NEW YORK – Physicians at Boston Children’s Hospital replaced the mitral valves of eight infants with irreparable mitral valve disease with a valve that offers the opportunity of sequential expansion as the child grows, according to Dr. Sitaram M. Emani. The results were presented at the 2013 Mitral Valve Conclave earlier this year.

"The Melody valve retains its competence if you expand it before putting it in. We asked whether the valve retains the ability to maintain competence even if expansion is performed after implantation as the patient grows," said Dr. Emani, a pediatric cardiac surgeon at Boston Children’s Hospital.

 All photos courtesy Dr. Sitaram M. Emani

According to Dr. Emani, the current options for infants with damaged mitral valves that are beyond repair are replacement with mechanical or bioprosthetic valves or the Ross mitral procedure. Perhaps the main disadvantage of these options is the lack of a prosthetic valve small enough for an infant, one that is less than 12 mm in diameter. Another problem is the possibility of stenosis developing as the child grows, since the diameters of the prosthetics are fixed. Other drawbacks are that supra-annular fixation is generally associated with poor outcomes and that annular fixation limits the ability to upsize at reoperation.

The Melody valve is an externally stented bovine jugular vein graft that was designed for transcatheter pulmonary valve replacement. In this study, the valve was inserted surgically. The valve maintains competence over a range of sizes up to 22 mm. Although this valve is not approved for use for mitral valve replacement, the hope of using such a prosthetic is that it can be enlarged in the catheterization laboratory as the child grows.

Dr. Emani did a retrospective study of his experience with the Melody valve for mitral valve replacement in eight infants less than 12 months of age. The median age at implantation was 6 months (range, 1-9 months). Four infants had an atrioventricular canal (AVC) defect and four had congenital mitral valve stenosis. Most of the children had two prior operations for mitral valve repair. The longest follow-up to date has been 2 years.

At a median follow-up of 8 months, regurgitation on the echocardiogram was considered to be mild or less in all patients. The median gradient was 3 mm Hg (range, 2-7 mm Hg) on the immediate postoperative echocardiogram. Three patients developed a mild paravalvular leak; one of these patients had undergone aggressive stent resection, a modification Dr. Emani does not recommend. One patient developed left ventricular outflow tract obstruction (LVOTO), which Dr. Emani attributed to the lack of distal stent fixation in this patient. Another patient with an AVC defect developed complete heart block.

One patient who died 3 days postoperatively had heterotaxy, severe mitral regurgitation, and prior ventricular failure on extracorporeal membrane oxygenation support. That patient had undergone valve implantation as a last resort.

Three patients underwent sequential expansion about 6 months after implantation. After valve expansion, the median balloon size was 12 mm, ranging from 12 to 16 mm. None of the patients developed worsening valvular function and all had relief of obstruction. Transcatheter intervention was used to correct a paravalvular leak in one patient and to treat a left ventricular outflow tract problem in another. None of the patients developed endocarditis or a strut fracture, "although I worry about strut fracture if aggressive stent resection and manipulation is performed," he said at the meeting, which was sponsored by the AATS.

Dr. Emani offered some procedural tips. First, the Melody valve must be optimized for surgical implantation in infants. The length of the valve must be reduced by trimming it to reduce the chance of LVOTO or pulmonary vein obstruction. He recommends sizing the valves by echocardiogram and fixating the distal stent to the inferior free wall of the ventricle.

He reported that friction of the stent against the annulus prevents leakage. Early on he used a pericardial cuff to anchor to the annulus, particularly in patients who had undergone failed AVC repair. He tries to preserve at least part of the anterior leaflet to facilitate suture placement and create a "stand-off" from the LVOTO.

Dr. Emani also advised limiting intraoperative dilation to no more than 1 mm greater than the measured annulus. "Try not to overdilate at implantation to avoid heart block, LVOTO, and coronary compression. The nice thing is you don’t have to decide then and there what size you want. You can go back to the cath lab and, under direct visualization with the coronary view, you can dilate it under more controlled circumstances.

"The hope is that we will be able to dilate these valves as the patients grow into adolescence. If we can dilate them up to 22 mm, hopefully we will decrease the number of repeat replacements, delay the time to reoperation, and perhaps modify our thresholds for tolerating significant disease after unsuccessful repairs."

Dr. Emani reported no disclosures.

NEW YORK – Physicians at Boston Children’s Hospital replaced the mitral valves of eight infants with irreparable mitral valve disease with a valve that offers the opportunity of sequential expansion as the child grows, according to Dr. Sitaram M. Emani. The results were presented at the 2013 Mitral Valve Conclave earlier this year.

"The Melody valve retains its competence if you expand it before putting it in. We asked whether the valve retains the ability to maintain competence even if expansion is performed after implantation as the patient grows," said Dr. Emani, a pediatric cardiac surgeon at Boston Children’s Hospital.

 All photos courtesy Dr. Sitaram M. Emani

According to Dr. Emani, the current options for infants with damaged mitral valves that are beyond repair are replacement with mechanical or bioprosthetic valves or the Ross mitral procedure. Perhaps the main disadvantage of these options is the lack of a prosthetic valve small enough for an infant, one that is less than 12 mm in diameter. Another problem is the possibility of stenosis developing as the child grows, since the diameters of the prosthetics are fixed. Other drawbacks are that supra-annular fixation is generally associated with poor outcomes and that annular fixation limits the ability to upsize at reoperation.

The Melody valve is an externally stented bovine jugular vein graft that was designed for transcatheter pulmonary valve replacement. In this study, the valve was inserted surgically. The valve maintains competence over a range of sizes up to 22 mm. Although this valve is not approved for use for mitral valve replacement, the hope of using such a prosthetic is that it can be enlarged in the catheterization laboratory as the child grows.

Dr. Emani did a retrospective study of his experience with the Melody valve for mitral valve replacement in eight infants less than 12 months of age. The median age at implantation was 6 months (range, 1-9 months). Four infants had an atrioventricular canal (AVC) defect and four had congenital mitral valve stenosis. Most of the children had two prior operations for mitral valve repair. The longest follow-up to date has been 2 years.

At a median follow-up of 8 months, regurgitation on the echocardiogram was considered to be mild or less in all patients. The median gradient was 3 mm Hg (range, 2-7 mm Hg) on the immediate postoperative echocardiogram. Three patients developed a mild paravalvular leak; one of these patients had undergone aggressive stent resection, a modification Dr. Emani does not recommend. One patient developed left ventricular outflow tract obstruction (LVOTO), which Dr. Emani attributed to the lack of distal stent fixation in this patient. Another patient with an AVC defect developed complete heart block.

One patient who died 3 days postoperatively had heterotaxy, severe mitral regurgitation, and prior ventricular failure on extracorporeal membrane oxygenation support. That patient had undergone valve implantation as a last resort.

Three patients underwent sequential expansion about 6 months after implantation. After valve expansion, the median balloon size was 12 mm, ranging from 12 to 16 mm. None of the patients developed worsening valvular function and all had relief of obstruction. Transcatheter intervention was used to correct a paravalvular leak in one patient and to treat a left ventricular outflow tract problem in another. None of the patients developed endocarditis or a strut fracture, "although I worry about strut fracture if aggressive stent resection and manipulation is performed," he said at the meeting, which was sponsored by the AATS.

Dr. Emani offered some procedural tips. First, the Melody valve must be optimized for surgical implantation in infants. The length of the valve must be reduced by trimming it to reduce the chance of LVOTO or pulmonary vein obstruction. He recommends sizing the valves by echocardiogram and fixating the distal stent to the inferior free wall of the ventricle.

He reported that friction of the stent against the annulus prevents leakage. Early on he used a pericardial cuff to anchor to the annulus, particularly in patients who had undergone failed AVC repair. He tries to preserve at least part of the anterior leaflet to facilitate suture placement and create a "stand-off" from the LVOTO.

Dr. Emani also advised limiting intraoperative dilation to no more than 1 mm greater than the measured annulus. "Try not to overdilate at implantation to avoid heart block, LVOTO, and coronary compression. The nice thing is you don’t have to decide then and there what size you want. You can go back to the cath lab and, under direct visualization with the coronary view, you can dilate it under more controlled circumstances.

"The hope is that we will be able to dilate these valves as the patients grow into adolescence. If we can dilate them up to 22 mm, hopefully we will decrease the number of repeat replacements, delay the time to reoperation, and perhaps modify our thresholds for tolerating significant disease after unsuccessful repairs."

Dr. Emani reported no disclosures.

NEW YORK – Physicians at Boston Children’s Hospital replaced the mitral valves of eight infants with irreparable mitral valve disease with a valve that offers the opportunity of sequential expansion as the child grows, according to Dr. Sitaram M. Emani. The results were presented at the 2013 Mitral Valve Conclave earlier this year.

"The Melody valve retains its competence if you expand it before putting it in. We asked whether the valve retains the ability to maintain competence even if expansion is performed after implantation as the patient grows," said Dr. Emani, a pediatric cardiac surgeon at Boston Children’s Hospital.

 All photos courtesy Dr. Sitaram M. Emani

According to Dr. Emani, the current options for infants with damaged mitral valves that are beyond repair are replacement with mechanical or bioprosthetic valves or the Ross mitral procedure. Perhaps the main disadvantage of these options is the lack of a prosthetic valve small enough for an infant, one that is less than 12 mm in diameter. Another problem is the possibility of stenosis developing as the child grows, since the diameters of the prosthetics are fixed. Other drawbacks are that supra-annular fixation is generally associated with poor outcomes and that annular fixation limits the ability to upsize at reoperation.

The Melody valve is an externally stented bovine jugular vein graft that was designed for transcatheter pulmonary valve replacement. In this study, the valve was inserted surgically. The valve maintains competence over a range of sizes up to 22 mm. Although this valve is not approved for use for mitral valve replacement, the hope of using such a prosthetic is that it can be enlarged in the catheterization laboratory as the child grows.

Dr. Emani did a retrospective study of his experience with the Melody valve for mitral valve replacement in eight infants less than 12 months of age. The median age at implantation was 6 months (range, 1-9 months). Four infants had an atrioventricular canal (AVC) defect and four had congenital mitral valve stenosis. Most of the children had two prior operations for mitral valve repair. The longest follow-up to date has been 2 years.

At a median follow-up of 8 months, regurgitation on the echocardiogram was considered to be mild or less in all patients. The median gradient was 3 mm Hg (range, 2-7 mm Hg) on the immediate postoperative echocardiogram. Three patients developed a mild paravalvular leak; one of these patients had undergone aggressive stent resection, a modification Dr. Emani does not recommend. One patient developed left ventricular outflow tract obstruction (LVOTO), which Dr. Emani attributed to the lack of distal stent fixation in this patient. Another patient with an AVC defect developed complete heart block.

One patient who died 3 days postoperatively had heterotaxy, severe mitral regurgitation, and prior ventricular failure on extracorporeal membrane oxygenation support. That patient had undergone valve implantation as a last resort.

Three patients underwent sequential expansion about 6 months after implantation. After valve expansion, the median balloon size was 12 mm, ranging from 12 to 16 mm. None of the patients developed worsening valvular function and all had relief of obstruction. Transcatheter intervention was used to correct a paravalvular leak in one patient and to treat a left ventricular outflow tract problem in another. None of the patients developed endocarditis or a strut fracture, "although I worry about strut fracture if aggressive stent resection and manipulation is performed," he said at the meeting, which was sponsored by the AATS.

Dr. Emani offered some procedural tips. First, the Melody valve must be optimized for surgical implantation in infants. The length of the valve must be reduced by trimming it to reduce the chance of LVOTO or pulmonary vein obstruction. He recommends sizing the valves by echocardiogram and fixating the distal stent to the inferior free wall of the ventricle.

He reported that friction of the stent against the annulus prevents leakage. Early on he used a pericardial cuff to anchor to the annulus, particularly in patients who had undergone failed AVC repair. He tries to preserve at least part of the anterior leaflet to facilitate suture placement and create a "stand-off" from the LVOTO.

Dr. Emani also advised limiting intraoperative dilation to no more than 1 mm greater than the measured annulus. "Try not to overdilate at implantation to avoid heart block, LVOTO, and coronary compression. The nice thing is you don’t have to decide then and there what size you want. You can go back to the cath lab and, under direct visualization with the coronary view, you can dilate it under more controlled circumstances.

"The hope is that we will be able to dilate these valves as the patients grow into adolescence. If we can dilate them up to 22 mm, hopefully we will decrease the number of repeat replacements, delay the time to reoperation, and perhaps modify our thresholds for tolerating significant disease after unsuccessful repairs."

Dr. Emani reported no disclosures.

