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Official Newspaper of the American College of Surgeons
Most kneecap pain can be managed conservatively
SEATTLE – In about 80% of patients, patellofemoral knee pain is due to muscular dysfunction and often responds to strengthening and other conservative measures, according to Dr. Christian Lattermann of the department of orthopedic surgery at the University of Kentucky, Lexington.
Surgery should be the last option, and "only if you have identified a structural or functional pathology that you can correct." When surgery is indicated, lateral releases should be avoided; lateral retinacular lengthening is the better option because it preserves the anatomical bridle that keeps the knee cap tracking properly. "Surgically, you can lengthen it by about 2 cm, and that’s usually enough," Dr. Lattermann said at the annual meeting of the American Orthopaedic Society for Sports Medicine.
Patellofemoral pain is common but also frustrating to treat. Finding the cause is difficult; whether it’s subluxation, instability, plica, tendinitis, or simply a noisy knee, "all of it will be described to you as pain. You need to figure it out," he said.
Injections might help. "If you inject them, and they have absolutely no pain," it suggests extraarticular issues. In those cases, "rehab is probably your first bet." Meanwhile, effusions hint at intraarticular pathology, he said.
"McConnell taping is an excellent tool, and will help make the surgical decision. If it’s truly effective," soft tissue realignment might be enough, he said.
"If you have a patient who tells you they have pain all the time everywhere, then think about deconditioning." After perhaps years of compensating for chronic knee problems, the musculature is weak – perhaps in both knees – and gait alterations are also likely. Patients "are basically slamming into their knee cap with every step. You have to start the process of getting them out of that," and it doesn’t involve surgery, at least at first, he said.
"Many of these patients are difficult to manage because as soon as you want to look at their knee, they start becoming apprehensive. It’s not because they are crazy, but because they’ve had experiences that were hard to deal with. You can often help them by talking and identifying those for them, and putting them into perspective," he said.
If they only have pain, "we essentially start with physical therapy," including strengthening and stretching the core, hip, and leg muscles. Even in patients with apprehension or instability, "I’d be very careful to try to identify muscular dysfunction. You always need to treat that," Dr. Lattermann said.
Runners and other athletes might get into problems by overdoing it, which can lead to chronic muscle fatigue and patella overload. For some, the root of the problem might be an odd gait or an odd way or running. "You need to basically teach these people how to move properly," he said.
In addition to MRI and CT to assess anatomy and biomechanics, bone scans might demonstrate a "hot spot that will help guide you." Also, when it’s an issue, weight is a "discussion that happens almost every time with every patient," he said.
Dr. Lattermann is a consultant for Ceterix, Icartilage, and Sanofi/Genzyme.
SEATTLE – In about 80% of patients, patellofemoral knee pain is due to muscular dysfunction and often responds to strengthening and other conservative measures, according to Dr. Christian Lattermann of the department of orthopedic surgery at the University of Kentucky, Lexington.
Surgery should be the last option, and "only if you have identified a structural or functional pathology that you can correct." When surgery is indicated, lateral releases should be avoided; lateral retinacular lengthening is the better option because it preserves the anatomical bridle that keeps the knee cap tracking properly. "Surgically, you can lengthen it by about 2 cm, and that’s usually enough," Dr. Lattermann said at the annual meeting of the American Orthopaedic Society for Sports Medicine.
Patellofemoral pain is common but also frustrating to treat. Finding the cause is difficult; whether it’s subluxation, instability, plica, tendinitis, or simply a noisy knee, "all of it will be described to you as pain. You need to figure it out," he said.
Injections might help. "If you inject them, and they have absolutely no pain," it suggests extraarticular issues. In those cases, "rehab is probably your first bet." Meanwhile, effusions hint at intraarticular pathology, he said.
"McConnell taping is an excellent tool, and will help make the surgical decision. If it’s truly effective," soft tissue realignment might be enough, he said.
"If you have a patient who tells you they have pain all the time everywhere, then think about deconditioning." After perhaps years of compensating for chronic knee problems, the musculature is weak – perhaps in both knees – and gait alterations are also likely. Patients "are basically slamming into their knee cap with every step. You have to start the process of getting them out of that," and it doesn’t involve surgery, at least at first, he said.
"Many of these patients are difficult to manage because as soon as you want to look at their knee, they start becoming apprehensive. It’s not because they are crazy, but because they’ve had experiences that were hard to deal with. You can often help them by talking and identifying those for them, and putting them into perspective," he said.
If they only have pain, "we essentially start with physical therapy," including strengthening and stretching the core, hip, and leg muscles. Even in patients with apprehension or instability, "I’d be very careful to try to identify muscular dysfunction. You always need to treat that," Dr. Lattermann said.
Runners and other athletes might get into problems by overdoing it, which can lead to chronic muscle fatigue and patella overload. For some, the root of the problem might be an odd gait or an odd way or running. "You need to basically teach these people how to move properly," he said.
In addition to MRI and CT to assess anatomy and biomechanics, bone scans might demonstrate a "hot spot that will help guide you." Also, when it’s an issue, weight is a "discussion that happens almost every time with every patient," he said.
Dr. Lattermann is a consultant for Ceterix, Icartilage, and Sanofi/Genzyme.
SEATTLE – In about 80% of patients, patellofemoral knee pain is due to muscular dysfunction and often responds to strengthening and other conservative measures, according to Dr. Christian Lattermann of the department of orthopedic surgery at the University of Kentucky, Lexington.
Surgery should be the last option, and "only if you have identified a structural or functional pathology that you can correct." When surgery is indicated, lateral releases should be avoided; lateral retinacular lengthening is the better option because it preserves the anatomical bridle that keeps the knee cap tracking properly. "Surgically, you can lengthen it by about 2 cm, and that’s usually enough," Dr. Lattermann said at the annual meeting of the American Orthopaedic Society for Sports Medicine.
Patellofemoral pain is common but also frustrating to treat. Finding the cause is difficult; whether it’s subluxation, instability, plica, tendinitis, or simply a noisy knee, "all of it will be described to you as pain. You need to figure it out," he said.
Injections might help. "If you inject them, and they have absolutely no pain," it suggests extraarticular issues. In those cases, "rehab is probably your first bet." Meanwhile, effusions hint at intraarticular pathology, he said.
"McConnell taping is an excellent tool, and will help make the surgical decision. If it’s truly effective," soft tissue realignment might be enough, he said.
"If you have a patient who tells you they have pain all the time everywhere, then think about deconditioning." After perhaps years of compensating for chronic knee problems, the musculature is weak – perhaps in both knees – and gait alterations are also likely. Patients "are basically slamming into their knee cap with every step. You have to start the process of getting them out of that," and it doesn’t involve surgery, at least at first, he said.
"Many of these patients are difficult to manage because as soon as you want to look at their knee, they start becoming apprehensive. It’s not because they are crazy, but because they’ve had experiences that were hard to deal with. You can often help them by talking and identifying those for them, and putting them into perspective," he said.
If they only have pain, "we essentially start with physical therapy," including strengthening and stretching the core, hip, and leg muscles. Even in patients with apprehension or instability, "I’d be very careful to try to identify muscular dysfunction. You always need to treat that," Dr. Lattermann said.
Runners and other athletes might get into problems by overdoing it, which can lead to chronic muscle fatigue and patella overload. For some, the root of the problem might be an odd gait or an odd way or running. "You need to basically teach these people how to move properly," he said.
In addition to MRI and CT to assess anatomy and biomechanics, bone scans might demonstrate a "hot spot that will help guide you." Also, when it’s an issue, weight is a "discussion that happens almost every time with every patient," he said.
Dr. Lattermann is a consultant for Ceterix, Icartilage, and Sanofi/Genzyme.
AT THE AOSSM 2014 ANNUAL MEETING
Prevention program led to steep drop in postop pneumonia cases
A quality improvement program cut postoperative pneumonia rates by 43.6%, investigators reported July 23 in JAMA Surgery.
The small, single-center retrospective cohort study is the first to present long-term findings for such a program, said Dr. Hadiza Kazaure at Stanford (Calif.) University and her associates.
The program, which investigators started at a Stanford-affiliated Veterans Affairs hospital, included coughing and deep-breathing exercises with incentive spirometry, a twice-daily oral chlorhexidine hygiene, ambulation with pain control, elevating the head of the bed by 30 degrees and sitting for meals, educating surgical nursing staff about their roles in preventing pneumonia, and automating physician orders for pneumonia prevention, the researchers said (JAMA Surg. 2014 July 23 [doi:10.1001/jamasurg.2014.1216]).
The investigators calculated postimplementation rates of ward-acquired pneumonia in all noncardiac, unventilated surgical patients in the 5 years after the program started, they said.
Among 4,099 hospitalized patients who were at risk, 18 (0.44%) developed postoperative pneumonia, a 43.6% drop from the preprogram rate of 0.78%, the investigators reported.
By comparison, the postintervention rate for the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) was 582% higher than that of the VA hospital for 2008-2012. By achieving the VA hospital program’s results, the hospitals in the ACS-NSQIP could save about $280 million, Dr. Kazaure and her associates said.
The database abstraction methods used to choose patients were validated, but nonetheless could have caused selection errors. Also, few patients developed pneumonia, which kept the investigators from tracking trends over time on the ward, they said. "Based on published data, we used a national average of $46,400 cost of care per postoperative pneumonia case to estimate potential cost savings in our analyses," they added. "The validity of cost estimates in this study to individual hospitals must be considered because geographic variation in cost of care is well established."
The authors reported no funding sources or conflicts of interest.
The "remarkably low" baseline rate of postoperative pneumonia "calls into question the adequacy of detection and reporting of pneumonia" on the surgical ward, making findings "of somewhat less consequence," Dr. Catherine Lewis said.
"Moreover, the authors’ program was implemented and evaluated over a period in which there was an ongoing shift from open to laparoscopic or robotic surgical techniques, which has been shown to significantly decrease the rates of postoperative pneumonia, particularly in colorectal and prostate operations," she said.
The authors did not examine whether changes in patient care or surgical technique affected postoperative pneumonia rates, Dr. Lewis noted. She pointed to other research showing that using a neuraxial blockade instead of general anesthesia led to a significant drop in postoperative pneumonia, as did using selective nasogastric decompression (Ann. Intern. Med. 2006;144:596-608).
