexibility of multiple options for participation in the first and second years will help ensure a smooth transition to the new payment system, and the continued delivery of quality care to Medicare patients living with rheumatic diseases,” the organization said in a statement. “We also appreciated the broadening of exemptions from the program, which will help to protect small practices that already struggle to keep up with administrative burdens, along with the reduction in the number of required measures to be reported.”
The American Osteopathic Association applauded the flexibility being offered, but found it “disappointing that many of those currently in patient-centered medical homes will still not qualify for [APMs] and opportunities to enter other such value-based models remain limited.”
To that end, CMS officials said that the agency is looking into creating an accountable care organization (ACO) “Track 1 Plus” model that would qualify for as an APM. Currently, ACOs that are in Track 1 share savings but do not assume risk. The agency said that the Track 1 Plus model would have organizations assuming some nominal level of risk that would be smaller, compared with those in the Medicare Shared Savings Program (MSSP) Track 2 and Track 3, as well as those that qualify as Next Generation ACOs. CMS plans to have the ACO Track 1 Plus Model ready for the 2018 reporting year.
The National Association of ACOs expressed disappointment that those ACOs that fall in the Track 1 of the MSSP do not qualify as an APM, but it is “incredibly pleased that CMS recognizes the need for a new model and is taking steps to develop a new MSSP Track 1 Plus,” President and CEO Clif Gaus said in a statement.
More CMS-issued information and educational material about the MACRA final rule can be found here.
Physicians who do not have a large Medicare population or who do not bill much to Medicare Part B will get a bit more breathing room to avoid having to participate in MACRA’s Quality Payment Program.
In a final rule posted Oct. 14 that sets out how the Medicare Access and CHIP Reauthorization Act (MACRA) will work, the Centers for Medicare & Medicaid Services increased the threshold for inclusion in the new value-based payment program from the initial proposal of physicians who bill Medicare more than $10,000 per year or treat more than 100 Medicare patients per year to those who bill more than $30,000 per year or provide care to more than 100 Medicare patients per year.
However, agency officials noted that it is committed to helping these small and solo practices become active participants in the Quality Payment Program.
“We heard these concerns and are taking additional steps to aid small practices, including reducing the time and cost to participate, excluding more small practices, increasing the availability of Advanced APMs [Alternative Payment Models] to small practices, allowing practices to begin participation at their own pace, changing one of the qualifications for participation in Advanced APMs to be practice-based as an alternative to total cost–based, and conducting significant technical support and outreach to small practices using $20 million a year over the next 5 years.”
CMS officials estimate that the new threshold will exclude an estimated 380,000 physicians and health care providers, up from about 225,000 under the initially proposed threshold.
Mr. Slavitt added that with these changes, “we estimate that small physicians will have the same level of participation as that of other practice sizes.”
The flexibility of participation was first announced Sept. 8, in a blog post outlining four options for participation in the Quality Payment Program:
• Option 1: Test the quality payment program in 2017 by submitting data without facing any negative payment adjustments. This will give physicians the year to make sure their processes are in place and ready for broader participation in 2018 and beyond.
• Option 2: Delay the start of the performance period and participate for just part of 2017. Depending on how long a physician delays reporting quality information back to CMS, they could still qualify for a smaller bonus payment.
• Option 3: Participate for the entire calendar year as called for by the law and be eligible for the full participation bonuses.
• Option 4: For those who qualify, participate in an Advanced Alternative Payment Model beginning next year.
That said, under the final rule, those who fail to do the bare minimum and report no data in 2017 will face a 4% pay cut in 2019.
“I am sure that is going to impact some providers,” John Feore, director at Avalere Health, said in an interview. “But with the options, you can report on a very small number of measures, one for each of the categories, for a continuous 90-day period and you will be sort of held harmless [and able] to transition over time into the program.”
Mr. Feore said that did not see any surprises in his initial quick scan of the final rule and that he views the increased flexibility as positive.
“CMS is understanding that MACRA is a pretty substantial change,” he said. “They are calling [2017] a transition year. They are even referring to 2018 as a transition year with more details to come. They are responding to stakeholder concerns that it was a little too much too soon and there is varying degrees of readiness.”
Physician organizations were supportive of the final rule, particularly regarding how it addresses the concerns of small/solo practices.
CMS officials “took a significant step last month to address AMA concerns about the original proposal,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “The final rule includes additional steps to help small and rural practices by raising the low-volume threshold exemption, and practices of all sizes will benefit from reduced MIPS reporting requirements. Our initial review indicates that CMS has been responsive to many concerns raised by the AMA.”
American College of Cardiology President Richard A. Chazal, MD, said in a statement that the organization is “encouraged to see that CMS has made several changes in the final rule based on comments by the clinician community.”
The American College of Rheumatology also expressed support.
“Giving providers the flexibility of multiple options for participation in the first and second years will help ensure a smooth transition to the new payment system, and the continued delivery of quality care to Medicare patients living with rheumatic diseases,” the organization said in a statement. “We also appreciated the broadening of exemptions from the program, which will help to protect small practices that already struggle to keep up with administrative burdens, along with the reduction in the number of required measures to be reported.”
The American Osteopathic Association applauded the flexibility being offered, but found it “disappointing that many of those currently in patient-centered medical homes will still not qualify for [APMs] and opportunities to enter other such value-based models remain limited.”
To that end, CMS officials said that the agency is looking into creating an accountable care organization (ACO) “Track 1 Plus” model that would qualify for as an APM. Currently, ACOs that are in Track 1 share savings but do not assume risk. The agency said that the Track 1 Plus model would have organizations assuming some nominal level of risk that would be smaller, compared with those in the Medicare Shared Savings Program (MSSP) Track 2 and Track 3, as well as those that qualify as Next Generation ACOs. CMS plans to have the ACO Track 1 Plus Model ready for the 2018 reporting year.
The National Association of ACOs expressed disappointment that those ACOs that fall in the Track 1 of the MSSP do not qualify as an APM, but it is “incredibly pleased that CMS recognizes the need for a new model and is taking steps to develop a new MSSP Track 1 Plus,” President and CEO Clif Gaus said in a statement.
More CMS-issued information and educational material about the MACRA final rule can be found here.
Patients want surgery for ventral hernia despite risks and comorbidity obstacles
An in-depth qualitative survey of patients’ expectations and satisfaction regarding ventral hernia management showed that while most were satisfied with surgical outcomes, many were uninformed about postoperative adverse outcomes and many were dissatisfied with nonoperative management.
Zeinab M. Alawadi, MD, and a team of researchers at the University of Texas Health Sciences Center, Houston, initially interviewed 30 patients seeking care for ventral hernia at a safety-net hospital prior to their surgical consultation about factors guiding their decision-making framework. A second interview was conducted 6 months later, asking about their level of satisfaction with their care and outcomes. The study appeared online Oct. 11 in the Journal of the American College of Surgeons.