What is the best possible medication history? How is it done? Who should do it? When should it be done during a patient’s journey in and out of the hospital? What medication discrepancies—and potential adverse drug events—are most likely?

Those are questions veteran hospitalist Jason Stein, MD, tried to answer during an HM13 breakout session on medication reconciliation at the Gaylord National Resort and Conference Center in National Harbor, Md.

"How do you know as the discharging provider if the medication list you’re looking at is gold or garbage?" said Dr. Stein, associate director for quality improvement (QI) at Emory University in Atlanta and a mentor for SHM’s Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS) quality-research initiative.

“Sometimes it’s impossible to know what the patient was or wasn’t taking, but it doesn’t mean you don’t do your best,” he said, adding that hospitalists should attempt to get at least one reliable, corroborating source of information for a patient’s medical history.

Sometimes it is necessary to speak to family members or the community pharmacy, Dr. Schnipper said, because many patients can’t remember all of the drugs they are taking. Trying to do medication reconciliation at the time of discharge when BPMH has not been done can lead to more work for the provider, medication errors, or rehospitalizations. Ideally, knowledge of what the patient was taking before admission, as well as the patient’s health literacy and adherence history, should be gathered and documented once, early, and well during the hospitalization by a trained provider, according to Dr. Schnipper.

An SHM survey, however, showed 50% to 70% percent of front-line providers have never received BPMH training, and 60% say they are not given the time.¹

“Not knowing means a diligent provider would need to take a BPMH at discharge, which is a waste,” Dr. Stein said. It would be nice to tell from the electronic health record whether a true BPMH had been taken for every hospitalized patient—or at least every high-risk patient—but this goal is not well-supported by current information technology, MARQUIS investigators said they have learned.

The MARQUIS program was launched in 2011 with a grant from the federal Agency for Healthcare Research and Quality. It began with a thorough review of the literature on medication reconciliation and the development of a toolkit of best practices. In 2012, six pilot sites were offered a menu of 11 MARQUIS medication-reconciliation interventions to choose from and help in implementing them from an SHM mentor, with expertise in both QI and medication safety.

Listen to more of our interview with MARQUIS principal investigator Jeffrey Schnipper MD, MPH, FHM.

Participating sites have mobilized high-level hospital leadership and utilize a local champion, usually a hospitalist, tools for assessing high-risk patients, medication-reconciliation assistants or counselors, and pharmacist involvement. Different sites have employed different professional staff to take medication histories.

Dr. Schnipper said he expects another round of MARQUIS-mentored implementation, probably in 2014, after data from the first round have been analyzed. The program is tracking such outcomes as the number of potentially harmful, unintentional medication discrepancies per patient at participating sites.

The MARQUIS toolkit is available on the SHM website. TH

Larry Beresford is a freelance writer in San Francisco.

Reference

1. Schnipper JL, Mueller SK, Salanitro AH, Stein J. Got Med Wreck? Targeted Repairs from the Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS). PowerPoint presentation at Society of Hospital Medicine annual meeting, May 16-19, 2013, National Harbor, Md.

What is the best possible medication history? How is it done? Who should do it? When should it be done during a patient’s journey in and out of the hospital? What medication discrepancies—and potential adverse drug events—are most likely?

Those are questions veteran hospitalist Jason Stein, MD, tried to answer during an HM13 breakout session on medication reconciliation at the Gaylord National Resort and Conference Center in National Harbor, Md.

"How do you know as the discharging provider if the medication list you’re looking at is gold or garbage?" said Dr. Stein, associate director for quality improvement (QI) at Emory University in Atlanta and a mentor for SHM’s Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS) quality-research initiative.

“Sometimes it’s impossible to know what the patient was or wasn’t taking, but it doesn’t mean you don’t do your best,” he said, adding that hospitalists should attempt to get at least one reliable, corroborating source of information for a patient’s medical history.

Sometimes it is necessary to speak to family members or the community pharmacy, Dr. Schnipper said, because many patients can’t remember all of the drugs they are taking. Trying to do medication reconciliation at the time of discharge when BPMH has not been done can lead to more work for the provider, medication errors, or rehospitalizations. Ideally, knowledge of what the patient was taking before admission, as well as the patient’s health literacy and adherence history, should be gathered and documented once, early, and well during the hospitalization by a trained provider, according to Dr. Schnipper.

An SHM survey, however, showed 50% to 70% percent of front-line providers have never received BPMH training, and 60% say they are not given the time.¹

“Not knowing means a diligent provider would need to take a BPMH at discharge, which is a waste,” Dr. Stein said. It would be nice to tell from the electronic health record whether a true BPMH had been taken for every hospitalized patient—or at least every high-risk patient—but this goal is not well-supported by current information technology, MARQUIS investigators said they have learned.

The MARQUIS program was launched in 2011 with a grant from the federal Agency for Healthcare Research and Quality. It began with a thorough review of the literature on medication reconciliation and the development of a toolkit of best practices. In 2012, six pilot sites were offered a menu of 11 MARQUIS medication-reconciliation interventions to choose from and help in implementing them from an SHM mentor, with expertise in both QI and medication safety.

Listen to more of our interview with MARQUIS principal investigator Jeffrey Schnipper MD, MPH, FHM.

Participating sites have mobilized high-level hospital leadership and utilize a local champion, usually a hospitalist, tools for assessing high-risk patients, medication-reconciliation assistants or counselors, and pharmacist involvement. Different sites have employed different professional staff to take medication histories.

Dr. Schnipper said he expects another round of MARQUIS-mentored implementation, probably in 2014, after data from the first round have been analyzed. The program is tracking such outcomes as the number of potentially harmful, unintentional medication discrepancies per patient at participating sites.

The MARQUIS toolkit is available on the SHM website. TH

Larry Beresford is a freelance writer in San Francisco.

Reference

1. Schnipper JL, Mueller SK, Salanitro AH, Stein J. Got Med Wreck? Targeted Repairs from the Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS). PowerPoint presentation at Society of Hospital Medicine annual meeting, May 16-19, 2013, National Harbor, Md.

What is the best possible medication history? How is it done? Who should do it? When should it be done during a patient’s journey in and out of the hospital? What medication discrepancies—and potential adverse drug events—are most likely?

Those are questions veteran hospitalist Jason Stein, MD, tried to answer during an HM13 breakout session on medication reconciliation at the Gaylord National Resort and Conference Center in National Harbor, Md.

"How do you know as the discharging provider if the medication list you’re looking at is gold or garbage?" said Dr. Stein, associate director for quality improvement (QI) at Emory University in Atlanta and a mentor for SHM’s Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS) quality-research initiative.

“Sometimes it’s impossible to know what the patient was or wasn’t taking, but it doesn’t mean you don’t do your best,” he said, adding that hospitalists should attempt to get at least one reliable, corroborating source of information for a patient’s medical history.

Sometimes it is necessary to speak to family members or the community pharmacy, Dr. Schnipper said, because many patients can’t remember all of the drugs they are taking. Trying to do medication reconciliation at the time of discharge when BPMH has not been done can lead to more work for the provider, medication errors, or rehospitalizations. Ideally, knowledge of what the patient was taking before admission, as well as the patient’s health literacy and adherence history, should be gathered and documented once, early, and well during the hospitalization by a trained provider, according to Dr. Schnipper.

An SHM survey, however, showed 50% to 70% percent of front-line providers have never received BPMH training, and 60% say they are not given the time.¹

“Not knowing means a diligent provider would need to take a BPMH at discharge, which is a waste,” Dr. Stein said. It would be nice to tell from the electronic health record whether a true BPMH had been taken for every hospitalized patient—or at least every high-risk patient—but this goal is not well-supported by current information technology, MARQUIS investigators said they have learned.

The MARQUIS program was launched in 2011 with a grant from the federal Agency for Healthcare Research and Quality. It began with a thorough review of the literature on medication reconciliation and the development of a toolkit of best practices. In 2012, six pilot sites were offered a menu of 11 MARQUIS medication-reconciliation interventions to choose from and help in implementing them from an SHM mentor, with expertise in both QI and medication safety.

Listen to more of our interview with MARQUIS principal investigator Jeffrey Schnipper MD, MPH, FHM.

Participating sites have mobilized high-level hospital leadership and utilize a local champion, usually a hospitalist, tools for assessing high-risk patients, medication-reconciliation assistants or counselors, and pharmacist involvement. Different sites have employed different professional staff to take medication histories.

Dr. Schnipper said he expects another round of MARQUIS-mentored implementation, probably in 2014, after data from the first round have been analyzed. The program is tracking such outcomes as the number of potentially harmful, unintentional medication discrepancies per patient at participating sites.

The MARQUIS toolkit is available on the SHM website. TH

Larry Beresford is a freelance writer in San Francisco.

Reference

1. Schnipper JL, Mueller SK, Salanitro AH, Stein J. Got Med Wreck? Targeted Repairs from the Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS). PowerPoint presentation at Society of Hospital Medicine annual meeting, May 16-19, 2013, National Harbor, Md.

She presented to the trauma bay after transfer from another hospital. She had fallen out of bed at the nursing home, and they had sent her to the emergency department for evaluation. Her head CT demonstrated a subacute chronic subdural hematoma. She had fallen a month ago and had been seen at the same hospital and was transferred to us then, too, but not as a trauma. Admitted to another service for a few days, she had subsequently been sent to the nursing home with weekly head CT scans for follow-up. Today’s CT showed continued resolution of her subdural hematoma, but since she had fallen and had an abnormal CT scan, she was transferred to us as a trauma for further evaluation.

The patient was elderly, in her 90s, with end-stage dementia. The trauma team descended on her as we do with all traumas – to evaluate for life-threatening injuries. Airway, breathing, circulation. Does she need to be intubated? What is her blood pressure? Place IVs and draw blood. Put her quickly on the monitors, undress her completely. Roll her on her side to examine her back. Make sure she is in a rigid C-collar and cannot move her neck until we are sure it isn’t fractured. She cannot sit up despite her desire to do so, thus requiring us to hold her down, so she doesn’t injure herself or others. In the midst of all this, she kept screaming, "Why do you keep doing this to me?" That was all she said. Repeatedly. As I sorted out the events of the past month, read the radiologist report from the referring institution that documented improvement in her scans, and reviewed all the CTs on disc, I wondered the same, "Why are we doing this to you?" She didn’t need a trauma center or the trauma team. What she needed was a goals of care discussion and POLST (Physician Orders for Life-Sustaining Treatment) document.

We, as doctors, are poor at discussing goals of care. Even for those patients who are expected to do well, we do not address code status, or ask them what they want if things go poorly. Recently, the University of California published their results with a quality improvement program to document advance care planning discussions. Between July 2011 and May 2012 on the medical service, they created an incentive program for documentation of goals of care and identification of a surrogate decision maker. If 75% of patients had the two items documented in the medical record, then the residents received a $400 incentive. Documentation (and likely actual discussion) increased from 22% in July to 90% by October and remained at that level. There were reminders and feedback, and it seems likely a component of peer pressure among the residents to ensure everyone received the incentive. The study did not track outcomes or documentation rates after the program was over. The study did show that behavior of initiating difficult end-of-life (EOL) planning discussions can be improved in a quality improvement program. (JAMA Intern. Med. 2013 [doi: 10.1001/jamainternmed.2013.8158]).

Ideally, the next step would be to document the use of POLST (www.polst.org) orders. POLST is a bright pink form that documents the patient’s preferences for code status, treatment options (full including ICU, limited, or comfort measures including no transport to hospital) artificial nutrition and hydration, and antibiotics. POLST is signed by a physician and, therefore, it can be applied across care settings. If it is signed by the patient, it cannot be overridden by the surrogate, and there are legal protections for health care providers.

We admitted the patient in the trauma bay, not because she needed acute care, but because she needed goals of care defined. We consulted Palliative Medicine and had the social worker identify a decision maker. Palliative Medicine worked with the surrogate decision maker to set goals of care: feeding tube, follow-up scans, code status, and most importantly POLST orders. Regrettably, it took a trip to the Trauma Bay after multiple interactions with the health care system to evaluate what really was in the best interest of the patient and what she would have wanted. She told us as best she could that she did not want what we were doing to her. This time, we listened.

Dr Toevs is a trauma critical care surgeon at Allegheny General Hospital in Pittsburgh, Pa. She has a Masters degree in bioethics and board-certification in hospice and palliative medicine.