Previously, the authors of the current study reported that postoperative non–ventilator-associated pneumonia rates did not change after they started their program, Dr. Lewis said. The number of ward cases decreased, but the number of non–ventilator-associated pneumonia intensive care unit cases increased, so the decrease could reflect redistribution in the location of patients, she said.
But the authors also deserved praise for developing and starting a relatively cost- and time-efficient quality improvement measure, Dr. Lewis added. She said that such programs could increase awareness and education among health care providers who care for patients after surgery.
Dr. Lewis specializes in general, critical care, and trauma surgery at the University of California, Los Angeles. The remarks were excerpted from her invited editorial accompanying Dr. Kazaure’s report (JAMA Surg. 2014 July 23 [doi:10.1001/jamasurg.2014.1249]).
The "remarkably low" baseline rate of postoperative pneumonia "calls into question the adequacy of detection and reporting of pneumonia" on the surgical ward, making findings "of somewhat less consequence," Dr. Catherine Lewis said.
"Moreover, the authors’ program was implemented and evaluated over a period in which there was an ongoing shift from open to laparoscopic or robotic surgical techniques, which has been shown to significantly decrease the rates of postoperative pneumonia, particularly in colorectal and prostate operations," she said.
The authors did not examine whether changes in patient care or surgical technique affected postoperative pneumonia rates, Dr. Lewis noted. She pointed to other research showing that using a neuraxial blockade instead of general anesthesia led to a significant drop in postoperative pneumonia, as did using selective nasogastric decompression (Ann. Intern. Med. 2006;144:596-608).
Previously, the authors of the current study reported that postoperative non–ventilator-associated pneumonia rates did not change after they started their program, Dr. Lewis said. The number of ward cases decreased, but the number of non–ventilator-associated pneumonia intensive care unit cases increased, so the decrease could reflect redistribution in the location of patients, she said.
But the authors also deserved praise for developing and starting a relatively cost- and time-efficient quality improvement measure, Dr. Lewis added. She said that such programs could increase awareness and education among health care providers who care for patients after surgery.
Dr. Lewis specializes in general, critical care, and trauma surgery at the University of California, Los Angeles. The remarks were excerpted from her invited editorial accompanying Dr. Kazaure’s report (JAMA Surg. 2014 July 23 [doi:10.1001/jamasurg.2014.1249]).
The "remarkably low" baseline rate of postoperative pneumonia "calls into question the adequacy of detection and reporting of pneumonia" on the surgical ward, making findings "of somewhat less consequence," Dr. Catherine Lewis said.
"Moreover, the authors’ program was implemented and evaluated over a period in which there was an ongoing shift from open to laparoscopic or robotic surgical techniques, which has been shown to significantly decrease the rates of postoperative pneumonia, particularly in colorectal and prostate operations," she said.
The authors did not examine whether changes in patient care or surgical technique affected postoperative pneumonia rates, Dr. Lewis noted. She pointed to other research showing that using a neuraxial blockade instead of general anesthesia led to a significant drop in postoperative pneumonia, as did using selective nasogastric decompression (Ann. Intern. Med. 2006;144:596-608).
Previously, the authors of the current study reported that postoperative non–ventilator-associated pneumonia rates did not change after they started their program, Dr. Lewis said. The number of ward cases decreased, but the number of non–ventilator-associated pneumonia intensive care unit cases increased, so the decrease could reflect redistribution in the location of patients, she said.
But the authors also deserved praise for developing and starting a relatively cost- and time-efficient quality improvement measure, Dr. Lewis added. She said that such programs could increase awareness and education among health care providers who care for patients after surgery.
Dr. Lewis specializes in general, critical care, and trauma surgery at the University of California, Los Angeles. The remarks were excerpted from her invited editorial accompanying Dr. Kazaure’s report (JAMA Surg. 2014 July 23 [doi:10.1001/jamasurg.2014.1249]).
A quality improvement program cut postoperative pneumonia rates by 43.6%, investigators reported July 23 in JAMA Surgery.
The small, single-center retrospective cohort study is the first to present long-term findings for such a program, said Dr. Hadiza Kazaure at Stanford (Calif.) University and her associates.
The program, which investigators started at a Stanford-affiliated Veterans Affairs hospital, included coughing and deep-breathing exercises with incentive spirometry, a twice-daily oral chlorhexidine hygiene, ambulation with pain control, elevating the head of the bed by 30 degrees and sitting for meals, educating surgical nursing staff about their roles in preventing pneumonia, and automating physician orders for pneumonia prevention, the researchers said (JAMA Surg. 2014 July 23 [doi:10.1001/jamasurg.2014.1216]).
The investigators calculated postimplementation rates of ward-acquired pneumonia in all noncardiac, unventilated surgical patients in the 5 years after the program started, they said.
Among 4,099 hospitalized patients who were at risk, 18 (0.44%) developed postoperative pneumonia, a 43.6% drop from the preprogram rate of 0.78%, the investigators reported.
By comparison, the postintervention rate for the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) was 582% higher than that of the VA hospital for 2008-2012. By achieving the VA hospital program’s results, the hospitals in the ACS-NSQIP could save about $280 million, Dr. Kazaure and her associates said.
The database abstraction methods used to choose patients were validated, but nonetheless could have caused selection errors. Also, few patients developed pneumonia, which kept the investigators from tracking trends over time on the ward, they said. "Based on published data, we used a national average of $46,400 cost of care per postoperative pneumonia case to estimate potential cost savings in our analyses," they added. "The validity of cost estimates in this study to individual hospitals must be considered because geographic variation in cost of care is well established."
The authors reported no funding sources or conflicts of interest.
A quality improvement program cut postoperative pneumonia rates by 43.6%, investigators reported July 23 in JAMA Surgery.
The small, single-center retrospective cohort study is the first to present long-term findings for such a program, said Dr. Hadiza Kazaure at Stanford (Calif.) University and her associates.
The program, which investigators started at a Stanford-affiliated Veterans Affairs hospital, included coughing and deep-breathing exercises with incentive spirometry, a twice-daily oral chlorhexidine hygiene, ambulation with pain control, elevating the head of the bed by 30 degrees and sitting for meals, educating surgical nursing staff about their roles in preventing pneumonia, and automating physician orders for pneumonia prevention, the researchers said (JAMA Surg. 2014 July 23 [doi:10.1001/jamasurg.2014.1216]).
The investigators calculated postimplementation rates of ward-acquired pneumonia in all noncardiac, unventilated surgical patients in the 5 years after the program started, they said.
Among 4,099 hospitalized patients who were at risk, 18 (0.44%) developed postoperative pneumonia, a 43.6% drop from the preprogram rate of 0.78%, the investigators reported.
By comparison, the postintervention rate for the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) was 582% higher than that of the VA hospital for 2008-2012. By achieving the VA hospital program’s results, the hospitals in the ACS-NSQIP could save about $280 million, Dr. Kazaure and her associates said.
The database abstraction methods used to choose patients were validated, but nonetheless could have caused selection errors. Also, few patients developed pneumonia, which kept the investigators from tracking trends over time on the ward, they said. "Based on published data, we used a national average of $46,400 cost of care per postoperative pneumonia case to estimate potential cost savings in our analyses," they added. "The validity of cost estimates in this study to individual hospitals must be considered because geographic variation in cost of care is well established."
The authors reported no funding sources or conflicts of interest.
FROM JAMA SURGERY
Key clinical point: Cost-effective quality improvement programs can potentially prevent postoperative pneumonia in unventilated patients.
Major finding: Among 4,099 hospitalized patients at risk between 2008 and 2012, 18 (0.44%) developed postoperative pneumonia, a 43.6% decrease from the preintervention rate of 0.78%.
Data source: Retrospective cohort study of all noncardiac surgical patients who acquired postoperative pneumonia on a Veterans Affairs hospital ward from 2008 to 2012.
Disclosures: The authors reported no funding sources or conflicts of interest.
ERAS program for colorectal surgery cut length of stay, costs in community setting
A hospital’s program to enhance recovery after colorectal surgery cut length of stay by 3 days and saved up to $4,800 per patient without increasing postoperative morbidity or 30-day readmission rates, investigators reported online July 23 in JAMA Surgery.
The study extends the evidence base for colorectal enhanced recovery after surgery (ERAS) programs to community hospital settings, said Dr. Cristina Geltzeiler of Oregon Health and Science University in Portland and her associates.
The investigators studied practice patterns and patient outcomes for 1 year before and 2 years after starting a colorectal ERAS program for 244 patients. The program featured preadmission patient education, preoperative bowel preparation for left-sided and rectal procedures, use of intrathecal spinal anesthetics, conservative fluid management, minimal use of narcotics, and early resumption of oral intake and ambulation after surgery, the researchers reported (JAMA Surg. 2014 July 23 [doi: 10.1001/jamasurg.2014.675]). Discharge criteria did not change, they noted.
After program implementation, use of laparoscopy increased by almost 30% (from 57.4% to 88.8%; P less than .001) and length of stay fell by 3 days (from 6.7 to 3.7 days; P less than .001), while 30-day readmission rates did not increase (17.6% vs. 12.5%), the investigators reported.
The percentage of patients who used postoperative narcotic analgesia also fell substantially (from 63.2% to 15%; P less than .001), as did duration of narcotic use (from 67.8 hours to 47.1 hours; P = .02), ileus (from 13.2% to 2.5% of patients; P = .02) and intra-abdominal infections (from 7.4% to 2.5% of patients; P = .24), the investigators said. Outcomes did not differ significantly for patients with colorectal cancer, they added.
"Development and implementation of the program required multidisciplinary collaboration among surgeons, nursing staff, anesthesia providers, pharmacists, operating room staff, clinics, and preadmission services," said Dr. Geltzeiler and her associates. To gain program buy-in, leaders organized discussions and presentations of published ERAS literature, and also used clear, consistent messaging about expectations for patients’ activity, diet, and pain management throughout the perioperative period, the researchers added.
A trend toward referring patients to a smaller pool of colorectal specialists during the study period could have affected results, the investigators noted. They added that rates of superficial wound infection were probably underreported because such infections tend to occur after discharge.
The authors reported no funding sources or conflicts of interest.
A hospital’s program to enhance recovery after colorectal surgery cut length of stay by 3 days and saved up to $4,800 per patient without increasing postoperative morbidity or 30-day readmission rates, investigators reported online July 23 in JAMA Surgery.
