WASHINGTON – Several endoscopic bariatric procedures for weight loss have recently entered routine U.S. practice, but the procedures are much less likely to achieve meaningful weight loss for patients unless they are paired with frequent patient contact and used in the context of a multidimensional lifestyle intervention, Shelby Sullivan, MD, said at the annual Digestive Disease Week.^®

Mitchel L. Zoler/MDedge News

Another tip for providers is to have protocols in place to both prevent and, when necessary, manage potential complications. This can involve administration of additional antibiotics beyond what’s used for prophylaxis, treatment with additional IV fluid, and imaging. Complication prevention and management of complications when they occur are two of the most important steps to take to make sure that an elective obesity intervention practice runs smoothly, Dr. Sullivan said. “Make sure you can manage these patients safely,” she admonished. Also, be sure to arrange in advance for institutional approval for using whatever devices the procedure requires, and make sure you have malpractice coverage for any novel devices or procedures. Approval for use of a novel device often requires documentation of specialized training or certification.

Endoscopic weight loss procedures often are not fully or even partially covered by health insurance, which means that patients will pay most or all of the costs out of pocket and, hence, the clinician should look on this practice as a “concierge service.” Therefore, the clinician should be especially attuned to ensuring that the staff is uniformly courteous, and be alert for any overt or covert obesity bias the staff may have that could mar a patient’s experience. You need a “reliable and compassionate” staff, Dr. Sullivan advised, and the staff should schedule patient appointments that minimize wait times.

[email protected]

WASHINGTON – Several endoscopic bariatric procedures for weight loss have recently entered routine U.S. practice, but the procedures are much less likely to achieve meaningful weight loss for patients unless they are paired with frequent patient contact and used in the context of a multidimensional lifestyle intervention, Shelby Sullivan, MD, said at the annual Digestive Disease Week.^®

Mitchel L. Zoler/MDedge News

Another tip for providers is to have protocols in place to both prevent and, when necessary, manage potential complications. This can involve administration of additional antibiotics beyond what’s used for prophylaxis, treatment with additional IV fluid, and imaging. Complication prevention and management of complications when they occur are two of the most important steps to take to make sure that an elective obesity intervention practice runs smoothly, Dr. Sullivan said. “Make sure you can manage these patients safely,” she admonished. Also, be sure to arrange in advance for institutional approval for using whatever devices the procedure requires, and make sure you have malpractice coverage for any novel devices or procedures. Approval for use of a novel device often requires documentation of specialized training or certification.

Endoscopic weight loss procedures often are not fully or even partially covered by health insurance, which means that patients will pay most or all of the costs out of pocket and, hence, the clinician should look on this practice as a “concierge service.” Therefore, the clinician should be especially attuned to ensuring that the staff is uniformly courteous, and be alert for any overt or covert obesity bias the staff may have that could mar a patient’s experience. You need a “reliable and compassionate” staff, Dr. Sullivan advised, and the staff should schedule patient appointments that minimize wait times.

[email protected]

WASHINGTON – Several endoscopic bariatric procedures for weight loss have recently entered routine U.S. practice, but the procedures are much less likely to achieve meaningful weight loss for patients unless they are paired with frequent patient contact and used in the context of a multidimensional lifestyle intervention, Shelby Sullivan, MD, said at the annual Digestive Disease Week.^®

Mitchel L. Zoler/MDedge News

Another tip for providers is to have protocols in place to both prevent and, when necessary, manage potential complications. This can involve administration of additional antibiotics beyond what’s used for prophylaxis, treatment with additional IV fluid, and imaging. Complication prevention and management of complications when they occur are two of the most important steps to take to make sure that an elective obesity intervention practice runs smoothly, Dr. Sullivan said. “Make sure you can manage these patients safely,” she admonished. Also, be sure to arrange in advance for institutional approval for using whatever devices the procedure requires, and make sure you have malpractice coverage for any novel devices or procedures. Approval for use of a novel device often requires documentation of specialized training or certification.

Endoscopic weight loss procedures often are not fully or even partially covered by health insurance, which means that patients will pay most or all of the costs out of pocket and, hence, the clinician should look on this practice as a “concierge service.” Therefore, the clinician should be especially attuned to ensuring that the staff is uniformly courteous, and be alert for any overt or covert obesity bias the staff may have that could mar a patient’s experience. You need a “reliable and compassionate” staff, Dr. Sullivan advised, and the staff should schedule patient appointments that minimize wait times.

[email protected]

Vesicovaginal fistulas (VVFs) are the most common type of urogenital fistulas – approximately three times more common than ureterovaginal fistulas – and can be a debilitating problem for women.

Most of the research published in recent years on VVFs and other urogenital fistulas comes from developing countries where these abnormal communications are a common complication of obstructed labor. In the United States, despite a relative paucity of data, VVFs are known to occur most often as a sequelae of gynecologic surgery, usually hysterectomy. Estimates of the incidence of VVF and other urogenital fistula formation are debated but have ranged from 0.5% or less after simple hysterectomy to as high as 2% after radical hysterectomy. Most VVFs are believed to occur after hysterectomy performed for benign disease, and many – but not all – are caused by inadvertent bladder injury that was not recognized intraoperatively.

Women who have had one or more cesarean deliveries and those who have had prior pelvic or vaginal surgery are at increased risk. In addition, both radiation therapy and inflammation that occur with diseases such as pelvic inflammatory disease or inflammatory bowel disease can negatively affect tissue quality and healing from surgical procedures – and can lead ultimately to the development of urogenital fistulas – although even less is known about incidence in these cases.
 

Prevention

Intraoperatively, VVFs may best be prevented through careful mobilization of the bladder off the vaginal wall, the use of delayed absorbable sutures (preferably Vicryl sutures), and the use of cystoscopy to assess the bladder for injury. If cystoscopy is not available, retrograde filling with a Foley catheter will still be helpful.

An overly aggressive approach to creating the bladder flap during hysterectomy and other surgeries can increase the risk of devascularization and the subsequent formation of fistulas. When the blood supply is found to have been compromised, affected tissue can be strengthened by oversewing with imbrication. When an inadvertent cystotomy is identified, repair is often best achieved with omental tissue interposed between the bladder and vagina. If there is any doubt about bladder integrity, an interposition graft between the bladder flap and the vaginal cuff will help reduce the incidence of fistula formation. Whenever overlapping suture lines occur (the vaginal cuff and the cystotomy repair), the risk of VVF formation will increase. Other than that using omentum, peritoneal grafts will also work well.

VVF formation may still occur, however, despite recognition and repair of an injury – and despite normal findings on cystoscopy. In patients who have had prior cesarean deliveries or other prior pelvic surgery, for example, tissue devascularization may cause a delayed injury, with the process of tissue necrosis and VVF formation occurring up to a month after surgery. It is important to appreciate the factors that predispose patients to VVF and to anticipate an increased risk, but in many cases of delayed VVF, it’s quite possible that nothing could have been done to prevent the problem.
 

Work-up

Courtesy of John Miklos, MD

Vesicovaginal fistulas typically present as painless, continuous urine leakage from the vagina. The medical history should include standard questions about pelvic health history and symptom characteristics (in order to exclude hematuria or leakage of fluid other than urine), as well as questions aimed at differentiating symptoms of VVF from other causes of urinary incontinence, such as stress incontinence. In my experience, urine leakage is often incorrectly dismissed as stress incontinence when it is actually VVF. A high index of suspicion will help make an earlier diagnosis. This does not usually change the management, but helps manage the anxiety, expectations, and needs of the patient.

I recommend beginning the work-up for a suspected VVF with a thorough cystoscopic evaluation of the bladder for injury. An irregular appearance of the bladder, signs of inflammation, and poor or absent ureteral efflux are often indicative of VVF in the presence of vaginal leakage. Following cystoscopy, I perform a split speculum examination of the vagina. Most injuries will be on the anterior wall or the apex (cuff). A recently formed fistula may appear as a hole or as a small, red area of granulation tissue with no visible opening.

Courtesy of John Miklos, MD

It can be difficult to visualize the vaginal fistula opening of more mature fistulas; similarly, very small fistulas may be difficult to find because of their size and the anatomy of the vagina. When a prior hysterectomy has led to a fistula, the vaginal fistula opening is typically located in the upper third of the vagina or at the vaginal cuff. If cuff sutures are still intact, this may also make localization of the fistula more difficult.

Leakage in the vagina can sometimes be detected with a retrograde filling of the bladder; other times, it is possible to detect leakage without filling the bladder. In all cases, it’s important to remember that more than one fistula – and more than one fistula type – may be present. A VVF and ureterovaginal fistula will sometimes occur together, which means that abnormal cystoscopy findings in a patient who experiences leakage does not necessarily rule out the presence of a concurrent ureterovaginal fistula.

Phenazopyridine (Pyridium) administered orally will turn the urine orange and can help visualize the leakage of urine into the vagina. When used in combination with the use of blue dye (methylene blue) infused into the bladder, a VVF may be distinguished from a ureterovaginal fistula. To completely evaluate the number and location of fistulas, however, imaging studies are necessary. In my experience, a CT urogram with IV contrast can also help localize ureteral injuries.
 

Surgical treatment

VVFs can almost always be repaired vaginally. If the fistula is too high in location or too complex, then an abdominal approach, either robotic, laparoscopic, or open, may be necessary. I prefer a vaginal approach to VVF repair whenever feasible because of its straightforward nature, lower morbidity, and high rate of success on the first attempt. Failure rates are between 5% and 20% for each attempt, so more than one surgery may be required. It is not unreasonable to attempt two or three vaginal approach repairs if each successive attempt results in a smaller fistula. A decision to go abdominal must be made based on the chances of a successful vaginal approach and on the patient’s wishes.

Courtesy of Dionysios Veronikis, MD

Successful fistula repair requires tension-free suture lines, no overlapping suture lines, and good vascular supply to the tissue. The timing of repair has long been controversial, but barring the presence of active pelvic infection, which may require an immediate surgical approach, the timing of fistula repair depends almost solely on the quality of the surrounding tissue. This relates to the need for a good vascular supply.

Early repair can be done if the tissue is pliable and healthy. But in general, if surgery is performed too close to the time of injury, the surrounding tissue will be erythematous and likely to break down with closure. The goal is to wait until the granulation tissue has dissipated and the area is no longer inflamed; after gynecologic surgery, this generally occurs within 6-12 weeks.

Regular vaginal exams about every 2 weeks can be used to monitor progress. During the waiting period, catheterization of the bladder can improve comfort for the patient and may even allow for spontaneous closure of the fistula. In fact, I usually tell patients who are diagnosed with a VVF within the first few weeks after surgery that spontaneous closure is a possible outcome given continuous urinary drainage for up to 30 days, provided that the VVF is small enough. This may be optimistic thinking on the part of the surgeon and the patient, but there is little downside to this approach.

The Latzko technique described in 1992 is still widely used for vaginal repair of VVFs. With this approach, the vaginal epithelium is incised around the fistula, and vaginal epithelial flaps are raised and removed around the fistula tract (in a circle of about 2-3 cm in diameter) for a multilayer approximation of healthy tissues. Several layers are sometimes needed, but in most cases, two layers are sufficient.

In my experience, a modified approach to the traditional Latzko procedure is more successful. Prior to closure, either anterior or posterior to the VVF, a small rim of vaginal epithelium is removed and, on the other side, the epithelium is mobilized at least 1 cm lateral to the fistula on both sides, and about 2 cm distal. This allows for the creation of a small, modified, thumbnail flap that completely patches the fistula closure without tension and without the need for any overlapping suture lines. The key is to secure flap tissue from the side where there appears to be more vaginal tissue. The tissue should be loose; if there appears to be any strain, the repair is likely to fail.

There are not enough data from the United States or other developed countries to demonstrate the superiority of this modified approach, but data from the obstetric population in Africa – and my own experience – suggest that it yields better outcomes.

A VVF that is larger may require the use of additional sources of tissue. A graft called the Martius graft, or labial fibrofatty tissue graft, is sometimes used to reinforce repairs of larger fistulas, even those that are high in the vaginal vault. The procedure involves a vertical incision on the inner side of the labium majus and detachment of fibroadipose tissue from its underlying bulbocavernosus muscle. This fat-pad flap is vascularized and thus serves as a pedicled graft. It can be tunneled under the vaginal epithelium to reach the site of closure. The procedure has limited use with the vaginal approach to VVF, but is important to be aware of.

Other sources of grafts or flaps that can sometimes be used with the vaginal approach include the gracilis muscle, the gluteal muscle and peritoneum, and fasciocutaneous tissue from the inner thigh.

The avoidance of overlapping suture lines and multiple layers of closure will help ensure a water-tight closure. If there is any leakage upon testing the integrity of the repair, particularly one that is vaginally approached, such leakage will continue and the repair will have been unsuccessful. In an abdominal surgery for VVF, a small amount of remaining leakage will probably resolve on its own after 10-14 days of catheter placement.

Placement of a Jackson-Pratt (JP) drain is controversial. It has been suggested that a JP drain placed on continuous suction will pull urine out of the bladder and increase the risk of a fistula. I don’t place a JP drain in my repairs as I find them to not be helpful. A cystogram can be done 1 week after repair to confirm healing, but there is some debate about whether or not the procedure is useful at that point. In my experience, if the patient does not have a cystogram and gets postrepair leakage, I have the same information as I would have obtained through a positive finding on a cystogram.
 

Dr. Garely is chair of obstetrics and gynecology and director of urogynecology and pelvic reconstructive surgery at the South Nassau Communities Hospital, Oceanside, N.Y., and a clinical professor of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai, New York. He has no disclosures related to this column.

Vesicovaginal fistulas (VVFs) are the most common type of urogenital fistulas – approximately three times more common than ureterovaginal fistulas – and can be a debilitating problem for women.

Most of the research published in recent years on VVFs and other urogenital fistulas comes from developing countries where these abnormal communications are a common complication of obstructed labor. In the United States, despite a relative paucity of data, VVFs are known to occur most often as a sequelae of gynecologic surgery, usually hysterectomy. Estimates of the incidence of VVF and other urogenital fistula formation are debated but have ranged from 0.5% or less after simple hysterectomy to as high as 2% after radical hysterectomy. Most VVFs are believed to occur after hysterectomy performed for benign disease, and many – but not all – are caused by inadvertent bladder injury that was not recognized intraoperatively.

Women who have had one or more cesarean deliveries and those who have had prior pelvic or vaginal surgery are at increased risk. In addition, both radiation therapy and inflammation that occur with diseases such as pelvic inflammatory disease or inflammatory bowel disease can negatively affect tissue quality and healing from surgical procedures – and can lead ultimately to the development of urogenital fistulas – although even less is known about incidence in these cases.
 

Prevention

Intraoperatively, VVFs may best be prevented through careful mobilization of the bladder off the vaginal wall, the use of delayed absorbable sutures (preferably Vicryl sutures), and the use of cystoscopy to assess the bladder for injury. If cystoscopy is not available, retrograde filling with a Foley catheter will still be helpful.