She presented to the trauma bay after transfer from another hospital. She had fallen out of bed at the nursing home, and they had sent her to the emergency department for evaluation. Her head CT demonstrated a subacute chronic subdural hematoma. She had fallen a month ago and had been seen at the same hospital and was transferred to us then, too, but not as a trauma. Admitted to another service for a few days, she had subsequently been sent to the nursing home with weekly head CT scans for follow-up. Today’s CT showed continued resolution of her subdural hematoma, but since she had fallen and had an abnormal CT scan, she was transferred to us as a trauma for further evaluation.

The patient was elderly, in her 90s, with end-stage dementia. The trauma team descended on her as we do with all traumas – to evaluate for life-threatening injuries. Airway, breathing, circulation. Does she need to be intubated? What is her blood pressure? Place IVs and draw blood. Put her quickly on the monitors, undress her completely. Roll her on her side to examine her back. Make sure she is in a rigid C-collar and cannot move her neck until we are sure it isn’t fractured. She cannot sit up despite her desire to do so, thus requiring us to hold her down, so she doesn’t injure herself or others. In the midst of all this, she kept screaming, "Why do you keep doing this to me?" That was all she said. Repeatedly. As I sorted out the events of the past month, read the radiologist report from the referring institution that documented improvement in her scans, and reviewed all the CTs on disc, I wondered the same, "Why are we doing this to you?" She didn’t need a trauma center or the trauma team. What she needed was a goals of care discussion and POLST (Physician Orders for Life-Sustaining Treatment) document.

We, as doctors, are poor at discussing goals of care. Even for those patients who are expected to do well, we do not address code status, or ask them what they want if things go poorly. Recently, the University of California published their results with a quality improvement program to document advance care planning discussions. Between July 2011 and May 2012 on the medical service, they created an incentive program for documentation of goals of care and identification of a surrogate decision maker. If 75% of patients had the two items documented in the medical record, then the residents received a $400 incentive. Documentation (and likely actual discussion) increased from 22% in July to 90% by October and remained at that level. There were reminders and feedback, and it seems likely a component of peer pressure among the residents to ensure everyone received the incentive. The study did not track outcomes or documentation rates after the program was over. The study did show that behavior of initiating difficult end-of-life (EOL) planning discussions can be improved in a quality improvement program. (JAMA Intern. Med. 2013 [doi: 10.1001/jamainternmed.2013.8158]).

Ideally, the next step would be to document the use of POLST (www.polst.org) orders. POLST is a bright pink form that documents the patient’s preferences for code status, treatment options (full including ICU, limited, or comfort measures including no transport to hospital) artificial nutrition and hydration, and antibiotics. POLST is signed by a physician and, therefore, it can be applied across care settings. If it is signed by the patient, it cannot be overridden by the surrogate, and there are legal protections for health care providers.

We admitted the patient in the trauma bay, not because she needed acute care, but because she needed goals of care defined. We consulted Palliative Medicine and had the social worker identify a decision maker. Palliative Medicine worked with the surrogate decision maker to set goals of care: feeding tube, follow-up scans, code status, and most importantly POLST orders. Regrettably, it took a trip to the Trauma Bay after multiple interactions with the health care system to evaluate what really was in the best interest of the patient and what she would have wanted. She told us as best she could that she did not want what we were doing to her. This time, we listened.

Dr Toevs is a trauma critical care surgeon at Allegheny General Hospital in Pittsburgh, Pa. She has a Masters degree in bioethics and board-certification in hospice and palliative medicine.

She presented to the trauma bay after transfer from another hospital. She had fallen out of bed at the nursing home, and they had sent her to the emergency department for evaluation. Her head CT demonstrated a subacute chronic subdural hematoma. She had fallen a month ago and had been seen at the same hospital and was transferred to us then, too, but not as a trauma. Admitted to another service for a few days, she had subsequently been sent to the nursing home with weekly head CT scans for follow-up. Today’s CT showed continued resolution of her subdural hematoma, but since she had fallen and had an abnormal CT scan, she was transferred to us as a trauma for further evaluation.

The patient was elderly, in her 90s, with end-stage dementia. The trauma team descended on her as we do with all traumas – to evaluate for life-threatening injuries. Airway, breathing, circulation. Does she need to be intubated? What is her blood pressure? Place IVs and draw blood. Put her quickly on the monitors, undress her completely. Roll her on her side to examine her back. Make sure she is in a rigid C-collar and cannot move her neck until we are sure it isn’t fractured. She cannot sit up despite her desire to do so, thus requiring us to hold her down, so she doesn’t injure herself or others. In the midst of all this, she kept screaming, "Why do you keep doing this to me?" That was all she said. Repeatedly. As I sorted out the events of the past month, read the radiologist report from the referring institution that documented improvement in her scans, and reviewed all the CTs on disc, I wondered the same, "Why are we doing this to you?" She didn’t need a trauma center or the trauma team. What she needed was a goals of care discussion and POLST (Physician Orders for Life-Sustaining Treatment) document.

We, as doctors, are poor at discussing goals of care. Even for those patients who are expected to do well, we do not address code status, or ask them what they want if things go poorly. Recently, the University of California published their results with a quality improvement program to document advance care planning discussions. Between July 2011 and May 2012 on the medical service, they created an incentive program for documentation of goals of care and identification of a surrogate decision maker. If 75% of patients had the two items documented in the medical record, then the residents received a $400 incentive. Documentation (and likely actual discussion) increased from 22% in July to 90% by October and remained at that level. There were reminders and feedback, and it seems likely a component of peer pressure among the residents to ensure everyone received the incentive. The study did not track outcomes or documentation rates after the program was over. The study did show that behavior of initiating difficult end-of-life (EOL) planning discussions can be improved in a quality improvement program. (JAMA Intern. Med. 2013 [doi: 10.1001/jamainternmed.2013.8158]).

Ideally, the next step would be to document the use of POLST (www.polst.org) orders. POLST is a bright pink form that documents the patient’s preferences for code status, treatment options (full including ICU, limited, or comfort measures including no transport to hospital) artificial nutrition and hydration, and antibiotics. POLST is signed by a physician and, therefore, it can be applied across care settings. If it is signed by the patient, it cannot be overridden by the surrogate, and there are legal protections for health care providers.

We admitted the patient in the trauma bay, not because she needed acute care, but because she needed goals of care defined. We consulted Palliative Medicine and had the social worker identify a decision maker. Palliative Medicine worked with the surrogate decision maker to set goals of care: feeding tube, follow-up scans, code status, and most importantly POLST orders. Regrettably, it took a trip to the Trauma Bay after multiple interactions with the health care system to evaluate what really was in the best interest of the patient and what she would have wanted. She told us as best she could that she did not want what we were doing to her. This time, we listened.

Dr Toevs is a trauma critical care surgeon at Allegheny General Hospital in Pittsburgh, Pa. She has a Masters degree in bioethics and board-certification in hospice and palliative medicine.

Fecal incontinence is a socially embarrassing condition that affects approximately 18 million adults in the United States.¹ Its true incidence is likely much higher than reported, however, as many patients are reluctant to discuss it.

A recent study found that nearly 20% of women experience fecal incontinence at least once a year, and 9.5% experience it al least once a month.² Only 28% of these women had ever discussed their symptoms with a physician, however.³ Women who did seek care were more likely to consult a family physician or internist (75%) than a ­gynecologist (7%).³

Until recently, few options were available for patients with fecal incontinence who had not benefited from conservative measures. Many patients simply had to live with their symptoms or undergo a diverting ostomy to control the chronic involuntary drainage.

Recent years have seen the development of new minimally invasive and highly successful techniques to treat fecal incontinence. Greater awareness of the prevalence of fecal incontinence and its devastating impact on quality of life is needed for this problem to be fully addressed, however. In this article, we review the recommended evaluation of a patient who reports fecal incontinence and describe the range of treatment options.

Fecal incontinence is a symptom, not a diagnosis
Although the most common historical factor contributing to fecal incontinence is obstetric trauma, there are several other causes of this condition. A detailed history and physical examination are vital to determine whether the patient is experiencing true fecal incontinence, or whether she is leaking for other reasons—so-called pseudo-incontinence.

Conditions that can mimic fecal incontinence include:

• prolapsing hemorrhoids
• anal fistula
• sexually transmitted infection
• benign or malignant anorectal neoplasms
• dermatologic conditions.

True fecal incontinence may be active (loss of stool despite the patient’s best effort to control it) or passive (loss of stool without the patient’s awareness). Among the causes of true fecal incontinence are:

• anal sphincter injury (obstetric tear, anorectal surgery such as fistulotomy, or trauma)
• denervation of the pelvic floor from pudendal nerve injury during childbirth
• chronic rectal prolapse
• neurologic conditions (spina bifida, myelomeningocele)
• noncompliant rectum from inflammatory bowel disease
• radiation proctitis.

The maintenance of continence requires a complex interaction between the sphincter muscle, the puborectalis muscle (which acts as a sling), rectal capacity and compliance, stool volume and frequency, and neurologic mechanisms.

Diagnosis and management require an experienced physician
We believe that patients reporting fecal incontinence are best worked up and managed by a physician who is well versed in the various diagnoses associated with fecal incontinence, as well as the most current treatments.

Diagnosis entails some detective work
When a patient reports fecal incontinence, she should be asked to elaborate on the circumstances surrounding the complaint and the frequency of its occurrence, duration of symptoms, and nature of the incontinence (gas, liquid, or solid).
Validated quality-of-life instruments, such as the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS) may be helpful in documenting the severity of the symptoms and improvement after treatment (TABLE).⁴

One factor that current scoring systems fail to capture is urgency. In many instances, urgency is the symptom most distressing to the patient. Be sure to ask about it.

A detailed obstetric history also is important. It is not uncommon for a patient to develop symptoms 20 years or longer after the injury. Also review the patient’s medical history for inflammatory bowel disease, neurologic disorders, and any history of pelvic radiation for help in determining the cause of symptoms.

In addition, ask the patient about any other pelvic floor symptoms, such as voiding dysfunction and problems with pelvic organ prolapse. And question her about stool consistency and frequency. In some cases, diarrhea can lead to fecal incontinence and is usually managed conservatively.

Physical exam: Focus on the perineum and anus
A detailed physical examination is warranted to determine the state of the ­patient’s ­sphincter musculature and rule out other causes of pseudo-incontinence, such as hemorrhoids or anal fistula. Inspect the perineum for thinning of the perineal body and scars from prior surgery.
A patulous anus may be a sign of rectal prolapse. To check for it, ask the patient to strain on the commode. If rectal prolapse is present, it will become apparent upon straining. If prolapse is detected, surgical treatment of the prolapse would be the first step in managing the incontinence.

A simple test of neurologic function is to try to elicit an anal “wink” in response to a pinprick.

A digital rectal exam allows the assessment of resting and squeeze tone, as well as the use of accessory muscles, such as the gluteus maximus, during squeezing.

Rigid or flexible proctoscopy may be indicated to rule out inflammatory bowel disease, radiation proctitis, and rectal neoplasm, depending on the patient’s history. 

A few diagnostic adjuncts can help
Several adjuncts to physical examination can provide more detailed information about the patient’s condition and facilitate the development of an individualized treatment plan. For example, if rectal prolapse, rectocele with delayed emptying, or enterocele is suspected, consider defecography. If voiding dysfunction coexists with the fecal incontinence, urodynamic testing and cystoscopy may be indicated.

We routinely perform physiology testing and endoanal ultrasound if surgery is planned to address the fecal incontinence, although routine use of these adjuncts is controversial. Because many patients can be managed with conservative medical measures, we do not find it necessary to perform these tests at the time of the first visit.

Anal physiology testing includes manometry (a measure of both resting and squeeze tone) and pudendal nerve terminal motor latency testing.

Manometry can help quantify the severity of muscle weakness and determine the presence or absence of normal anal reflexes. Pudendal nerve testing assesses the innervation of the anal sphincter. There is some evidence that patients who have a pudendal neuropathy have a poor outcome with sphincteroplasty,⁵ although that evidence is controversial. The findings from physiology studies have not been correlated with outcomes of newer treatments, such as sacral neuromodulation (InterStim, Medtronic, Minneapolis, Minnesota). Each physiology lab uses different equipment, so “normal” values vary between institutions.                

Endoanal ultrasound is easily performed in an office setting. It is well tolerated and provides anatomic detail of the sphincter musculature. We use a 13-MHz rotating probe to provide 3D imaging of the anal canal. The internal sphincter is represented by a hypoechoic circle surrounded by the hyperechoic external sphincter (FIGURE 1).

In the hands of an experienced examiner, the sensitivity and specificity of endoanal ultrasound in detecting sphincter defects approaches 100%.^6,7 Ultrasound also enables measurement of the perineal body. A normal perineal body measures 10 to 15 mm.