The study extends the evidence base for colorectal enhanced recovery after surgery (ERAS) programs to community hospital settings, said Dr. Cristina Geltzeiler of Oregon Health and Science University in Portland and her associates.
The investigators studied practice patterns and patient outcomes for 1 year before and 2 years after starting a colorectal ERAS program for 244 patients. The program featured preadmission patient education, preoperative bowel preparation for left-sided and rectal procedures, use of intrathecal spinal anesthetics, conservative fluid management, minimal use of narcotics, and early resumption of oral intake and ambulation after surgery, the researchers reported (JAMA Surg. 2014 July 23 [doi: 10.1001/jamasurg.2014.675]). Discharge criteria did not change, they noted.
After program implementation, use of laparoscopy increased by almost 30% (from 57.4% to 88.8%; P less than .001) and length of stay fell by 3 days (from 6.7 to 3.7 days; P less than .001), while 30-day readmission rates did not increase (17.6% vs. 12.5%), the investigators reported.
The percentage of patients who used postoperative narcotic analgesia also fell substantially (from 63.2% to 15%; P less than .001), as did duration of narcotic use (from 67.8 hours to 47.1 hours; P = .02), ileus (from 13.2% to 2.5% of patients; P = .02) and intra-abdominal infections (from 7.4% to 2.5% of patients; P = .24), the investigators said. Outcomes did not differ significantly for patients with colorectal cancer, they added.
"Development and implementation of the program required multidisciplinary collaboration among surgeons, nursing staff, anesthesia providers, pharmacists, operating room staff, clinics, and preadmission services," said Dr. Geltzeiler and her associates. To gain program buy-in, leaders organized discussions and presentations of published ERAS literature, and also used clear, consistent messaging about expectations for patients’ activity, diet, and pain management throughout the perioperative period, the researchers added.
A trend toward referring patients to a smaller pool of colorectal specialists during the study period could have affected results, the investigators noted. They added that rates of superficial wound infection were probably underreported because such infections tend to occur after discharge.
The authors reported no funding sources or conflicts of interest.
A hospital’s program to enhance recovery after colorectal surgery cut length of stay by 3 days and saved up to $4,800 per patient without increasing postoperative morbidity or 30-day readmission rates, investigators reported online July 23 in JAMA Surgery.
The study extends the evidence base for colorectal enhanced recovery after surgery (ERAS) programs to community hospital settings, said Dr. Cristina Geltzeiler of Oregon Health and Science University in Portland and her associates.
The investigators studied practice patterns and patient outcomes for 1 year before and 2 years after starting a colorectal ERAS program for 244 patients. The program featured preadmission patient education, preoperative bowel preparation for left-sided and rectal procedures, use of intrathecal spinal anesthetics, conservative fluid management, minimal use of narcotics, and early resumption of oral intake and ambulation after surgery, the researchers reported (JAMA Surg. 2014 July 23 [doi: 10.1001/jamasurg.2014.675]). Discharge criteria did not change, they noted.
After program implementation, use of laparoscopy increased by almost 30% (from 57.4% to 88.8%; P less than .001) and length of stay fell by 3 days (from 6.7 to 3.7 days; P less than .001), while 30-day readmission rates did not increase (17.6% vs. 12.5%), the investigators reported.
The percentage of patients who used postoperative narcotic analgesia also fell substantially (from 63.2% to 15%; P less than .001), as did duration of narcotic use (from 67.8 hours to 47.1 hours; P = .02), ileus (from 13.2% to 2.5% of patients; P = .02) and intra-abdominal infections (from 7.4% to 2.5% of patients; P = .24), the investigators said. Outcomes did not differ significantly for patients with colorectal cancer, they added.
"Development and implementation of the program required multidisciplinary collaboration among surgeons, nursing staff, anesthesia providers, pharmacists, operating room staff, clinics, and preadmission services," said Dr. Geltzeiler and her associates. To gain program buy-in, leaders organized discussions and presentations of published ERAS literature, and also used clear, consistent messaging about expectations for patients’ activity, diet, and pain management throughout the perioperative period, the researchers added.
A trend toward referring patients to a smaller pool of colorectal specialists during the study period could have affected results, the investigators noted. They added that rates of superficial wound infection were probably underreported because such infections tend to occur after discharge.
The authors reported no funding sources or conflicts of interest.
FROM JAMA SURGERY
Key clinical point: Enhanced recovery after surgery (ERAS) programs appear to be feasible for colorectal surgery patients in a community hospital setting.
Major finding: After program implementation, use of laparoscopy increased by almost 30% (from 57.4% to 88.8%; P less than .001) and length of stay fell by 3 days (from 6.7 to 3.7 days; P less than .001), while 30-day readmission rates did not increase (17.6% vs. 12.5%).
Data source: Prospective cohort study of 244 patients undergoing elective colorectal surgery before or after ERAS program implementation.
Disclosures: The authors reported no funding sources or conflicts of interest.
Surgery in an aging population
Men and women older than 65 years make up the fastest-growing portion of the U.S. population. By 2020, more than 16% of the American population is projected to be older than 65 years of age, according to projections by the U.S. Census.
As the population ages, an increasing proportion of our patients will be considered elderly (greater than 65 years), and up to 50% of surgeries will be performed in these patients. Perioperative mortality has decreased over the past 50 years in all patients, but elderly patients continue to have higher perioperative morbidity and mortality than their younger counterparts (Mt. Sinai J. Med. 2012;79:95-106). This increased morbidity is particularly relevant to gynecologists as 60% of the population older than 65 years is female. It is also important to note that 30-day mortality is higher in patients older than 80 years.
Significant risk factors in any surgical population include underlying cardiac and pulmonary disease, smoking, obesity, prior or current abdominal/thoracic surgery, and type of anesthesia (Prim. Care 1989;16:361-76).
Studies conflict on whether age alone is an independent risk factor for perioperative morbidity and mortality. Older patients tend to have more underlying diseases, thus placing them at increased risk for perioperative morbidity. Unfortunately, the presence of coexisting comorbidities does not alone account for poor outcomes. In one large population-based study, even healthy elderly patients continued to have higher morbidity and mortality. This is likely because elderly patients respond differently to perioperative physiologic stressors and pharmacologic interventions (Anesthesiology 2009;110:1176-81).
Organ function declines with age, but there is wide inter- and intraindividual variability in the rate of decline (Anesthesiology 2009;110:1176-81). Because of the potential for interpatient aging differences, gynecologists must assess each patient; chronologic age and biologic age can differ significantly (Semin. Perioper. Nurs. 1997;6:14-20). There are changes in pharmacokinetics and pharmacodynamics related to age and organ function changes. Alterations in kidney and liver function result in slower rates of drug metabolism, potentially increasing concentrations of medications in older patients. In addition to considering alterations in dosing, physicians must consider the possibility of increased or decreased sensitivities to medications resulting from alterations in pharmacodynamics.
Patients over 80 years old have increased perioperative morbidity and mortality. Respiratory and urinary tract complications are the most common, but cardiac complications are more severe in these patients (Mt. Sinai J. Med. 2012;79:95-106). Respiratory complications account for 40% of surgical complications and up to 20% of all surgery-related deaths. Respiratory morbidity is increased in patients who are under anesthesia for more than 3 hours or have abdominal and/or thoracic incisions (Can. Oper. Room Nurs. J. 2007;25:34-5, 37-41). Although less prevalent, cardiovascular complications can be devastating short term, accounting for 50% of postoperative mortality in the elderly. Complications increase with age, and 20% of patients older than 80 years experience at least one complication, which is particularly concerning given that the presence of one complication increases mortality sixfold.
In addition to being at greater risk for physical complications, elderly patients are at increased risk of experiencing psychological and neurologic complications in the postoperative period. Up to 15% of elderly patients can develop postoperative delirium, which is associated with longer hospital stays and other long-term consequences (Prim. Care 1989;16:361-76). Postoperative cognitive decline is a research finding of deterioration in neurocognitive testing that is also seen in elderly patients. Practically, this decline is manifested by a decreased ability to perform activities of daily living and instrumental activities of daily living. This decline may resolve over the first year postoperatively, and the incidence ranges from 5% to 15%. Patients older than 70 years are more likely to experience postoperative delirium and cognitive decline (Curr. Opin. Anaesthesiol. 2010;23:201-8).
As the population ages, gynecologists are going to face an increase in the number of women requiring surgical intervention for both benign and malignant indications. A thorough knowledge of the risks associated with this population is of the utmost importance so that we can appropriately counsel our patients and their families and take steps to minimize complications.
Dr. Hacker is a rising fourth-year resident in the department obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Gehrig is professor and director of gynecologic oncology at the university. Dr. Hacker and Dr. Gehrig said they had no relevant financial disclosures.
Men and women older than 65 years make up the fastest-growing portion of the U.S. population. By 2020, more than 16% of the American population is projected to be older than 65 years of age, according to projections by the U.S. Census.
As the population ages, an increasing proportion of our patients will be considered elderly (greater than 65 years), and up to 50% of surgeries will be performed in these patients. Perioperative mortality has decreased over the past 50 years in all patients, but elderly patients continue to have higher perioperative morbidity and mortality than their younger counterparts (Mt. Sinai J. Med. 2012;79:95-106). This increased morbidity is particularly relevant to gynecologists as 60% of the population older than 65 years is female. It is also important to note that 30-day mortality is higher in patients older than 80 years.
Significant risk factors in any surgical population include underlying cardiac and pulmonary disease, smoking, obesity, prior or current abdominal/thoracic surgery, and type of anesthesia (Prim. Care 1989;16:361-76).
Studies conflict on whether age alone is an independent risk factor for perioperative morbidity and mortality. Older patients tend to have more underlying diseases, thus placing them at increased risk for perioperative morbidity. Unfortunately, the presence of coexisting comorbidities does not alone account for poor outcomes. In one large population-based study, even healthy elderly patients continued to have higher morbidity and mortality. This is likely because elderly patients respond differently to perioperative physiologic stressors and pharmacologic interventions (Anesthesiology 2009;110:1176-81).