An overly aggressive approach to creating the bladder flap during hysterectomy and other surgeries can increase the risk of devascularization and the subsequent formation of fistulas. When the blood supply is found to have been compromised, affected tissue can be strengthened by oversewing with imbrication. When an inadvertent cystotomy is identified, repair is often best achieved with omental tissue interposed between the bladder and vagina. If there is any doubt about bladder integrity, an interposition graft between the bladder flap and the vaginal cuff will help reduce the incidence of fistula formation. Whenever overlapping suture lines occur (the vaginal cuff and the cystotomy repair), the risk of VVF formation will increase. Other than that using omentum, peritoneal grafts will also work well.

VVF formation may still occur, however, despite recognition and repair of an injury – and despite normal findings on cystoscopy. In patients who have had prior cesarean deliveries or other prior pelvic surgery, for example, tissue devascularization may cause a delayed injury, with the process of tissue necrosis and VVF formation occurring up to a month after surgery. It is important to appreciate the factors that predispose patients to VVF and to anticipate an increased risk, but in many cases of delayed VVF, it’s quite possible that nothing could have been done to prevent the problem.
 

Work-up

Courtesy of John Miklos, MD

Vesicovaginal fistulas typically present as painless, continuous urine leakage from the vagina. The medical history should include standard questions about pelvic health history and symptom characteristics (in order to exclude hematuria or leakage of fluid other than urine), as well as questions aimed at differentiating symptoms of VVF from other causes of urinary incontinence, such as stress incontinence. In my experience, urine leakage is often incorrectly dismissed as stress incontinence when it is actually VVF. A high index of suspicion will help make an earlier diagnosis. This does not usually change the management, but helps manage the anxiety, expectations, and needs of the patient.

I recommend beginning the work-up for a suspected VVF with a thorough cystoscopic evaluation of the bladder for injury. An irregular appearance of the bladder, signs of inflammation, and poor or absent ureteral efflux are often indicative of VVF in the presence of vaginal leakage. Following cystoscopy, I perform a split speculum examination of the vagina. Most injuries will be on the anterior wall or the apex (cuff). A recently formed fistula may appear as a hole or as a small, red area of granulation tissue with no visible opening.

Courtesy of John Miklos, MD

It can be difficult to visualize the vaginal fistula opening of more mature fistulas; similarly, very small fistulas may be difficult to find because of their size and the anatomy of the vagina. When a prior hysterectomy has led to a fistula, the vaginal fistula opening is typically located in the upper third of the vagina or at the vaginal cuff. If cuff sutures are still intact, this may also make localization of the fistula more difficult.

Leakage in the vagina can sometimes be detected with a retrograde filling of the bladder; other times, it is possible to detect leakage without filling the bladder. In all cases, it’s important to remember that more than one fistula – and more than one fistula type – may be present. A VVF and ureterovaginal fistula will sometimes occur together, which means that abnormal cystoscopy findings in a patient who experiences leakage does not necessarily rule out the presence of a concurrent ureterovaginal fistula.

Phenazopyridine (Pyridium) administered orally will turn the urine orange and can help visualize the leakage of urine into the vagina. When used in combination with the use of blue dye (methylene blue) infused into the bladder, a VVF may be distinguished from a ureterovaginal fistula. To completely evaluate the number and location of fistulas, however, imaging studies are necessary. In my experience, a CT urogram with IV contrast can also help localize ureteral injuries.
 

Surgical treatment

VVFs can almost always be repaired vaginally. If the fistula is too high in location or too complex, then an abdominal approach, either robotic, laparoscopic, or open, may be necessary. I prefer a vaginal approach to VVF repair whenever feasible because of its straightforward nature, lower morbidity, and high rate of success on the first attempt. Failure rates are between 5% and 20% for each attempt, so more than one surgery may be required. It is not unreasonable to attempt two or three vaginal approach repairs if each successive attempt results in a smaller fistula. A decision to go abdominal must be made based on the chances of a successful vaginal approach and on the patient’s wishes.

Courtesy of Dionysios Veronikis, MD

Successful fistula repair requires tension-free suture lines, no overlapping suture lines, and good vascular supply to the tissue. The timing of repair has long been controversial, but barring the presence of active pelvic infection, which may require an immediate surgical approach, the timing of fistula repair depends almost solely on the quality of the surrounding tissue. This relates to the need for a good vascular supply.

Early repair can be done if the tissue is pliable and healthy. But in general, if surgery is performed too close to the time of injury, the surrounding tissue will be erythematous and likely to break down with closure. The goal is to wait until the granulation tissue has dissipated and the area is no longer inflamed; after gynecologic surgery, this generally occurs within 6-12 weeks.

Regular vaginal exams about every 2 weeks can be used to monitor progress. During the waiting period, catheterization of the bladder can improve comfort for the patient and may even allow for spontaneous closure of the fistula. In fact, I usually tell patients who are diagnosed with a VVF within the first few weeks after surgery that spontaneous closure is a possible outcome given continuous urinary drainage for up to 30 days, provided that the VVF is small enough. This may be optimistic thinking on the part of the surgeon and the patient, but there is little downside to this approach.

The Latzko technique described in 1992 is still widely used for vaginal repair of VVFs. With this approach, the vaginal epithelium is incised around the fistula, and vaginal epithelial flaps are raised and removed around the fistula tract (in a circle of about 2-3 cm in diameter) for a multilayer approximation of healthy tissues. Several layers are sometimes needed, but in most cases, two layers are sufficient.

In my experience, a modified approach to the traditional Latzko procedure is more successful. Prior to closure, either anterior or posterior to the VVF, a small rim of vaginal epithelium is removed and, on the other side, the epithelium is mobilized at least 1 cm lateral to the fistula on both sides, and about 2 cm distal. This allows for the creation of a small, modified, thumbnail flap that completely patches the fistula closure without tension and without the need for any overlapping suture lines. The key is to secure flap tissue from the side where there appears to be more vaginal tissue. The tissue should be loose; if there appears to be any strain, the repair is likely to fail.

There are not enough data from the United States or other developed countries to demonstrate the superiority of this modified approach, but data from the obstetric population in Africa – and my own experience – suggest that it yields better outcomes.

A VVF that is larger may require the use of additional sources of tissue. A graft called the Martius graft, or labial fibrofatty tissue graft, is sometimes used to reinforce repairs of larger fistulas, even those that are high in the vaginal vault. The procedure involves a vertical incision on the inner side of the labium majus and detachment of fibroadipose tissue from its underlying bulbocavernosus muscle. This fat-pad flap is vascularized and thus serves as a pedicled graft. It can be tunneled under the vaginal epithelium to reach the site of closure. The procedure has limited use with the vaginal approach to VVF, but is important to be aware of.

Other sources of grafts or flaps that can sometimes be used with the vaginal approach include the gracilis muscle, the gluteal muscle and peritoneum, and fasciocutaneous tissue from the inner thigh.

The avoidance of overlapping suture lines and multiple layers of closure will help ensure a water-tight closure. If there is any leakage upon testing the integrity of the repair, particularly one that is vaginally approached, such leakage will continue and the repair will have been unsuccessful. In an abdominal surgery for VVF, a small amount of remaining leakage will probably resolve on its own after 10-14 days of catheter placement.

Placement of a Jackson-Pratt (JP) drain is controversial. It has been suggested that a JP drain placed on continuous suction will pull urine out of the bladder and increase the risk of a fistula. I don’t place a JP drain in my repairs as I find them to not be helpful. A cystogram can be done 1 week after repair to confirm healing, but there is some debate about whether or not the procedure is useful at that point. In my experience, if the patient does not have a cystogram and gets postrepair leakage, I have the same information as I would have obtained through a positive finding on a cystogram.
 

Dr. Garely is chair of obstetrics and gynecology and director of urogynecology and pelvic reconstructive surgery at the South Nassau Communities Hospital, Oceanside, N.Y., and a clinical professor of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai, New York. He has no disclosures related to this column.

Vesicovaginal fistulas (VVFs) are the most common type of urogenital fistulas – approximately three times more common than ureterovaginal fistulas – and can be a debilitating problem for women.

Most of the research published in recent years on VVFs and other urogenital fistulas comes from developing countries where these abnormal communications are a common complication of obstructed labor. In the United States, despite a relative paucity of data, VVFs are known to occur most often as a sequelae of gynecologic surgery, usually hysterectomy. Estimates of the incidence of VVF and other urogenital fistula formation are debated but have ranged from 0.5% or less after simple hysterectomy to as high as 2% after radical hysterectomy. Most VVFs are believed to occur after hysterectomy performed for benign disease, and many – but not all – are caused by inadvertent bladder injury that was not recognized intraoperatively.

Women who have had one or more cesarean deliveries and those who have had prior pelvic or vaginal surgery are at increased risk. In addition, both radiation therapy and inflammation that occur with diseases such as pelvic inflammatory disease or inflammatory bowel disease can negatively affect tissue quality and healing from surgical procedures – and can lead ultimately to the development of urogenital fistulas – although even less is known about incidence in these cases.
 

Prevention

Intraoperatively, VVFs may best be prevented through careful mobilization of the bladder off the vaginal wall, the use of delayed absorbable sutures (preferably Vicryl sutures), and the use of cystoscopy to assess the bladder for injury. If cystoscopy is not available, retrograde filling with a Foley catheter will still be helpful.

An overly aggressive approach to creating the bladder flap during hysterectomy and other surgeries can increase the risk of devascularization and the subsequent formation of fistulas. When the blood supply is found to have been compromised, affected tissue can be strengthened by oversewing with imbrication. When an inadvertent cystotomy is identified, repair is often best achieved with omental tissue interposed between the bladder and vagina. If there is any doubt about bladder integrity, an interposition graft between the bladder flap and the vaginal cuff will help reduce the incidence of fistula formation. Whenever overlapping suture lines occur (the vaginal cuff and the cystotomy repair), the risk of VVF formation will increase. Other than that using omentum, peritoneal grafts will also work well.

VVF formation may still occur, however, despite recognition and repair of an injury – and despite normal findings on cystoscopy. In patients who have had prior cesarean deliveries or other prior pelvic surgery, for example, tissue devascularization may cause a delayed injury, with the process of tissue necrosis and VVF formation occurring up to a month after surgery. It is important to appreciate the factors that predispose patients to VVF and to anticipate an increased risk, but in many cases of delayed VVF, it’s quite possible that nothing could have been done to prevent the problem.
 

Work-up

Courtesy of John Miklos, MD

Vesicovaginal fistulas typically present as painless, continuous urine leakage from the vagina. The medical history should include standard questions about pelvic health history and symptom characteristics (in order to exclude hematuria or leakage of fluid other than urine), as well as questions aimed at differentiating symptoms of VVF from other causes of urinary incontinence, such as stress incontinence. In my experience, urine leakage is often incorrectly dismissed as stress incontinence when it is actually VVF. A high index of suspicion will help make an earlier diagnosis. This does not usually change the management, but helps manage the anxiety, expectations, and needs of the patient.

I recommend beginning the work-up for a suspected VVF with a thorough cystoscopic evaluation of the bladder for injury. An irregular appearance of the bladder, signs of inflammation, and poor or absent ureteral efflux are often indicative of VVF in the presence of vaginal leakage. Following cystoscopy, I perform a split speculum examination of the vagina. Most injuries will be on the anterior wall or the apex (cuff). A recently formed fistula may appear as a hole or as a small, red area of granulation tissue with no visible opening.

Courtesy of John Miklos, MD

It can be difficult to visualize the vaginal fistula opening of more mature fistulas; similarly, very small fistulas may be difficult to find because of their size and the anatomy of the vagina. When a prior hysterectomy has led to a fistula, the vaginal fistula opening is typically located in the upper third of the vagina or at the vaginal cuff. If cuff sutures are still intact, this may also make localization of the fistula more difficult.

Leakage in the vagina can sometimes be detected with a retrograde filling of the bladder; other times, it is possible to detect leakage without filling the bladder. In all cases, it’s important to remember that more than one fistula – and more than one fistula type – may be present. A VVF and ureterovaginal fistula will sometimes occur together, which means that abnormal cystoscopy findings in a patient who experiences leakage does not necessarily rule out the presence of a concurrent ureterovaginal fistula.

Phenazopyridine (Pyridium) administered orally will turn the urine orange and can help visualize the leakage of urine into the vagina. When used in combination with the use of blue dye (methylene blue) infused into the bladder, a VVF may be distinguished from a ureterovaginal fistula. To completely evaluate the number and location of fistulas, however, imaging studies are necessary. In my experience, a CT urogram with IV contrast can also help localize ureteral injuries.
 

Surgical treatment

VVFs can almost always be repaired vaginally. If the fistula is too high in location or too complex, then an abdominal approach, either robotic, laparoscopic, or open, may be necessary. I prefer a vaginal approach to VVF repair whenever feasible because of its straightforward nature, lower morbidity, and high rate of success on the first attempt. Failure rates are between 5% and 20% for each attempt, so more than one surgery may be required. It is not unreasonable to attempt two or three vaginal approach repairs if each successive attempt results in a smaller fistula. A decision to go abdominal must be made based on the chances of a successful vaginal approach and on the patient’s wishes.

Courtesy of Dionysios Veronikis, MD

Successful fistula repair requires tension-free suture lines, no overlapping suture lines, and good vascular supply to the tissue. The timing of repair has long been controversial, but barring the presence of active pelvic infection, which may require an immediate surgical approach, the timing of fistula repair depends almost solely on the quality of the surrounding tissue. This relates to the need for a good vascular supply.

Early repair can be done if the tissue is pliable and healthy. But in general, if surgery is performed too close to the time of injury, the surrounding tissue will be erythematous and likely to break down with closure. The goal is to wait until the granulation tissue has dissipated and the area is no longer inflamed; after gynecologic surgery, this generally occurs within 6-12 weeks.

Regular vaginal exams about every 2 weeks can be used to monitor progress. During the waiting period, catheterization of the bladder can improve comfort for the patient and may even allow for spontaneous closure of the fistula. In fact, I usually tell patients who are diagnosed with a VVF within the first few weeks after surgery that spontaneous closure is a possible outcome given continuous urinary drainage for up to 30 days, provided that the VVF is small enough. This may be optimistic thinking on the part of the surgeon and the patient, but there is little downside to this approach.

The Latzko technique described in 1992 is still widely used for vaginal repair of VVFs. With this approach, the vaginal epithelium is incised around the fistula, and vaginal epithelial flaps are raised and removed around the fistula tract (in a circle of about 2-3 cm in diameter) for a multilayer approximation of healthy tissues. Several layers are sometimes needed, but in most cases, two layers are sufficient.