For treatment, try conservative measures first
Bulking agents (fiber), constipating agents (loperamide, etc.), or a laxative regimen with scheduled disimpactions (in patients who have pelvic outlet constipation and overflow incontinence) often can control the symptoms of fecal incontinence, making further interventions unnecessary.

Biofeedback is another option. It uses visual, auditory, and sensory information to train patients to better control anal sphincter muscle function.

A recent randomized study found manometric biofeedback to be superior to simple Kegel exercises in improving fecal continence.⁸ In this study, 76% of patients in the biofeedback group experienced symptom improvement, compared with 41% of patients in the pelvic floor exercise group (P <.001). The long-term benefits of biofeedback are less clear, and patients often need to be reminded to perform their exercises at home and to attend occasional refresher-training sessions. Nevertheless, biofeedback is an important noninvasive option for patients in whom medical management has failed.

Minimally invasive options are now available
Over the past 2 years, minimally invasive treatments for fecal incontinence have emerged, including an implantable sacral neuromodulation device (InterStim) and an injectable dextranomer (Solesta; Salix Pharmaceuticals, Raleigh, North Carolina). Previously, the only surgical option for fecal incontinence was a sphincter repair if a defect was present. The new options may help patients improve their quality of life without having to undergo major surgery.

No one has directly compared the outcomes of these procedures when they are performed by a colorectal surgeon versus a physician of another specialty. It is our belief that the treating physician should have a strong interest in caring for these complex patients and a good working knowledge of the various treatment options.

Related Article Obstetric anal sphincter injury: 7 critical questions about care Ranee Thakar, MD, MRCOG (February 2008)

Sacral neuromodulation
This technique initially was developed for the treatment of overactive bladder and nonobstructive urinary retention and has been used in the United States for the past 15 years for these indications. Improvement in fecal continence was observed in these patients, prompting further studies of its efficacy. In 2011, it was approved by the US Food and Drug Administration (FDA) for the treatment of fecal incontinence. It has since revolutionized the treatment of this disorder, offering a minimally invasive and highly successful alternative to sphincteroplasty.

The InterStim procedure is the only therapeutic modality to include a test phase. The outpatient procedure involves sterile placement of an electrode through the S3 foramen to stimulate the S3 nerve root using fluoroscopic guidance (FIGURES 2 and 3). Patients who experience at least 50% improvement in symptoms are then offered placement of a permanent stimulator.

In most series, approximately 90% of patients have a positive test and progress to implantation. A recent US multicenter clinical trial indicated that 86% of patients achieved an improvement in continence of at least 50%, and 40% of patients were completely continent at 3 years.⁹ The number of episodes of incontinence decreased from a mean of 9.4/week to 1.7/week.⁹ Quality of life also improved greatly. Few complications have been reported, the most notable of which is infection (10.8% in the US multicenter trial⁹).

Another advantage of sacral neuromodulation: It can be used successfully in patients with external sphincter defects as large as 120º. A study by Tjandra and colleagues found that 65% of patients experienced improvement in symptoms of at least 50%, and 47% of patients (more than 50% of whom had external sphincter defects as large as 120º) became completely continent.¹⁰

The only variable shown to predict success with sacral  neuromodulation is a positive response to the test implant procedure.

In our experience, this procedure is easy to perform and well tolerated, even in elderly patients with multiple comorbidities. The procedure has the additional advantage of potentially improving concomitant urinary symptoms as well.

The major disadvantage of sacral neuromodulation is its cost, although most major insurance carriers cover it. There is no well-conducted cost-effectiveness analysis comparing this modality to other treatments.

Related Article Interstim: An implantable device for implacable urinary symptoms Deborah L. Myers, MD (October 2006)

Injectable agents
Several biocompatible bulking agents have been tested in the treatment of fecal incontinence. These compounds traditionally have been used to treat mild fecal incontinence, or to treat patients with isolated internal sphincter defects. 
More recently, an injectable dextranomer in stabilized hyaluronic acid was approved by the FDA and marketed as Solesta. Graf and colleagues randomly allocated 136 patients to injection and 70 patients to sham injection. Patients with external sphincter defects were excluded. At 6 months, 52% of patients in the active treatment group experienced an improvement in continence of at least 50%, compared with 31% of patients injected with placebo.¹¹

The advantage of this procedure is its minimally invasive nature (submucosal injection performed in the office). The disadvantage: a lack of long-term efficacy data, although unpublished data suggest that patients who improve after an injection see a durable response at 3 years.

This easy, office-based treatment is ideal for patients with minor incontinence or persistent symptoms after another procedure.

Sphincter repair
Anterior sphincteroplasty has been the mainstay of surgical treatment for patients with a sphincter defect. With the patient in a dorsal lithotomy or prone position on the ­operating-room table, a transverse perineal incision is made, and the ends of the severed sphincter muscle are located and mobilized. The repair then can be performed in an end-to-end manner or by overlapping the muscles in the anterior midline (FIGURE 4).

Some of the debatable technical issues of this procedure include:

• whether to overlap the muscles or scar tissue
• whether to repair internal and external defects together or separately
• how the age of the patient affects the outcome.

In regard to the first issue, there may be a superior outcome with overlapping repairs, but they carry a higher risk of dyspareunia and evacuation difficulties. Some surgeons will attempt a separate repair of the internal and external sphincter muscles if it appears feasible. Most often, both muscles are ­tethered together with scar tissue and separate repair is not possible. There are no conclusive data to demonstrate the superiority of either approach.

As for age, the traditional teaching was that older patients do not benefit from this procedure as much as younger patients do. However, a recent study found no differences in the CCF-FIS score in patients older than age 60, compared with younger patients.¹² Investigators concluded that sphincteroplasty can be offered to both young and older ­patients.¹²

Although sphincteroplasty often leads to excellent short-term improvement, with 60% to 90% of patients experiencing a good or excellent outcome, nearly all series indicate a decline over the long term (>5 years). A recent systematic review found that as few as 12% of patients experience a good or excellent result, depending on the series.¹³

We offer sphincter repair to young women with a new sphincter defect after delivery. For older patients, we offer sacral neuromodulation as a first-line treatment.

Other surgical options
We believe that most patients with fecal incontinence can be managed using conservative measures, sacral neuromodulation, injectable dextranomer, or sphincter repair. However, several other options are available.

Artificial bowel sphincter
The artificial bowel sphincter was first described in 1987 and has been modified over the years. The system currently is marketed as the Acticon Neosphincter (American Medical Systems, Minnetonka, Minnesota). The procedure involves the creation of a subcutaneous tunnel around the anus so that an inflatable cuff can be positioned there. A pump then is tunneled through a Pfannenstiel incision to the labia or scrotum, and a reservoir is positioned in the space of Retzius. The device maintains continence by keeping the cuff inflated during the resting state and by pumping fluid from the cuff to the reservoir when the patient needs to evacuate.

The major barrier to utilization of the artificial bowel sphincter is infection. In a series of 112 patients who were implanted with the sphincter, 384 device-related adverse events occurred in 99 patients.¹⁴ A total of 73 revision operations were required in 51 patients (46%). Twenty-five percent of patients developed infection that required surgical revision, and 37% had the device explanted. Eighty-five percent of patients with a functional device had a successful outcome.¹⁴

Given the device-related challenges and infectious complications, patients should be considered for less invasive treatments before being offered an artificial bowel
sphincter.

Radiofrequency current
The Secca procedure (Curon Medical, Fremont, California) involves the application of radiofrequency current to the anal canal to generate thermal energy. This procedure causes contraction of collagen fibers, which are permanently shortened, and leads to tightening of the muscle. It is performed under intravenous sedation on an outpatient basis.

This approach is indicated for patients with mild to moderate fecal incontinence who have not responded to conservative management. An external sphincter defect is a contraindication.

Small, nonrandomized studies have found improvement in the CCF-FIS score in patients treated with this approach.¹⁵ The major limitation of this treatment is the lack of high-level clinical evidence demonstrating its efficacy and safety.

Antegrade continence enema
This approach, also known as the Malone procedure, is usually reserved for debilitating incontinence or constipation in the pediatric population. An appendicostomy is constructed at the navel, allowing daily introduction of a catheter and antegrade enema. The purpose is to perform rapid, controlled emptying of the colon at times chosen by the patient. It is also reserved as a last resort for patients considering an ostomy.

Adult patients with neurologic problems, such as spina bifida, may be candidates for this procedure, provided they are highly motivated.

Fecal diversion
Creation of a colostomy or ileostomy is usually the last resort for a patient with fecal incontinence. We are fortunate that there are an increasing number of options that may improve the patient’s condition before colostomy is required.

If fecal diversion is chosen by the patient, it is important to involve an enterostomal therapist for site marking and patient education. A well-constructed ostomy is essential, as this option often is permanent.

Up and coming options
A novel treatment approach for fecal incontinence is the magnetic anal sphincter. The device, marketed as the FENIX Continence Restoration System (Torax Medical, Shoreview, Minnesota) consists of a series of titanium beads with magnetic cores that are interlinked with titanium wires. The device is designed to encircle the external anal sphincter muscle, reinforce the sphincter, and expand to allow passage of stool at a socially appropriate time.

Preliminary data from 16 patients indicate a mean decrease in the number of episodes of incontinence from 7.2/week to 0.7/week, as well as a mean reduction in the CCF-FIS score from 17.2 to 8.7.¹⁶ Two de­vices were removed due to infection, and one device passed spontaneously after disconnection of the suture.¹⁶

This device is not approved by the FDA, but it may become a promising treatment if its safety and efficacy can be established in larger clinical trials.

The TOPAS sling (American Medical Systems) is currently being studied in a Phase 3, multicenter, nonrandomized, clinical trial (NCT01090739) for the treatment of fecal incontinence.¹⁷ The sling is implanted using a minimally invasive transobturator approach; two needle-passers deliver the sling ­assembly. Two small posterior incisions facilitate the postanal placement of the mesh.

This procedure replicates the anorectal angle created by the puborectalis muscle. Although it may become a minimally invasive treatment in the future, final results of the Phase 3 trial are not expected until 2016.

Tibial nerve stimulation is commonly used for urinary urge incontinence. Several small series have documented modest success with its application to fecal incontinence.¹⁸

The outpatient procedure involves the insertion of a needle electrode three fingerbreadths above the medial malleolus, followed by electrical stimulation. The current is slowly increased until a sensory or motor response (tingling under the sole of the foot or great toe plantar flexion) is elicited. Treatment necessitates several outpatient sessions.

In a recent series, the mean CCF-FIS decreased from 12.2/20 at baseline to 9.1/20 ­after treatment (P <.0001).¹⁸

The role of this procedure in the treatment algorithm for fecal incontinence remains to be determined.

What we offer patients
Fecal incontinence is a debilitating condition with an increasing number of potential therapeutic options. It clearly is under-recognized by patients and physicians alike.

After a thorough work-up, conservative treatment options should be offered first. When those fail, we generally recommend a trial of sacral neuromodulation for patients with no sphincter defect. When a sphincter defect is present, we counsel the patient about the merits of sphincter repair versus a trial of neuromodulation. These options have the most robust data supporting their clinical use, and have been used successfully in our own practices.

Given the continuous development of other therapeutic modalities, it is likely that future treatments will involve a stepwise progression of approaches. The need for colostomy should diminish in coming years as more minimally invasive techniques become available. 

Fecal incontinence is a socially embarrassing condition that affects approximately 18 million adults in the United States.¹ Its true incidence is likely much higher than reported, however, as many patients are reluctant to discuss it.

A recent study found that nearly 20% of women experience fecal incontinence at least once a year, and 9.5% experience it al least once a month.² Only 28% of these women had ever discussed their symptoms with a physician, however.³ Women who did seek care were more likely to consult a family physician or internist (75%) than a ­gynecologist (7%).³

Until recently, few options were available for patients with fecal incontinence who had not benefited from conservative measures. Many patients simply had to live with their symptoms or undergo a diverting ostomy to control the chronic involuntary drainage.

Recent years have seen the development of new minimally invasive and highly successful techniques to treat fecal incontinence. Greater awareness of the prevalence of fecal incontinence and its devastating impact on quality of life is needed for this problem to be fully addressed, however. In this article, we review the recommended evaluation of a patient who reports fecal incontinence and describe the range of treatment options.

Fecal incontinence is a symptom, not a diagnosis
Although the most common historical factor contributing to fecal incontinence is obstetric trauma, there are several other causes of this condition. A detailed history and physical examination are vital to determine whether the patient is experiencing true fecal incontinence, or whether she is leaking for other reasons—so-called pseudo-incontinence.