Organ function declines with age, but there is wide inter- and intraindividual variability in the rate of decline (Anesthesiology 2009;110:1176-81). Because of the potential for interpatient aging differences, gynecologists must assess each patient; chronologic age and biologic age can differ significantly (Semin. Perioper. Nurs. 1997;6:14-20). There are changes in pharmacokinetics and pharmacodynamics related to age and organ function changes. Alterations in kidney and liver function result in slower rates of drug metabolism, potentially increasing concentrations of medications in older patients. In addition to considering alterations in dosing, physicians must consider the possibility of increased or decreased sensitivities to medications resulting from alterations in pharmacodynamics.
Patients over 80 years old have increased perioperative morbidity and mortality. Respiratory and urinary tract complications are the most common, but cardiac complications are more severe in these patients (Mt. Sinai J. Med. 2012;79:95-106). Respiratory complications account for 40% of surgical complications and up to 20% of all surgery-related deaths. Respiratory morbidity is increased in patients who are under anesthesia for more than 3 hours or have abdominal and/or thoracic incisions (Can. Oper. Room Nurs. J. 2007;25:34-5, 37-41). Although less prevalent, cardiovascular complications can be devastating short term, accounting for 50% of postoperative mortality in the elderly. Complications increase with age, and 20% of patients older than 80 years experience at least one complication, which is particularly concerning given that the presence of one complication increases mortality sixfold.
In addition to being at greater risk for physical complications, elderly patients are at increased risk of experiencing psychological and neurologic complications in the postoperative period. Up to 15% of elderly patients can develop postoperative delirium, which is associated with longer hospital stays and other long-term consequences (Prim. Care 1989;16:361-76). Postoperative cognitive decline is a research finding of deterioration in neurocognitive testing that is also seen in elderly patients. Practically, this decline is manifested by a decreased ability to perform activities of daily living and instrumental activities of daily living. This decline may resolve over the first year postoperatively, and the incidence ranges from 5% to 15%. Patients older than 70 years are more likely to experience postoperative delirium and cognitive decline (Curr. Opin. Anaesthesiol. 2010;23:201-8).
As the population ages, gynecologists are going to face an increase in the number of women requiring surgical intervention for both benign and malignant indications. A thorough knowledge of the risks associated with this population is of the utmost importance so that we can appropriately counsel our patients and their families and take steps to minimize complications.
Dr. Hacker is a rising fourth-year resident in the department obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Gehrig is professor and director of gynecologic oncology at the university. Dr. Hacker and Dr. Gehrig said they had no relevant financial disclosures.
Men and women older than 65 years make up the fastest-growing portion of the U.S. population. By 2020, more than 16% of the American population is projected to be older than 65 years of age, according to projections by the U.S. Census.
As the population ages, an increasing proportion of our patients will be considered elderly (greater than 65 years), and up to 50% of surgeries will be performed in these patients. Perioperative mortality has decreased over the past 50 years in all patients, but elderly patients continue to have higher perioperative morbidity and mortality than their younger counterparts (Mt. Sinai J. Med. 2012;79:95-106). This increased morbidity is particularly relevant to gynecologists as 60% of the population older than 65 years is female. It is also important to note that 30-day mortality is higher in patients older than 80 years.
Significant risk factors in any surgical population include underlying cardiac and pulmonary disease, smoking, obesity, prior or current abdominal/thoracic surgery, and type of anesthesia (Prim. Care 1989;16:361-76).
Studies conflict on whether age alone is an independent risk factor for perioperative morbidity and mortality. Older patients tend to have more underlying diseases, thus placing them at increased risk for perioperative morbidity. Unfortunately, the presence of coexisting comorbidities does not alone account for poor outcomes. In one large population-based study, even healthy elderly patients continued to have higher morbidity and mortality. This is likely because elderly patients respond differently to perioperative physiologic stressors and pharmacologic interventions (Anesthesiology 2009;110:1176-81).
Organ function declines with age, but there is wide inter- and intraindividual variability in the rate of decline (Anesthesiology 2009;110:1176-81). Because of the potential for interpatient aging differences, gynecologists must assess each patient; chronologic age and biologic age can differ significantly (Semin. Perioper. Nurs. 1997;6:14-20). There are changes in pharmacokinetics and pharmacodynamics related to age and organ function changes. Alterations in kidney and liver function result in slower rates of drug metabolism, potentially increasing concentrations of medications in older patients. In addition to considering alterations in dosing, physicians must consider the possibility of increased or decreased sensitivities to medications resulting from alterations in pharmacodynamics.
Patients over 80 years old have increased perioperative morbidity and mortality. Respiratory and urinary tract complications are the most common, but cardiac complications are more severe in these patients (Mt. Sinai J. Med. 2012;79:95-106). Respiratory complications account for 40% of surgical complications and up to 20% of all surgery-related deaths. Respiratory morbidity is increased in patients who are under anesthesia for more than 3 hours or have abdominal and/or thoracic incisions (Can. Oper. Room Nurs. J. 2007;25:34-5, 37-41). Although less prevalent, cardiovascular complications can be devastating short term, accounting for 50% of postoperative mortality in the elderly. Complications increase with age, and 20% of patients older than 80 years experience at least one complication, which is particularly concerning given that the presence of one complication increases mortality sixfold.
In addition to being at greater risk for physical complications, elderly patients are at increased risk of experiencing psychological and neurologic complications in the postoperative period. Up to 15% of elderly patients can develop postoperative delirium, which is associated with longer hospital stays and other long-term consequences (Prim. Care 1989;16:361-76). Postoperative cognitive decline is a research finding of deterioration in neurocognitive testing that is also seen in elderly patients. Practically, this decline is manifested by a decreased ability to perform activities of daily living and instrumental activities of daily living. This decline may resolve over the first year postoperatively, and the incidence ranges from 5% to 15%. Patients older than 70 years are more likely to experience postoperative delirium and cognitive decline (Curr. Opin. Anaesthesiol. 2010;23:201-8).
As the population ages, gynecologists are going to face an increase in the number of women requiring surgical intervention for both benign and malignant indications. A thorough knowledge of the risks associated with this population is of the utmost importance so that we can appropriately counsel our patients and their families and take steps to minimize complications.
Dr. Hacker is a rising fourth-year resident in the department obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Gehrig is professor and director of gynecologic oncology at the university. Dr. Hacker and Dr. Gehrig said they had no relevant financial disclosures.
Conflicting rulings raise questions about legality of ACA premium subsidies
Two conflicting appeals court decisions issued July 22 seem to put the tax subsidies offered by the Affordable Care Act – and potentially, the entire law itself – on either shaky or firm legal footing, depending on who’s doing the analysis.
Both cases were originally brought by plaintiffs who contended that the Obama Administration did not have the legal authority to issue subsidies to low-income individuals who buy insurance on the federal marketplace. They said that the ACA explicitly said that credits were only available to "state-established exchanges." When lower courts ruled against them, they appealed.
The District of Columbia Circuit of the U.S. Court of Appeals sided with the plaintiffs in Halbig v. Burwell, 2-1. The 4th Circuit of the U.S. Court of Appeals, on the other hand, sided unanimously with the government in King v. Burwell.
An estimated 5 million people have received subsidies from the 36 federal marketplaces, putting them at risk for losing those tax credits. For the time being, however, people who have been deemed eligible for subsidies will continue to receive them. And those who sign up for insurance in the next open enrollment period beginning Nov. 15 will also likely get subsidies.
"This ruling does not have any practical impact on Americans’ ability to receive tax credits right now," White House spokesman Josh Earnest said about the ruling in Halbig v. Burwell. In a briefing after both decisions were handed down, Mr. Earnest also said that the administration would essentially appeal that ruling by seeking a decision by the full panel of 11 judges who sit on the D.C. Circuit.
"You don’t need a fancy legal degree to understand that Congress intended for every eligible American to have access to tax credits that would lower their health care costs," whether state or federal officials were running the marketplace, Mr. Earnest said.
The lead plaintiff in the case heard by the D.C. Circuit was brought by Jacqueline Halbig, a senior policy adviser in the Department of Health & Human Services under President George W. Bush. The two judges ruling for her and her coplaintiffs said that their reading of the ACA "plainly makes subsidies available only on exchanges established by the states." The "legislative record provides little indication one way or the other of congressional intent, but the statutory text does," they said, adding that the language in the law is "conclusive evidence of Congress’ intent."
They said they reached their conclusion "with reluctance," because "our ruling will likely have significant consequences both for the millions of individuals receiving tax credits through federal exchanges and for health insurance markets more broadly."
Judge Harry Edwards dissented. "This case is about appellants’ not-so-veiled attempt to gut the Patient Protection and Affordable Care Act." The argument that Congress only intended to pay subsidies on state exchanges as a way to encourage states to run their own exchanges "is nonsense, made up out of whole cloth."
Judge Edwards added, "There is no credible evidence in the record that Congress intended to condition subsidies on whether a state, as opposed to HHS, established the exchange. Nor is there credible evidence that any state even considered the possibility that its taxpayers would be denied subsidies if the state opted to allow HHS to establish an exchange on its behalf."
Those who support premium subsidies said they were dismayed by the D.C. Circuit’s ruling, but that it would not likely stand.
"Today’s decision represents the high-water mark for Affordable Care Act opponents, but the water will recede very quickly," said Ron Pollack, Executive Director of Families USA, in a statement.
The American Cancer Society, American Cancer Society Cancer Action Network, American Diabetes Association, and American Heart Association filed a joint statement saying that they believed the Halbig decision could be disastrous. "On behalf of the tens of millions of people nationwide who have experienced cancer, diabetes, heart disease, and stroke, we are deeply disappointed with the decision of the U.S. Court of Appeals for the D.C. Circuit, which denies premium tax credits that make health coverage more affordable to people who buy a plan in the federally facilitated marketplace," they said. But, they added that it would not likely be upheld.
Others who opposed the ACA and the subsidy scheme applauded the Halbig decision.
"The president has been spending money illegally, the court has ruled," said Michael Cannon, director of Health Policy Studies at the Washington, D.C.-based Cato Institute, in a briefing. An article by Mr. Cannon and economist Jonathan Adler led to the Halbig filing.
In a statement, Sen. Ted Cruz (R-Tex.), who filed a friend of the court brief in King v. Burwell, said that the D.C. Circuit’s decision "is a repudiation of Obamacare and all the lawlessness that has come with it."