The initial interview revealed that most patients had limited knowledge about risks and potential adverse outcomes of surgery, but nearly three-quarters of them wanted to undergo surgery for their ventral hernias. Only 7 of the 30 patients were treated surgically and of those, 2 reported an unexpected level of postoperative pain and dissatisfaction with the surgery outcome. The remaining five patients who had surgery were extremely satisfied with their decision.
Most of those interviewed had nonoperative management of their hernias, due to factors such as obesity, diabetes, and smoking. These patients expressed dissatisfaction with the obstacles of meeting surgical criteria, in particular the difficulties of losing weight and coping with diabetes. “From patients’ perspectives, the additional challenges of managing their diabetes and difficulties with exercising due to painful hernias represent overwhelming barriers to treating their obesity. Patients’ accounts do not reflect a simple failure to adhere to medical recommendations but substantial obstacles to losing weight,” the researchers noted. But these patients also expressed willingness to try to meet surgical criteria and to take responsibility for recurrence prevention by self-management.
This study provides insight into patient perceptions and expectation of ventral hernia surgery. “Several findings in this study suggest a need for better education and counseling of patients regarding the natural history of hernias and the risks and benefits of different management strategies. Self-contradicting patient responses regarding knowledge of surgical risks and benefits may represent poor communication by the physicians or poor understanding by the patients. As a result, patients appeared to have unrealistic expectations of surgery. In addition, contrary to the literature, patients appeared to disregard the physicians’ risk assessment and persisted in their preferences for surgical management, even after counseling.”
This work was supported by the Center for Clinical and Translational Sciences, which is funded by National Institutes of Health Clinical and Translational Award UL1 TR000371 and KL2 TR000370 from the National Center for Advancing Translational Sciences. The authors had no disclosures.
Read the complete study at goo.gl/pq4fjz.
An in-depth qualitative survey of patients’ expectations and satisfaction regarding ventral hernia management showed that while most were satisfied with surgical outcomes, many were uninformed about postoperative adverse outcomes and many were dissatisfied with nonoperative management.
Zeinab M. Alawadi, MD, and a team of researchers at the University of Texas Health Sciences Center, Houston, initially interviewed 30 patients seeking care for ventral hernia at a safety-net hospital prior to their surgical consultation about factors guiding their decision-making framework. A second interview was conducted 6 months later, asking about their level of satisfaction with their care and outcomes. The study appeared online Oct. 11 in the Journal of the American College of Surgeons.
The initial interview revealed that most patients had limited knowledge about risks and potential adverse outcomes of surgery, but nearly three-quarters of them wanted to undergo surgery for their ventral hernias. Only 7 of the 30 patients were treated surgically and of those, 2 reported an unexpected level of postoperative pain and dissatisfaction with the surgery outcome. The remaining five patients who had surgery were extremely satisfied with their decision.
Most of those interviewed had nonoperative management of their hernias, due to factors such as obesity, diabetes, and smoking. These patients expressed dissatisfaction with the obstacles of meeting surgical criteria, in particular the difficulties of losing weight and coping with diabetes. “From patients’ perspectives, the additional challenges of managing their diabetes and difficulties with exercising due to painful hernias represent overwhelming barriers to treating their obesity. Patients’ accounts do not reflect a simple failure to adhere to medical recommendations but substantial obstacles to losing weight,” the researchers noted. But these patients also expressed willingness to try to meet surgical criteria and to take responsibility for recurrence prevention by self-management.
This study provides insight into patient perceptions and expectation of ventral hernia surgery. “Several findings in this study suggest a need for better education and counseling of patients regarding the natural history of hernias and the risks and benefits of different management strategies. Self-contradicting patient responses regarding knowledge of surgical risks and benefits may represent poor communication by the physicians or poor understanding by the patients. As a result, patients appeared to have unrealistic expectations of surgery. In addition, contrary to the literature, patients appeared to disregard the physicians’ risk assessment and persisted in their preferences for surgical management, even after counseling.”
This work was supported by the Center for Clinical and Translational Sciences, which is funded by National Institutes of Health Clinical and Translational Award UL1 TR000371 and KL2 TR000370 from the National Center for Advancing Translational Sciences. The authors had no disclosures.
Read the complete study at goo.gl/pq4fjz.
An in-depth qualitative survey of patients’ expectations and satisfaction regarding ventral hernia management showed that while most were satisfied with surgical outcomes, many were uninformed about postoperative adverse outcomes and many were dissatisfied with nonoperative management.
Zeinab M. Alawadi, MD, and a team of researchers at the University of Texas Health Sciences Center, Houston, initially interviewed 30 patients seeking care for ventral hernia at a safety-net hospital prior to their surgical consultation about factors guiding their decision-making framework. A second interview was conducted 6 months later, asking about their level of satisfaction with their care and outcomes. The study appeared online Oct. 11 in the Journal of the American College of Surgeons.
The initial interview revealed that most patients had limited knowledge about risks and potential adverse outcomes of surgery, but nearly three-quarters of them wanted to undergo surgery for their ventral hernias. Only 7 of the 30 patients were treated surgically and of those, 2 reported an unexpected level of postoperative pain and dissatisfaction with the surgery outcome. The remaining five patients who had surgery were extremely satisfied with their decision.
Most of those interviewed had nonoperative management of their hernias, due to factors such as obesity, diabetes, and smoking. These patients expressed dissatisfaction with the obstacles of meeting surgical criteria, in particular the difficulties of losing weight and coping with diabetes. “From patients’ perspectives, the additional challenges of managing their diabetes and difficulties with exercising due to painful hernias represent overwhelming barriers to treating their obesity. Patients’ accounts do not reflect a simple failure to adhere to medical recommendations but substantial obstacles to losing weight,” the researchers noted. But these patients also expressed willingness to try to meet surgical criteria and to take responsibility for recurrence prevention by self-management.
This study provides insight into patient perceptions and expectation of ventral hernia surgery. “Several findings in this study suggest a need for better education and counseling of patients regarding the natural history of hernias and the risks and benefits of different management strategies. Self-contradicting patient responses regarding knowledge of surgical risks and benefits may represent poor communication by the physicians or poor understanding by the patients. As a result, patients appeared to have unrealistic expectations of surgery. In addition, contrary to the literature, patients appeared to disregard the physicians’ risk assessment and persisted in their preferences for surgical management, even after counseling.”
This work was supported by the Center for Clinical and Translational Sciences, which is funded by National Institutes of Health Clinical and Translational Award UL1 TR000371 and KL2 TR000370 from the National Center for Advancing Translational Sciences. The authors had no disclosures.
Read the complete study at goo.gl/pq4fjz.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
CMS pilot aims to reduce physician administrative burdens
Officials at the Centers for Medicare & Medicaid Services are launching a new initiative aimed at reducing administrative burdens for physicians who participate in certain value-based payment models.