In my experience, a modified approach to the traditional Latzko procedure is more successful. Prior to closure, either anterior or posterior to the VVF, a small rim of vaginal epithelium is removed and, on the other side, the epithelium is mobilized at least 1 cm lateral to the fistula on both sides, and about 2 cm distal. This allows for the creation of a small, modified, thumbnail flap that completely patches the fistula closure without tension and without the need for any overlapping suture lines. The key is to secure flap tissue from the side where there appears to be more vaginal tissue. The tissue should be loose; if there appears to be any strain, the repair is likely to fail.

There are not enough data from the United States or other developed countries to demonstrate the superiority of this modified approach, but data from the obstetric population in Africa – and my own experience – suggest that it yields better outcomes.

A VVF that is larger may require the use of additional sources of tissue. A graft called the Martius graft, or labial fibrofatty tissue graft, is sometimes used to reinforce repairs of larger fistulas, even those that are high in the vaginal vault. The procedure involves a vertical incision on the inner side of the labium majus and detachment of fibroadipose tissue from its underlying bulbocavernosus muscle. This fat-pad flap is vascularized and thus serves as a pedicled graft. It can be tunneled under the vaginal epithelium to reach the site of closure. The procedure has limited use with the vaginal approach to VVF, but is important to be aware of.

Other sources of grafts or flaps that can sometimes be used with the vaginal approach include the gracilis muscle, the gluteal muscle and peritoneum, and fasciocutaneous tissue from the inner thigh.

The avoidance of overlapping suture lines and multiple layers of closure will help ensure a water-tight closure. If there is any leakage upon testing the integrity of the repair, particularly one that is vaginally approached, such leakage will continue and the repair will have been unsuccessful. In an abdominal surgery for VVF, a small amount of remaining leakage will probably resolve on its own after 10-14 days of catheter placement.

Placement of a Jackson-Pratt (JP) drain is controversial. It has been suggested that a JP drain placed on continuous suction will pull urine out of the bladder and increase the risk of a fistula. I don’t place a JP drain in my repairs as I find them to not be helpful. A cystogram can be done 1 week after repair to confirm healing, but there is some debate about whether or not the procedure is useful at that point. In my experience, if the patient does not have a cystogram and gets postrepair leakage, I have the same information as I would have obtained through a positive finding on a cystogram.
 

Dr. Garely is chair of obstetrics and gynecology and director of urogynecology and pelvic reconstructive surgery at the South Nassau Communities Hospital, Oceanside, N.Y., and a clinical professor of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai, New York. He has no disclosures related to this column.

I have been a member of the American Gastroenterological Association since my first year of GI fellowship. Out of all the GI professional societies, I have always considered it to be my home. AGA is the organization I turn to for direction on providing high-value and quality care to my patients, up-to-date information on research and technology innovations in our specialty, education and training programs for the next generation of gastroenterology and hepatology providers, and for my own continued learning. I have received so many benefits from my membership and am always looking to pay back my appreciation. A wonderful way to do this was through my participation in the Future Leaders Program, which “provides a pathway within the organization for selected participants to network, connect with mentors, develop leadership skills, and learn about AGA’s governance and operations while advancing their careers and supporting the profession.” I can honestly say that the program delivers on all of these promises.

Copyright Expressive Images

The program started with a meeting at AGA headquarters in Bethesda, Md., where we were introduced to key AGA staff, learned about the core mission and goals of AGA, and received training in leadership skills. I was able to gain invaluable insight into the leadership and governance of the AGA and now have a better understanding of the AGA’s commitment to maintaining a vital organization. At this meeting, we were assigned two mentors – one for career coaching and one to guide us through our main project. We worked closely with these mentors throughout the program, and I have no doubt these relationships will continue well into the future. For the main project we were assigned to a team with another participant to research and develop a project that aligned with the overall strategic plan of the AGA and fulfilled a need or gap within the organization. The projects covered topics such as ways to engage early-career professionals in the AGA Community, enhance access to the AGA guidelines, increase membership, highlight top publications from the AGA journals, expand networking among fellows and early career members, develop education metrics, and provide educational opportunities for international members. We worked on our main project remotely with our teams over 6 months, culminating in a final presentation that was shared with all participants in the Future Leaders Program, as well as AGA committees. Some of these projects already are being implemented. It was a truly amazing experience to work closely with the knowledgeable and dedicated AGA staff, gain skills in teamwork and strategic planning, and hear about the innovative ideas from all the participants in the Future Leaders Program.

In addition to the initial meeting in Bethesda, we attended a reception at Digestive Disease Week^® with alumni from the prior class of Future Leaders, a face-to-face meeting in Washington held in conjunction with the AGA Joint Committee Meetings, participated in Advocacy Day after the fall meeting, and attended some virtual roundtable discussions. One of the virtual discussions focused on our final project, which allowed us to apply our skills in strategic planning on a smaller scale to proposals for microvolunteerism. These proposals allow for convenient, short-term volunteer activities that move forward the mission of the AGA and cultivate local leaders. The microvolunteerism proposals are a fantastic example of AGA leadership’s understanding that utilizing and engaging members is one of the best ways to ensure a vital and relevant organization. I am excited to see some of the proposals come to fruition over the next few years.

Through the Future Leaders Program, I not only learned a lot about the AGA but also a great deal about myself. I learned about my own leadership style, which for those of you who know me would not be surprised to find out is “harmony.” I see the possibilities in others and try to capitalize on this potential to achieve our mutual goals. I learned how this leadership style can contribute to organizations as a whole, but also the importance of incorporating multiple leadership styles in all projects. This is valuable information that I have no doubt will help throughout my career. This program also provided an opportunity for me to connect and network with colleagues across the country whom I may not have otherwise met. These connections resulted in new research collaborations, as well as new friendships. As the 2018 AGA Future Leaders Program came to a close, I found myself with a deeper understanding of the mission and vision of the AGA, opportunities for more involvement, and a stronger commitment to our organization. I hope to one day participate as a mentor to other future leaders in the program. I encourage everyone interested in gaining leadership skills and more insight into the governance and operations of the AGA to apply.

Since the AGA Future Leaders Program began in the spring of 2015, two classes of 18 participants and nine mentors have participated in the 18-month comprehensive leadership development program. Nearly all of the Future Leaders Program alumni are serving the AGA in a variety of leadership capacities including serving on committees, the editorial boards, or volunteering as speakers and authors for AGA publications and events.

The next Future Leaders Program will begin in the spring of 2019 and the opportunity to apply will launch this fall.


Dr. Weiss is assistant professor, division of gastroenterology and hepatology; director, UW Health Gastrointestinal Genetics Clinic, University of Wisconsin School of Medicine and Public Health, Madison.

I have been a member of the American Gastroenterological Association since my first year of GI fellowship. Out of all the GI professional societies, I have always considered it to be my home. AGA is the organization I turn to for direction on providing high-value and quality care to my patients, up-to-date information on research and technology innovations in our specialty, education and training programs for the next generation of gastroenterology and hepatology providers, and for my own continued learning. I have received so many benefits from my membership and am always looking to pay back my appreciation. A wonderful way to do this was through my participation in the Future Leaders Program, which “provides a pathway within the organization for selected participants to network, connect with mentors, develop leadership skills, and learn about AGA’s governance and operations while advancing their careers and supporting the profession.” I can honestly say that the program delivers on all of these promises.

Copyright Expressive Images

The program started with a meeting at AGA headquarters in Bethesda, Md., where we were introduced to key AGA staff, learned about the core mission and goals of AGA, and received training in leadership skills. I was able to gain invaluable insight into the leadership and governance of the AGA and now have a better understanding of the AGA’s commitment to maintaining a vital organization. At this meeting, we were assigned two mentors – one for career coaching and one to guide us through our main project. We worked closely with these mentors throughout the program, and I have no doubt these relationships will continue well into the future. For the main project we were assigned to a team with another participant to research and develop a project that aligned with the overall strategic plan of the AGA and fulfilled a need or gap within the organization. The projects covered topics such as ways to engage early-career professionals in the AGA Community, enhance access to the AGA guidelines, increase membership, highlight top publications from the AGA journals, expand networking among fellows and early career members, develop education metrics, and provide educational opportunities for international members. We worked on our main project remotely with our teams over 6 months, culminating in a final presentation that was shared with all participants in the Future Leaders Program, as well as AGA committees. Some of these projects already are being implemented. It was a truly amazing experience to work closely with the knowledgeable and dedicated AGA staff, gain skills in teamwork and strategic planning, and hear about the innovative ideas from all the participants in the Future Leaders Program.

In addition to the initial meeting in Bethesda, we attended a reception at Digestive Disease Week^® with alumni from the prior class of Future Leaders, a face-to-face meeting in Washington held in conjunction with the AGA Joint Committee Meetings, participated in Advocacy Day after the fall meeting, and attended some virtual roundtable discussions. One of the virtual discussions focused on our final project, which allowed us to apply our skills in strategic planning on a smaller scale to proposals for microvolunteerism. These proposals allow for convenient, short-term volunteer activities that move forward the mission of the AGA and cultivate local leaders. The microvolunteerism proposals are a fantastic example of AGA leadership’s understanding that utilizing and engaging members is one of the best ways to ensure a vital and relevant organization. I am excited to see some of the proposals come to fruition over the next few years.

Through the Future Leaders Program, I not only learned a lot about the AGA but also a great deal about myself. I learned about my own leadership style, which for those of you who know me would not be surprised to find out is “harmony.” I see the possibilities in others and try to capitalize on this potential to achieve our mutual goals. I learned how this leadership style can contribute to organizations as a whole, but also the importance of incorporating multiple leadership styles in all projects. This is valuable information that I have no doubt will help throughout my career. This program also provided an opportunity for me to connect and network with colleagues across the country whom I may not have otherwise met. These connections resulted in new research collaborations, as well as new friendships. As the 2018 AGA Future Leaders Program came to a close, I found myself with a deeper understanding of the mission and vision of the AGA, opportunities for more involvement, and a stronger commitment to our organization. I hope to one day participate as a mentor to other future leaders in the program. I encourage everyone interested in gaining leadership skills and more insight into the governance and operations of the AGA to apply.

Since the AGA Future Leaders Program began in the spring of 2015, two classes of 18 participants and nine mentors have participated in the 18-month comprehensive leadership development program. Nearly all of the Future Leaders Program alumni are serving the AGA in a variety of leadership capacities including serving on committees, the editorial boards, or volunteering as speakers and authors for AGA publications and events.

The next Future Leaders Program will begin in the spring of 2019 and the opportunity to apply will launch this fall.


Dr. Weiss is assistant professor, division of gastroenterology and hepatology; director, UW Health Gastrointestinal Genetics Clinic, University of Wisconsin School of Medicine and Public Health, Madison.

I have been a member of the American Gastroenterological Association since my first year of GI fellowship. Out of all the GI professional societies, I have always considered it to be my home. AGA is the organization I turn to for direction on providing high-value and quality care to my patients, up-to-date information on research and technology innovations in our specialty, education and training programs for the next generation of gastroenterology and hepatology providers, and for my own continued learning. I have received so many benefits from my membership and am always looking to pay back my appreciation. A wonderful way to do this was through my participation in the Future Leaders Program, which “provides a pathway within the organization for selected participants to network, connect with mentors, develop leadership skills, and learn about AGA’s governance and operations while advancing their careers and supporting the profession.” I can honestly say that the program delivers on all of these promises.

Copyright Expressive Images

The program started with a meeting at AGA headquarters in Bethesda, Md., where we were introduced to key AGA staff, learned about the core mission and goals of AGA, and received training in leadership skills. I was able to gain invaluable insight into the leadership and governance of the AGA and now have a better understanding of the AGA’s commitment to maintaining a vital organization. At this meeting, we were assigned two mentors – one for career coaching and one to guide us through our main project. We worked closely with these mentors throughout the program, and I have no doubt these relationships will continue well into the future. For the main project we were assigned to a team with another participant to research and develop a project that aligned with the overall strategic plan of the AGA and fulfilled a need or gap within the organization. The projects covered topics such as ways to engage early-career professionals in the AGA Community, enhance access to the AGA guidelines, increase membership, highlight top publications from the AGA journals, expand networking among fellows and early career members, develop education metrics, and provide educational opportunities for international members. We worked on our main project remotely with our teams over 6 months, culminating in a final presentation that was shared with all participants in the Future Leaders Program, as well as AGA committees. Some of these projects already are being implemented. It was a truly amazing experience to work closely with the knowledgeable and dedicated AGA staff, gain skills in teamwork and strategic planning, and hear about the innovative ideas from all the participants in the Future Leaders Program.

In addition to the initial meeting in Bethesda, we attended a reception at Digestive Disease Week^® with alumni from the prior class of Future Leaders, a face-to-face meeting in Washington held in conjunction with the AGA Joint Committee Meetings, participated in Advocacy Day after the fall meeting, and attended some virtual roundtable discussions. One of the virtual discussions focused on our final project, which allowed us to apply our skills in strategic planning on a smaller scale to proposals for microvolunteerism. These proposals allow for convenient, short-term volunteer activities that move forward the mission of the AGA and cultivate local leaders. The microvolunteerism proposals are a fantastic example of AGA leadership’s understanding that utilizing and engaging members is one of the best ways to ensure a vital and relevant organization. I am excited to see some of the proposals come to fruition over the next few years.

Through the Future Leaders Program, I not only learned a lot about the AGA but also a great deal about myself. I learned about my own leadership style, which for those of you who know me would not be surprised to find out is “harmony.” I see the possibilities in others and try to capitalize on this potential to achieve our mutual goals. I learned how this leadership style can contribute to organizations as a whole, but also the importance of incorporating multiple leadership styles in all projects. This is valuable information that I have no doubt will help throughout my career. This program also provided an opportunity for me to connect and network with colleagues across the country whom I may not have otherwise met. These connections resulted in new research collaborations, as well as new friendships. As the 2018 AGA Future Leaders Program came to a close, I found myself with a deeper understanding of the mission and vision of the AGA, opportunities for more involvement, and a stronger commitment to our organization. I hope to one day participate as a mentor to other future leaders in the program. I encourage everyone interested in gaining leadership skills and more insight into the governance and operations of the AGA to apply.

Since the AGA Future Leaders Program began in the spring of 2015, two classes of 18 participants and nine mentors have participated in the 18-month comprehensive leadership development program. Nearly all of the Future Leaders Program alumni are serving the AGA in a variety of leadership capacities including serving on committees, the editorial boards, or volunteering as speakers and authors for AGA publications and events.

The next Future Leaders Program will begin in the spring of 2019 and the opportunity to apply will launch this fall.


Dr. Weiss is assistant professor, division of gastroenterology and hepatology; director, UW Health Gastrointestinal Genetics Clinic, University of Wisconsin School of Medicine and Public Health, Madison.