Conditions that can mimic fecal incontinence include:

• prolapsing hemorrhoids
• anal fistula
• sexually transmitted infection
• benign or malignant anorectal neoplasms
• dermatologic conditions.

True fecal incontinence may be active (loss of stool despite the patient’s best effort to control it) or passive (loss of stool without the patient’s awareness). Among the causes of true fecal incontinence are:

• anal sphincter injury (obstetric tear, anorectal surgery such as fistulotomy, or trauma)
• denervation of the pelvic floor from pudendal nerve injury during childbirth
• chronic rectal prolapse
• neurologic conditions (spina bifida, myelomeningocele)
• noncompliant rectum from inflammatory bowel disease
• radiation proctitis.

The maintenance of continence requires a complex interaction between the sphincter muscle, the puborectalis muscle (which acts as a sling), rectal capacity and compliance, stool volume and frequency, and neurologic mechanisms.

Diagnosis and management require an experienced physician
We believe that patients reporting fecal incontinence are best worked up and managed by a physician who is well versed in the various diagnoses associated with fecal incontinence, as well as the most current treatments.

Diagnosis entails some detective work
When a patient reports fecal incontinence, she should be asked to elaborate on the circumstances surrounding the complaint and the frequency of its occurrence, duration of symptoms, and nature of the incontinence (gas, liquid, or solid).
Validated quality-of-life instruments, such as the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS) may be helpful in documenting the severity of the symptoms and improvement after treatment (TABLE).⁴

One factor that current scoring systems fail to capture is urgency. In many instances, urgency is the symptom most distressing to the patient. Be sure to ask about it.

A detailed obstetric history also is important. It is not uncommon for a patient to develop symptoms 20 years or longer after the injury. Also review the patient’s medical history for inflammatory bowel disease, neurologic disorders, and any history of pelvic radiation for help in determining the cause of symptoms.

In addition, ask the patient about any other pelvic floor symptoms, such as voiding dysfunction and problems with pelvic organ prolapse. And question her about stool consistency and frequency. In some cases, diarrhea can lead to fecal incontinence and is usually managed conservatively.

Physical exam: Focus on the perineum and anus
A detailed physical examination is warranted to determine the state of the ­patient’s ­sphincter musculature and rule out other causes of pseudo-incontinence, such as hemorrhoids or anal fistula. Inspect the perineum for thinning of the perineal body and scars from prior surgery.
A patulous anus may be a sign of rectal prolapse. To check for it, ask the patient to strain on the commode. If rectal prolapse is present, it will become apparent upon straining. If prolapse is detected, surgical treatment of the prolapse would be the first step in managing the incontinence.

A simple test of neurologic function is to try to elicit an anal “wink” in response to a pinprick.

A digital rectal exam allows the assessment of resting and squeeze tone, as well as the use of accessory muscles, such as the gluteus maximus, during squeezing.

Rigid or flexible proctoscopy may be indicated to rule out inflammatory bowel disease, radiation proctitis, and rectal neoplasm, depending on the patient’s history. 

A few diagnostic adjuncts can help
Several adjuncts to physical examination can provide more detailed information about the patient’s condition and facilitate the development of an individualized treatment plan. For example, if rectal prolapse, rectocele with delayed emptying, or enterocele is suspected, consider defecography. If voiding dysfunction coexists with the fecal incontinence, urodynamic testing and cystoscopy may be indicated.

We routinely perform physiology testing and endoanal ultrasound if surgery is planned to address the fecal incontinence, although routine use of these adjuncts is controversial. Because many patients can be managed with conservative medical measures, we do not find it necessary to perform these tests at the time of the first visit.

Anal physiology testing includes manometry (a measure of both resting and squeeze tone) and pudendal nerve terminal motor latency testing.

Manometry can help quantify the severity of muscle weakness and determine the presence or absence of normal anal reflexes. Pudendal nerve testing assesses the innervation of the anal sphincter. There is some evidence that patients who have a pudendal neuropathy have a poor outcome with sphincteroplasty,⁵ although that evidence is controversial. The findings from physiology studies have not been correlated with outcomes of newer treatments, such as sacral neuromodulation (InterStim, Medtronic, Minneapolis, Minnesota). Each physiology lab uses different equipment, so “normal” values vary between institutions.                

Endoanal ultrasound is easily performed in an office setting. It is well tolerated and provides anatomic detail of the sphincter musculature. We use a 13-MHz rotating probe to provide 3D imaging of the anal canal. The internal sphincter is represented by a hypoechoic circle surrounded by the hyperechoic external sphincter (FIGURE 1).

In the hands of an experienced examiner, the sensitivity and specificity of endoanal ultrasound in detecting sphincter defects approaches 100%.^6,7 Ultrasound also enables measurement of the perineal body. A normal perineal body measures 10 to 15 mm.

For treatment, try conservative measures first
Bulking agents (fiber), constipating agents (loperamide, etc.), or a laxative regimen with scheduled disimpactions (in patients who have pelvic outlet constipation and overflow incontinence) often can control the symptoms of fecal incontinence, making further interventions unnecessary.

Biofeedback is another option. It uses visual, auditory, and sensory information to train patients to better control anal sphincter muscle function.

A recent randomized study found manometric biofeedback to be superior to simple Kegel exercises in improving fecal continence.⁸ In this study, 76% of patients in the biofeedback group experienced symptom improvement, compared with 41% of patients in the pelvic floor exercise group (P <.001). The long-term benefits of biofeedback are less clear, and patients often need to be reminded to perform their exercises at home and to attend occasional refresher-training sessions. Nevertheless, biofeedback is an important noninvasive option for patients in whom medical management has failed.

Minimally invasive options are now available
Over the past 2 years, minimally invasive treatments for fecal incontinence have emerged, including an implantable sacral neuromodulation device (InterStim) and an injectable dextranomer (Solesta; Salix Pharmaceuticals, Raleigh, North Carolina). Previously, the only surgical option for fecal incontinence was a sphincter repair if a defect was present. The new options may help patients improve their quality of life without having to undergo major surgery.

No one has directly compared the outcomes of these procedures when they are performed by a colorectal surgeon versus a physician of another specialty. It is our belief that the treating physician should have a strong interest in caring for these complex patients and a good working knowledge of the various treatment options.

Related Article Obstetric anal sphincter injury: 7 critical questions about care Ranee Thakar, MD, MRCOG (February 2008)

Sacral neuromodulation
This technique initially was developed for the treatment of overactive bladder and nonobstructive urinary retention and has been used in the United States for the past 15 years for these indications. Improvement in fecal continence was observed in these patients, prompting further studies of its efficacy. In 2011, it was approved by the US Food and Drug Administration (FDA) for the treatment of fecal incontinence. It has since revolutionized the treatment of this disorder, offering a minimally invasive and highly successful alternative to sphincteroplasty.

The InterStim procedure is the only therapeutic modality to include a test phase. The outpatient procedure involves sterile placement of an electrode through the S3 foramen to stimulate the S3 nerve root using fluoroscopic guidance (FIGURES 2 and 3). Patients who experience at least 50% improvement in symptoms are then offered placement of a permanent stimulator.

In most series, approximately 90% of patients have a positive test and progress to implantation. A recent US multicenter clinical trial indicated that 86% of patients achieved an improvement in continence of at least 50%, and 40% of patients were completely continent at 3 years.⁹ The number of episodes of incontinence decreased from a mean of 9.4/week to 1.7/week.⁹ Quality of life also improved greatly. Few complications have been reported, the most notable of which is infection (10.8% in the US multicenter trial⁹).

Another advantage of sacral neuromodulation: It can be used successfully in patients with external sphincter defects as large as 120º. A study by Tjandra and colleagues found that 65% of patients experienced improvement in symptoms of at least 50%, and 47% of patients (more than 50% of whom had external sphincter defects as large as 120º) became completely continent.¹⁰

The only variable shown to predict success with sacral  neuromodulation is a positive response to the test implant procedure.

In our experience, this procedure is easy to perform and well tolerated, even in elderly patients with multiple comorbidities. The procedure has the additional advantage of potentially improving concomitant urinary symptoms as well.

The major disadvantage of sacral neuromodulation is its cost, although most major insurance carriers cover it. There is no well-conducted cost-effectiveness analysis comparing this modality to other treatments.

Related Article Interstim: An implantable device for implacable urinary symptoms Deborah L. Myers, MD (October 2006)

Injectable agents
Several biocompatible bulking agents have been tested in the treatment of fecal incontinence. These compounds traditionally have been used to treat mild fecal incontinence, or to treat patients with isolated internal sphincter defects. 
More recently, an injectable dextranomer in stabilized hyaluronic acid was approved by the FDA and marketed as Solesta. Graf and colleagues randomly allocated 136 patients to injection and 70 patients to sham injection. Patients with external sphincter defects were excluded. At 6 months, 52% of patients in the active treatment group experienced an improvement in continence of at least 50%, compared with 31% of patients injected with placebo.¹¹

The advantage of this procedure is its minimally invasive nature (submucosal injection performed in the office). The disadvantage: a lack of long-term efficacy data, although unpublished data suggest that patients who improve after an injection see a durable response at 3 years.

This easy, office-based treatment is ideal for patients with minor incontinence or persistent symptoms after another procedure.

Sphincter repair
Anterior sphincteroplasty has been the mainstay of surgical treatment for patients with a sphincter defect. With the patient in a dorsal lithotomy or prone position on the ­operating-room table, a transverse perineal incision is made, and the ends of the severed sphincter muscle are located and mobilized. The repair then can be performed in an end-to-end manner or by overlapping the muscles in the anterior midline (FIGURE 4).

Some of the debatable technical issues of this procedure include:

• whether to overlap the muscles or scar tissue
• whether to repair internal and external defects together or separately
• how the age of the patient affects the outcome.

In regard to the first issue, there may be a superior outcome with overlapping repairs, but they carry a higher risk of dyspareunia and evacuation difficulties. Some surgeons will attempt a separate repair of the internal and external sphincter muscles if it appears feasible. Most often, both muscles are ­tethered together with scar tissue and separate repair is not possible. There are no conclusive data to demonstrate the superiority of either approach.

As for age, the traditional teaching was that older patients do not benefit from this procedure as much as younger patients do. However, a recent study found no differences in the CCF-FIS score in patients older than age 60, compared with younger patients.¹² Investigators concluded that sphincteroplasty can be offered to both young and older ­patients.¹²

Although sphincteroplasty often leads to excellent short-term improvement, with 60% to 90% of patients experiencing a good or excellent outcome, nearly all series indicate a decline over the long term (>5 years). A recent systematic review found that as few as 12% of patients experience a good or excellent result, depending on the series.¹³

We offer sphincter repair to young women with a new sphincter defect after delivery. For older patients, we offer sacral neuromodulation as a first-line treatment.

Other surgical options
We believe that most patients with fecal incontinence can be managed using conservative measures, sacral neuromodulation, injectable dextranomer, or sphincter repair. However, several other options are available.

Artificial bowel sphincter
The artificial bowel sphincter was first described in 1987 and has been modified over the years. The system currently is marketed as the Acticon Neosphincter (American Medical Systems, Minnetonka, Minnesota). The procedure involves the creation of a subcutaneous tunnel around the anus so that an inflatable cuff can be positioned there. A pump then is tunneled through a Pfannenstiel incision to the labia or scrotum, and a reservoir is positioned in the space of Retzius. The device maintains continence by keeping the cuff inflated during the resting state and by pumping fluid from the cuff to the reservoir when the patient needs to evacuate.

The major barrier to utilization of the artificial bowel sphincter is infection. In a series of 112 patients who were implanted with the sphincter, 384 device-related adverse events occurred in 99 patients.¹⁴ A total of 73 revision operations were required in 51 patients (46%). Twenty-five percent of patients developed infection that required surgical revision, and 37% had the device explanted. Eighty-five percent of patients with a functional device had a successful outcome.¹⁴

Given the device-related challenges and infectious complications, patients should be considered for less invasive treatments before being offered an artificial bowel
sphincter.

Radiofrequency current
The Secca procedure (Curon Medical, Fremont, California) involves the application of radiofrequency current to the anal canal to generate thermal energy. This procedure causes contraction of collagen fibers, which are permanently shortened, and leads to tightening of the muscle. It is performed under intravenous sedation on an outpatient basis.

This approach is indicated for patients with mild to moderate fecal incontinence who have not responded to conservative management. An external sphincter defect is a contraindication.

Small, nonrandomized studies have found improvement in the CCF-FIS score in patients treated with this approach.¹⁵ The major limitation of this treatment is the lack of high-level clinical evidence demonstrating its efficacy and safety.