Under an 18-month pilot, providers practicing within certain Advanced Alternative Payment Models (Advanced APMs) will be relieved of additional documentation scrutiny under Medicare medical review programs, according to an Oct. 13 CMS announcement. As part of the effort, the agency will direct Medicare Administrative Contractors and Recovery Audit Contractors to consider doctors participating in Advanced APMs as a low-priority for postpayment claim reviews.
“As we implement the Quality Payment Program under [the Medicare Access and CHIP Reauthorization Act of 2015], we cannot do it without making a sustained, long-term commitment to take a holistic view on the demands on the physician and clinician workforce,” Mr. Slavitt said in a statement. “The new initiative will launch a nationwide effort to work with the clinician community to improve Medicare regulations, policies, and interaction points to address issues and to help get physicians back to the most important thing they do – taking care of patients.”
The pilot will have two phases, beginning in early 2017, and will include Advanced APMs, Next Generation Accountable Care Organizations, Medicare Shared Savings Program Track 2 and Track 3 participants, Pioneer Accountable Care Organizations, and Oncology Care Model two-sided track participants.
As part of the program, clinicians will be engaged in regional discussions with CMS regarding documentation requirements and their interactions with the agency. To that end, each of the 10 CMS regional offices will oversee local meetings to gather feedback from physician practices within the next 6 months and conduct regular meetings thereafter. The local meetings will result in a report with targeted recommendations to the CMS Administrator in 2017.
The American Medical Association praised the effort to reduce regulatory burdens.
The American College of Physicians also applauded the initiative, but said the initiative should be expanded to include other advanced APMs, such as the Comprehensive Primary Care Plus program, Nitin S. Damle, MD, the college’s president, said in a statement.
“It is critical to us that this initiative be conducted in addition to – not in lieu of – other needed reforms to reduce burdensome administrative tasks and simplify MACRA implementation,” Dr. Damle said.
[email protected]
On Twitter @legal_med
Officials at the Centers for Medicare & Medicaid Services are launching a new initiative aimed at reducing administrative burdens for physicians who participate in certain value-based payment models.
Under an 18-month pilot, providers practicing within certain Advanced Alternative Payment Models (Advanced APMs) will be relieved of additional documentation scrutiny under Medicare medical review programs, according to an Oct. 13 CMS announcement. As part of the effort, the agency will direct Medicare Administrative Contractors and Recovery Audit Contractors to consider doctors participating in Advanced APMs as a low-priority for postpayment claim reviews.
“As we implement the Quality Payment Program under [the Medicare Access and CHIP Reauthorization Act of 2015], we cannot do it without making a sustained, long-term commitment to take a holistic view on the demands on the physician and clinician workforce,” Mr. Slavitt said in a statement. “The new initiative will launch a nationwide effort to work with the clinician community to improve Medicare regulations, policies, and interaction points to address issues and to help get physicians back to the most important thing they do – taking care of patients.”
The pilot will have two phases, beginning in early 2017, and will include Advanced APMs, Next Generation Accountable Care Organizations, Medicare Shared Savings Program Track 2 and Track 3 participants, Pioneer Accountable Care Organizations, and Oncology Care Model two-sided track participants.
As part of the program, clinicians will be engaged in regional discussions with CMS regarding documentation requirements and their interactions with the agency. To that end, each of the 10 CMS regional offices will oversee local meetings to gather feedback from physician practices within the next 6 months and conduct regular meetings thereafter. The local meetings will result in a report with targeted recommendations to the CMS Administrator in 2017.
The American Medical Association praised the effort to reduce regulatory burdens.
The American College of Physicians also applauded the initiative, but said the initiative should be expanded to include other advanced APMs, such as the Comprehensive Primary Care Plus program, Nitin S. Damle, MD, the college’s president, said in a statement.
“It is critical to us that this initiative be conducted in addition to – not in lieu of – other needed reforms to reduce burdensome administrative tasks and simplify MACRA implementation,” Dr. Damle said.
[email protected]
On Twitter @legal_med
Officials at the Centers for Medicare & Medicaid Services are launching a new initiative aimed at reducing administrative burdens for physicians who participate in certain value-based payment models.
Under an 18-month pilot, providers practicing within certain Advanced Alternative Payment Models (Advanced APMs) will be relieved of additional documentation scrutiny under Medicare medical review programs, according to an Oct. 13 CMS announcement. As part of the effort, the agency will direct Medicare Administrative Contractors and Recovery Audit Contractors to consider doctors participating in Advanced APMs as a low-priority for postpayment claim reviews.
“As we implement the Quality Payment Program under [the Medicare Access and CHIP Reauthorization Act of 2015], we cannot do it without making a sustained, long-term commitment to take a holistic view on the demands on the physician and clinician workforce,” Mr. Slavitt said in a statement. “The new initiative will launch a nationwide effort to work with the clinician community to improve Medicare regulations, policies, and interaction points to address issues and to help get physicians back to the most important thing they do – taking care of patients.”
The pilot will have two phases, beginning in early 2017, and will include Advanced APMs, Next Generation Accountable Care Organizations, Medicare Shared Savings Program Track 2 and Track 3 participants, Pioneer Accountable Care Organizations, and Oncology Care Model two-sided track participants.
As part of the program, clinicians will be engaged in regional discussions with CMS regarding documentation requirements and their interactions with the agency. To that end, each of the 10 CMS regional offices will oversee local meetings to gather feedback from physician practices within the next 6 months and conduct regular meetings thereafter. The local meetings will result in a report with targeted recommendations to the CMS Administrator in 2017.
The American Medical Association praised the effort to reduce regulatory burdens.
The American College of Physicians also applauded the initiative, but said the initiative should be expanded to include other advanced APMs, such as the Comprehensive Primary Care Plus program, Nitin S. Damle, MD, the college’s president, said in a statement.
“It is critical to us that this initiative be conducted in addition to – not in lieu of – other needed reforms to reduce burdensome administrative tasks and simplify MACRA implementation,” Dr. Damle said.
[email protected]
On Twitter @legal_med
Risk model predicts chronic postop pain for VHR patients
Postoperative pain that lingers for months is a common outcome of ventral hernia repair surgery. A predictive model has been developed by investigators at the Carolina Medical Center in Charlotte, N.C., to determine which hernia patients are at risk for chronic postoperative pain.
Tiffany C. Cox, MD, and the research team used the International Hernia Mesh Registry to obtain a sample of 887 ventral hernia repair patients that had surgery between 2007 and 2014. Data on postoperative pain was based on the Carolinas Comfort Scale questionnaire administered at 1, 6 and 12 months after surgery. Logistic regression analyses were used to determine independent predictors of postoperative chronic pain and a risk model was developed (Am J Surg. 2016 Sep; 212[3]:501-10).
The investigators concluded that the statistically significant predictors of risk for developing chronic postoperative pain at 1 year were preoperative pain and pain at 1 month of 2 or greater on the Carolina Comfort Scale (odds ratio, 2.97 and 2.64, respectively), female sex (OR, 1.74), and repair of recurrent hernias (OR, 1.59).