Vesicovaginal fistula continues to be the most common form of genitourinary fistula, with resultant diminishment in quality of life secondary to physical and psychosocial distress. While it has been reported that 1 million women in Sub-Saharan Africa have untreated vesicovaginal fistula secondary to obstetric trauma, vesicovaginal fistulas are relatively rare in the United States. Per the United States National Hospital Discharge Survey, in 2007, fewer than 5,000 vesicovaginal fistula repairs were performed out of over 2.3 million procedures involving the female urinary and genital system.

The rarity of the diagnosis is also reflected in data collected from the English National Health Service, where vesicovaginal fistula occurred in 1 in 788 hysterectomies (although more common in radical hysterectomy, at 1 in 87).

In a recent systematic review and meta-analysis on the management of vesicovaginal fistulas in women following benign gynecologic surgery, Bodner-Adler et al. evaluated 282 full-text articles to identify 124 studies for inclusion (PLoS One. 2017 Feb 22;12[2]:e0171554). Only ten studies involved solely conservative management with prolonged bladder drainage. Dismal success was noted: 8%. Surgery was performed in 96.4% of cases (1379/1430); transvaginal in 39%, transabdominal/transvesical in 36%, laparoscopic/robotic approach in 15%, and transabdominal/transvaginal in 3%. Overall success rate in these surgical cases was 97.98% (95% confidence interval, 96.13%-99.29%); with similar procedural success: transvaginal, 89.96%-97.49%; transabdominal/transvesical, 94.55%-99.18%; and laparoscopic/robotic, 96.85%-99.99%. Studies are very limited comparing the various surgical techniques, with only one study comparing transvaginal, transabdominal, and laparoscopic approaches. Interestingly, in this study, the laparoscopic approach was noted to have the least morbidity (Ou CS et al. J Lapraoendosc Adv Surg Tech A. 2004 Feb;14(1):17-21).

For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Alan D. Garely, MD, FACOG, FACS, of the Icahn School of Medicine at Mount Sinai, New York. Dr. Garely has served on the board of directors for the American Urogynecologic Society, serves as chair of the gynecology and obstetrics advisory board for the American College of Surgeons, and has published numerous papers and book chapters.

It is a pleasure to welcome Dr. Garely to this edition of the Master Class in Gynecologic Surgery.

Dr. Miller is a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL. He has no disclosures related to this column.

Vesicovaginal fistula continues to be the most common form of genitourinary fistula, with resultant diminishment in quality of life secondary to physical and psychosocial distress. While it has been reported that 1 million women in Sub-Saharan Africa have untreated vesicovaginal fistula secondary to obstetric trauma, vesicovaginal fistulas are relatively rare in the United States. Per the United States National Hospital Discharge Survey, in 2007, fewer than 5,000 vesicovaginal fistula repairs were performed out of over 2.3 million procedures involving the female urinary and genital system.

The rarity of the diagnosis is also reflected in data collected from the English National Health Service, where vesicovaginal fistula occurred in 1 in 788 hysterectomies (although more common in radical hysterectomy, at 1 in 87).

In a recent systematic review and meta-analysis on the management of vesicovaginal fistulas in women following benign gynecologic surgery, Bodner-Adler et al. evaluated 282 full-text articles to identify 124 studies for inclusion (PLoS One. 2017 Feb 22;12[2]:e0171554). Only ten studies involved solely conservative management with prolonged bladder drainage. Dismal success was noted: 8%. Surgery was performed in 96.4% of cases (1379/1430); transvaginal in 39%, transabdominal/transvesical in 36%, laparoscopic/robotic approach in 15%, and transabdominal/transvaginal in 3%. Overall success rate in these surgical cases was 97.98% (95% confidence interval, 96.13%-99.29%); with similar procedural success: transvaginal, 89.96%-97.49%; transabdominal/transvesical, 94.55%-99.18%; and laparoscopic/robotic, 96.85%-99.99%. Studies are very limited comparing the various surgical techniques, with only one study comparing transvaginal, transabdominal, and laparoscopic approaches. Interestingly, in this study, the laparoscopic approach was noted to have the least morbidity (Ou CS et al. J Lapraoendosc Adv Surg Tech A. 2004 Feb;14(1):17-21).

For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Alan D. Garely, MD, FACOG, FACS, of the Icahn School of Medicine at Mount Sinai, New York. Dr. Garely has served on the board of directors for the American Urogynecologic Society, serves as chair of the gynecology and obstetrics advisory board for the American College of Surgeons, and has published numerous papers and book chapters.

It is a pleasure to welcome Dr. Garely to this edition of the Master Class in Gynecologic Surgery.

Dr. Miller is a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL. He has no disclosures related to this column.

Vesicovaginal fistula continues to be the most common form of genitourinary fistula, with resultant diminishment in quality of life secondary to physical and psychosocial distress. While it has been reported that 1 million women in Sub-Saharan Africa have untreated vesicovaginal fistula secondary to obstetric trauma, vesicovaginal fistulas are relatively rare in the United States. Per the United States National Hospital Discharge Survey, in 2007, fewer than 5,000 vesicovaginal fistula repairs were performed out of over 2.3 million procedures involving the female urinary and genital system.

The rarity of the diagnosis is also reflected in data collected from the English National Health Service, where vesicovaginal fistula occurred in 1 in 788 hysterectomies (although more common in radical hysterectomy, at 1 in 87).

In a recent systematic review and meta-analysis on the management of vesicovaginal fistulas in women following benign gynecologic surgery, Bodner-Adler et al. evaluated 282 full-text articles to identify 124 studies for inclusion (PLoS One. 2017 Feb 22;12[2]:e0171554). Only ten studies involved solely conservative management with prolonged bladder drainage. Dismal success was noted: 8%. Surgery was performed in 96.4% of cases (1379/1430); transvaginal in 39%, transabdominal/transvesical in 36%, laparoscopic/robotic approach in 15%, and transabdominal/transvaginal in 3%. Overall success rate in these surgical cases was 97.98% (95% confidence interval, 96.13%-99.29%); with similar procedural success: transvaginal, 89.96%-97.49%; transabdominal/transvesical, 94.55%-99.18%; and laparoscopic/robotic, 96.85%-99.99%. Studies are very limited comparing the various surgical techniques, with only one study comparing transvaginal, transabdominal, and laparoscopic approaches. Interestingly, in this study, the laparoscopic approach was noted to have the least morbidity (Ou CS et al. J Lapraoendosc Adv Surg Tech A. 2004 Feb;14(1):17-21).

For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Alan D. Garely, MD, FACOG, FACS, of the Icahn School of Medicine at Mount Sinai, New York. Dr. Garely has served on the board of directors for the American Urogynecologic Society, serves as chair of the gynecology and obstetrics advisory board for the American College of Surgeons, and has published numerous papers and book chapters.

It is a pleasure to welcome Dr. Garely to this edition of the Master Class in Gynecologic Surgery.

Dr. Miller is a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL. He has no disclosures related to this column.

Hypertension, diabetes, and smoking in midlife are potentially modifiable risk factors for late-onset epilepsy, according to a study that also found an increased risk with the apolipoprotein E4 (APOE4) genotype and in black individuals.

ricky_68fr/fotolia

Emily L. Johnson, MD, of Johns Hopkins University, Baltimore, and her coauthors analyzed data from 10,420 participants in the Atherosclerosis Risk in Communities prospective cohort study and found 596 who developed late-onset epilepsy (LOE), defined as recurrent unprovoked seizures starting at 60 years or older.

The study, published online July 23 in JAMA Neurology, showed that individuals with hypertension at baseline had a 30% higher risk of LOE, those who smoked had a 9% higher risk, and those with diabetes had a 45% higher risk. However, the increased risk associated with smoking was evident only in women, who had a 27% higher risk.

Participants with incident stroke had a 3.38-fold higher risk of LOE, and those with dementia had a 2.56-fold higher risk, Dr. Johnson and her colleagues reported.

“The association of LOE with vascular and lifestyle risk factors persisted after participants with diagnosis of clinical stroke or dementia were included or censored, suggesting that these risk factors may contribute to LOE even in the absence of dementia or clinical stroke,” the investigators wrote.

However, higher levels of physical activity decreased the risk by 10%, and moderate alcohol consumption – defined as 1-7 standard drinks per week – was associated with a 28% reduction.

Race and geographic location both influenced the risk of LOE; black participants showed a 66% higher risk, compared with whites, and black participants in Mississippi and North Carolina had a higher risk than did North Carolina white participants. The highest risk of LOE was seen in black participants with diabetes.

“The reasons for the different incidences of LOE by race/ethnicity may be owing to differing effects of comorbidities, such as diabetes, for which we found a significantly higher effect in black individuals than in white individuals,” the authors wrote.

Individuals who had one APOE4 allele showed a 46% higher risk, and those with two alleles showed a 2.57-fold higher risk.

“The APOE4 genotype is the major genetic risk factor for Alzheimer’s disease, which is associated with epilepsy; however, no prior association between APOE4 and LOE has previously been shown,” the authors reported.

The researchers noted that their findings suggested that lifestyle modifications earlier in life could mitigate some of the risk factors associated with LOE, and could also help identify patients at higher risk for the disease.

No funding was declared. One author declared consultancy and investigator positions with private industry.

SOURCE: Johnson E et al. JAMA Neurol, 2018 July 23. doi: 10.1001/jamaneurol.2018.1935.
 

Hypertension, diabetes, and smoking in midlife are potentially modifiable risk factors for late-onset epilepsy, according to a study that also found an increased risk with the apolipoprotein E4 (APOE4) genotype and in black individuals.

ricky_68fr/fotolia

Emily L. Johnson, MD, of Johns Hopkins University, Baltimore, and her coauthors analyzed data from 10,420 participants in the Atherosclerosis Risk in Communities prospective cohort study and found 596 who developed late-onset epilepsy (LOE), defined as recurrent unprovoked seizures starting at 60 years or older.

The study, published online July 23 in JAMA Neurology, showed that individuals with hypertension at baseline had a 30% higher risk of LOE, those who smoked had a 9% higher risk, and those with diabetes had a 45% higher risk. However, the increased risk associated with smoking was evident only in women, who had a 27% higher risk.

Participants with incident stroke had a 3.38-fold higher risk of LOE, and those with dementia had a 2.56-fold higher risk, Dr. Johnson and her colleagues reported.

“The association of LOE with vascular and lifestyle risk factors persisted after participants with diagnosis of clinical stroke or dementia were included or censored, suggesting that these risk factors may contribute to LOE even in the absence of dementia or clinical stroke,” the investigators wrote.

However, higher levels of physical activity decreased the risk by 10%, and moderate alcohol consumption – defined as 1-7 standard drinks per week – was associated with a 28% reduction.

Race and geographic location both influenced the risk of LOE; black participants showed a 66% higher risk, compared with whites, and black participants in Mississippi and North Carolina had a higher risk than did North Carolina white participants. The highest risk of LOE was seen in black participants with diabetes.

“The reasons for the different incidences of LOE by race/ethnicity may be owing to differing effects of comorbidities, such as diabetes, for which we found a significantly higher effect in black individuals than in white individuals,” the authors wrote.

Individuals who had one APOE4 allele showed a 46% higher risk, and those with two alleles showed a 2.57-fold higher risk.

“The APOE4 genotype is the major genetic risk factor for Alzheimer’s disease, which is associated with epilepsy; however, no prior association between APOE4 and LOE has previously been shown,” the authors reported.

The researchers noted that their findings suggested that lifestyle modifications earlier in life could mitigate some of the risk factors associated with LOE, and could also help identify patients at higher risk for the disease.

No funding was declared. One author declared consultancy and investigator positions with private industry.

SOURCE: Johnson E et al. JAMA Neurol, 2018 July 23. doi: 10.1001/jamaneurol.2018.1935.
 

Hypertension, diabetes, and smoking in midlife are potentially modifiable risk factors for late-onset epilepsy, according to a study that also found an increased risk with the apolipoprotein E4 (APOE4) genotype and in black individuals.

ricky_68fr/fotolia

Emily L. Johnson, MD, of Johns Hopkins University, Baltimore, and her coauthors analyzed data from 10,420 participants in the Atherosclerosis Risk in Communities prospective cohort study and found 596 who developed late-onset epilepsy (LOE), defined as recurrent unprovoked seizures starting at 60 years or older.

The study, published online July 23 in JAMA Neurology, showed that individuals with hypertension at baseline had a 30% higher risk of LOE, those who smoked had a 9% higher risk, and those with diabetes had a 45% higher risk. However, the increased risk associated with smoking was evident only in women, who had a 27% higher risk.

Participants with incident stroke had a 3.38-fold higher risk of LOE, and those with dementia had a 2.56-fold higher risk, Dr. Johnson and her colleagues reported.

“The association of LOE with vascular and lifestyle risk factors persisted after participants with diagnosis of clinical stroke or dementia were included or censored, suggesting that these risk factors may contribute to LOE even in the absence of dementia or clinical stroke,” the investigators wrote.

However, higher levels of physical activity decreased the risk by 10%, and moderate alcohol consumption – defined as 1-7 standard drinks per week – was associated with a 28% reduction.

Race and geographic location both influenced the risk of LOE; black participants showed a 66% higher risk, compared with whites, and black participants in Mississippi and North Carolina had a higher risk than did North Carolina white participants. The highest risk of LOE was seen in black participants with diabetes.

“The reasons for the different incidences of LOE by race/ethnicity may be owing to differing effects of comorbidities, such as diabetes, for which we found a significantly higher effect in black individuals than in white individuals,” the authors wrote.

Individuals who had one APOE4 allele showed a 46% higher risk, and those with two alleles showed a 2.57-fold higher risk.

“The APOE4 genotype is the major genetic risk factor for Alzheimer’s disease, which is associated with epilepsy; however, no prior association between APOE4 and LOE has previously been shown,” the authors reported.

The researchers noted that their findings suggested that lifestyle modifications earlier in life could mitigate some of the risk factors associated with LOE, and could also help identify patients at higher risk for the disease.

No funding was declared. One author declared consultancy and investigator positions with private industry.

SOURCE: Johnson E et al. JAMA Neurol, 2018 July 23. doi: 10.1001/jamaneurol.2018.1935.
 

There’s more evidence that the vaunted reputation of fish oil is all wet: An updated Cochrane Library review finds that boosting two components of omega-3 fats – mainly through supplements such as fish oil – has little or no impact on cardiac health or overall mortality.

©Clayton Hansen/iStockphoto

“Although EPA and DHA reduce triglycerides, supplementary omega-3 fats are probably not useful for preventing or treating heart and circulatory diseases,” the researchers wrote, referring to eicosapentaenoic acid and docosahexaenoic acid, two sources of omega-3 fats in fish.

They did find signs that boosting intake of plant-based alpha-linolenic acid (ALA) “may be slightly protective for some heart and circulatory diseases.” However, they deemed the evidence to be of low quality compared with the high- to moderate-quality evidence supporting the conclusions regarding omega-3 fats from fish.