Antegrade continence enema
This approach, also known as the Malone procedure, is usually reserved for debilitating incontinence or constipation in the pediatric population. An appendicostomy is constructed at the navel, allowing daily introduction of a catheter and antegrade enema. The purpose is to perform rapid, controlled emptying of the colon at times chosen by the patient. It is also reserved as a last resort for patients considering an ostomy.

Adult patients with neurologic problems, such as spina bifida, may be candidates for this procedure, provided they are highly motivated.

Fecal diversion
Creation of a colostomy or ileostomy is usually the last resort for a patient with fecal incontinence. We are fortunate that there are an increasing number of options that may improve the patient’s condition before colostomy is required.

If fecal diversion is chosen by the patient, it is important to involve an enterostomal therapist for site marking and patient education. A well-constructed ostomy is essential, as this option often is permanent.

Up and coming options
A novel treatment approach for fecal incontinence is the magnetic anal sphincter. The device, marketed as the FENIX Continence Restoration System (Torax Medical, Shoreview, Minnesota) consists of a series of titanium beads with magnetic cores that are interlinked with titanium wires. The device is designed to encircle the external anal sphincter muscle, reinforce the sphincter, and expand to allow passage of stool at a socially appropriate time.

Preliminary data from 16 patients indicate a mean decrease in the number of episodes of incontinence from 7.2/week to 0.7/week, as well as a mean reduction in the CCF-FIS score from 17.2 to 8.7.¹⁶ Two de­vices were removed due to infection, and one device passed spontaneously after disconnection of the suture.¹⁶

This device is not approved by the FDA, but it may become a promising treatment if its safety and efficacy can be established in larger clinical trials.

The TOPAS sling (American Medical Systems) is currently being studied in a Phase 3, multicenter, nonrandomized, clinical trial (NCT01090739) for the treatment of fecal incontinence.¹⁷ The sling is implanted using a minimally invasive transobturator approach; two needle-passers deliver the sling ­assembly. Two small posterior incisions facilitate the postanal placement of the mesh.

This procedure replicates the anorectal angle created by the puborectalis muscle. Although it may become a minimally invasive treatment in the future, final results of the Phase 3 trial are not expected until 2016.

Tibial nerve stimulation is commonly used for urinary urge incontinence. Several small series have documented modest success with its application to fecal incontinence.¹⁸

The outpatient procedure involves the insertion of a needle electrode three fingerbreadths above the medial malleolus, followed by electrical stimulation. The current is slowly increased until a sensory or motor response (tingling under the sole of the foot or great toe plantar flexion) is elicited. Treatment necessitates several outpatient sessions.

In a recent series, the mean CCF-FIS decreased from 12.2/20 at baseline to 9.1/20 ­after treatment (P <.0001).¹⁸

The role of this procedure in the treatment algorithm for fecal incontinence remains to be determined.

What we offer patients
Fecal incontinence is a debilitating condition with an increasing number of potential therapeutic options. It clearly is under-recognized by patients and physicians alike.

After a thorough work-up, conservative treatment options should be offered first. When those fail, we generally recommend a trial of sacral neuromodulation for patients with no sphincter defect. When a sphincter defect is present, we counsel the patient about the merits of sphincter repair versus a trial of neuromodulation. These options have the most robust data supporting their clinical use, and have been used successfully in our own practices.

Given the continuous development of other therapeutic modalities, it is likely that future treatments will involve a stepwise progression of approaches. The need for colostomy should diminish in coming years as more minimally invasive techniques become available. 

Fecal incontinence is a socially embarrassing condition that affects approximately 18 million adults in the United States.¹ Its true incidence is likely much higher than reported, however, as many patients are reluctant to discuss it.

A recent study found that nearly 20% of women experience fecal incontinence at least once a year, and 9.5% experience it al least once a month.² Only 28% of these women had ever discussed their symptoms with a physician, however.³ Women who did seek care were more likely to consult a family physician or internist (75%) than a ­gynecologist (7%).³

Until recently, few options were available for patients with fecal incontinence who had not benefited from conservative measures. Many patients simply had to live with their symptoms or undergo a diverting ostomy to control the chronic involuntary drainage.

Recent years have seen the development of new minimally invasive and highly successful techniques to treat fecal incontinence. Greater awareness of the prevalence of fecal incontinence and its devastating impact on quality of life is needed for this problem to be fully addressed, however. In this article, we review the recommended evaluation of a patient who reports fecal incontinence and describe the range of treatment options.

Fecal incontinence is a symptom, not a diagnosis
Although the most common historical factor contributing to fecal incontinence is obstetric trauma, there are several other causes of this condition. A detailed history and physical examination are vital to determine whether the patient is experiencing true fecal incontinence, or whether she is leaking for other reasons—so-called pseudo-incontinence.

Conditions that can mimic fecal incontinence include:

• prolapsing hemorrhoids
• anal fistula
• sexually transmitted infection
• benign or malignant anorectal neoplasms
• dermatologic conditions.

True fecal incontinence may be active (loss of stool despite the patient’s best effort to control it) or passive (loss of stool without the patient’s awareness). Among the causes of true fecal incontinence are:

• anal sphincter injury (obstetric tear, anorectal surgery such as fistulotomy, or trauma)
• denervation of the pelvic floor from pudendal nerve injury during childbirth
• chronic rectal prolapse
• neurologic conditions (spina bifida, myelomeningocele)
• noncompliant rectum from inflammatory bowel disease
• radiation proctitis.

The maintenance of continence requires a complex interaction between the sphincter muscle, the puborectalis muscle (which acts as a sling), rectal capacity and compliance, stool volume and frequency, and neurologic mechanisms.

Diagnosis and management require an experienced physician
We believe that patients reporting fecal incontinence are best worked up and managed by a physician who is well versed in the various diagnoses associated with fecal incontinence, as well as the most current treatments.

Diagnosis entails some detective work
When a patient reports fecal incontinence, she should be asked to elaborate on the circumstances surrounding the complaint and the frequency of its occurrence, duration of symptoms, and nature of the incontinence (gas, liquid, or solid).
Validated quality-of-life instruments, such as the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS) may be helpful in documenting the severity of the symptoms and improvement after treatment (TABLE).⁴

One factor that current scoring systems fail to capture is urgency. In many instances, urgency is the symptom most distressing to the patient. Be sure to ask about it.

A detailed obstetric history also is important. It is not uncommon for a patient to develop symptoms 20 years or longer after the injury. Also review the patient’s medical history for inflammatory bowel disease, neurologic disorders, and any history of pelvic radiation for help in determining the cause of symptoms.

In addition, ask the patient about any other pelvic floor symptoms, such as voiding dysfunction and problems with pelvic organ prolapse. And question her about stool consistency and frequency. In some cases, diarrhea can lead to fecal incontinence and is usually managed conservatively.

Physical exam: Focus on the perineum and anus
A detailed physical examination is warranted to determine the state of the ­patient’s ­sphincter musculature and rule out other causes of pseudo-incontinence, such as hemorrhoids or anal fistula. Inspect the perineum for thinning of the perineal body and scars from prior surgery.
A patulous anus may be a sign of rectal prolapse. To check for it, ask the patient to strain on the commode. If rectal prolapse is present, it will become apparent upon straining. If prolapse is detected, surgical treatment of the prolapse would be the first step in managing the incontinence.

A simple test of neurologic function is to try to elicit an anal “wink” in response to a pinprick.

A digital rectal exam allows the assessment of resting and squeeze tone, as well as the use of accessory muscles, such as the gluteus maximus, during squeezing.

Rigid or flexible proctoscopy may be indicated to rule out inflammatory bowel disease, radiation proctitis, and rectal neoplasm, depending on the patient’s history. 

A few diagnostic adjuncts can help
Several adjuncts to physical examination can provide more detailed information about the patient’s condition and facilitate the development of an individualized treatment plan. For example, if rectal prolapse, rectocele with delayed emptying, or enterocele is suspected, consider defecography. If voiding dysfunction coexists with the fecal incontinence, urodynamic testing and cystoscopy may be indicated.

We routinely perform physiology testing and endoanal ultrasound if surgery is planned to address the fecal incontinence, although routine use of these adjuncts is controversial. Because many patients can be managed with conservative medical measures, we do not find it necessary to perform these tests at the time of the first visit.

Anal physiology testing includes manometry (a measure of both resting and squeeze tone) and pudendal nerve terminal motor latency testing.

Manometry can help quantify the severity of muscle weakness and determine the presence or absence of normal anal reflexes. Pudendal nerve testing assesses the innervation of the anal sphincter. There is some evidence that patients who have a pudendal neuropathy have a poor outcome with sphincteroplasty,⁵ although that evidence is controversial. The findings from physiology studies have not been correlated with outcomes of newer treatments, such as sacral neuromodulation (InterStim, Medtronic, Minneapolis, Minnesota). Each physiology lab uses different equipment, so “normal” values vary between institutions.                

Endoanal ultrasound is easily performed in an office setting. It is well tolerated and provides anatomic detail of the sphincter musculature. We use a 13-MHz rotating probe to provide 3D imaging of the anal canal. The internal sphincter is represented by a hypoechoic circle surrounded by the hyperechoic external sphincter (FIGURE 1).

In the hands of an experienced examiner, the sensitivity and specificity of endoanal ultrasound in detecting sphincter defects approaches 100%.^6,7 Ultrasound also enables measurement of the perineal body. A normal perineal body measures 10 to 15 mm.

For treatment, try conservative measures first
Bulking agents (fiber), constipating agents (loperamide, etc.), or a laxative regimen with scheduled disimpactions (in patients who have pelvic outlet constipation and overflow incontinence) often can control the symptoms of fecal incontinence, making further interventions unnecessary.

Biofeedback is another option. It uses visual, auditory, and sensory information to train patients to better control anal sphincter muscle function.

A recent randomized study found manometric biofeedback to be superior to simple Kegel exercises in improving fecal continence.⁸ In this study, 76% of patients in the biofeedback group experienced symptom improvement, compared with 41% of patients in the pelvic floor exercise group (P <.001). The long-term benefits of biofeedback are less clear, and patients often need to be reminded to perform their exercises at home and to attend occasional refresher-training sessions. Nevertheless, biofeedback is an important noninvasive option for patients in whom medical management has failed.

Minimally invasive options are now available
Over the past 2 years, minimally invasive treatments for fecal incontinence have emerged, including an implantable sacral neuromodulation device (InterStim) and an injectable dextranomer (Solesta; Salix Pharmaceuticals, Raleigh, North Carolina). Previously, the only surgical option for fecal incontinence was a sphincter repair if a defect was present. The new options may help patients improve their quality of life without having to undergo major surgery.

No one has directly compared the outcomes of these procedures when they are performed by a colorectal surgeon versus a physician of another specialty. It is our belief that the treating physician should have a strong interest in caring for these complex patients and a good working knowledge of the various treatment options.

Related Article Obstetric anal sphincter injury: 7 critical questions about care Ranee Thakar, MD, MRCOG (February 2008)

Sacral neuromodulation
This technique initially was developed for the treatment of overactive bladder and nonobstructive urinary retention and has been used in the United States for the past 15 years for these indications. Improvement in fecal continence was observed in these patients, prompting further studies of its efficacy. In 2011, it was approved by the US Food and Drug Administration (FDA) for the treatment of fecal incontinence. It has since revolutionized the treatment of this disorder, offering a minimally invasive and highly successful alternative to sphincteroplasty.

The InterStim procedure is the only therapeutic modality to include a test phase. The outpatient procedure involves sterile placement of an electrode through the S3 foramen to stimulate the S3 nerve root using fluoroscopic guidance (FIGURES 2 and 3). Patients who experience at least 50% improvement in symptoms are then offered placement of a permanent stimulator.

In most series, approximately 90% of patients have a positive test and progress to implantation. A recent US multicenter clinical trial indicated that 86% of patients achieved an improvement in continence of at least 50%, and 40% of patients were completely continent at 3 years.⁹ The number of episodes of incontinence decreased from a mean of 9.4/week to 1.7/week.⁹ Quality of life also improved greatly. Few complications have been reported, the most notable of which is infection (10.8% in the US multicenter trial⁹).

Another advantage of sacral neuromodulation: It can be used successfully in patients with external sphincter defects as large as 120º. A study by Tjandra and colleagues found that 65% of patients experienced improvement in symptoms of at least 50%, and 47% of patients (more than 50% of whom had external sphincter defects as large as 120º) became completely continent.¹⁰

The only variable shown to predict success with sacral  neuromodulation is a positive response to the test implant procedure.

In our experience, this procedure is easy to perform and well tolerated, even in elderly patients with multiple comorbidities. The procedure has the additional advantage of potentially improving concomitant urinary symptoms as well.