The plaintiffs in King v. Burwell, however, were handed a setback by the 4th Circuit. The four individual plaintiffs, all of whom live in Virginia, which does not have a state-run exchange, did not want to be forced to buy health insurance, but said that if they didn’t, they’d be penalized. Since the ACA will give them a subsidy to buy coverage, they would be forced either to buy insurance or pay a penalty for not having coverage, they said.
They added that Congress said that only state-run marketplaces could receive federal subsidies.
The judges ruled against them, saying "we are not persuaded by the plaintiffs’ ‘coercion’ argument." They did say, however, that there was some confusion in the law. "We cannot discern whether Congress intended one way or another to make the tax credits available on HHS-facilitated exchanges," they wrote, adding that "the relevant statutory sections appear to conflict with one another, yielding different possible interpretations."
But in the end, the judges concluded that it was "clear that widely available tax credits are essential to fulfilling the Act’s primary goals and that Congress was aware of their importance when drafting the bill." Therefore, the Internal Revenue Service’s rule authorizing tax credits was "a permissible exercise of the agency’s discretion."
Mr. Cannon of the Cato Institute said that he views the 4th Circuit ruling as a kind of loss for the Obama administration because the judges said that the language in the ACA was ambiguous on the subsidies.
Families USA’s Ron Pollack, however, said that he thought the administration would ultimately prevail.
"As of today, eight judges – two federal district court judges and six appellate judges – have ruled on these challenges. Altogether, six judges have ruled that the cases should be dismissed, and only two have upheld plaintiffs’ claims," he said in a statement.
There are still more legal proceedings to be decided before there is a definitive answer on whether the subsidies – and the ACA itself – are legal. The full D.C. Circuit has to choose whether to hear the Halbig case, and the plaintiffs in the 4th Circuit could also ask for a hearing by the full panel of judges.
There are two additional major cases questioning the legality of the subsidies pending at the appeals court level.
One or all of the cases could be taken to the U.S. Supreme Court.
On Twitter @aliciaault
Two conflicting appeals court decisions issued July 22 seem to put the tax subsidies offered by the Affordable Care Act – and potentially, the entire law itself – on either shaky or firm legal footing, depending on who’s doing the analysis.
Both cases were originally brought by plaintiffs who contended that the Obama Administration did not have the legal authority to issue subsidies to low-income individuals who buy insurance on the federal marketplace. They said that the ACA explicitly said that credits were only available to "state-established exchanges." When lower courts ruled against them, they appealed.
The District of Columbia Circuit of the U.S. Court of Appeals sided with the plaintiffs in Halbig v. Burwell, 2-1. The 4th Circuit of the U.S. Court of Appeals, on the other hand, sided unanimously with the government in King v. Burwell.
An estimated 5 million people have received subsidies from the 36 federal marketplaces, putting them at risk for losing those tax credits. For the time being, however, people who have been deemed eligible for subsidies will continue to receive them. And those who sign up for insurance in the next open enrollment period beginning Nov. 15 will also likely get subsidies.
"This ruling does not have any practical impact on Americans’ ability to receive tax credits right now," White House spokesman Josh Earnest said about the ruling in Halbig v. Burwell. In a briefing after both decisions were handed down, Mr. Earnest also said that the administration would essentially appeal that ruling by seeking a decision by the full panel of 11 judges who sit on the D.C. Circuit.
"You don’t need a fancy legal degree to understand that Congress intended for every eligible American to have access to tax credits that would lower their health care costs," whether state or federal officials were running the marketplace, Mr. Earnest said.
The lead plaintiff in the case heard by the D.C. Circuit was brought by Jacqueline Halbig, a senior policy adviser in the Department of Health & Human Services under President George W. Bush. The two judges ruling for her and her coplaintiffs said that their reading of the ACA "plainly makes subsidies available only on exchanges established by the states." The "legislative record provides little indication one way or the other of congressional intent, but the statutory text does," they said, adding that the language in the law is "conclusive evidence of Congress’ intent."
They said they reached their conclusion "with reluctance," because "our ruling will likely have significant consequences both for the millions of individuals receiving tax credits through federal exchanges and for health insurance markets more broadly."
Judge Harry Edwards dissented. "This case is about appellants’ not-so-veiled attempt to gut the Patient Protection and Affordable Care Act." The argument that Congress only intended to pay subsidies on state exchanges as a way to encourage states to run their own exchanges "is nonsense, made up out of whole cloth."
Judge Edwards added, "There is no credible evidence in the record that Congress intended to condition subsidies on whether a state, as opposed to HHS, established the exchange. Nor is there credible evidence that any state even considered the possibility that its taxpayers would be denied subsidies if the state opted to allow HHS to establish an exchange on its behalf."
Those who support premium subsidies said they were dismayed by the D.C. Circuit’s ruling, but that it would not likely stand.
"Today’s decision represents the high-water mark for Affordable Care Act opponents, but the water will recede very quickly," said Ron Pollack, Executive Director of Families USA, in a statement.
The American Cancer Society, American Cancer Society Cancer Action Network, American Diabetes Association, and American Heart Association filed a joint statement saying that they believed the Halbig decision could be disastrous. "On behalf of the tens of millions of people nationwide who have experienced cancer, diabetes, heart disease, and stroke, we are deeply disappointed with the decision of the U.S. Court of Appeals for the D.C. Circuit, which denies premium tax credits that make health coverage more affordable to people who buy a plan in the federally facilitated marketplace," they said. But, they added that it would not likely be upheld.
Others who opposed the ACA and the subsidy scheme applauded the Halbig decision.
"The president has been spending money illegally, the court has ruled," said Michael Cannon, director of Health Policy Studies at the Washington, D.C.-based Cato Institute, in a briefing. An article by Mr. Cannon and economist Jonathan Adler led to the Halbig filing.
In a statement, Sen. Ted Cruz (R-Tex.), who filed a friend of the court brief in King v. Burwell, said that the D.C. Circuit’s decision "is a repudiation of Obamacare and all the lawlessness that has come with it."
The plaintiffs in King v. Burwell, however, were handed a setback by the 4th Circuit. The four individual plaintiffs, all of whom live in Virginia, which does not have a state-run exchange, did not want to be forced to buy health insurance, but said that if they didn’t, they’d be penalized. Since the ACA will give them a subsidy to buy coverage, they would be forced either to buy insurance or pay a penalty for not having coverage, they said.
They added that Congress said that only state-run marketplaces could receive federal subsidies.
The judges ruled against them, saying "we are not persuaded by the plaintiffs’ ‘coercion’ argument." They did say, however, that there was some confusion in the law. "We cannot discern whether Congress intended one way or another to make the tax credits available on HHS-facilitated exchanges," they wrote, adding that "the relevant statutory sections appear to conflict with one another, yielding different possible interpretations."
But in the end, the judges concluded that it was "clear that widely available tax credits are essential to fulfilling the Act’s primary goals and that Congress was aware of their importance when drafting the bill." Therefore, the Internal Revenue Service’s rule authorizing tax credits was "a permissible exercise of the agency’s discretion."
Mr. Cannon of the Cato Institute said that he views the 4th Circuit ruling as a kind of loss for the Obama administration because the judges said that the language in the ACA was ambiguous on the subsidies.
Families USA’s Ron Pollack, however, said that he thought the administration would ultimately prevail.
"As of today, eight judges – two federal district court judges and six appellate judges – have ruled on these challenges. Altogether, six judges have ruled that the cases should be dismissed, and only two have upheld plaintiffs’ claims," he said in a statement.
There are still more legal proceedings to be decided before there is a definitive answer on whether the subsidies – and the ACA itself – are legal. The full D.C. Circuit has to choose whether to hear the Halbig case, and the plaintiffs in the 4th Circuit could also ask for a hearing by the full panel of judges.
There are two additional major cases questioning the legality of the subsidies pending at the appeals court level.
One or all of the cases could be taken to the U.S. Supreme Court.
On Twitter @aliciaault
Two conflicting appeals court decisions issued July 22 seem to put the tax subsidies offered by the Affordable Care Act – and potentially, the entire law itself – on either shaky or firm legal footing, depending on who’s doing the analysis.
Both cases were originally brought by plaintiffs who contended that the Obama Administration did not have the legal authority to issue subsidies to low-income individuals who buy insurance on the federal marketplace. They said that the ACA explicitly said that credits were only available to "state-established exchanges." When lower courts ruled against them, they appealed.
The District of Columbia Circuit of the U.S. Court of Appeals sided with the plaintiffs in Halbig v. Burwell, 2-1. The 4th Circuit of the U.S. Court of Appeals, on the other hand, sided unanimously with the government in King v. Burwell.
An estimated 5 million people have received subsidies from the 36 federal marketplaces, putting them at risk for losing those tax credits. For the time being, however, people who have been deemed eligible for subsidies will continue to receive them. And those who sign up for insurance in the next open enrollment period beginning Nov. 15 will also likely get subsidies.
"This ruling does not have any practical impact on Americans’ ability to receive tax credits right now," White House spokesman Josh Earnest said about the ruling in Halbig v. Burwell. In a briefing after both decisions were handed down, Mr. Earnest also said that the administration would essentially appeal that ruling by seeking a decision by the full panel of 11 judges who sit on the D.C. Circuit.
"You don’t need a fancy legal degree to understand that Congress intended for every eligible American to have access to tax credits that would lower their health care costs," whether state or federal officials were running the marketplace, Mr. Earnest said.
The lead plaintiff in the case heard by the D.C. Circuit was brought by Jacqueline Halbig, a senior policy adviser in the Department of Health & Human Services under President George W. Bush. The two judges ruling for her and her coplaintiffs said that their reading of the ACA "plainly makes subsidies available only on exchanges established by the states." The "legislative record provides little indication one way or the other of congressional intent, but the statutory text does," they said, adding that the language in the law is "conclusive evidence of Congress’ intent."
They said they reached their conclusion "with reluctance," because "our ruling will likely have significant consequences both for the millions of individuals receiving tax credits through federal exchanges and for health insurance markets more broadly."
Judge Harry Edwards dissented. "This case is about appellants’ not-so-veiled attempt to gut the Patient Protection and Affordable Care Act." The argument that Congress only intended to pay subsidies on state exchanges as a way to encourage states to run their own exchanges "is nonsense, made up out of whole cloth."