The review, led by Asmaa S. Abdelhamid, MBBCH, MSc, MD, of the University of East Anglia, was commissioned by the World Health Organization and published on July 18, 2018, in Cochrane Database of Systematic Reviews (doi: 10.1002/14651858.CD003177.pub3). It updates a 2004 Cochrane Library review.

As the review notes, “there is a great deal of public belief in the cardiovascular benefits of omega-3 fats.” But research in recent years has questioned the benefits of fish oil supplementation.

For the new review, the researchers focused on studies that boosted omega-3 fat intake using EPA, DHA and ALA.

The researchers included 79 randomized controlled trials with a total of more than 112,000 adult participants. The studies examined the cardiac and circulatory system effects of greater omega-3 consumption for at least a year compared with controls. Most trials tested supplementation with capsules, but some relied on boosting intake of foods or simply making dietary recommendations.

The studies were conducted in North America, Europe, Australia, and Asia. Researchers determined that 25 trials were designed well enough to be deemed “very trustworthy.”

According to the review’s meta-analysis, increasing intake of long-chain omega-3 fatty acids (EPA and DHA) had little to no effect on all-cause mortality (relative risk, 0.98; 39 trials), cardiovascular mortality (RR, 0.95; 25 trials), cardiovascular events (RR, 0.99; 38 trials), coronary heart disease mortality (RR, 0.93; 21 trials) and arrhythmia (RR, 0.97; 28 trials), while there was a potential boost in stroke risk (RR, 1.06; 28 trials).

The investigators noted that the relative risk of coronary heart disease events fell (RR, 0.93; 28 trials), but this did not hold up after sensitivity analysis. All these trials were deemed of moderate or high quality.

As for increased ALA intake, the researchers found little or no effect on all-cause mortality (RR, 1.01; four trials) and cardiovascular mortality (RR, 0.96; four trials) or coronary heart disease events (RR, 1.00, four trials).

Although the researchers deemed the evidence on ALA to be of low quality, there’s a possible decreased risk of cardiovascular events (RR, 0.95; five trials), coronary heart disease mortality (RR, 0.95; three trials) and arrhythmia (RR, 0.79; one trial). It’s not clear if increased ALA intake affects stroke risk.

“There was no evidence that increasing LCn3 [long-chain omega-3 fatty acids] or ALA altered serious adverse events, adiposity, or lipids, although LCn3 slightly reduced triglycerides and increased HDL. ALA probably reduces HDL (high- or moderate-quality evidence),” the researchers wrote.

Why have some earlier studies suggested a significant effect, enough to help convince millions of Americans to add fish oil pills to their diets? “Previous suggestions of benefits from EPA and DHA supplements appear to spring from trials with higher risk of bias,” the researchers wrote. Robert A. Vogel, MD, a cardiologist at the University of Colorado Denver who is familiar with the review findings, said in an interview that “it’s hard to recommend taking fish oil for heart disease. Even if there’s some effect, it’s got to be a very small, 5%-7% reduction at the best.

“That is not to say that there isn’t an effect on triglycerides,” he added. “[Fish oil] is an accepted way of reducing triglycerides. But you don’t reduce triglycerides to reduce heart disease. There are other risks to high triglycerides, such as pancreatitis.”

Dr. Vogel said he’s never taken fish oil supplements, but he does eat fish 5-6 times a week.

The review was funded by the University of East Anglia, Cochrane Heart Group, and the National Institute for Health Research. The review authors reported no relevant disclosures. Dr. Vogel disclosed consulting for the Pritikin Longevity Center.

SOURCE: Abdelhamid AS et al. Cochrane Database Syst Rev. 2018 Jul 18. doi: 10.1002/14651858.CD003177.pub3.

There’s more evidence that the vaunted reputation of fish oil is all wet: An updated Cochrane Library review finds that boosting two components of omega-3 fats – mainly through supplements such as fish oil – has little or no impact on cardiac health or overall mortality.

©Clayton Hansen/iStockphoto

“Although EPA and DHA reduce triglycerides, supplementary omega-3 fats are probably not useful for preventing or treating heart and circulatory diseases,” the researchers wrote, referring to eicosapentaenoic acid and docosahexaenoic acid, two sources of omega-3 fats in fish.

They did find signs that boosting intake of plant-based alpha-linolenic acid (ALA) “may be slightly protective for some heart and circulatory diseases.” However, they deemed the evidence to be of low quality compared with the high- to moderate-quality evidence supporting the conclusions regarding omega-3 fats from fish.

The review, led by Asmaa S. Abdelhamid, MBBCH, MSc, MD, of the University of East Anglia, was commissioned by the World Health Organization and published on July 18, 2018, in Cochrane Database of Systematic Reviews (doi: 10.1002/14651858.CD003177.pub3). It updates a 2004 Cochrane Library review.

As the review notes, “there is a great deal of public belief in the cardiovascular benefits of omega-3 fats.” But research in recent years has questioned the benefits of fish oil supplementation.

For the new review, the researchers focused on studies that boosted omega-3 fat intake using EPA, DHA and ALA.

The researchers included 79 randomized controlled trials with a total of more than 112,000 adult participants. The studies examined the cardiac and circulatory system effects of greater omega-3 consumption for at least a year compared with controls. Most trials tested supplementation with capsules, but some relied on boosting intake of foods or simply making dietary recommendations.

The studies were conducted in North America, Europe, Australia, and Asia. Researchers determined that 25 trials were designed well enough to be deemed “very trustworthy.”

According to the review’s meta-analysis, increasing intake of long-chain omega-3 fatty acids (EPA and DHA) had little to no effect on all-cause mortality (relative risk, 0.98; 39 trials), cardiovascular mortality (RR, 0.95; 25 trials), cardiovascular events (RR, 0.99; 38 trials), coronary heart disease mortality (RR, 0.93; 21 trials) and arrhythmia (RR, 0.97; 28 trials), while there was a potential boost in stroke risk (RR, 1.06; 28 trials).

The investigators noted that the relative risk of coronary heart disease events fell (RR, 0.93; 28 trials), but this did not hold up after sensitivity analysis. All these trials were deemed of moderate or high quality.

As for increased ALA intake, the researchers found little or no effect on all-cause mortality (RR, 1.01; four trials) and cardiovascular mortality (RR, 0.96; four trials) or coronary heart disease events (RR, 1.00, four trials).

Although the researchers deemed the evidence on ALA to be of low quality, there’s a possible decreased risk of cardiovascular events (RR, 0.95; five trials), coronary heart disease mortality (RR, 0.95; three trials) and arrhythmia (RR, 0.79; one trial). It’s not clear if increased ALA intake affects stroke risk.

“There was no evidence that increasing LCn3 [long-chain omega-3 fatty acids] or ALA altered serious adverse events, adiposity, or lipids, although LCn3 slightly reduced triglycerides and increased HDL. ALA probably reduces HDL (high- or moderate-quality evidence),” the researchers wrote.

Why have some earlier studies suggested a significant effect, enough to help convince millions of Americans to add fish oil pills to their diets? “Previous suggestions of benefits from EPA and DHA supplements appear to spring from trials with higher risk of bias,” the researchers wrote. Robert A. Vogel, MD, a cardiologist at the University of Colorado Denver who is familiar with the review findings, said in an interview that “it’s hard to recommend taking fish oil for heart disease. Even if there’s some effect, it’s got to be a very small, 5%-7% reduction at the best.

“That is not to say that there isn’t an effect on triglycerides,” he added. “[Fish oil] is an accepted way of reducing triglycerides. But you don’t reduce triglycerides to reduce heart disease. There are other risks to high triglycerides, such as pancreatitis.”

Dr. Vogel said he’s never taken fish oil supplements, but he does eat fish 5-6 times a week.

The review was funded by the University of East Anglia, Cochrane Heart Group, and the National Institute for Health Research. The review authors reported no relevant disclosures. Dr. Vogel disclosed consulting for the Pritikin Longevity Center.

SOURCE: Abdelhamid AS et al. Cochrane Database Syst Rev. 2018 Jul 18. doi: 10.1002/14651858.CD003177.pub3.

There’s more evidence that the vaunted reputation of fish oil is all wet: An updated Cochrane Library review finds that boosting two components of omega-3 fats – mainly through supplements such as fish oil – has little or no impact on cardiac health or overall mortality.

©Clayton Hansen/iStockphoto

“Although EPA and DHA reduce triglycerides, supplementary omega-3 fats are probably not useful for preventing or treating heart and circulatory diseases,” the researchers wrote, referring to eicosapentaenoic acid and docosahexaenoic acid, two sources of omega-3 fats in fish.

They did find signs that boosting intake of plant-based alpha-linolenic acid (ALA) “may be slightly protective for some heart and circulatory diseases.” However, they deemed the evidence to be of low quality compared with the high- to moderate-quality evidence supporting the conclusions regarding omega-3 fats from fish.

The review, led by Asmaa S. Abdelhamid, MBBCH, MSc, MD, of the University of East Anglia, was commissioned by the World Health Organization and published on July 18, 2018, in Cochrane Database of Systematic Reviews (doi: 10.1002/14651858.CD003177.pub3). It updates a 2004 Cochrane Library review.

As the review notes, “there is a great deal of public belief in the cardiovascular benefits of omega-3 fats.” But research in recent years has questioned the benefits of fish oil supplementation.

For the new review, the researchers focused on studies that boosted omega-3 fat intake using EPA, DHA and ALA.

The researchers included 79 randomized controlled trials with a total of more than 112,000 adult participants. The studies examined the cardiac and circulatory system effects of greater omega-3 consumption for at least a year compared with controls. Most trials tested supplementation with capsules, but some relied on boosting intake of foods or simply making dietary recommendations.

The studies were conducted in North America, Europe, Australia, and Asia. Researchers determined that 25 trials were designed well enough to be deemed “very trustworthy.”

According to the review’s meta-analysis, increasing intake of long-chain omega-3 fatty acids (EPA and DHA) had little to no effect on all-cause mortality (relative risk, 0.98; 39 trials), cardiovascular mortality (RR, 0.95; 25 trials), cardiovascular events (RR, 0.99; 38 trials), coronary heart disease mortality (RR, 0.93; 21 trials) and arrhythmia (RR, 0.97; 28 trials), while there was a potential boost in stroke risk (RR, 1.06; 28 trials).

The investigators noted that the relative risk of coronary heart disease events fell (RR, 0.93; 28 trials), but this did not hold up after sensitivity analysis. All these trials were deemed of moderate or high quality.

As for increased ALA intake, the researchers found little or no effect on all-cause mortality (RR, 1.01; four trials) and cardiovascular mortality (RR, 0.96; four trials) or coronary heart disease events (RR, 1.00, four trials).

Although the researchers deemed the evidence on ALA to be of low quality, there’s a possible decreased risk of cardiovascular events (RR, 0.95; five trials), coronary heart disease mortality (RR, 0.95; three trials) and arrhythmia (RR, 0.79; one trial). It’s not clear if increased ALA intake affects stroke risk.

“There was no evidence that increasing LCn3 [long-chain omega-3 fatty acids] or ALA altered serious adverse events, adiposity, or lipids, although LCn3 slightly reduced triglycerides and increased HDL. ALA probably reduces HDL (high- or moderate-quality evidence),” the researchers wrote.

Why have some earlier studies suggested a significant effect, enough to help convince millions of Americans to add fish oil pills to their diets? “Previous suggestions of benefits from EPA and DHA supplements appear to spring from trials with higher risk of bias,” the researchers wrote. Robert A. Vogel, MD, a cardiologist at the University of Colorado Denver who is familiar with the review findings, said in an interview that “it’s hard to recommend taking fish oil for heart disease. Even if there’s some effect, it’s got to be a very small, 5%-7% reduction at the best.

“That is not to say that there isn’t an effect on triglycerides,” he added. “[Fish oil] is an accepted way of reducing triglycerides. But you don’t reduce triglycerides to reduce heart disease. There are other risks to high triglycerides, such as pancreatitis.”

Dr. Vogel said he’s never taken fish oil supplements, but he does eat fish 5-6 times a week.

The review was funded by the University of East Anglia, Cochrane Heart Group, and the National Institute for Health Research. The review authors reported no relevant disclosures. Dr. Vogel disclosed consulting for the Pritikin Longevity Center.

SOURCE: Abdelhamid AS et al. Cochrane Database Syst Rev. 2018 Jul 18. doi: 10.1002/14651858.CD003177.pub3.

Physician associations are expressing mixed feelings about dramatic changes proposed for Year 3 of the Quality Payment Program (QPP) by the Centers for Medicare & Medicaid Services.

Copyright roobcio/Thinkstock

Under its 2019 QPP proposal, CMS plans to remove 34 process-based measures within the program considered to be low value or low priority so that providers can focus more on meaningful measures that affect health outcomes, according to the agency. CMS also calls for the streamlining of the “interoperability performance category” within the Merit-Based Incentive Payment System (MIPS) to create a more simplified scoring methodology.

In regard to alternative payment models (APMs), CMS seeks to update the Advanced APM Certified EHR Technology (CEHRT) threshold so that an Advanced APM must require at least 75% of eligible clinicians in each APM entity to use CEHRT. The agency also plans to extend the 8% revenue-based nominal amount standard for Advanced APMs through performance year 2024.

Ana Maria Lopez, MD, president for the American College of Physicians said the they were pleased that CMS proposed the removal of a number of quality measures deemed to be of low value. “ACP commends CMS for taking major steps to reduce unnecessary administrative tasks that are detracting from the patient-physician relationship,” Dr. Lopez said in a statement.

But ACP officials also noted that they were disappointed that CMS did not heed calls to streamline MIPS requirements and scoring, establish a minimum 90-day reporting period for all performance categories, or reduce the total number of quality measures.

ACP supports CMS’ promoting of interoperability by requiring CEHRT, but it urged the agency to allow at least 6 months for vendors and physicians to implement system upgrades in order to ensure a smooth transition and avoid disruptions to patient care. Additionally, CMS needs to “think about ways to mitigate costs associated with implementation, especially for small practices,” Dr. Lopez said in the statement.

In an interview, Michael L. Munger, MD, president for the American Academy of Family Physicians, said that his group is reviewing the proposed QPP regulations and plans to offer its full perspective during the comment period.

“Our initial assessment indicates CMS continues progress to simplify and modernize in documentation requirements for evaluation and management office visits,” Dr. Munger said. “Reforming the U.S. health care system is an ongoing process, and the AAFP looks forward to working with CMS to ensure continued progress.”

As part of the proposed QPP changes, CMS for the first time is proposing to allow physicians to opt-in to the MIPS program if they are prepared to meet the program’s requirements. The proposal also adds a new exemption to MIPS participation: Doctors who perform 200 or fewer services under the Medicare fee schedule. The proposal retains its previous exemption thresholds for participating in MIPS – physicians who bill Medicare $90,000 or less annually and see 200 or fewer Medicare patients are excused from the program.