The predictive model for chronic postoperative pain may be helpful to surgeons in counseling patients and in devising postoperative interventions.
The investigators had no disclosures.
Read the full study at goo.gl/MRjM66.
Postoperative pain that lingers for months is a common outcome of ventral hernia repair surgery. A predictive model has been developed by investigators at the Carolina Medical Center in Charlotte, N.C., to determine which hernia patients are at risk for chronic postoperative pain.
Tiffany C. Cox, MD, and the research team used the International Hernia Mesh Registry to obtain a sample of 887 ventral hernia repair patients that had surgery between 2007 and 2014. Data on postoperative pain was based on the Carolinas Comfort Scale questionnaire administered at 1, 6 and 12 months after surgery. Logistic regression analyses were used to determine independent predictors of postoperative chronic pain and a risk model was developed (Am J Surg. 2016 Sep; 212[3]:501-10).
The investigators concluded that the statistically significant predictors of risk for developing chronic postoperative pain at 1 year were preoperative pain and pain at 1 month of 2 or greater on the Carolina Comfort Scale (odds ratio, 2.97 and 2.64, respectively), female sex (OR, 1.74), and repair of recurrent hernias (OR, 1.59).
The predictive model for chronic postoperative pain may be helpful to surgeons in counseling patients and in devising postoperative interventions.
The investigators had no disclosures.
Read the full study at goo.gl/MRjM66.
Postoperative pain that lingers for months is a common outcome of ventral hernia repair surgery. A predictive model has been developed by investigators at the Carolina Medical Center in Charlotte, N.C., to determine which hernia patients are at risk for chronic postoperative pain.
Tiffany C. Cox, MD, and the research team used the International Hernia Mesh Registry to obtain a sample of 887 ventral hernia repair patients that had surgery between 2007 and 2014. Data on postoperative pain was based on the Carolinas Comfort Scale questionnaire administered at 1, 6 and 12 months after surgery. Logistic regression analyses were used to determine independent predictors of postoperative chronic pain and a risk model was developed (Am J Surg. 2016 Sep; 212[3]:501-10).
The investigators concluded that the statistically significant predictors of risk for developing chronic postoperative pain at 1 year were preoperative pain and pain at 1 month of 2 or greater on the Carolina Comfort Scale (odds ratio, 2.97 and 2.64, respectively), female sex (OR, 1.74), and repair of recurrent hernias (OR, 1.59).
The predictive model for chronic postoperative pain may be helpful to surgeons in counseling patients and in devising postoperative interventions.
The investigators had no disclosures.
Read the full study at goo.gl/MRjM66.
FROM THE AMERICAN JOURNAL OF SURGERY
Laparoscopy comparable to open staging for uterine papillary serous cancer
BOSTON – Laparoscopic staging of patients with uterine papillary serous carcinoma is a safe alternative to open staging and may offer some advantages, according to findings presented at the annual Minimally Invasive Surgery Week.
“Traditionally, serous papillary cancer has been treated different than the other endometrial cancers, the reason being is that it tends to behave more like ovarian cancer,” Jeanette Voice, MD, of Richmond University Medical Center in Staten Island, N.Y., said at the meeting, which was held by the Society for Laparoendoscopic Surgeons. “Patients with serous papillary cancer tend to be older [so] these patients may benefit from a less invasive surgical approach.”
Dr. Voice and her coinvestigators conducted an 8-year retrospective study of laparoscopic and open-staged cases treated from March 2007 through May 2015. Initially, 59 patients with pathology-confirmed uterine papillary serous carcinoma were identified over that time period, and were divided into two cohorts: one receiving open surgery (37 patients) and one receiving laparoscopic surgery (22 patients).
Median age, body mass index, and prior abdominal surgery rate were not significantly different between the two cohorts.
In terms of intraoperative factors, median operative times for the open and laparoscopic cohorts were similar: 196 minutes versus 216 minutes, respectively (P = .561). Similarly, the number of pelvic lymph node dissections and rate of omentectomy were also not significantly different: 18 nodes (open) versus 16 nodes (laparoscopic) (P = .96), and 100% (open) versus 91% (laparoscopic) (P = .08).
However, laparoscopic patients had more favorable median estimated blood loss (310 mL versus 175 mL, P = .048) and shorter hospital stays (4 days versus 1 day, P less than .042).
Laparoscopic patients also achieved more robust debulking to zero centimeter residual disease, with 90.5% of patients achieving it versus 65.7% of those in the open surgery cohort, but the difference was not statistically significant (P = .1).
In terms of postoperative adjuvant therapy – brachytherapy, external beam radiation, and chemotherapy – there were no significant differences in outcomes between the two cohorts. Recurrence rates were also similar, with nine recurrences in the open cohort and eight recurrences in the laparoscopic cohort. The estimated 36-month progression-free survival rates were “almost identical,” with 55.3% in the open cohort versus 53.3% in the laparoscopic (P = .727), according to Dr. Voice.
Postoperative complications were more common in the open surgery cohort (29.7%), compared with 13.6% in the laparoscopic cohort, but no statistically significant difference was found between them (P = .16).
Dr. Voice did not report information on financial disclosures.
BOSTON – Laparoscopic staging of patients with uterine papillary serous carcinoma is a safe alternative to open staging and may offer some advantages, according to findings presented at the annual Minimally Invasive Surgery Week.
“Traditionally, serous papillary cancer has been treated different than the other endometrial cancers, the reason being is that it tends to behave more like ovarian cancer,” Jeanette Voice, MD, of Richmond University Medical Center in Staten Island, N.Y., said at the meeting, which was held by the Society for Laparoendoscopic Surgeons. “Patients with serous papillary cancer tend to be older [so] these patients may benefit from a less invasive surgical approach.”
Dr. Voice and her coinvestigators conducted an 8-year retrospective study of laparoscopic and open-staged cases treated from March 2007 through May 2015. Initially, 59 patients with pathology-confirmed uterine papillary serous carcinoma were identified over that time period, and were divided into two cohorts: one receiving open surgery (37 patients) and one receiving laparoscopic surgery (22 patients).
Median age, body mass index, and prior abdominal surgery rate were not significantly different between the two cohorts.
In terms of intraoperative factors, median operative times for the open and laparoscopic cohorts were similar: 196 minutes versus 216 minutes, respectively (P = .561). Similarly, the number of pelvic lymph node dissections and rate of omentectomy were also not significantly different: 18 nodes (open) versus 16 nodes (laparoscopic) (P = .96), and 100% (open) versus 91% (laparoscopic) (P = .08).
However, laparoscopic patients had more favorable median estimated blood loss (310 mL versus 175 mL, P = .048) and shorter hospital stays (4 days versus 1 day, P less than .042).
Laparoscopic patients also achieved more robust debulking to zero centimeter residual disease, with 90.5% of patients achieving it versus 65.7% of those in the open surgery cohort, but the difference was not statistically significant (P = .1).