Judge Edwards added, "There is no credible evidence in the record that Congress intended to condition subsidies on whether a state, as opposed to HHS, established the exchange. Nor is there credible evidence that any state even considered the possibility that its taxpayers would be denied subsidies if the state opted to allow HHS to establish an exchange on its behalf."
Those who support premium subsidies said they were dismayed by the D.C. Circuit’s ruling, but that it would not likely stand.
"Today’s decision represents the high-water mark for Affordable Care Act opponents, but the water will recede very quickly," said Ron Pollack, Executive Director of Families USA, in a statement.
The American Cancer Society, American Cancer Society Cancer Action Network, American Diabetes Association, and American Heart Association filed a joint statement saying that they believed the Halbig decision could be disastrous. "On behalf of the tens of millions of people nationwide who have experienced cancer, diabetes, heart disease, and stroke, we are deeply disappointed with the decision of the U.S. Court of Appeals for the D.C. Circuit, which denies premium tax credits that make health coverage more affordable to people who buy a plan in the federally facilitated marketplace," they said. But, they added that it would not likely be upheld.
Others who opposed the ACA and the subsidy scheme applauded the Halbig decision.
"The president has been spending money illegally, the court has ruled," said Michael Cannon, director of Health Policy Studies at the Washington, D.C.-based Cato Institute, in a briefing. An article by Mr. Cannon and economist Jonathan Adler led to the Halbig filing.
In a statement, Sen. Ted Cruz (R-Tex.), who filed a friend of the court brief in King v. Burwell, said that the D.C. Circuit’s decision "is a repudiation of Obamacare and all the lawlessness that has come with it."
The plaintiffs in King v. Burwell, however, were handed a setback by the 4th Circuit. The four individual plaintiffs, all of whom live in Virginia, which does not have a state-run exchange, did not want to be forced to buy health insurance, but said that if they didn’t, they’d be penalized. Since the ACA will give them a subsidy to buy coverage, they would be forced either to buy insurance or pay a penalty for not having coverage, they said.
They added that Congress said that only state-run marketplaces could receive federal subsidies.
The judges ruled against them, saying "we are not persuaded by the plaintiffs’ ‘coercion’ argument." They did say, however, that there was some confusion in the law. "We cannot discern whether Congress intended one way or another to make the tax credits available on HHS-facilitated exchanges," they wrote, adding that "the relevant statutory sections appear to conflict with one another, yielding different possible interpretations."
But in the end, the judges concluded that it was "clear that widely available tax credits are essential to fulfilling the Act’s primary goals and that Congress was aware of their importance when drafting the bill." Therefore, the Internal Revenue Service’s rule authorizing tax credits was "a permissible exercise of the agency’s discretion."
Mr. Cannon of the Cato Institute said that he views the 4th Circuit ruling as a kind of loss for the Obama administration because the judges said that the language in the ACA was ambiguous on the subsidies.
Families USA’s Ron Pollack, however, said that he thought the administration would ultimately prevail.
"As of today, eight judges – two federal district court judges and six appellate judges – have ruled on these challenges. Altogether, six judges have ruled that the cases should be dismissed, and only two have upheld plaintiffs’ claims," he said in a statement.
There are still more legal proceedings to be decided before there is a definitive answer on whether the subsidies – and the ACA itself – are legal. The full D.C. Circuit has to choose whether to hear the Halbig case, and the plaintiffs in the 4th Circuit could also ask for a hearing by the full panel of judges.
There are two additional major cases questioning the legality of the subsidies pending at the appeals court level.
One or all of the cases could be taken to the U.S. Supreme Court.
On Twitter @aliciaault
Judges reveal secrets to successful malpractice trials
When it comes to the outcome of a medical malpractice jury trial, a physician’s attitude, demeanor, and presentation make all the difference, say judges who’ve presided over many such cases.
"The fact finder has to look at them and find them credible and sincere when they’re hearing their story," said Lorenzo F. Garcia, chief magistrate judge emeritus for the U.S. District Court for the District of New Mexico. "There’s truth and there’s perception, and perception can trump the truth. In litigation, being right isn’t always good enough. You can be right in a claim or right in a defense and still lose if the fact finder doesn’t believe the testimony or dislikes a person, witness, or an attorney."
Exhibiting arrogance or defensiveness when testifying can quickly sway a jury against a defendant doctor, adds Judge Garcia, who provided trial insight with several other judges at the American Conference Institute’s obstetric malpractice claims forum. When taking the stand, it helps to remain respectful at all times, refrain from acting combative, and demonstrate concern when discussing patients who were injured, he said.
Physicians should also be aware of how their attorneys are presenting themselves and interacting with legal parties. Being rude to judges, litigants, or attorneys can have a negative impact on jurors’ view of that particular side, said Sandra Mazer Moss, a retired Philadelphia Court of Common Pleas judge.
Doctors have a critical role in helping court participants understand the medicine surrounding a case, notes Judge Mazer Moss, who also spoke at the ACI conference. This includes properly preparing attorneys to speak about medical events and ensuring jurors clearly understand medical facts.
Health providers "can help explain procedures so that attorneys can understand and relay the information," she noted. "When you put a witness on the stand, they have to [clearly] explain how the procedure was done. It would help if the doctor had physical aids, PowerPoint [slides], or models."
However, Judge Garcia stresses that physicians and their attorneys shouldn’t overly rely on technology during a trial. He has presided over medical malpractice cases in which electronic equipment failed and caused long delays, he said. In some cases, the technology problems prevented plaintiffs or defendants from effectively presenting their arguments.
"To start a trial in such a fashion and see that jurors are not happy and that time is going by; there’s a valuable lesson" there, he said. "Make sure you practice and try the technology ahead of time. [Technology] can be exceedingly effective, or it can be a disaster if it doesn’t work well."
Another contributor to a successful malpractice case is the ability to tell a powerful story, Judge Garcia said. In his experience, litigants who choose a central theme and weave that idea throughout the trial are most effective. For example, the defense may open the trial by emphasizing that the case is about a patient’s bad luck, not bad medicine, and coming back to that point throughout the proceedings.
"Quite frankly, that’s what jurors like to hear," he said. "They want to hear a story, so part of the preparation is trying to find the most important [piece] of the litigation and developing a story that can be a recurring theme. The development of a theme is one of the most significant tasks parties can engage in, and it assists in the presentation of the claim or the defense."
When it comes to the outcome of a medical malpractice jury trial, a physician’s attitude, demeanor, and presentation make all the difference, say judges who’ve presided over many such cases.
"The fact finder has to look at them and find them credible and sincere when they’re hearing their story," said Lorenzo F. Garcia, chief magistrate judge emeritus for the U.S. District Court for the District of New Mexico. "There’s truth and there’s perception, and perception can trump the truth. In litigation, being right isn’t always good enough. You can be right in a claim or right in a defense and still lose if the fact finder doesn’t believe the testimony or dislikes a person, witness, or an attorney."
Exhibiting arrogance or defensiveness when testifying can quickly sway a jury against a defendant doctor, adds Judge Garcia, who provided trial insight with several other judges at the American Conference Institute’s obstetric malpractice claims forum. When taking the stand, it helps to remain respectful at all times, refrain from acting combative, and demonstrate concern when discussing patients who were injured, he said.
Physicians should also be aware of how their attorneys are presenting themselves and interacting with legal parties. Being rude to judges, litigants, or attorneys can have a negative impact on jurors’ view of that particular side, said Sandra Mazer Moss, a retired Philadelphia Court of Common Pleas judge.
Doctors have a critical role in helping court participants understand the medicine surrounding a case, notes Judge Mazer Moss, who also spoke at the ACI conference. This includes properly preparing attorneys to speak about medical events and ensuring jurors clearly understand medical facts.
Health providers "can help explain procedures so that attorneys can understand and relay the information," she noted. "When you put a witness on the stand, they have to [clearly] explain how the procedure was done. It would help if the doctor had physical aids, PowerPoint [slides], or models."
However, Judge Garcia stresses that physicians and their attorneys shouldn’t overly rely on technology during a trial. He has presided over medical malpractice cases in which electronic equipment failed and caused long delays, he said. In some cases, the technology problems prevented plaintiffs or defendants from effectively presenting their arguments.
"To start a trial in such a fashion and see that jurors are not happy and that time is going by; there’s a valuable lesson" there, he said. "Make sure you practice and try the technology ahead of time. [Technology] can be exceedingly effective, or it can be a disaster if it doesn’t work well."
Another contributor to a successful malpractice case is the ability to tell a powerful story, Judge Garcia said. In his experience, litigants who choose a central theme and weave that idea throughout the trial are most effective. For example, the defense may open the trial by emphasizing that the case is about a patient’s bad luck, not bad medicine, and coming back to that point throughout the proceedings.
"Quite frankly, that’s what jurors like to hear," he said. "They want to hear a story, so part of the preparation is trying to find the most important [piece] of the litigation and developing a story that can be a recurring theme. The development of a theme is one of the most significant tasks parties can engage in, and it assists in the presentation of the claim or the defense."
When it comes to the outcome of a medical malpractice jury trial, a physician’s attitude, demeanor, and presentation make all the difference, say judges who’ve presided over many such cases.
"The fact finder has to look at them and find them credible and sincere when they’re hearing their story," said Lorenzo F. Garcia, chief magistrate judge emeritus for the U.S. District Court for the District of New Mexico. "There’s truth and there’s perception, and perception can trump the truth. In litigation, being right isn’t always good enough. You can be right in a claim or right in a defense and still lose if the fact finder doesn’t believe the testimony or dislikes a person, witness, or an attorney."
Exhibiting arrogance or defensiveness when testifying can quickly sway a jury against a defendant doctor, adds Judge Garcia, who provided trial insight with several other judges at the American Conference Institute’s obstetric malpractice claims forum. When taking the stand, it helps to remain respectful at all times, refrain from acting combative, and demonstrate concern when discussing patients who were injured, he said.
Physicians should also be aware of how their attorneys are presenting themselves and interacting with legal parties. Being rude to judges, litigants, or attorneys can have a negative impact on jurors’ view of that particular side, said Sandra Mazer Moss, a retired Philadelphia Court of Common Pleas judge.
Doctors have a critical role in helping court participants understand the medicine surrounding a case, notes Judge Mazer Moss, who also spoke at the ACI conference. This includes properly preparing attorneys to speak about medical events and ensuring jurors clearly understand medical facts.