CMS also proposes to add new episode-based measures to the cost performance category and to create an option to use facility-based quality and cost performance measures for certain facility-based clinicians. The QPP proposal includes a number of changes for small medical practices, which include the following:

• Continuing the small practice bonus, but including it in the quality performance category score of clinicians in small practices instead of as a standalone bonus.
• Awarding small practices three points for quality measures that don’t meet the data completeness requirements.
• Consolidating the low-volume threshold determination periods with the determination period for identifying a small practice.

David Daikh, MD, president for the American College of Rheumatology, said the ACR appreciates CMS’ emphasis on supporting the development of alternative payment models (APMs) and is encouraged by the agency’s proposal to allow more physicians to participate.

“However, we are concerned that eliminating the MIPS small practice bonus as a stand-alone bonus and instead folding it into the quality performance score would dilute the bonus and hurt small and rural providers,” Dr. Daikh said in a statement. “The ACR strongly supports maintaining the small practice bonus as a five-point stand-alone bonus that is added to the final score.”

Meanwhile, Jerry Penso, MD, president and CEO for the American Medical Group Association expressed disappointment that CMS did not lower its exclusion threshold for MIPS. Through the Bipartisan Budget Act of 2018, CMS plans to continue “the gradual implementation of certain MIPS requirements to ease administrative burden on clinicians,” according to a CMS fact sheet. This includes flexible performance thresholds until the fifth year of the QPP. The agency previously required the MIPS cost performance category to have a weight of 30% in Year 3 of the program (performance period 2019); however, the weight is now required to be no less than 10% and no more than 30% for the third, fourth and fifth years of the QPP.

Dr. Penso noted that as authorized by the Medicare Access and CHIP Reauthorization Act (MACRA), providers were given the opportunity to earn an adjustment of up to 7% on their Medicare Part B payments in 2021 based on their 2019 performance.

“However, as indicated in [the] proposal, CMS estimates the overall payment adjustment will be 2%,” Dr. Penso said in a statement. “We are concerned that CMS has again opted not to recognize the efforts of high-performing AMGA members. As we enter the program’s third year, it is time for CMS to honor congressional intent and use MIPS to create value for Medicare.”

Some specialty associations, including the American Academy of Dermatology, said they are still reviewing the proposed policies and could not comment on the changes at this time.

“The American Academy of Dermatology is still looking at the proposed rule and the implications it may have on board-certified dermatologists and their patients,” an association spokesperson said in an interview.

Comments on the proposed rule will be accepted at www.regulations.gov until Sept. 10.

Physician associations are expressing mixed feelings about dramatic changes proposed for Year 3 of the Quality Payment Program (QPP) by the Centers for Medicare & Medicaid Services.

Copyright roobcio/Thinkstock

Under its 2019 QPP proposal, CMS plans to remove 34 process-based measures within the program considered to be low value or low priority so that providers can focus more on meaningful measures that affect health outcomes, according to the agency. CMS also calls for the streamlining of the “interoperability performance category” within the Merit-Based Incentive Payment System (MIPS) to create a more simplified scoring methodology.

In regard to alternative payment models (APMs), CMS seeks to update the Advanced APM Certified EHR Technology (CEHRT) threshold so that an Advanced APM must require at least 75% of eligible clinicians in each APM entity to use CEHRT. The agency also plans to extend the 8% revenue-based nominal amount standard for Advanced APMs through performance year 2024.

Ana Maria Lopez, MD, president for the American College of Physicians said the they were pleased that CMS proposed the removal of a number of quality measures deemed to be of low value. “ACP commends CMS for taking major steps to reduce unnecessary administrative tasks that are detracting from the patient-physician relationship,” Dr. Lopez said in a statement.

But ACP officials also noted that they were disappointed that CMS did not heed calls to streamline MIPS requirements and scoring, establish a minimum 90-day reporting period for all performance categories, or reduce the total number of quality measures.

ACP supports CMS’ promoting of interoperability by requiring CEHRT, but it urged the agency to allow at least 6 months for vendors and physicians to implement system upgrades in order to ensure a smooth transition and avoid disruptions to patient care. Additionally, CMS needs to “think about ways to mitigate costs associated with implementation, especially for small practices,” Dr. Lopez said in the statement.

In an interview, Michael L. Munger, MD, president for the American Academy of Family Physicians, said that his group is reviewing the proposed QPP regulations and plans to offer its full perspective during the comment period.

“Our initial assessment indicates CMS continues progress to simplify and modernize in documentation requirements for evaluation and management office visits,” Dr. Munger said. “Reforming the U.S. health care system is an ongoing process, and the AAFP looks forward to working with CMS to ensure continued progress.”

As part of the proposed QPP changes, CMS for the first time is proposing to allow physicians to opt-in to the MIPS program if they are prepared to meet the program’s requirements. The proposal also adds a new exemption to MIPS participation: Doctors who perform 200 or fewer services under the Medicare fee schedule. The proposal retains its previous exemption thresholds for participating in MIPS – physicians who bill Medicare $90,000 or less annually and see 200 or fewer Medicare patients are excused from the program.

CMS also proposes to add new episode-based measures to the cost performance category and to create an option to use facility-based quality and cost performance measures for certain facility-based clinicians. The QPP proposal includes a number of changes for small medical practices, which include the following:

• Continuing the small practice bonus, but including it in the quality performance category score of clinicians in small practices instead of as a standalone bonus.
• Awarding small practices three points for quality measures that don’t meet the data completeness requirements.
• Consolidating the low-volume threshold determination periods with the determination period for identifying a small practice.

David Daikh, MD, president for the American College of Rheumatology, said the ACR appreciates CMS’ emphasis on supporting the development of alternative payment models (APMs) and is encouraged by the agency’s proposal to allow more physicians to participate.

“However, we are concerned that eliminating the MIPS small practice bonus as a stand-alone bonus and instead folding it into the quality performance score would dilute the bonus and hurt small and rural providers,” Dr. Daikh said in a statement. “The ACR strongly supports maintaining the small practice bonus as a five-point stand-alone bonus that is added to the final score.”

Meanwhile, Jerry Penso, MD, president and CEO for the American Medical Group Association expressed disappointment that CMS did not lower its exclusion threshold for MIPS. Through the Bipartisan Budget Act of 2018, CMS plans to continue “the gradual implementation of certain MIPS requirements to ease administrative burden on clinicians,” according to a CMS fact sheet. This includes flexible performance thresholds until the fifth year of the QPP. The agency previously required the MIPS cost performance category to have a weight of 30% in Year 3 of the program (performance period 2019); however, the weight is now required to be no less than 10% and no more than 30% for the third, fourth and fifth years of the QPP.

Dr. Penso noted that as authorized by the Medicare Access and CHIP Reauthorization Act (MACRA), providers were given the opportunity to earn an adjustment of up to 7% on their Medicare Part B payments in 2021 based on their 2019 performance.

“However, as indicated in [the] proposal, CMS estimates the overall payment adjustment will be 2%,” Dr. Penso said in a statement. “We are concerned that CMS has again opted not to recognize the efforts of high-performing AMGA members. As we enter the program’s third year, it is time for CMS to honor congressional intent and use MIPS to create value for Medicare.”

Some specialty associations, including the American Academy of Dermatology, said they are still reviewing the proposed policies and could not comment on the changes at this time.

“The American Academy of Dermatology is still looking at the proposed rule and the implications it may have on board-certified dermatologists and their patients,” an association spokesperson said in an interview.

Comments on the proposed rule will be accepted at www.regulations.gov until Sept. 10.

Physician associations are expressing mixed feelings about dramatic changes proposed for Year 3 of the Quality Payment Program (QPP) by the Centers for Medicare & Medicaid Services.

Copyright roobcio/Thinkstock

Under its 2019 QPP proposal, CMS plans to remove 34 process-based measures within the program considered to be low value or low priority so that providers can focus more on meaningful measures that affect health outcomes, according to the agency. CMS also calls for the streamlining of the “interoperability performance category” within the Merit-Based Incentive Payment System (MIPS) to create a more simplified scoring methodology.

In regard to alternative payment models (APMs), CMS seeks to update the Advanced APM Certified EHR Technology (CEHRT) threshold so that an Advanced APM must require at least 75% of eligible clinicians in each APM entity to use CEHRT. The agency also plans to extend the 8% revenue-based nominal amount standard for Advanced APMs through performance year 2024.

Ana Maria Lopez, MD, president for the American College of Physicians said the they were pleased that CMS proposed the removal of a number of quality measures deemed to be of low value. “ACP commends CMS for taking major steps to reduce unnecessary administrative tasks that are detracting from the patient-physician relationship,” Dr. Lopez said in a statement.

But ACP officials also noted that they were disappointed that CMS did not heed calls to streamline MIPS requirements and scoring, establish a minimum 90-day reporting period for all performance categories, or reduce the total number of quality measures.

ACP supports CMS’ promoting of interoperability by requiring CEHRT, but it urged the agency to allow at least 6 months for vendors and physicians to implement system upgrades in order to ensure a smooth transition and avoid disruptions to patient care. Additionally, CMS needs to “think about ways to mitigate costs associated with implementation, especially for small practices,” Dr. Lopez said in the statement.

In an interview, Michael L. Munger, MD, president for the American Academy of Family Physicians, said that his group is reviewing the proposed QPP regulations and plans to offer its full perspective during the comment period.

“Our initial assessment indicates CMS continues progress to simplify and modernize in documentation requirements for evaluation and management office visits,” Dr. Munger said. “Reforming the U.S. health care system is an ongoing process, and the AAFP looks forward to working with CMS to ensure continued progress.”

As part of the proposed QPP changes, CMS for the first time is proposing to allow physicians to opt-in to the MIPS program if they are prepared to meet the program’s requirements. The proposal also adds a new exemption to MIPS participation: Doctors who perform 200 or fewer services under the Medicare fee schedule. The proposal retains its previous exemption thresholds for participating in MIPS – physicians who bill Medicare $90,000 or less annually and see 200 or fewer Medicare patients are excused from the program.

CMS also proposes to add new episode-based measures to the cost performance category and to create an option to use facility-based quality and cost performance measures for certain facility-based clinicians. The QPP proposal includes a number of changes for small medical practices, which include the following:

• Continuing the small practice bonus, but including it in the quality performance category score of clinicians in small practices instead of as a standalone bonus.
• Awarding small practices three points for quality measures that don’t meet the data completeness requirements.
• Consolidating the low-volume threshold determination periods with the determination period for identifying a small practice.

David Daikh, MD, president for the American College of Rheumatology, said the ACR appreciates CMS’ emphasis on supporting the development of alternative payment models (APMs) and is encouraged by the agency’s proposal to allow more physicians to participate.

“However, we are concerned that eliminating the MIPS small practice bonus as a stand-alone bonus and instead folding it into the quality performance score would dilute the bonus and hurt small and rural providers,” Dr. Daikh said in a statement. “The ACR strongly supports maintaining the small practice bonus as a five-point stand-alone bonus that is added to the final score.”

Meanwhile, Jerry Penso, MD, president and CEO for the American Medical Group Association expressed disappointment that CMS did not lower its exclusion threshold for MIPS. Through the Bipartisan Budget Act of 2018, CMS plans to continue “the gradual implementation of certain MIPS requirements to ease administrative burden on clinicians,” according to a CMS fact sheet. This includes flexible performance thresholds until the fifth year of the QPP. The agency previously required the MIPS cost performance category to have a weight of 30% in Year 3 of the program (performance period 2019); however, the weight is now required to be no less than 10% and no more than 30% for the third, fourth and fifth years of the QPP.

Dr. Penso noted that as authorized by the Medicare Access and CHIP Reauthorization Act (MACRA), providers were given the opportunity to earn an adjustment of up to 7% on their Medicare Part B payments in 2021 based on their 2019 performance.

“However, as indicated in [the] proposal, CMS estimates the overall payment adjustment will be 2%,” Dr. Penso said in a statement. “We are concerned that CMS has again opted not to recognize the efforts of high-performing AMGA members. As we enter the program’s third year, it is time for CMS to honor congressional intent and use MIPS to create value for Medicare.”

Some specialty associations, including the American Academy of Dermatology, said they are still reviewing the proposed policies and could not comment on the changes at this time.

“The American Academy of Dermatology is still looking at the proposed rule and the implications it may have on board-certified dermatologists and their patients,” an association spokesperson said in an interview.

Comments on the proposed rule will be accepted at www.regulations.gov until Sept. 10.

Surgeons in the United States have been slow to adopt minimally invasive surgical techniques for inguinal hernia repairs, according to data from more than 6,000 patients.

“The benefit of MIS over open repair is recognized for patients with bilateral or recurrent inguinal hernias, and current guidelines recommend MIS repair for these cases,” wrote Joceline V. Vu, MD, of the University of Michigan, Ann Arbor, and her colleagues.

In a study published in Surgical Endoscopy, the researchers assessed surgeons’ practice patterns for hernia repair, with a primary outcome of minimally invasive surgery (MIS) rates per individual surgeon. They reviewed data from a statewide clinical registry of 6,723 adults older than 18 years who underwent elective hernia surgery in Michigan between 2012 and 2016.

Overall, the surgeons’ use of MIS varied, but more than half (58%) of the surgeons performed no MIS for hernia repair. For those who did use MIS, it was used in 41% of bilateral hernias and 38% of recurrent hernias.

Surgeons were significantly less likely to use MIS for hernia on patients aged 65 years and older (odds ratio, 0.68, P = .003), or those who were black (OR 0.75, P = .045). MIS repair also was significantly less likely for patients with chronic obstructive pulmonary disease (OR 0.57, P less than .001) or patients in American Society of Anesthesiologists Classification under 3 (OR 0.79, P less than .001).

Of the 227 surgeons who performed MIS, 71 (31%) had MIS utilization rates of 75% or higher and were defined as high-utilization surgeons. Overall, 75% of the MIS repairs were performed by 14% of the surgeons.

The surgeons with the highest use of MIS were unevenly distributed across the state; the Ann Arbor region had the highest percentage of high MIS-use surgeons (22%), compared with the Lansing area, in which 2% of surgeons were high users of MIS.

The risk-adjusted rate of MIS for inguinal hernia repair varied significantly across six regions of the state, from 10% to 48%, and the regions with the highest rates were those with the highest percentage of high-MIS use surgeons.

“These findings suggest that a large portion of decision making to offer MIS repair may depend on surgeon differences, rather than clinical appropriateness,” the researchers said. “The likelihood that a patient receives MIS repair may thus be predetermined by the surgeon to whom they are referred,” they added.

“Whether through novel training interventions or by establishing regional referral networks to improve access to MIS repair, improvement in MIS delivery and access is needed to reduce disparity and promote evidence-based practice,” they concluded.

The findings were limited by several factors including the potential for bias because of the observational nature of the study, the potential lack of generalizability of the findings, and lack of data on the particular attributes of the hernias, the researchers said.