In terms of postoperative adjuvant therapy – brachytherapy, external beam radiation, and chemotherapy – there were no significant differences in outcomes between the two cohorts. Recurrence rates were also similar, with nine recurrences in the open cohort and eight recurrences in the laparoscopic cohort. The estimated 36-month progression-free survival rates were “almost identical,” with 55.3% in the open cohort versus 53.3% in the laparoscopic (P = .727), according to Dr. Voice.
Postoperative complications were more common in the open surgery cohort (29.7%), compared with 13.6% in the laparoscopic cohort, but no statistically significant difference was found between them (P = .16).
Dr. Voice did not report information on financial disclosures.
BOSTON – Laparoscopic staging of patients with uterine papillary serous carcinoma is a safe alternative to open staging and may offer some advantages, according to findings presented at the annual Minimally Invasive Surgery Week.
“Traditionally, serous papillary cancer has been treated different than the other endometrial cancers, the reason being is that it tends to behave more like ovarian cancer,” Jeanette Voice, MD, of Richmond University Medical Center in Staten Island, N.Y., said at the meeting, which was held by the Society for Laparoendoscopic Surgeons. “Patients with serous papillary cancer tend to be older [so] these patients may benefit from a less invasive surgical approach.”
Dr. Voice and her coinvestigators conducted an 8-year retrospective study of laparoscopic and open-staged cases treated from March 2007 through May 2015. Initially, 59 patients with pathology-confirmed uterine papillary serous carcinoma were identified over that time period, and were divided into two cohorts: one receiving open surgery (37 patients) and one receiving laparoscopic surgery (22 patients).
Median age, body mass index, and prior abdominal surgery rate were not significantly different between the two cohorts.
In terms of intraoperative factors, median operative times for the open and laparoscopic cohorts were similar: 196 minutes versus 216 minutes, respectively (P = .561). Similarly, the number of pelvic lymph node dissections and rate of omentectomy were also not significantly different: 18 nodes (open) versus 16 nodes (laparoscopic) (P = .96), and 100% (open) versus 91% (laparoscopic) (P = .08).
However, laparoscopic patients had more favorable median estimated blood loss (310 mL versus 175 mL, P = .048) and shorter hospital stays (4 days versus 1 day, P less than .042).
Laparoscopic patients also achieved more robust debulking to zero centimeter residual disease, with 90.5% of patients achieving it versus 65.7% of those in the open surgery cohort, but the difference was not statistically significant (P = .1).
In terms of postoperative adjuvant therapy – brachytherapy, external beam radiation, and chemotherapy – there were no significant differences in outcomes between the two cohorts. Recurrence rates were also similar, with nine recurrences in the open cohort and eight recurrences in the laparoscopic cohort. The estimated 36-month progression-free survival rates were “almost identical,” with 55.3% in the open cohort versus 53.3% in the laparoscopic (P = .727), according to Dr. Voice.
Postoperative complications were more common in the open surgery cohort (29.7%), compared with 13.6% in the laparoscopic cohort, but no statistically significant difference was found between them (P = .16).
Dr. Voice did not report information on financial disclosures.
AT MINIMALLY INVASIVE SURGERY WEEK
Key clinical point:
Major finding: Laparoscopic patients had lower median estimated blood loss (310 mL v. 175 mL, P = .048) and shorter hospital stays (4 days v. 1 day, P less than .042).
Data source: Retrospective review of data on 59 open and laparoscopic patients over 8 years.
Disclosures: Dr. Voice did not report information on financial disclosures.
Registry helps track pelvic organ prolapse outcomes in the U.S.
DENVER – Catherine Bradley, MD, said during a presentation at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“This is a unique collaborative registry created in response to U.S. industry requirements. There are many benefits to using this approach, but also many challenges. It’s a work in progress,” said Dr. Bradley, of the University of Iowa, Iowa City. She chairs the American Urogynecologic Society Research Council, which helps oversee the registry.
The purpose of the PFDR is to fulfill requirements from the Food and Drug Administration for postmarketing studies of the vaginal mesh procedure, to give surgeons a pelvic organ prolapse treatment database to track individual and aggregate outcomes for research and quality improvement purposes, and to create a framework for future clinical studies, according to Dr. Bradley.
As such, the PFDR comprises two interrelated registries, Dr. Bradley noted. The PFDR-I includes industry-sponsored studies, while the PFDR-R is the independent research registry of the American Urogynecologic Society. The PFDR previously included a third quality improvement registry, which in January 2016 was moved to a separate platform called AQUIRE.
The PFDR-I is tracking 1,620 patients who underwent 1,386 procedures for pelvic organ prolapse as part of four studies sponsored by three manufacturers, according to Dr. Bradley. The PFDR-R, for its part, has eight active sites and has enrolled 179 patients with pelvic organ prolapse, 154 of whom underwent mesh surgery and 25 of whom received vaginal pessaries, she said.
The PFDR-R is voluntary and has faced some barriers in the 10 months since its launch, Dr. Bradley said. Participation increases workload for physicians as well as data entry personnel, and patients must provide informed consent to be entered into the registry. But the benefits of participating are also substantial, she emphasized. The PFDR-R will enable surgeons to track their own outcomes in terms of caseload, anatomic outcomes, symptoms and quality of life, and adverse events. They can download their own data, compare their outcomes to others as part of highly granular benchmarking initiatives, and propose and conduct studies of the entire registry.
The PFDR is supported by ACell, ASTORA Women’s Health, Boston Scientific, and Coloplast. Dr. Bradley reported having no conflicts of interest.
DENVER – Catherine Bradley, MD, said during a presentation at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“This is a unique collaborative registry created in response to U.S. industry requirements. There are many benefits to using this approach, but also many challenges. It’s a work in progress,” said Dr. Bradley, of the University of Iowa, Iowa City. She chairs the American Urogynecologic Society Research Council, which helps oversee the registry.
The purpose of the PFDR is to fulfill requirements from the Food and Drug Administration for postmarketing studies of the vaginal mesh procedure, to give surgeons a pelvic organ prolapse treatment database to track individual and aggregate outcomes for research and quality improvement purposes, and to create a framework for future clinical studies, according to Dr. Bradley.
As such, the PFDR comprises two interrelated registries, Dr. Bradley noted. The PFDR-I includes industry-sponsored studies, while the PFDR-R is the independent research registry of the American Urogynecologic Society. The PFDR previously included a third quality improvement registry, which in January 2016 was moved to a separate platform called AQUIRE.
The PFDR-I is tracking 1,620 patients who underwent 1,386 procedures for pelvic organ prolapse as part of four studies sponsored by three manufacturers, according to Dr. Bradley. The PFDR-R, for its part, has eight active sites and has enrolled 179 patients with pelvic organ prolapse, 154 of whom underwent mesh surgery and 25 of whom received vaginal pessaries, she said.