Health providers "can help explain procedures so that attorneys can understand and relay the information," she noted. "When you put a witness on the stand, they have to [clearly] explain how the procedure was done. It would help if the doctor had physical aids, PowerPoint [slides], or models."
However, Judge Garcia stresses that physicians and their attorneys shouldn’t overly rely on technology during a trial. He has presided over medical malpractice cases in which electronic equipment failed and caused long delays, he said. In some cases, the technology problems prevented plaintiffs or defendants from effectively presenting their arguments.
"To start a trial in such a fashion and see that jurors are not happy and that time is going by; there’s a valuable lesson" there, he said. "Make sure you practice and try the technology ahead of time. [Technology] can be exceedingly effective, or it can be a disaster if it doesn’t work well."
Another contributor to a successful malpractice case is the ability to tell a powerful story, Judge Garcia said. In his experience, litigants who choose a central theme and weave that idea throughout the trial are most effective. For example, the defense may open the trial by emphasizing that the case is about a patient’s bad luck, not bad medicine, and coming back to that point throughout the proceedings.
"Quite frankly, that’s what jurors like to hear," he said. "They want to hear a story, so part of the preparation is trying to find the most important [piece] of the litigation and developing a story that can be a recurring theme. The development of a theme is one of the most significant tasks parties can engage in, and it assists in the presentation of the claim or the defense."
Judges reveal secrets to successful malpractice trials
When it comes to the outcome of a medical malpractice jury trial, a physician’s attitude, demeanor, and presentation make all the difference, say judges who’ve presided over many such cases.
"The fact finder has to look at them and find them credible and sincere when they’re hearing their story," said Lorenzo F. Garcia, chief magistrate judge emeritus for the U.S. District Court for the District of New Mexico. "There’s truth and there’s perception, and perception can trump the truth. In litigation, being right isn’t always good enough. You can be right in a claim or right in a defense and still lose if the fact finder doesn’t believe the testimony or dislikes a person, witness, or an attorney."
Exhibiting arrogance or defensiveness when testifying can quickly sway a jury against a defendant doctor, adds Judge Garcia, who provided trial insight with several other judges at the American Conference Institute’s obstetric malpractice claims forum. When taking the stand, it helps to remain respectful at all times, refrain from acting combative, and demonstrate concern when discussing patients who were injured, he said.
Physicians should also be aware of how their attorneys are presenting themselves and interacting with legal parties. Being rude to judges, litigants, or attorneys can have a negative impact on jurors’ view of that particular side, said Sandra Mazer Moss, a retired Philadelphia Court of Common Pleas judge.
Doctors have a critical role in helping court participants understand the medicine surrounding a case, notes Judge Mazer Moss, who also spoke at the ACI conference. This includes properly preparing attorneys to speak about medical events and ensuring jurors clearly understand medical facts.
Health providers "can help explain procedures so that attorneys can understand and relay the information," she noted. "When you put a witness on the stand, they have to [clearly] explain how the procedure was done. It would help if the doctor had physical aids, PowerPoint [slides], or models."
However, Judge Garcia stresses that physicians and their attorneys shouldn’t overly rely on technology during a trial. He has presided over medical malpractice cases in which electronic equipment failed and caused long delays, he said. In some cases, the technology problems prevented plaintiffs or defendants from effectively presenting their arguments.
"To start a trial in such a fashion and see that jurors are not happy and that time is going by; there’s a valuable lesson" there, he said. "Make sure you practice and try the technology ahead of time. [Technology] can be exceedingly effective, or it can be a disaster if it doesn’t work well."
Another contributor to a successful malpractice case is the ability to tell a powerful story, Judge Garcia said. In his experience, litigants who choose a central theme and weave that idea throughout the trial are most effective. For example, the defense may open the trial by emphasizing that the case is about a patient’s bad luck, not bad medicine, and coming back to that point throughout the proceedings.
"Quite frankly, that’s what jurors like to hear," he said. "They want to hear a story, so part of the preparation is trying to find the most important [piece] of the litigation and developing a story that can be a recurring theme. The development of a theme is one of the most significant tasks parties can engage in, and it assists in the presentation of the claim or the defense."
When it comes to the outcome of a medical malpractice jury trial, a physician’s attitude, demeanor, and presentation make all the difference, say judges who’ve presided over many such cases.
"The fact finder has to look at them and find them credible and sincere when they’re hearing their story," said Lorenzo F. Garcia, chief magistrate judge emeritus for the U.S. District Court for the District of New Mexico. "There’s truth and there’s perception, and perception can trump the truth. In litigation, being right isn’t always good enough. You can be right in a claim or right in a defense and still lose if the fact finder doesn’t believe the testimony or dislikes a person, witness, or an attorney."
Exhibiting arrogance or defensiveness when testifying can quickly sway a jury against a defendant doctor, adds Judge Garcia, who provided trial insight with several other judges at the American Conference Institute’s obstetric malpractice claims forum. When taking the stand, it helps to remain respectful at all times, refrain from acting combative, and demonstrate concern when discussing patients who were injured, he said.
Physicians should also be aware of how their attorneys are presenting themselves and interacting with legal parties. Being rude to judges, litigants, or attorneys can have a negative impact on jurors’ view of that particular side, said Sandra Mazer Moss, a retired Philadelphia Court of Common Pleas judge.
Doctors have a critical role in helping court participants understand the medicine surrounding a case, notes Judge Mazer Moss, who also spoke at the ACI conference. This includes properly preparing attorneys to speak about medical events and ensuring jurors clearly understand medical facts.
Health providers "can help explain procedures so that attorneys can understand and relay the information," she noted. "When you put a witness on the stand, they have to [clearly] explain how the procedure was done. It would help if the doctor had physical aids, PowerPoint [slides], or models."
However, Judge Garcia stresses that physicians and their attorneys shouldn’t overly rely on technology during a trial. He has presided over medical malpractice cases in which electronic equipment failed and caused long delays, he said. In some cases, the technology problems prevented plaintiffs or defendants from effectively presenting their arguments.
"To start a trial in such a fashion and see that jurors are not happy and that time is going by; there’s a valuable lesson" there, he said. "Make sure you practice and try the technology ahead of time. [Technology] can be exceedingly effective, or it can be a disaster if it doesn’t work well."
Another contributor to a successful malpractice case is the ability to tell a powerful story, Judge Garcia said. In his experience, litigants who choose a central theme and weave that idea throughout the trial are most effective. For example, the defense may open the trial by emphasizing that the case is about a patient’s bad luck, not bad medicine, and coming back to that point throughout the proceedings.
"Quite frankly, that’s what jurors like to hear," he said. "They want to hear a story, so part of the preparation is trying to find the most important [piece] of the litigation and developing a story that can be a recurring theme. The development of a theme is one of the most significant tasks parties can engage in, and it assists in the presentation of the claim or the defense."
When it comes to the outcome of a medical malpractice jury trial, a physician’s attitude, demeanor, and presentation make all the difference, say judges who’ve presided over many such cases.
"The fact finder has to look at them and find them credible and sincere when they’re hearing their story," said Lorenzo F. Garcia, chief magistrate judge emeritus for the U.S. District Court for the District of New Mexico. "There’s truth and there’s perception, and perception can trump the truth. In litigation, being right isn’t always good enough. You can be right in a claim or right in a defense and still lose if the fact finder doesn’t believe the testimony or dislikes a person, witness, or an attorney."
Exhibiting arrogance or defensiveness when testifying can quickly sway a jury against a defendant doctor, adds Judge Garcia, who provided trial insight with several other judges at the American Conference Institute’s obstetric malpractice claims forum. When taking the stand, it helps to remain respectful at all times, refrain from acting combative, and demonstrate concern when discussing patients who were injured, he said.
Physicians should also be aware of how their attorneys are presenting themselves and interacting with legal parties. Being rude to judges, litigants, or attorneys can have a negative impact on jurors’ view of that particular side, said Sandra Mazer Moss, a retired Philadelphia Court of Common Pleas judge.
Doctors have a critical role in helping court participants understand the medicine surrounding a case, notes Judge Mazer Moss, who also spoke at the ACI conference. This includes properly preparing attorneys to speak about medical events and ensuring jurors clearly understand medical facts.
Health providers "can help explain procedures so that attorneys can understand and relay the information," she noted. "When you put a witness on the stand, they have to [clearly] explain how the procedure was done. It would help if the doctor had physical aids, PowerPoint [slides], or models."
However, Judge Garcia stresses that physicians and their attorneys shouldn’t overly rely on technology during a trial. He has presided over medical malpractice cases in which electronic equipment failed and caused long delays, he said. In some cases, the technology problems prevented plaintiffs or defendants from effectively presenting their arguments.
"To start a trial in such a fashion and see that jurors are not happy and that time is going by; there’s a valuable lesson" there, he said. "Make sure you practice and try the technology ahead of time. [Technology] can be exceedingly effective, or it can be a disaster if it doesn’t work well."
Another contributor to a successful malpractice case is the ability to tell a powerful story, Judge Garcia said. In his experience, litigants who choose a central theme and weave that idea throughout the trial are most effective. For example, the defense may open the trial by emphasizing that the case is about a patient’s bad luck, not bad medicine, and coming back to that point throughout the proceedings.
"Quite frankly, that’s what jurors like to hear," he said. "They want to hear a story, so part of the preparation is trying to find the most important [piece] of the litigation and developing a story that can be a recurring theme. The development of a theme is one of the most significant tasks parties can engage in, and it assists in the presentation of the claim or the defense."
Study provides cancer risk estimates among women undergoing morcellation
An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.
The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.
But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.
Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.
The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)
Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."
One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."
The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.
The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.
"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."
Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.
The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.
"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.
"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.
On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.
The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.
The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.
An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.
The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.
But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.
Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.
The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)
Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."
One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."
The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.
The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.
"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."
Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.
The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.
"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.
"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.
On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.
The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.
The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.
An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.
The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.
But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.
Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.
The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)
Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."
One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."
The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.
The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.
"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."
Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.
The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.
"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.
"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.
On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.
The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.
The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.
FROM JAMA
Key clinical point: A study that provides an estimate of malignancies specifically among women undergoing morcellation and minimally invasive hysterectomy provides valuable information on the risk overall, and risk stratified by age, that can be used in patient counseling.