Dr. Vu disclosed funding from the National Institutes of Health but had no financial conflicts to disclose. One of the study coauthors disclosed a relationship with Medtronic.

SOURCE: Vu JV et al. Surg Endosc. 2018 Jul 9. doi: 10.1007/s00464-018-6322-x.

Surgeons in the United States have been slow to adopt minimally invasive surgical techniques for inguinal hernia repairs, according to data from more than 6,000 patients.

“The benefit of MIS over open repair is recognized for patients with bilateral or recurrent inguinal hernias, and current guidelines recommend MIS repair for these cases,” wrote Joceline V. Vu, MD, of the University of Michigan, Ann Arbor, and her colleagues.

In a study published in Surgical Endoscopy, the researchers assessed surgeons’ practice patterns for hernia repair, with a primary outcome of minimally invasive surgery (MIS) rates per individual surgeon. They reviewed data from a statewide clinical registry of 6,723 adults older than 18 years who underwent elective hernia surgery in Michigan between 2012 and 2016.

Overall, the surgeons’ use of MIS varied, but more than half (58%) of the surgeons performed no MIS for hernia repair. For those who did use MIS, it was used in 41% of bilateral hernias and 38% of recurrent hernias.

Surgeons were significantly less likely to use MIS for hernia on patients aged 65 years and older (odds ratio, 0.68, P = .003), or those who were black (OR 0.75, P = .045). MIS repair also was significantly less likely for patients with chronic obstructive pulmonary disease (OR 0.57, P less than .001) or patients in American Society of Anesthesiologists Classification under 3 (OR 0.79, P less than .001).

Of the 227 surgeons who performed MIS, 71 (31%) had MIS utilization rates of 75% or higher and were defined as high-utilization surgeons. Overall, 75% of the MIS repairs were performed by 14% of the surgeons.

The surgeons with the highest use of MIS were unevenly distributed across the state; the Ann Arbor region had the highest percentage of high MIS-use surgeons (22%), compared with the Lansing area, in which 2% of surgeons were high users of MIS.

The risk-adjusted rate of MIS for inguinal hernia repair varied significantly across six regions of the state, from 10% to 48%, and the regions with the highest rates were those with the highest percentage of high-MIS use surgeons.

“These findings suggest that a large portion of decision making to offer MIS repair may depend on surgeon differences, rather than clinical appropriateness,” the researchers said. “The likelihood that a patient receives MIS repair may thus be predetermined by the surgeon to whom they are referred,” they added.

“Whether through novel training interventions or by establishing regional referral networks to improve access to MIS repair, improvement in MIS delivery and access is needed to reduce disparity and promote evidence-based practice,” they concluded.

The findings were limited by several factors including the potential for bias because of the observational nature of the study, the potential lack of generalizability of the findings, and lack of data on the particular attributes of the hernias, the researchers said.

Dr. Vu disclosed funding from the National Institutes of Health but had no financial conflicts to disclose. One of the study coauthors disclosed a relationship with Medtronic.

SOURCE: Vu JV et al. Surg Endosc. 2018 Jul 9. doi: 10.1007/s00464-018-6322-x.

Surgeons in the United States have been slow to adopt minimally invasive surgical techniques for inguinal hernia repairs, according to data from more than 6,000 patients.

“The benefit of MIS over open repair is recognized for patients with bilateral or recurrent inguinal hernias, and current guidelines recommend MIS repair for these cases,” wrote Joceline V. Vu, MD, of the University of Michigan, Ann Arbor, and her colleagues.

In a study published in Surgical Endoscopy, the researchers assessed surgeons’ practice patterns for hernia repair, with a primary outcome of minimally invasive surgery (MIS) rates per individual surgeon. They reviewed data from a statewide clinical registry of 6,723 adults older than 18 years who underwent elective hernia surgery in Michigan between 2012 and 2016.

Overall, the surgeons’ use of MIS varied, but more than half (58%) of the surgeons performed no MIS for hernia repair. For those who did use MIS, it was used in 41% of bilateral hernias and 38% of recurrent hernias.

Surgeons were significantly less likely to use MIS for hernia on patients aged 65 years and older (odds ratio, 0.68, P = .003), or those who were black (OR 0.75, P = .045). MIS repair also was significantly less likely for patients with chronic obstructive pulmonary disease (OR 0.57, P less than .001) or patients in American Society of Anesthesiologists Classification under 3 (OR 0.79, P less than .001).

Of the 227 surgeons who performed MIS, 71 (31%) had MIS utilization rates of 75% or higher and were defined as high-utilization surgeons. Overall, 75% of the MIS repairs were performed by 14% of the surgeons.

The surgeons with the highest use of MIS were unevenly distributed across the state; the Ann Arbor region had the highest percentage of high MIS-use surgeons (22%), compared with the Lansing area, in which 2% of surgeons were high users of MIS.

The risk-adjusted rate of MIS for inguinal hernia repair varied significantly across six regions of the state, from 10% to 48%, and the regions with the highest rates were those with the highest percentage of high-MIS use surgeons.

“These findings suggest that a large portion of decision making to offer MIS repair may depend on surgeon differences, rather than clinical appropriateness,” the researchers said. “The likelihood that a patient receives MIS repair may thus be predetermined by the surgeon to whom they are referred,” they added.

“Whether through novel training interventions or by establishing regional referral networks to improve access to MIS repair, improvement in MIS delivery and access is needed to reduce disparity and promote evidence-based practice,” they concluded.

The findings were limited by several factors including the potential for bias because of the observational nature of the study, the potential lack of generalizability of the findings, and lack of data on the particular attributes of the hernias, the researchers said.

Dr. Vu disclosed funding from the National Institutes of Health but had no financial conflicts to disclose. One of the study coauthors disclosed a relationship with Medtronic.

SOURCE: Vu JV et al. Surg Endosc. 2018 Jul 9. doi: 10.1007/s00464-018-6322-x.

Cervical dysplasia is commonly diagnosed in women who have completed childbearing and don’t desire future fertility. While diagnostic and/or definitive therapy for cervical dysplasia can include hysterectomy, there are important considerations to make when offering this procedure to patients.

Pitfalls

Hysterectomy is commonly requested by patients upon learning of cervical dysplasia, particularly if they have chronic human papillomavirus (HPV) infection and have experienced years of frequent surveillance and interventions. They may see hysterectomy as an option to avoid this close surveillance and to be free of their dysplasia. There are two main concerns with offering hysterectomy as the primary surgical option for the management of dysplasia. Firstly, it may not be curative, and secondly, it may be an inadequate excisional procedure, particularly if the patient has occult invasive disease that has not been adequately diagnosed with a loop electrosurgical excision procedure (LEEP) or a cone biopsy procedure.

It is important to counsel these patients that surgery is not a treatment for high-risk HPV infection, which is the underlying etiology of their disease. With that etiology, HPV infection is likely to persist after hysterectomy and they may develop vaginal or vulvar dysplasia. Therefore, the American Society for Colposcopy and Cervical Pathology recommends that cytology and/or high-risk HPV surveillance continue following hysterectomy if that surgery was performed for dysplasia.¹ Hysterectomy is not a means to avoid years of surveillance testing. Approximately 10% of women who have hysterectomy for cervical dysplasia develop vaginal dysplasia or cancer after surgery.^2,3 This is similar to the likelihood of recurrent dysplasia after an alternative excisional procedure. In my experience, this diagnosis is often met with enormous frustration for the patient who thought that her hysterectomy would be the cure of her HPV-related disease. Thorough colposcopic evaluation of the vagina can be technically challenging after hysterectomy because of difficulty adequately visualizing lesions within the vaginal rugations, particularly within the puckered lateral vaginal fornices, the most common location for dysplasia.³ We will explore the diagnosis and treatment options for vaginal dysplasia further in a future column.

It is critical that, if patients are offered hysterectomy for treatment of cervical dysplasia, they are counseled that it may not be curative, that they will require long-term vaginal surveillance, and that they are at continued risk for vaginal and vulvar cancer.

An additional concern with performing hysterectomy for definitive management of cervical dysplasia is the concern that occult cancer may be missed preoperatively, and that the hysterectomy is inadequate surgical clearance of the disease. Approximately 2%-5% of patients with a high-grade squamous intraepithelial lesion or equivocal Pap test have occult cervical cancer.⁴ A similar proportion of patients with cervical intraepithelial neoplasia stage III or adenocarcinoma in situ on colposcopy biopsy have invasive carcinoma on evaluation of an excisional specimen.⁵ The traditional surgical approach has dictated that a modified (type II) or extended (type III) radical hysterectomy be performed in the setting of FIGO stage IA2 or greater cervical cancer. Radical hysterectomies remove parametrial tissue, effectively achieving a wider margin around the primary lesion. This is important because cervical cancer primarily spreads via direct extension.

The appropriate radicality of surgery for microscopic lesions is debated. It has been proposed that for very small, low-risk lesions, a traditional extrafascial hysterectomy or trachelectomy, or possibly even a large conization, may be adequate.⁶ However, this is controversial, and National Comprehensive Cancer Network guidelines still advocate for radical procedures for these lesions.⁷ Certainly an excisional procedure (LEEP or cone) should first be performed to define the size and histologic features of the lesion, and ideally, evaluation and counseling with a gynecologic oncologist should be performed prior to offering patients with a stage IA2 or greater lesion an extrafascial hysterectomy. Additionally, a separate decision would need to be made regarding the need for lymphadenectomy, as this is typically recommended for patients with stage IA2 or greater lesions.

Patients should be counseled that, if extrafascial (simple) hysterectomy is chosen as the primary excisional procedure, they may require additional therapy (additional surgery, or radiation and possibly chemotherapy) if cancer is found in the specimen and the parametrial margin is inadequate. Additionally, and of more concern, if the lesion is a bulky lesion extending into the parametrium and not recognized preoperatively, a “cut-through” hysterectomy will be inadvertently performed (in which margins are grossly positive). These situations typically feature heavy blood loss with patients at increased risk for immediate surgical complications. Postoperatively, prognosis is substantially worse for patients who have had a cut-through hysterectomy, compared stage for stage with patients who primarily received a radical procedure with negative margins or primary chemotherapy and radiation.⁸ Otherwise said, their risk for death is higher if this error is made. Therefore a thorough examination is essential prior to performing hysterectomy for dysplasia. Any suspicion of bulky cancer should be considered a contraindication for proceeding.
 

Preoperative evaluation

As a rule, no patient should transition directly from cytologic evaluation with Pap screening to hysterectomy. A colposcopic evaluation of the cervix and vagina accompanied with a thorough bimanual rectovaginal examination should always be performed first. Biopsies of the ectocervix and ideally the endocervix should be obtained because the accuracy of histology is greater than that of cytology. For patients with cervical intraepithelial neoplasia stage I lesions, hysterectomy is not appropriate, as these patients have an extremely low risk for the development of cervical cancer, and the risks and costs of hysterectomy are not justified in such a population.

Surgeons should wait at least 6 weeks following conization or LEEP before performing hysterectomy in order to minimize the likelihood of perioperative complications.⁹

Substituting LEEP or cone with hysterectomy

In general, it is the most prudent approach to first perform a diagnostic excision with LEEP or cone biopsy before proceeding with hysterectomy for definitive surgery. However, there may be some situations in which this is not feasible. In patients whose cervix is very small and flush with the vagina, an excisional procedure may not be technically possible without concern for damage to adjacent structures. In these patients, after a thorough exam has evaluated for gross disease, a hysterectomy may be the only way to adequately diagnose and treat high-grade dysplasia through excision. For patients with limited access to resources, transportation, or a concern for noncompliance with follow-up, surgeons may wish to offer patients primary hysterectomy rather than a staged procedure.

Hysterectomy remains a potential option for treatment of cervical dysplasia. However, patients should be made aware of the risks of undertreatment of occult cancers, the need for long-term surveillance testing, and the risk for future vaginal dysplasia or cancer. Ideally a comprehensive, stepwise assessment from cytology to colposcopy and examination to diagnostic excisional procedure will first take place to proceed safely with this approach.

References

1. Saslow D et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012 May-Jun;62(3):147-72.

2. Schockaert S et al. Incidence of vaginal intraepithelial neoplasia after hysterectomy for cervical intraepithelial neoplasia: a retrospective study. Am J Obstet Gynecol. 2008 Aug;199(2):113.e1-5.

3. Kalogirou D et al. Vaginal intraepithelial neoplasia (VAIN) following hysterectomy in patients treated for carcinoma in situ of the cervix. Eur J Gynaecol Oncol. 1997;18(3):188-91.

4. Landy R et al. Evaluating cytology for the detection of invasive cervical cancer. Cytopathology. 2016 Jun;27(3):201-9.

5. Latif NA et al. Management of adenocarcinoma in situ of the uterine cervix: a comparison of loop electrosurgical excision procedure and cold knife conization. J Low Genit Tract Dis. 2015 Apr;19(2):97-102.

6. Bai H et al. The potential for less radical surgery in women with stage IA2-IB1 cervical cancer. Int J Gynaecol Obstet. 2015 Sep;130(3):235-40.

7. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Version 2.2018. 2018 Jun 26.

8. Barber HR et al. Operative management of patients previously operated upon for a benign lesion with cervical cancer as a surprise finding. Am J Obstet Gynecol. 1968 Aug 1;101(7):959-65.

9. Sullivan SA et al. Association between timing of cervical excision procedure to minimally invasive hysterectomy and surgical complications. Gynecol Oncol. 2017 Feb;144(2):294-298.

Cervical dysplasia is commonly diagnosed in women who have completed childbearing and don’t desire future fertility. While diagnostic and/or definitive therapy for cervical dysplasia can include hysterectomy, there are important considerations to make when offering this procedure to patients.

Pitfalls

Hysterectomy is commonly requested by patients upon learning of cervical dysplasia, particularly if they have chronic human papillomavirus (HPV) infection and have experienced years of frequent surveillance and interventions. They may see hysterectomy as an option to avoid this close surveillance and to be free of their dysplasia. There are two main concerns with offering hysterectomy as the primary surgical option for the management of dysplasia. Firstly, it may not be curative, and secondly, it may be an inadequate excisional procedure, particularly if the patient has occult invasive disease that has not been adequately diagnosed with a loop electrosurgical excision procedure (LEEP) or a cone biopsy procedure.

It is important to counsel these patients that surgery is not a treatment for high-risk HPV infection, which is the underlying etiology of their disease. With that etiology, HPV infection is likely to persist after hysterectomy and they may develop vaginal or vulvar dysplasia. Therefore, the American Society for Colposcopy and Cervical Pathology recommends that cytology and/or high-risk HPV surveillance continue following hysterectomy if that surgery was performed for dysplasia.¹ Hysterectomy is not a means to avoid years of surveillance testing. Approximately 10% of women who have hysterectomy for cervical dysplasia develop vaginal dysplasia or cancer after surgery.^2,3 This is similar to the likelihood of recurrent dysplasia after an alternative excisional procedure. In my experience, this diagnosis is often met with enormous frustration for the patient who thought that her hysterectomy would be the cure of her HPV-related disease. Thorough colposcopic evaluation of the vagina can be technically challenging after hysterectomy because of difficulty adequately visualizing lesions within the vaginal rugations, particularly within the puckered lateral vaginal fornices, the most common location for dysplasia.³ We will explore the diagnosis and treatment options for vaginal dysplasia further in a future column.