The PFDR-R is voluntary and has faced some barriers in the 10 months since its launch, Dr. Bradley said. Participation increases workload for physicians as well as data entry personnel, and patients must provide informed consent to be entered into the registry. But the benefits of participating are also substantial, she emphasized. The PFDR-R will enable surgeons to track their own outcomes in terms of caseload, anatomic outcomes, symptoms and quality of life, and adverse events. They can download their own data, compare their outcomes to others as part of highly granular benchmarking initiatives, and propose and conduct studies of the entire registry.
The PFDR is supported by ACell, ASTORA Women’s Health, Boston Scientific, and Coloplast. Dr. Bradley reported having no conflicts of interest.
DENVER – Catherine Bradley, MD, said during a presentation at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“This is a unique collaborative registry created in response to U.S. industry requirements. There are many benefits to using this approach, but also many challenges. It’s a work in progress,” said Dr. Bradley, of the University of Iowa, Iowa City. She chairs the American Urogynecologic Society Research Council, which helps oversee the registry.
The purpose of the PFDR is to fulfill requirements from the Food and Drug Administration for postmarketing studies of the vaginal mesh procedure, to give surgeons a pelvic organ prolapse treatment database to track individual and aggregate outcomes for research and quality improvement purposes, and to create a framework for future clinical studies, according to Dr. Bradley.
As such, the PFDR comprises two interrelated registries, Dr. Bradley noted. The PFDR-I includes industry-sponsored studies, while the PFDR-R is the independent research registry of the American Urogynecologic Society. The PFDR previously included a third quality improvement registry, which in January 2016 was moved to a separate platform called AQUIRE.
The PFDR-I is tracking 1,620 patients who underwent 1,386 procedures for pelvic organ prolapse as part of four studies sponsored by three manufacturers, according to Dr. Bradley. The PFDR-R, for its part, has eight active sites and has enrolled 179 patients with pelvic organ prolapse, 154 of whom underwent mesh surgery and 25 of whom received vaginal pessaries, she said.
The PFDR-R is voluntary and has faced some barriers in the 10 months since its launch, Dr. Bradley said. Participation increases workload for physicians as well as data entry personnel, and patients must provide informed consent to be entered into the registry. But the benefits of participating are also substantial, she emphasized. The PFDR-R will enable surgeons to track their own outcomes in terms of caseload, anatomic outcomes, symptoms and quality of life, and adverse events. They can download their own data, compare their outcomes to others as part of highly granular benchmarking initiatives, and propose and conduct studies of the entire registry.
The PFDR is supported by ACell, ASTORA Women’s Health, Boston Scientific, and Coloplast. Dr. Bradley reported having no conflicts of interest.
AT PFD WEEK 2016
Underlay mesh for hernia repair yields better postop pain outcomes
Chronic pain that typically follows primary inguinal hernia repair can be significantly reduced by adopting procedures that use underlay mesh rather than overlay mesh, according to a new study published in the Journal of Surgical Research.
“Although chronic pain and discomfort is still one of the greatest problems after inguinal hernia repair due to the fact that it interferes with patients’ quality of life, there are very little data available from previous studies concerning presentation, diagnosis, and modes of treatment of this issue. In particular, the data in the literature concerning the cause of chronic pain are very limited,” wrote the authors, led by Hideyuki Takata, MD, of Nippon Medical School, Tokyo.
Dr. Takata and his coinvestigators looked at patients who underwent a mesh repair operation for primary inguinal hernia at a single institution – Nippon Medical School – between May 2011 and May 2014. All patients were aged 40 years or older, and the overwhelming majority were male. A total of 334 patients were identified, with 378 lesions among them; all patients’ operations were performed via the Lichtenstein (onlay mesh only), Ultrapro Plug (onlay and plug mesh), modified Kugel Patch (onlay and underlay mesh), or laparoscopic transabdominal preperitoneal (underlay mesh only, TAPP) surgical routes.
Forty-four patients had bilateral lesions, 152 had lesions on the right, and 138 on the left; 76 patients received Lichtenstein operations, 85 received Ultrapro Plug, 156 received modified Kugel Patch, and 61 received TAPP. (J Surg Res 2016 Aug 11. doi: 10.1016/j.jss.2016.08.027).
Patients received questionnaires at 2-3 weeks, 3 months, and 6 months after the operation to determine their pain and discomfort levels. Responses for all 378 lesions (100%) were received at the first follow-up, with questionnaires received for 229 lesions (60.5%) at the 3-month follow-up and 249 lesions (65.9%) at the 6-month follow-up. Of those who responded at the 6-month follow-up, 46 received Lichtenstein, 59 received Ultrapro Plug, 101 received modified Kugel Patch, and 61 received TAPP.
No patients reported moderate or severe pain while at rest. Mild pain was reported by 11 (4.4%) of all respondents; 0 of those who received Lichtenstein, 4 (6.8%) of those who received Ultrapro Plug, 7 (6.9%) of those who received modified Kugel Patch, and 0 of those who received TAPP (P less than .01).
Pain with movement was reported in 35 (14.1%) of respondents: 6 (13.0%) of those who received Lichtenstein, 7 (11.9%) of those who received Ultrapro Plug, 20 (19.8%) of those who received modified Kugel Patch, and 2 (4.7%) of those who received TAPP (P less than .05). One respondent reported experiencing moderate pain with movement, and that individual received Ultrapro Plug (1.7%). No patients reported experiencing severe pain with movement.
“We conclude that the sensory nerves in the inguinal region should be kept away from the mesh to prevent the development of chronic pain and discomfort,” the investigators concluded. “Further study is required to determine the mechanism involved in the generation of chronic pain and discomfort to improve the patient’s quality of life after primary inguinal hernia repair.”
No funding source was disclosed for this study. Dr. Takata and his coauthors did not report any relevant financial disclosures.
Chronic pain that typically follows primary inguinal hernia repair can be significantly reduced by adopting procedures that use underlay mesh rather than overlay mesh, according to a new study published in the Journal of Surgical Research.
“Although chronic pain and discomfort is still one of the greatest problems after inguinal hernia repair due to the fact that it interferes with patients’ quality of life, there are very little data available from previous studies concerning presentation, diagnosis, and modes of treatment of this issue. In particular, the data in the literature concerning the cause of chronic pain are very limited,” wrote the authors, led by Hideyuki Takata, MD, of Nippon Medical School, Tokyo.
Dr. Takata and his coinvestigators looked at patients who underwent a mesh repair operation for primary inguinal hernia at a single institution – Nippon Medical School – between May 2011 and May 2014. All patients were aged 40 years or older, and the overwhelming majority were male. A total of 334 patients were identified, with 378 lesions among them; all patients’ operations were performed via the Lichtenstein (onlay mesh only), Ultrapro Plug (onlay and plug mesh), modified Kugel Patch (onlay and underlay mesh), or laparoscopic transabdominal preperitoneal (underlay mesh only, TAPP) surgical routes.