The major disadvantage of sacral neuromodulation is its cost, although most major insurance carriers cover it. There is no well-conducted cost-effectiveness analysis comparing this modality to other treatments.

Related Article Interstim: An implantable device for implacable urinary symptoms Deborah L. Myers, MD (October 2006)

Injectable agents
Several biocompatible bulking agents have been tested in the treatment of fecal incontinence. These compounds traditionally have been used to treat mild fecal incontinence, or to treat patients with isolated internal sphincter defects. 
More recently, an injectable dextranomer in stabilized hyaluronic acid was approved by the FDA and marketed as Solesta. Graf and colleagues randomly allocated 136 patients to injection and 70 patients to sham injection. Patients with external sphincter defects were excluded. At 6 months, 52% of patients in the active treatment group experienced an improvement in continence of at least 50%, compared with 31% of patients injected with placebo.¹¹

The advantage of this procedure is its minimally invasive nature (submucosal injection performed in the office). The disadvantage: a lack of long-term efficacy data, although unpublished data suggest that patients who improve after an injection see a durable response at 3 years.

This easy, office-based treatment is ideal for patients with minor incontinence or persistent symptoms after another procedure.

Sphincter repair
Anterior sphincteroplasty has been the mainstay of surgical treatment for patients with a sphincter defect. With the patient in a dorsal lithotomy or prone position on the ­operating-room table, a transverse perineal incision is made, and the ends of the severed sphincter muscle are located and mobilized. The repair then can be performed in an end-to-end manner or by overlapping the muscles in the anterior midline (FIGURE 4).

Some of the debatable technical issues of this procedure include:

• whether to overlap the muscles or scar tissue
• whether to repair internal and external defects together or separately
• how the age of the patient affects the outcome.

In regard to the first issue, there may be a superior outcome with overlapping repairs, but they carry a higher risk of dyspareunia and evacuation difficulties. Some surgeons will attempt a separate repair of the internal and external sphincter muscles if it appears feasible. Most often, both muscles are ­tethered together with scar tissue and separate repair is not possible. There are no conclusive data to demonstrate the superiority of either approach.

As for age, the traditional teaching was that older patients do not benefit from this procedure as much as younger patients do. However, a recent study found no differences in the CCF-FIS score in patients older than age 60, compared with younger patients.¹² Investigators concluded that sphincteroplasty can be offered to both young and older ­patients.¹²

Although sphincteroplasty often leads to excellent short-term improvement, with 60% to 90% of patients experiencing a good or excellent outcome, nearly all series indicate a decline over the long term (>5 years). A recent systematic review found that as few as 12% of patients experience a good or excellent result, depending on the series.¹³

We offer sphincter repair to young women with a new sphincter defect after delivery. For older patients, we offer sacral neuromodulation as a first-line treatment.

Other surgical options
We believe that most patients with fecal incontinence can be managed using conservative measures, sacral neuromodulation, injectable dextranomer, or sphincter repair. However, several other options are available.

Artificial bowel sphincter
The artificial bowel sphincter was first described in 1987 and has been modified over the years. The system currently is marketed as the Acticon Neosphincter (American Medical Systems, Minnetonka, Minnesota). The procedure involves the creation of a subcutaneous tunnel around the anus so that an inflatable cuff can be positioned there. A pump then is tunneled through a Pfannenstiel incision to the labia or scrotum, and a reservoir is positioned in the space of Retzius. The device maintains continence by keeping the cuff inflated during the resting state and by pumping fluid from the cuff to the reservoir when the patient needs to evacuate.

The major barrier to utilization of the artificial bowel sphincter is infection. In a series of 112 patients who were implanted with the sphincter, 384 device-related adverse events occurred in 99 patients.¹⁴ A total of 73 revision operations were required in 51 patients (46%). Twenty-five percent of patients developed infection that required surgical revision, and 37% had the device explanted. Eighty-five percent of patients with a functional device had a successful outcome.¹⁴

Given the device-related challenges and infectious complications, patients should be considered for less invasive treatments before being offered an artificial bowel
sphincter.

Radiofrequency current
The Secca procedure (Curon Medical, Fremont, California) involves the application of radiofrequency current to the anal canal to generate thermal energy. This procedure causes contraction of collagen fibers, which are permanently shortened, and leads to tightening of the muscle. It is performed under intravenous sedation on an outpatient basis.

This approach is indicated for patients with mild to moderate fecal incontinence who have not responded to conservative management. An external sphincter defect is a contraindication.

Small, nonrandomized studies have found improvement in the CCF-FIS score in patients treated with this approach.¹⁵ The major limitation of this treatment is the lack of high-level clinical evidence demonstrating its efficacy and safety.

Antegrade continence enema
This approach, also known as the Malone procedure, is usually reserved for debilitating incontinence or constipation in the pediatric population. An appendicostomy is constructed at the navel, allowing daily introduction of a catheter and antegrade enema. The purpose is to perform rapid, controlled emptying of the colon at times chosen by the patient. It is also reserved as a last resort for patients considering an ostomy.

Adult patients with neurologic problems, such as spina bifida, may be candidates for this procedure, provided they are highly motivated.

Fecal diversion
Creation of a colostomy or ileostomy is usually the last resort for a patient with fecal incontinence. We are fortunate that there are an increasing number of options that may improve the patient’s condition before colostomy is required.

If fecal diversion is chosen by the patient, it is important to involve an enterostomal therapist for site marking and patient education. A well-constructed ostomy is essential, as this option often is permanent.

Up and coming options
A novel treatment approach for fecal incontinence is the magnetic anal sphincter. The device, marketed as the FENIX Continence Restoration System (Torax Medical, Shoreview, Minnesota) consists of a series of titanium beads with magnetic cores that are interlinked with titanium wires. The device is designed to encircle the external anal sphincter muscle, reinforce the sphincter, and expand to allow passage of stool at a socially appropriate time.

Preliminary data from 16 patients indicate a mean decrease in the number of episodes of incontinence from 7.2/week to 0.7/week, as well as a mean reduction in the CCF-FIS score from 17.2 to 8.7.¹⁶ Two de­vices were removed due to infection, and one device passed spontaneously after disconnection of the suture.¹⁶

This device is not approved by the FDA, but it may become a promising treatment if its safety and efficacy can be established in larger clinical trials.

The TOPAS sling (American Medical Systems) is currently being studied in a Phase 3, multicenter, nonrandomized, clinical trial (NCT01090739) for the treatment of fecal incontinence.¹⁷ The sling is implanted using a minimally invasive transobturator approach; two needle-passers deliver the sling ­assembly. Two small posterior incisions facilitate the postanal placement of the mesh.

This procedure replicates the anorectal angle created by the puborectalis muscle. Although it may become a minimally invasive treatment in the future, final results of the Phase 3 trial are not expected until 2016.

Tibial nerve stimulation is commonly used for urinary urge incontinence. Several small series have documented modest success with its application to fecal incontinence.¹⁸

The outpatient procedure involves the insertion of a needle electrode three fingerbreadths above the medial malleolus, followed by electrical stimulation. The current is slowly increased until a sensory or motor response (tingling under the sole of the foot or great toe plantar flexion) is elicited. Treatment necessitates several outpatient sessions.

In a recent series, the mean CCF-FIS decreased from 12.2/20 at baseline to 9.1/20 ­after treatment (P <.0001).¹⁸

The role of this procedure in the treatment algorithm for fecal incontinence remains to be determined.

What we offer patients
Fecal incontinence is a debilitating condition with an increasing number of potential therapeutic options. It clearly is under-recognized by patients and physicians alike.

After a thorough work-up, conservative treatment options should be offered first. When those fail, we generally recommend a trial of sacral neuromodulation for patients with no sphincter defect. When a sphincter defect is present, we counsel the patient about the merits of sphincter repair versus a trial of neuromodulation. These options have the most robust data supporting their clinical use, and have been used successfully in our own practices.

Given the continuous development of other therapeutic modalities, it is likely that future treatments will involve a stepwise progression of approaches. The need for colostomy should diminish in coming years as more minimally invasive techniques become available. 

Attention deficit is a common diagnosis with which many pediatricians are faced. In the more common scenario, the child presents anywhere from age 5 to 10 years with parental and teacher complaint of hyperactivity or academic underachievement. But, what do you do with the child who presents at age 11 years or high school age with no significant history of school failure or behavior issues? Is this a child whose symptoms were overlooked? New-onset inattention? Are they seeking medication to augment their intellectual ability to become more competitive? Or are they just drug seeking? Well, the truth is that any one of the above could be true, and only through careful analysis can you obtain the proper diagnosis.

For the adolescent that meets the DSM-IV criteria for attention-deficit/hyperactivity disorder (ADHD), it is possible that they have learned to compensate for their inattention and have been successful in maintaining a good grade-point average. Through detailed questioning about study habits and home environment, they likely required a lot of support from their parents to maintain organization and from tutors. Many children without comorbid conditions are very intelligent and are able to keep up with the course load until they reach high school. The demands for independence and the amount of class work required start to become overwhelming and grades start to decline. These children tend to do very well on stimulant medication.

Now for the child who presents with absolutely no past history of inattention, disorganization, hyperactivity, or impulsive behavior, it is important to do a detailed physical exam looking for symptoms that are consistent with Wilson’s disease, hyperthyroidism, or drug use. A careful social history will identify symptoms of depression, anxiety, and disruption within the home such as divorce, domestic violence, etc. Questions regarding school and social pressure such as bullying also are important to ask to identify a cause for the acute onset of inattention.

Red flags should be raised with a teen who has socially withdrawn, has defiant or high risk taking behaviors, and a history of illicit drug use. According to a study published in the British Journal of Psychiatry, stimulant used as prescribed actually lowers the risk of substance abuse (Br. J. Psychiatry 2013 [doi:10.1192/bjp.bp.112.124784]). But according to the National Institute of Drug Abuse, teens are using the stimulants to get a high by snorting or injecting the stimulant, making Adderall a hot commodity on college campuses. Stimulants are also used to "cram" for tests so teens are taking them to stay awake to study. Stimulants coupled with excessive caffeine lead to increased heart rates and blood pressure, as well as panic attacks. The DAWN Report (Drug Abuse Warning Network) published a warning on Jan. 24, 2013, stating that the number of emergency room visits increased threefold in young adults over the age of 18 years. Only a small increase was noted in teens aged 12-17 years, but they all were related to using stimulants improperly.

Choosing the right stimulant for the adolescent must take into consideration their social environment and their risk of drug abuse. Given that Adderall is an amphetamine, it should be used with caution and careful supervision, but since all stimulants can be abused, the same caution applies to them as well.

ADHD prevalence in adolescents aged 11-17 years is 10%-15% (CDC Weekly; Nov.12, 2010;59:1439-43). So evaluation and proper treatment can mean school success and continuing on to college. The diagnosis should not be excluded because it was not identified earlier, but other diagnoses must be considered.

Dr Pearce is a pediatrician in Frankfort, Ill.

[email protected]

Attention deficit is a common diagnosis with which many pediatricians are faced. In the more common scenario, the child presents anywhere from age 5 to 10 years with parental and teacher complaint of hyperactivity or academic underachievement. But, what do you do with the child who presents at age 11 years or high school age with no significant history of school failure or behavior issues? Is this a child whose symptoms were overlooked? New-onset inattention? Are they seeking medication to augment their intellectual ability to become more competitive? Or are they just drug seeking? Well, the truth is that any one of the above could be true, and only through careful analysis can you obtain the proper diagnosis.

For the adolescent that meets the DSM-IV criteria for attention-deficit/hyperactivity disorder (ADHD), it is possible that they have learned to compensate for their inattention and have been successful in maintaining a good grade-point average. Through detailed questioning about study habits and home environment, they likely required a lot of support from their parents to maintain organization and from tutors. Many children without comorbid conditions are very intelligent and are able to keep up with the course load until they reach high school. The demands for independence and the amount of class work required start to become overwhelming and grades start to decline. These children tend to do very well on stimulant medication.

Now for the child who presents with absolutely no past history of inattention, disorganization, hyperactivity, or impulsive behavior, it is important to do a detailed physical exam looking for symptoms that are consistent with Wilson’s disease, hyperthyroidism, or drug use. A careful social history will identify symptoms of depression, anxiety, and disruption within the home such as divorce, domestic violence, etc. Questions regarding school and social pressure such as bullying also are important to ask to identify a cause for the acute onset of inattention.