It is critical that, if patients are offered hysterectomy for treatment of cervical dysplasia, they are counseled that it may not be curative, that they will require long-term vaginal surveillance, and that they are at continued risk for vaginal and vulvar cancer.

An additional concern with performing hysterectomy for definitive management of cervical dysplasia is the concern that occult cancer may be missed preoperatively, and that the hysterectomy is inadequate surgical clearance of the disease. Approximately 2%-5% of patients with a high-grade squamous intraepithelial lesion or equivocal Pap test have occult cervical cancer.⁴ A similar proportion of patients with cervical intraepithelial neoplasia stage III or adenocarcinoma in situ on colposcopy biopsy have invasive carcinoma on evaluation of an excisional specimen.⁵ The traditional surgical approach has dictated that a modified (type II) or extended (type III) radical hysterectomy be performed in the setting of FIGO stage IA2 or greater cervical cancer. Radical hysterectomies remove parametrial tissue, effectively achieving a wider margin around the primary lesion. This is important because cervical cancer primarily spreads via direct extension.

The appropriate radicality of surgery for microscopic lesions is debated. It has been proposed that for very small, low-risk lesions, a traditional extrafascial hysterectomy or trachelectomy, or possibly even a large conization, may be adequate.⁶ However, this is controversial, and National Comprehensive Cancer Network guidelines still advocate for radical procedures for these lesions.⁷ Certainly an excisional procedure (LEEP or cone) should first be performed to define the size and histologic features of the lesion, and ideally, evaluation and counseling with a gynecologic oncologist should be performed prior to offering patients with a stage IA2 or greater lesion an extrafascial hysterectomy. Additionally, a separate decision would need to be made regarding the need for lymphadenectomy, as this is typically recommended for patients with stage IA2 or greater lesions.

Patients should be counseled that, if extrafascial (simple) hysterectomy is chosen as the primary excisional procedure, they may require additional therapy (additional surgery, or radiation and possibly chemotherapy) if cancer is found in the specimen and the parametrial margin is inadequate. Additionally, and of more concern, if the lesion is a bulky lesion extending into the parametrium and not recognized preoperatively, a “cut-through” hysterectomy will be inadvertently performed (in which margins are grossly positive). These situations typically feature heavy blood loss with patients at increased risk for immediate surgical complications. Postoperatively, prognosis is substantially worse for patients who have had a cut-through hysterectomy, compared stage for stage with patients who primarily received a radical procedure with negative margins or primary chemotherapy and radiation.⁸ Otherwise said, their risk for death is higher if this error is made. Therefore a thorough examination is essential prior to performing hysterectomy for dysplasia. Any suspicion of bulky cancer should be considered a contraindication for proceeding.
 

Preoperative evaluation

As a rule, no patient should transition directly from cytologic evaluation with Pap screening to hysterectomy. A colposcopic evaluation of the cervix and vagina accompanied with a thorough bimanual rectovaginal examination should always be performed first. Biopsies of the ectocervix and ideally the endocervix should be obtained because the accuracy of histology is greater than that of cytology. For patients with cervical intraepithelial neoplasia stage I lesions, hysterectomy is not appropriate, as these patients have an extremely low risk for the development of cervical cancer, and the risks and costs of hysterectomy are not justified in such a population.

Surgeons should wait at least 6 weeks following conization or LEEP before performing hysterectomy in order to minimize the likelihood of perioperative complications.⁹

Substituting LEEP or cone with hysterectomy

In general, it is the most prudent approach to first perform a diagnostic excision with LEEP or cone biopsy before proceeding with hysterectomy for definitive surgery. However, there may be some situations in which this is not feasible. In patients whose cervix is very small and flush with the vagina, an excisional procedure may not be technically possible without concern for damage to adjacent structures. In these patients, after a thorough exam has evaluated for gross disease, a hysterectomy may be the only way to adequately diagnose and treat high-grade dysplasia through excision. For patients with limited access to resources, transportation, or a concern for noncompliance with follow-up, surgeons may wish to offer patients primary hysterectomy rather than a staged procedure.

Hysterectomy remains a potential option for treatment of cervical dysplasia. However, patients should be made aware of the risks of undertreatment of occult cancers, the need for long-term surveillance testing, and the risk for future vaginal dysplasia or cancer. Ideally a comprehensive, stepwise assessment from cytology to colposcopy and examination to diagnostic excisional procedure will first take place to proceed safely with this approach.

References

1. Saslow D et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012 May-Jun;62(3):147-72.

2. Schockaert S et al. Incidence of vaginal intraepithelial neoplasia after hysterectomy for cervical intraepithelial neoplasia: a retrospective study. Am J Obstet Gynecol. 2008 Aug;199(2):113.e1-5.

3. Kalogirou D et al. Vaginal intraepithelial neoplasia (VAIN) following hysterectomy in patients treated for carcinoma in situ of the cervix. Eur J Gynaecol Oncol. 1997;18(3):188-91.

4. Landy R et al. Evaluating cytology for the detection of invasive cervical cancer. Cytopathology. 2016 Jun;27(3):201-9.

5. Latif NA et al. Management of adenocarcinoma in situ of the uterine cervix: a comparison of loop electrosurgical excision procedure and cold knife conization. J Low Genit Tract Dis. 2015 Apr;19(2):97-102.

6. Bai H et al. The potential for less radical surgery in women with stage IA2-IB1 cervical cancer. Int J Gynaecol Obstet. 2015 Sep;130(3):235-40.

7. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Version 2.2018. 2018 Jun 26.

8. Barber HR et al. Operative management of patients previously operated upon for a benign lesion with cervical cancer as a surprise finding. Am J Obstet Gynecol. 1968 Aug 1;101(7):959-65.

9. Sullivan SA et al. Association between timing of cervical excision procedure to minimally invasive hysterectomy and surgical complications. Gynecol Oncol. 2017 Feb;144(2):294-298.

Cervical dysplasia is commonly diagnosed in women who have completed childbearing and don’t desire future fertility. While diagnostic and/or definitive therapy for cervical dysplasia can include hysterectomy, there are important considerations to make when offering this procedure to patients.

Pitfalls

Hysterectomy is commonly requested by patients upon learning of cervical dysplasia, particularly if they have chronic human papillomavirus (HPV) infection and have experienced years of frequent surveillance and interventions. They may see hysterectomy as an option to avoid this close surveillance and to be free of their dysplasia. There are two main concerns with offering hysterectomy as the primary surgical option for the management of dysplasia. Firstly, it may not be curative, and secondly, it may be an inadequate excisional procedure, particularly if the patient has occult invasive disease that has not been adequately diagnosed with a loop electrosurgical excision procedure (LEEP) or a cone biopsy procedure.

It is important to counsel these patients that surgery is not a treatment for high-risk HPV infection, which is the underlying etiology of their disease. With that etiology, HPV infection is likely to persist after hysterectomy and they may develop vaginal or vulvar dysplasia. Therefore, the American Society for Colposcopy and Cervical Pathology recommends that cytology and/or high-risk HPV surveillance continue following hysterectomy if that surgery was performed for dysplasia.¹ Hysterectomy is not a means to avoid years of surveillance testing. Approximately 10% of women who have hysterectomy for cervical dysplasia develop vaginal dysplasia or cancer after surgery.^2,3 This is similar to the likelihood of recurrent dysplasia after an alternative excisional procedure. In my experience, this diagnosis is often met with enormous frustration for the patient who thought that her hysterectomy would be the cure of her HPV-related disease. Thorough colposcopic evaluation of the vagina can be technically challenging after hysterectomy because of difficulty adequately visualizing lesions within the vaginal rugations, particularly within the puckered lateral vaginal fornices, the most common location for dysplasia.³ We will explore the diagnosis and treatment options for vaginal dysplasia further in a future column.

It is critical that, if patients are offered hysterectomy for treatment of cervical dysplasia, they are counseled that it may not be curative, that they will require long-term vaginal surveillance, and that they are at continued risk for vaginal and vulvar cancer.

An additional concern with performing hysterectomy for definitive management of cervical dysplasia is the concern that occult cancer may be missed preoperatively, and that the hysterectomy is inadequate surgical clearance of the disease. Approximately 2%-5% of patients with a high-grade squamous intraepithelial lesion or equivocal Pap test have occult cervical cancer.⁴ A similar proportion of patients with cervical intraepithelial neoplasia stage III or adenocarcinoma in situ on colposcopy biopsy have invasive carcinoma on evaluation of an excisional specimen.⁵ The traditional surgical approach has dictated that a modified (type II) or extended (type III) radical hysterectomy be performed in the setting of FIGO stage IA2 or greater cervical cancer. Radical hysterectomies remove parametrial tissue, effectively achieving a wider margin around the primary lesion. This is important because cervical cancer primarily spreads via direct extension.

The appropriate radicality of surgery for microscopic lesions is debated. It has been proposed that for very small, low-risk lesions, a traditional extrafascial hysterectomy or trachelectomy, or possibly even a large conization, may be adequate.⁶ However, this is controversial, and National Comprehensive Cancer Network guidelines still advocate for radical procedures for these lesions.⁷ Certainly an excisional procedure (LEEP or cone) should first be performed to define the size and histologic features of the lesion, and ideally, evaluation and counseling with a gynecologic oncologist should be performed prior to offering patients with a stage IA2 or greater lesion an extrafascial hysterectomy. Additionally, a separate decision would need to be made regarding the need for lymphadenectomy, as this is typically recommended for patients with stage IA2 or greater lesions.

Patients should be counseled that, if extrafascial (simple) hysterectomy is chosen as the primary excisional procedure, they may require additional therapy (additional surgery, or radiation and possibly chemotherapy) if cancer is found in the specimen and the parametrial margin is inadequate. Additionally, and of more concern, if the lesion is a bulky lesion extending into the parametrium and not recognized preoperatively, a “cut-through” hysterectomy will be inadvertently performed (in which margins are grossly positive). These situations typically feature heavy blood loss with patients at increased risk for immediate surgical complications. Postoperatively, prognosis is substantially worse for patients who have had a cut-through hysterectomy, compared stage for stage with patients who primarily received a radical procedure with negative margins or primary chemotherapy and radiation.⁸ Otherwise said, their risk for death is higher if this error is made. Therefore a thorough examination is essential prior to performing hysterectomy for dysplasia. Any suspicion of bulky cancer should be considered a contraindication for proceeding.
 

Preoperative evaluation

As a rule, no patient should transition directly from cytologic evaluation with Pap screening to hysterectomy. A colposcopic evaluation of the cervix and vagina accompanied with a thorough bimanual rectovaginal examination should always be performed first. Biopsies of the ectocervix and ideally the endocervix should be obtained because the accuracy of histology is greater than that of cytology. For patients with cervical intraepithelial neoplasia stage I lesions, hysterectomy is not appropriate, as these patients have an extremely low risk for the development of cervical cancer, and the risks and costs of hysterectomy are not justified in such a population.

Surgeons should wait at least 6 weeks following conization or LEEP before performing hysterectomy in order to minimize the likelihood of perioperative complications.⁹

Substituting LEEP or cone with hysterectomy

In general, it is the most prudent approach to first perform a diagnostic excision with LEEP or cone biopsy before proceeding with hysterectomy for definitive surgery. However, there may be some situations in which this is not feasible. In patients whose cervix is very small and flush with the vagina, an excisional procedure may not be technically possible without concern for damage to adjacent structures. In these patients, after a thorough exam has evaluated for gross disease, a hysterectomy may be the only way to adequately diagnose and treat high-grade dysplasia through excision. For patients with limited access to resources, transportation, or a concern for noncompliance with follow-up, surgeons may wish to offer patients primary hysterectomy rather than a staged procedure.

Hysterectomy remains a potential option for treatment of cervical dysplasia. However, patients should be made aware of the risks of undertreatment of occult cancers, the need for long-term surveillance testing, and the risk for future vaginal dysplasia or cancer. Ideally a comprehensive, stepwise assessment from cytology to colposcopy and examination to diagnostic excisional procedure will first take place to proceed safely with this approach.

References

1. Saslow D et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012 May-Jun;62(3):147-72.

2. Schockaert S et al. Incidence of vaginal intraepithelial neoplasia after hysterectomy for cervical intraepithelial neoplasia: a retrospective study. Am J Obstet Gynecol. 2008 Aug;199(2):113.e1-5.

3. Kalogirou D et al. Vaginal intraepithelial neoplasia (VAIN) following hysterectomy in patients treated for carcinoma in situ of the cervix. Eur J Gynaecol Oncol. 1997;18(3):188-91.

4. Landy R et al. Evaluating cytology for the detection of invasive cervical cancer. Cytopathology. 2016 Jun;27(3):201-9.

5. Latif NA et al. Management of adenocarcinoma in situ of the uterine cervix: a comparison of loop electrosurgical excision procedure and cold knife conization. J Low Genit Tract Dis. 2015 Apr;19(2):97-102.

6. Bai H et al. The potential for less radical surgery in women with stage IA2-IB1 cervical cancer. Int J Gynaecol Obstet. 2015 Sep;130(3):235-40.

7. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Version 2.2018. 2018 Jun 26.

8. Barber HR et al. Operative management of patients previously operated upon for a benign lesion with cervical cancer as a surprise finding. Am J Obstet Gynecol. 1968 Aug 1;101(7):959-65.

9. Sullivan SA et al. Association between timing of cervical excision procedure to minimally invasive hysterectomy and surgical complications. Gynecol Oncol. 2017 Feb;144(2):294-298.

Applications are due by Aug. 2 for the SVS International Scholars Program, which provides up to four scholarships to qualified young vascular surgeons from countries other than the United States or Canada. Awardees receive $5,000 each, to attend the 2019 Vascular Annual Meeting and to visit clinical, teaching and research facilities in the U.S. and Canada.

Applications are due by Aug. 2 for the SVS International Scholars Program, which provides up to four scholarships to qualified young vascular surgeons from countries other than the United States or Canada. Awardees receive $5,000 each, to attend the 2019 Vascular Annual Meeting and to visit clinical, teaching and research facilities in the U.S. and Canada.

Applications are due by Aug. 2 for the SVS International Scholars Program, which provides up to four scholarships to qualified young vascular surgeons from countries other than the United States or Canada. Awardees receive $5,000 each, to attend the 2019 Vascular Annual Meeting and to visit clinical, teaching and research facilities in the U.S. and Canada.