Forty-four patients had bilateral lesions, 152 had lesions on the right, and 138 on the left; 76 patients received Lichtenstein operations, 85 received Ultrapro Plug, 156 received modified Kugel Patch, and 61 received TAPP. (J Surg Res 2016 Aug 11. doi: 10.1016/j.jss.2016.08.027).
Patients received questionnaires at 2-3 weeks, 3 months, and 6 months after the operation to determine their pain and discomfort levels. Responses for all 378 lesions (100%) were received at the first follow-up, with questionnaires received for 229 lesions (60.5%) at the 3-month follow-up and 249 lesions (65.9%) at the 6-month follow-up. Of those who responded at the 6-month follow-up, 46 received Lichtenstein, 59 received Ultrapro Plug, 101 received modified Kugel Patch, and 61 received TAPP.
No patients reported moderate or severe pain while at rest. Mild pain was reported by 11 (4.4%) of all respondents; 0 of those who received Lichtenstein, 4 (6.8%) of those who received Ultrapro Plug, 7 (6.9%) of those who received modified Kugel Patch, and 0 of those who received TAPP (P less than .01).
Pain with movement was reported in 35 (14.1%) of respondents: 6 (13.0%) of those who received Lichtenstein, 7 (11.9%) of those who received Ultrapro Plug, 20 (19.8%) of those who received modified Kugel Patch, and 2 (4.7%) of those who received TAPP (P less than .05). One respondent reported experiencing moderate pain with movement, and that individual received Ultrapro Plug (1.7%). No patients reported experiencing severe pain with movement.
“We conclude that the sensory nerves in the inguinal region should be kept away from the mesh to prevent the development of chronic pain and discomfort,” the investigators concluded. “Further study is required to determine the mechanism involved in the generation of chronic pain and discomfort to improve the patient’s quality of life after primary inguinal hernia repair.”
No funding source was disclosed for this study. Dr. Takata and his coauthors did not report any relevant financial disclosures.
Chronic pain that typically follows primary inguinal hernia repair can be significantly reduced by adopting procedures that use underlay mesh rather than overlay mesh, according to a new study published in the Journal of Surgical Research.
“Although chronic pain and discomfort is still one of the greatest problems after inguinal hernia repair due to the fact that it interferes with patients’ quality of life, there are very little data available from previous studies concerning presentation, diagnosis, and modes of treatment of this issue. In particular, the data in the literature concerning the cause of chronic pain are very limited,” wrote the authors, led by Hideyuki Takata, MD, of Nippon Medical School, Tokyo.
Dr. Takata and his coinvestigators looked at patients who underwent a mesh repair operation for primary inguinal hernia at a single institution – Nippon Medical School – between May 2011 and May 2014. All patients were aged 40 years or older, and the overwhelming majority were male. A total of 334 patients were identified, with 378 lesions among them; all patients’ operations were performed via the Lichtenstein (onlay mesh only), Ultrapro Plug (onlay and plug mesh), modified Kugel Patch (onlay and underlay mesh), or laparoscopic transabdominal preperitoneal (underlay mesh only, TAPP) surgical routes.
Forty-four patients had bilateral lesions, 152 had lesions on the right, and 138 on the left; 76 patients received Lichtenstein operations, 85 received Ultrapro Plug, 156 received modified Kugel Patch, and 61 received TAPP. (J Surg Res 2016 Aug 11. doi: 10.1016/j.jss.2016.08.027).
Patients received questionnaires at 2-3 weeks, 3 months, and 6 months after the operation to determine their pain and discomfort levels. Responses for all 378 lesions (100%) were received at the first follow-up, with questionnaires received for 229 lesions (60.5%) at the 3-month follow-up and 249 lesions (65.9%) at the 6-month follow-up. Of those who responded at the 6-month follow-up, 46 received Lichtenstein, 59 received Ultrapro Plug, 101 received modified Kugel Patch, and 61 received TAPP.
No patients reported moderate or severe pain while at rest. Mild pain was reported by 11 (4.4%) of all respondents; 0 of those who received Lichtenstein, 4 (6.8%) of those who received Ultrapro Plug, 7 (6.9%) of those who received modified Kugel Patch, and 0 of those who received TAPP (P less than .01).
Pain with movement was reported in 35 (14.1%) of respondents: 6 (13.0%) of those who received Lichtenstein, 7 (11.9%) of those who received Ultrapro Plug, 20 (19.8%) of those who received modified Kugel Patch, and 2 (4.7%) of those who received TAPP (P less than .05). One respondent reported experiencing moderate pain with movement, and that individual received Ultrapro Plug (1.7%). No patients reported experiencing severe pain with movement.
“We conclude that the sensory nerves in the inguinal region should be kept away from the mesh to prevent the development of chronic pain and discomfort,” the investigators concluded. “Further study is required to determine the mechanism involved in the generation of chronic pain and discomfort to improve the patient’s quality of life after primary inguinal hernia repair.”
No funding source was disclosed for this study. Dr. Takata and his coauthors did not report any relevant financial disclosures.
Key clinical point:
Major finding: Mild pain at rest and with movement were both significantly lower in patients who received TAPP than in those who received one of three other surgical procedures.
Data source: Retrospective analysis of 334 primary inguinal hernia patients with 378 lesions undergoing TAPP or Lichtenstein procedures.
Disclosures: The authors did not report any relevant financial disclosures.
Silicone joint arthroplasty for RA shows sustained improvements at 7 years
Rheumatoid arthritis patients who underwent silicone metacarpophalangeal joint replacement maintained significant improvement in ulnar drift and extensor lag after 7 years of follow-up in the prospective, multicenter Silicone Arthroplasty in Rheumatoid Arthritis (SARA) study.
The silicone metacarpophalangeal joint arthroplasty (SMPA) group also showed significantly better metacarpophalangeal (MCP) joint arc of motion, as well as function, aesthetics, and satisfaction scores than did patients in the cohort who chose nonsurgical management.
The practice of replacing deformed MCP joints with a hinged silicone implant has been around for almost half a century, the investigators noted, but despite widespread use, there is a lack of high-quality surgical outcomes data for the procedure. The authors suggested that the scarcity of data may create a barrier for surgical referrals from rheumatologists and could account for the declining rate of surgical intervention for RA joint deformities.
The significant improvement in ulnar drift that occurred in patients who underwent SMPA versus no surgery remained even after adjustment for baseline severity, age, sex, and use of biologics. The adjustment was especially important because the nonsurgical group had better function at baseline, with significantly stronger grip and pinch strength, better Michigan Hand Questionnaire (MHQ) scores, and significantly better ulnar drift, extensor lag, and arc of motion than in the surgical group (Arthritis Care Res. 2016 Oct 1. doi: 10.1002/acr.23105).
The nonsurgical group largely maintained its baseline functional state during the 7-year follow-up period except for a decline in pinch strength.