Red flags should be raised with a teen who has socially withdrawn, has defiant or high risk taking behaviors, and a history of illicit drug use. According to a study published in the British Journal of Psychiatry, stimulant used as prescribed actually lowers the risk of substance abuse (Br. J. Psychiatry 2013 [doi:10.1192/bjp.bp.112.124784]). But according to the National Institute of Drug Abuse, teens are using the stimulants to get a high by snorting or injecting the stimulant, making Adderall a hot commodity on college campuses. Stimulants are also used to "cram" for tests so teens are taking them to stay awake to study. Stimulants coupled with excessive caffeine lead to increased heart rates and blood pressure, as well as panic attacks. The DAWN Report (Drug Abuse Warning Network) published a warning on Jan. 24, 2013, stating that the number of emergency room visits increased threefold in young adults over the age of 18 years. Only a small increase was noted in teens aged 12-17 years, but they all were related to using stimulants improperly.

Choosing the right stimulant for the adolescent must take into consideration their social environment and their risk of drug abuse. Given that Adderall is an amphetamine, it should be used with caution and careful supervision, but since all stimulants can be abused, the same caution applies to them as well.

ADHD prevalence in adolescents aged 11-17 years is 10%-15% (CDC Weekly; Nov.12, 2010;59:1439-43). So evaluation and proper treatment can mean school success and continuing on to college. The diagnosis should not be excluded because it was not identified earlier, but other diagnoses must be considered.

Dr Pearce is a pediatrician in Frankfort, Ill.

[email protected]

Attention deficit is a common diagnosis with which many pediatricians are faced. In the more common scenario, the child presents anywhere from age 5 to 10 years with parental and teacher complaint of hyperactivity or academic underachievement. But, what do you do with the child who presents at age 11 years or high school age with no significant history of school failure or behavior issues? Is this a child whose symptoms were overlooked? New-onset inattention? Are they seeking medication to augment their intellectual ability to become more competitive? Or are they just drug seeking? Well, the truth is that any one of the above could be true, and only through careful analysis can you obtain the proper diagnosis.

For the adolescent that meets the DSM-IV criteria for attention-deficit/hyperactivity disorder (ADHD), it is possible that they have learned to compensate for their inattention and have been successful in maintaining a good grade-point average. Through detailed questioning about study habits and home environment, they likely required a lot of support from their parents to maintain organization and from tutors. Many children without comorbid conditions are very intelligent and are able to keep up with the course load until they reach high school. The demands for independence and the amount of class work required start to become overwhelming and grades start to decline. These children tend to do very well on stimulant medication.

Now for the child who presents with absolutely no past history of inattention, disorganization, hyperactivity, or impulsive behavior, it is important to do a detailed physical exam looking for symptoms that are consistent with Wilson’s disease, hyperthyroidism, or drug use. A careful social history will identify symptoms of depression, anxiety, and disruption within the home such as divorce, domestic violence, etc. Questions regarding school and social pressure such as bullying also are important to ask to identify a cause for the acute onset of inattention.

Red flags should be raised with a teen who has socially withdrawn, has defiant or high risk taking behaviors, and a history of illicit drug use. According to a study published in the British Journal of Psychiatry, stimulant used as prescribed actually lowers the risk of substance abuse (Br. J. Psychiatry 2013 [doi:10.1192/bjp.bp.112.124784]). But according to the National Institute of Drug Abuse, teens are using the stimulants to get a high by snorting or injecting the stimulant, making Adderall a hot commodity on college campuses. Stimulants are also used to "cram" for tests so teens are taking them to stay awake to study. Stimulants coupled with excessive caffeine lead to increased heart rates and blood pressure, as well as panic attacks. The DAWN Report (Drug Abuse Warning Network) published a warning on Jan. 24, 2013, stating that the number of emergency room visits increased threefold in young adults over the age of 18 years. Only a small increase was noted in teens aged 12-17 years, but they all were related to using stimulants improperly.

Choosing the right stimulant for the adolescent must take into consideration their social environment and their risk of drug abuse. Given that Adderall is an amphetamine, it should be used with caution and careful supervision, but since all stimulants can be abused, the same caution applies to them as well.

ADHD prevalence in adolescents aged 11-17 years is 10%-15% (CDC Weekly; Nov.12, 2010;59:1439-43). So evaluation and proper treatment can mean school success and continuing on to college. The diagnosis should not be excluded because it was not identified earlier, but other diagnoses must be considered.

Dr Pearce is a pediatrician in Frankfort, Ill.

[email protected]

Our nation is in the midst of an inexorable shift in health care delivery from "pay for volume" to "pay for value." It is well documented that our current largely fee-for-service system is unsustainable and a dramatic incentive shift must occur. Every provider needs to be committed to providing the highest quality at the lowest cost. This is the fundamental goal of the pay-for-value system.

If quality and patient satisfaction criteria are met and providers working together in an accountable care organization or similar entity create savings for a defined patient population, then the ACO usually gets a portion of the savings, commonly 50%. Unlike capitated arrangements, shared savings arrangements can avoid or limit downside financial risk and therefore can serve as stepping-stones toward fuller accountability and incentives. They are quite appropriate for start-up and smaller ACOs.

The ACO gets the savings, if there are any. But what the ACO does with them is crucial to the success and sustainability of the organization. "ACOs must offer a realistic and achievable opportunity for providers to share in the savings created from delivering higher-value care. The incentive system must reward providers for delivering efficient care as opposed to the current volume-driven system" (The ACO Toolkit; the Dartmouth Institute, p. 9, Jan. 2011).

If providers or hospital stakeholders feel that their efforts to drive value are not being fairly recognized, they will no longer participate meaningfully, the goals of value-based medicine will be thwarted, and savings will not occur in the long-run. Before signing a participation contract, physicians should scrutinize how each ACO plans to distribute the savings it receives.

The Centers for Medicare and Medicaid Services administers the Medicare Shared Savings Program (MSSP). The fact that CMS’s regulations concerning MSSP are not prescriptive about a given savings distribution formula gives ACOs flexibility in this area. But the regulations are specific about the ultimate purpose of distributions: "As part of its application, an ACO must describe the following: (1) how it plans to use shared savings payments, including the criteria it plans to employ for distributing shared savings among its ACO participants and ACO providers/suppliers, ... and (3) how the proposed plan will achieve the general aims of better care for individuals, better health for populations, and lower growth in expenditures" (42 CFR 425.204(d), 76 Fed. Reg. 6798 [Nov. 2, 2011]).

Fatal flaw?

Some ACOs, however, have lost sight of the fact that failure to have a fair shared savings distribution formula (linking relative distributions to relative contributions) will be fatal to its sustainability. Some view them as "profits" to go to the owners or shareholders. Some simply lock in a fixed allocation similar to fee-for-service payment ratios, without regard to who generated the savings. Some employers of physicians have contracted to compensate only on a work production basis with zero performance incentive payments at all. Other ACOs are putting off the issue because it is sensitive culturally. As health care moves more and more to value-based compensation, the distribution of savings must be viewed primarily as the providers’ professional remuneration and not corporate "profit." Payments for administrative services and debt service must, of course, come out of the savings distribution to "keep the pump primed," but they should be carefully managed. The bulk must be distributed in proportion to contribution toward quality and cost-effective care.

One physician stated, "No physician is going to join an ACO when someone else is telling them what they are worth unless they know that the savings distribution formula is impeccably fair." To those putting off design of a fair merit-based compensation system until there is more physician buy-in, we respectfully submit that you cannot get buy-in without one.

A need for honed metrics

Yes, this concept is pretty basic when you think about it. But though it may be easy to understand, it can be complex to implement, especially when multiple specialists and facilities are involved in an ACO’s care coordination. One not only needs to determine the relative potential and actual value contribution for each provider, but also the clinically valid metrics by which to measure them. Under fee for service, metrics for success were usually transactional and objective (in other words, volume of procedure times rate). An ACO’s success metrics may be neither. Success may come from things not happening (that is, fewer ED visits, avoidable admissions, and reduced readmissions). At the same time, the distribution model needs to be clear, practical, and capable of being understood by all.

But there can be a replicable framework for any ACO to use to create a fair and sustainable shared savings distribution model. There are necessary subjective judgments – at this time, many metrics are imprecise or nonexistent – and the sophistication of the distribution process must parallel the sophistication of the ACO’s infrastructure. But, if the right people are involved and apply the ACO’s guiding principles on savings allocation, participants will be appropriately incentivized. The precision of distribution application will grow over time. Don’t let the perfect be the enemy of the good.

The six guiding principles for shared savings distribution

Though application will vary widely because of differing circumstances and types of initiatives, chances for success will increase if every activity can be judged by whether it is consistent with a set of guiding principles viewed as fair by the ACO members. You may want to consider a savings distribution formula with the following principles:

• Eyes on the prize: Triple Aim. It offers incentives for the delivery of high-quality and cost-effective care to achieve the Triple Aim – better care for individuals, better health for populations, and lower per capita costs.

• Broad provider input. It is the result of input from a diverse spectrum of knowledgeable providers who understand what drives patient population value.

• Fairness. It is fair to all in that it links relative distribution to relative contribution to the organization’s total savings and quality performance, and adheres to measurable clinically valid metrics.

• Transparency. It is clear, transparent, practical to implement and replicable.

• Constant evolution. It adapts and improves as the capabilities and experience as the ACO grows.

• Maximized incentive to drive value by all participants. After prudently meeting overhead costs, it allows gradual transition as well as commercially reasonable return on capital investment or debt service. It makes the most of ongoing incentive programs for all to deliver value by distributing as much of the savings surplus as possible to those who generate them.

Weighting: How to assign relative percentage among providers

As mentioned, it is important that design of a fair distribution formula be the product of collaboration among informed and committed clinicians who understand patient population management. Like virtually all organization compensation formulas, the determination of relative contributions of the different providers in a given ACO, or care initiative within the ACO, will involve a certain amount of inherent subjectivity but will be guided by weighted criteria applied in good faith.

• Step 1: Break down each initiative into its value-adding elements and assign provider responsibility for each. The ACO will have a number of different care management initiatives. Some, like outpatient diabetes management, may be completely the responsibility of one provider specialty, (that is, primary care). Others may involve coordination across multiple settings for patients with multiple conditions involving multiple specialties. Each initiative was chosen for a reason – to drive value. In setting relative potential distribution percentages, envision the perfect implementation of each initiative. Next, look at what tasks or best practices are needed to drive success, and then who is assigned responsibility for each.

• Step 2: Assign relative percentages to each specialty relative to its potential to realize savings. For a pure primary care prevention initiative, they would get 100% in all categories. For multispecialty initiatives, the percentage is tied to the proportion of those savings predicted to flow from that provider class.

N.B.: Historically, cost centers are not necessarily the cost savers. A mature ACO will be able to allocate savings to each initiative and the relative savings distribution within each. But for a start-up ACO, because it is so apparently logical and fits the traditional fee-for-service mindset, it is tempting to look at claims differences in the various service categories, such as inpatient, outpatient, primary care, specialists, drugs, and ancillaries, and attribute savings to the provider historically billing for same (that is, hospitals get "credit" for reduced hospital costs). However, a successful wellness, prevention, or lifestyle counseling program in a medical home may be the reason those patients never go to the hospital. The radiologist embedded in the medical home diagnostic team may have helped make an informed image analysis confirming a negative result and avoided those admissions. But, do use those service categories to set cost targets.

• Step 3: Individual attribution. We now know every provider group’s potential savings, but how do we determine the actual distribution based on actual results? Select metrics that are accurately associated with the desired individual and collective conduct of that provider class. They should cover both quality and efficiency. In the value-based reimbursement world, even if the performance is superb, if it is not measured appropriately, it will not be rewarded.

Once the proper metrics are selected, each provider’s performance is measured.

Keep it simple and open

Pick a few of the very best quality and efficiency metrics and have them and the data collection process thoroughly vetted by the providers. Following the guiding principles, the distribution model will be a success if: (1) everyone understands that this is the best practical approach, (2) the process has been open, and (3) everyone is acting in good faith to have as fair a shared savings distribution process as the current sophistication level of the ACO’s infrastructure allows. It cannot be viewed as coming from a "black box." For a young ACO, it will be crude, at best, in the beginning.

Conclusion

Even at this dawning of the movement to value-based reimbursement in health care, a framework for a fair merit-based shared savings distribution is available to all ACOs. As ACOs gain actual performance data, their health information technology capabilities improve, and refined quality and efficiency metrics emerge, the process will evolve from an open and good-faith application of the guiding principles with limited tools, to more and more refined determinations of the sources of the ACO’s quality and savings results. The path will get easier over time, but the destination is always clear – distribution in proportion to contribution.

Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience assisting physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact the author ([email protected] or 919-821-6612).