Major finding: The prevalence of uterine cancer among women who underwent morcellation and a minimally invasive hysterectomy was 27/10,000 – about 1 in 370 women – a risk that significantly increased with age.
Data source: The study identified women who had a minimally invasive hysterectomy with morcellation from 2006 to 2012 in a national insurance database of over 500 hospitals, representing about 15% of hospitalizations.
Disclosures: The authors had no disclosures. Dr. Wright and one of the other authors are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.
Study provides cancer risk estimates among women undergoing morcellation
An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.
The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.
But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.
Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.
The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)
Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."
One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."
The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.
The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.
"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."
Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.
The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.
"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.
"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.
On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.
The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.
The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.
An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.
The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.
But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.
Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.
The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)
Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."
One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."
The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.
The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.
"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."
Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.
The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.
"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.
"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.
On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.
The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.
The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.
An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.
The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.
But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.
Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.
The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)
Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."
One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."
The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.
The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.
"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."
Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.
The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.
"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.
"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.
On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.
The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.
The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.
FROM JAMA
Key clinical point: A study that provides an estimate of malignancies specifically among women undergoing morcellation and minimally invasive hysterectomy provides valuable information on the risk overall, and risk stratified by age, that can be used in patient counseling.
Major finding: The prevalence of uterine cancer among women who underwent morcellation and a minimally invasive hysterectomy was 27/10,000 – about 1 in 370 women – a risk that significantly increased with age.
Data source: The study identified women who had a minimally invasive hysterectomy with morcellation from 2006 to 2012 in a national insurance database of over 500 hospitals, representing about 15% of hospitalizations.
Disclosures: The authors had no disclosures. Dr. Wright and one of the other authors are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.
Risks scream caution for catheter-directed thrombolysis for proximal DVT
Catheter-directed thrombolysis plus anticoagulation is no more effective than anticoagulation alone in preventing in-hospital death among adults who have lower-extremity proximal deep vein thrombosis, according to a nationwide observational study reported online July 21 in JAMA Internal Medicine.
However, catheter-directed thrombolysis carries higher risks, particularly serious bleeding risks such as intracranial hemorrhage, than does anticoagulation alone, and it costs nearly three times as much money. These findings highlight the need for randomized trials "to evaluate the magnitude of the effect of catheter-directed thrombolysis on ... mortality, postthrombotic syndrome, and recurrence of DVT [deep vein thrombosis]. In the absence of such data, it may be reasonable to restrict this form of therapy to those patients who have a low bleeding risk and a high risk for postthrombotic syndrome, such as patients with iliofemoral DVT," said Dr. Riyaz Bashir of the division of cardiovascular diseases, Temple University, Philadelphia, and his associates.
Conflicting data from several small studies as to the safety and effectiveness of catheter-directed thrombolysis have led professional societies to devise conflicting recommendations for its use: the American College of Chest Physicians advises against using the procedure, while the American Heart Association recommends it as a first-line therapy for certain patients. "We sought to assess real-world comparative-safety outcomes in patients proximal and caval DVT who underwent catheter-directed thrombolysis plus anticoagulation with a group treated with anticoagulation alone using risk-adjusted propensity-score matching," the investigators said.
They analyzed data from an Agency for Healthcare Research and Quality administrative database of patient discharges from approximately 1,000 nonfederal acute-care hospitals per year for a 6-year period. They identified 90,618 patients with a discharge diagnosis of proximal DVT; propensity-score matching yielded 3,594 well-matched patients in each study group. In-hospital mortality was not significantly different between patients who had catheter-directed thrombolysis plus anticoagulation (1.2%) and those who had anticoagulation alone (0.9%), Dr. Bashir and his associates wrote (JAMA Intern. Med. 2014 July 21 [doi:10.1001/jamainternmed.2014.3415]).
However, rates of blood transfusion (11.1% vs. 6.5%), pulmonary embolism (17.9% vs 11.4%), and intracranial hemorrhage (0.9% vs 0.3%) were significantly higher with the invasive intervention. And patients in the catheter-directed thrombolysis group required significantly longer hospitalizations (7.2 vs. 5.0 days) and incurred significantly higher hospital expenses ($85,094 vs. $28,164). "It is imperative that the magnitude of benefit from catheter-directed therapy be substantial to justify the increased initial resource utilization and bleeding risks of this therapy," the investigators noted.
Catheter-directed thrombolysis plus anticoagulation is no more effective than anticoagulation alone in preventing in-hospital death among adults who have lower-extremity proximal deep vein thrombosis, according to a nationwide observational study reported online July 21 in JAMA Internal Medicine.
However, catheter-directed thrombolysis carries higher risks, particularly serious bleeding risks such as intracranial hemorrhage, than does anticoagulation alone, and it costs nearly three times as much money. These findings highlight the need for randomized trials "to evaluate the magnitude of the effect of catheter-directed thrombolysis on ... mortality, postthrombotic syndrome, and recurrence of DVT [deep vein thrombosis]. In the absence of such data, it may be reasonable to restrict this form of therapy to those patients who have a low bleeding risk and a high risk for postthrombotic syndrome, such as patients with iliofemoral DVT," said Dr. Riyaz Bashir of the division of cardiovascular diseases, Temple University, Philadelphia, and his associates.
Conflicting data from several small studies as to the safety and effectiveness of catheter-directed thrombolysis have led professional societies to devise conflicting recommendations for its use: the American College of Chest Physicians advises against using the procedure, while the American Heart Association recommends it as a first-line therapy for certain patients. "We sought to assess real-world comparative-safety outcomes in patients proximal and caval DVT who underwent catheter-directed thrombolysis plus anticoagulation with a group treated with anticoagulation alone using risk-adjusted propensity-score matching," the investigators said.
They analyzed data from an Agency for Healthcare Research and Quality administrative database of patient discharges from approximately 1,000 nonfederal acute-care hospitals per year for a 6-year period. They identified 90,618 patients with a discharge diagnosis of proximal DVT; propensity-score matching yielded 3,594 well-matched patients in each study group. In-hospital mortality was not significantly different between patients who had catheter-directed thrombolysis plus anticoagulation (1.2%) and those who had anticoagulation alone (0.9%), Dr. Bashir and his associates wrote (JAMA Intern. Med. 2014 July 21 [doi:10.1001/jamainternmed.2014.3415]).
However, rates of blood transfusion (11.1% vs. 6.5%), pulmonary embolism (17.9% vs 11.4%), and intracranial hemorrhage (0.9% vs 0.3%) were significantly higher with the invasive intervention. And patients in the catheter-directed thrombolysis group required significantly longer hospitalizations (7.2 vs. 5.0 days) and incurred significantly higher hospital expenses ($85,094 vs. $28,164). "It is imperative that the magnitude of benefit from catheter-directed therapy be substantial to justify the increased initial resource utilization and bleeding risks of this therapy," the investigators noted.
Catheter-directed thrombolysis plus anticoagulation is no more effective than anticoagulation alone in preventing in-hospital death among adults who have lower-extremity proximal deep vein thrombosis, according to a nationwide observational study reported online July 21 in JAMA Internal Medicine.
However, catheter-directed thrombolysis carries higher risks, particularly serious bleeding risks such as intracranial hemorrhage, than does anticoagulation alone, and it costs nearly three times as much money. These findings highlight the need for randomized trials "to evaluate the magnitude of the effect of catheter-directed thrombolysis on ... mortality, postthrombotic syndrome, and recurrence of DVT [deep vein thrombosis]. In the absence of such data, it may be reasonable to restrict this form of therapy to those patients who have a low bleeding risk and a high risk for postthrombotic syndrome, such as patients with iliofemoral DVT," said Dr. Riyaz Bashir of the division of cardiovascular diseases, Temple University, Philadelphia, and his associates.
Conflicting data from several small studies as to the safety and effectiveness of catheter-directed thrombolysis have led professional societies to devise conflicting recommendations for its use: the American College of Chest Physicians advises against using the procedure, while the American Heart Association recommends it as a first-line therapy for certain patients. "We sought to assess real-world comparative-safety outcomes in patients proximal and caval DVT who underwent catheter-directed thrombolysis plus anticoagulation with a group treated with anticoagulation alone using risk-adjusted propensity-score matching," the investigators said.
They analyzed data from an Agency for Healthcare Research and Quality administrative database of patient discharges from approximately 1,000 nonfederal acute-care hospitals per year for a 6-year period. They identified 90,618 patients with a discharge diagnosis of proximal DVT; propensity-score matching yielded 3,594 well-matched patients in each study group. In-hospital mortality was not significantly different between patients who had catheter-directed thrombolysis plus anticoagulation (1.2%) and those who had anticoagulation alone (0.9%), Dr. Bashir and his associates wrote (JAMA Intern. Med. 2014 July 21 [doi:10.1001/jamainternmed.2014.3415]).
However, rates of blood transfusion (11.1% vs. 6.5%), pulmonary embolism (17.9% vs 11.4%), and intracranial hemorrhage (0.9% vs 0.3%) were significantly higher with the invasive intervention. And patients in the catheter-directed thrombolysis group required significantly longer hospitalizations (7.2 vs. 5.0 days) and incurred significantly higher hospital expenses ($85,094 vs. $28,164). "It is imperative that the magnitude of benefit from catheter-directed therapy be substantial to justify the increased initial resource utilization and bleeding risks of this therapy," the investigators noted.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Catheter-directed thrombolysis carries higher risks and may not improve outcomes for proximal DVT patients.
Major finding: In-hospital mortality was not significantly different between patients who had catheter-directed thrombolysis plus anticoagulation (1.2%) and those who had anticoagulation alone (0.9%), but rates of blood transfusion (11.1% vs 6.5%), pulmonary embolism (17.9% vs 11.4%), and intracranial hemorrhage (0.9% vs 0.3%) were significantly higher with the invasive intervention.
Data source: A propensity-matched analysis comparing the effectiveness and safety profiles between catheter-directed thrombolysis plus anticoagulation and anticoagulation alone in 3,594 adults across the country hospitalized with lower-extremity proximal DVT during a 6-year period.
Disclosures: This study was supported by Temple University Hospital, Philadelphia. Dr. Bashir reported no financial conflicts of interest; his associates reported ties to Covidien, Health Systems Networks, and Insight Telehealth.