“When the SMPA cohort was compared with the non-SMPA cohort, the covariate-adjusted difference showed significant benefits associated with SMPA hand outcome as measured by the MHQ function, aesthetics, and satisfaction scores, with no measures showing significantly better outcomes for the non-SMPA group,” the researchers wrote. “Although the average treatment effect estimate (ATT estimate) showed a decline over time for the average benefit from SMPA in those treated, the function score benefit as shown by the ATT estimate remained significant at year 5.”
Patients in the nonsurgical group were also given the option to crossover and receive surgery after 1 year, which two did. Eleven patients in the surgical group also decided to undergo surgery on their other hand.
Researchers saw one mild and three moderate implant-related adverse events during the study, including one patient who experienced ulnar deviation and needed a new joint replacement, one who dislocated the implant of the little finger a few weeks after insertion, and one who experienced sepsis in the joints 6 years after insertion and needed replacements for two implants. The fracture incidence of about 10% fits into the mid-range of previously reported fracture rates with this implant.
The study experienced significant losses to follow-up, particularly in the surgical group in which 7-year data were only available for 43% of participants in this group. The authors suggested this could have been because the surgical patients achieved their goals and were less inclined to the follow-up visits.
The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. No conflicts of interest were declared.
Rheumatoid arthritis patients who underwent silicone metacarpophalangeal joint replacement maintained significant improvement in ulnar drift and extensor lag after 7 years of follow-up in the prospective, multicenter Silicone Arthroplasty in Rheumatoid Arthritis (SARA) study.
The silicone metacarpophalangeal joint arthroplasty (SMPA) group also showed significantly better metacarpophalangeal (MCP) joint arc of motion, as well as function, aesthetics, and satisfaction scores than did patients in the cohort who chose nonsurgical management.
The practice of replacing deformed MCP joints with a hinged silicone implant has been around for almost half a century, the investigators noted, but despite widespread use, there is a lack of high-quality surgical outcomes data for the procedure. The authors suggested that the scarcity of data may create a barrier for surgical referrals from rheumatologists and could account for the declining rate of surgical intervention for RA joint deformities.
The significant improvement in ulnar drift that occurred in patients who underwent SMPA versus no surgery remained even after adjustment for baseline severity, age, sex, and use of biologics. The adjustment was especially important because the nonsurgical group had better function at baseline, with significantly stronger grip and pinch strength, better Michigan Hand Questionnaire (MHQ) scores, and significantly better ulnar drift, extensor lag, and arc of motion than in the surgical group (Arthritis Care Res. 2016 Oct 1. doi: 10.1002/acr.23105).
The nonsurgical group largely maintained its baseline functional state during the 7-year follow-up period except for a decline in pinch strength.
“When the SMPA cohort was compared with the non-SMPA cohort, the covariate-adjusted difference showed significant benefits associated with SMPA hand outcome as measured by the MHQ function, aesthetics, and satisfaction scores, with no measures showing significantly better outcomes for the non-SMPA group,” the researchers wrote. “Although the average treatment effect estimate (ATT estimate) showed a decline over time for the average benefit from SMPA in those treated, the function score benefit as shown by the ATT estimate remained significant at year 5.”
Patients in the nonsurgical group were also given the option to crossover and receive surgery after 1 year, which two did. Eleven patients in the surgical group also decided to undergo surgery on their other hand.
Researchers saw one mild and three moderate implant-related adverse events during the study, including one patient who experienced ulnar deviation and needed a new joint replacement, one who dislocated the implant of the little finger a few weeks after insertion, and one who experienced sepsis in the joints 6 years after insertion and needed replacements for two implants. The fracture incidence of about 10% fits into the mid-range of previously reported fracture rates with this implant.
The study experienced significant losses to follow-up, particularly in the surgical group in which 7-year data were only available for 43% of participants in this group. The authors suggested this could have been because the surgical patients achieved their goals and were less inclined to the follow-up visits.
The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. No conflicts of interest were declared.
Rheumatoid arthritis patients who underwent silicone metacarpophalangeal joint replacement maintained significant improvement in ulnar drift and extensor lag after 7 years of follow-up in the prospective, multicenter Silicone Arthroplasty in Rheumatoid Arthritis (SARA) study.
The silicone metacarpophalangeal joint arthroplasty (SMPA) group also showed significantly better metacarpophalangeal (MCP) joint arc of motion, as well as function, aesthetics, and satisfaction scores than did patients in the cohort who chose nonsurgical management.
The practice of replacing deformed MCP joints with a hinged silicone implant has been around for almost half a century, the investigators noted, but despite widespread use, there is a lack of high-quality surgical outcomes data for the procedure. The authors suggested that the scarcity of data may create a barrier for surgical referrals from rheumatologists and could account for the declining rate of surgical intervention for RA joint deformities.
The significant improvement in ulnar drift that occurred in patients who underwent SMPA versus no surgery remained even after adjustment for baseline severity, age, sex, and use of biologics. The adjustment was especially important because the nonsurgical group had better function at baseline, with significantly stronger grip and pinch strength, better Michigan Hand Questionnaire (MHQ) scores, and significantly better ulnar drift, extensor lag, and arc of motion than in the surgical group (Arthritis Care Res. 2016 Oct 1. doi: 10.1002/acr.23105).
The nonsurgical group largely maintained its baseline functional state during the 7-year follow-up period except for a decline in pinch strength.
“When the SMPA cohort was compared with the non-SMPA cohort, the covariate-adjusted difference showed significant benefits associated with SMPA hand outcome as measured by the MHQ function, aesthetics, and satisfaction scores, with no measures showing significantly better outcomes for the non-SMPA group,” the researchers wrote. “Although the average treatment effect estimate (ATT estimate) showed a decline over time for the average benefit from SMPA in those treated, the function score benefit as shown by the ATT estimate remained significant at year 5.”
Patients in the nonsurgical group were also given the option to crossover and receive surgery after 1 year, which two did. Eleven patients in the surgical group also decided to undergo surgery on their other hand.
Researchers saw one mild and three moderate implant-related adverse events during the study, including one patient who experienced ulnar deviation and needed a new joint replacement, one who dislocated the implant of the little finger a few weeks after insertion, and one who experienced sepsis in the joints 6 years after insertion and needed replacements for two implants. The fracture incidence of about 10% fits into the mid-range of previously reported fracture rates with this implant.
The study experienced significant losses to follow-up, particularly in the surgical group in which 7-year data were only available for 43% of participants in this group. The authors suggested this could have been because the surgical patients achieved their goals and were less inclined to the follow-up visits.
The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. No conflicts of interest were declared.
Key clinical point:
Major finding: Patients who elected to undergo silicone MCP joint replacement showed significant improvements in ulnar drift and extensor lag, as well as in function, aesthetics, and satisfaction scores at 7 years after the procedure.
Data source: Cohort study of 170 patients with rheumatoid arthritis–related severe deformity at the metacarpophalangeal joints.
Disclosures: The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. No conflicts of interest were declared.