Home oxygen upped survival in PAH with severely impaired DLCO

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– Pulmonary arterial hypertension (PAH) patients with severely impaired diffusing capacity of the lung for carbon monoxide (DLCO) were much more likely to survive when they received home oxygen therapy, according to a disease registry analysis.

“We all know that supplemental oxygen is widely used with PAH,” said Harrison W. Farber, MD, director of the pulmonary hypertension center at Boston University. But there are practically no data showing that it is successful, and there are even fewer data for patients with PAH who have very low diffusion capacity, he added.

That knowledge gap prompted Dr. Farber and his colleagues to analyze data from the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL), the largest disease registry in the world of patients with PAH.

“Patients in that group – the severe DLCO group – who got oxygen had poorer prognostic features but improved overall survival relative to those who didn’t,” Dr. Farber explained during a presentation at the annual meeting of the American College of Chest Physicians. “Based on this, it makes us think that home oxygen, supplemental oxygen treatment, is associated with improved survival in patients, especially those with severe DLCO and PAH.”

The 3,046 patients analyzed by Dr. Farber and his colleagues had World Health Organization Group 1 PAH with right heart catheterization hemodynamic criteria: a mean pulmonary artery pressure greater than 25 mm Hg, a pulmonary capillary wedge pressure less than or equal to 15 mm Hg, and a pulmonary vascular resistance of at least 3 Wood units (WU). Patients were at least 18 years of age and grouped by oxygen use, which was defined as any use at any time from study enrollment to the end of follow-up, and by DLCO group.

A total of 57% of the patients (1,734) received oxygen, and the remaining 43% of the patients (1,312) did not receive oxygen. Among the patients who received oxygen, 71% (1,227) received the therapy continuously, and 24% (408) received oxygen at night only.

The 424 patients with a DLCO of less than 40% were considered to have a severe DLCO impairment. The other two groups comprised 505 patients with a moderate DLCO impairment (at least 40%, but less than 60%) and 844 patients with a mild to normal DLCO (at least 60%). The DLCOs of 1,273 patients analyzed were unknown.

Among those patients with severe DLCO impairment, the risk of death was significantly lower in those who received oxygen, compared with those who did not receive oxygen (hazard ratio, 0.56; P = .0033). Oxygen use was associated with significant improvements in overall survival in both the newly diagnosed (HR, 0.47; P = .029) and previously diagnosed (HR, 0.59; P = .026) severe DLCO cohorts, Dr. Farber said.

Patients receiving oxygen were more likely to be treated with PAH-specific medications, regardless of their DLCO group.

Among the analysis’s limitations was that the lengths of time patients had been undergoing oxygen treatment were unknown. That prevented adjustments for duration of oxygen treatment, according to Dr. Farber.

Dr. Farber disclosed serving on the steering committees or advisory boards for Actelion, Bayer, Bellerophon, Gilead, and United Therapeutics. He has received research support from Actelion, Gilead, and United Therapeutics, and has been a speaker for Actelion, Bayer, and Gilead.

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– Pulmonary arterial hypertension (PAH) patients with severely impaired diffusing capacity of the lung for carbon monoxide (DLCO) were much more likely to survive when they received home oxygen therapy, according to a disease registry analysis.

“We all know that supplemental oxygen is widely used with PAH,” said Harrison W. Farber, MD, director of the pulmonary hypertension center at Boston University. But there are practically no data showing that it is successful, and there are even fewer data for patients with PAH who have very low diffusion capacity, he added.

That knowledge gap prompted Dr. Farber and his colleagues to analyze data from the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL), the largest disease registry in the world of patients with PAH.

“Patients in that group – the severe DLCO group – who got oxygen had poorer prognostic features but improved overall survival relative to those who didn’t,” Dr. Farber explained during a presentation at the annual meeting of the American College of Chest Physicians. “Based on this, it makes us think that home oxygen, supplemental oxygen treatment, is associated with improved survival in patients, especially those with severe DLCO and PAH.”

The 3,046 patients analyzed by Dr. Farber and his colleagues had World Health Organization Group 1 PAH with right heart catheterization hemodynamic criteria: a mean pulmonary artery pressure greater than 25 mm Hg, a pulmonary capillary wedge pressure less than or equal to 15 mm Hg, and a pulmonary vascular resistance of at least 3 Wood units (WU). Patients were at least 18 years of age and grouped by oxygen use, which was defined as any use at any time from study enrollment to the end of follow-up, and by DLCO group.

A total of 57% of the patients (1,734) received oxygen, and the remaining 43% of the patients (1,312) did not receive oxygen. Among the patients who received oxygen, 71% (1,227) received the therapy continuously, and 24% (408) received oxygen at night only.

The 424 patients with a DLCO of less than 40% were considered to have a severe DLCO impairment. The other two groups comprised 505 patients with a moderate DLCO impairment (at least 40%, but less than 60%) and 844 patients with a mild to normal DLCO (at least 60%). The DLCOs of 1,273 patients analyzed were unknown.

Among those patients with severe DLCO impairment, the risk of death was significantly lower in those who received oxygen, compared with those who did not receive oxygen (hazard ratio, 0.56; P = .0033). Oxygen use was associated with significant improvements in overall survival in both the newly diagnosed (HR, 0.47; P = .029) and previously diagnosed (HR, 0.59; P = .026) severe DLCO cohorts, Dr. Farber said.

Patients receiving oxygen were more likely to be treated with PAH-specific medications, regardless of their DLCO group.

Among the analysis’s limitations was that the lengths of time patients had been undergoing oxygen treatment were unknown. That prevented adjustments for duration of oxygen treatment, according to Dr. Farber.

Dr. Farber disclosed serving on the steering committees or advisory boards for Actelion, Bayer, Bellerophon, Gilead, and United Therapeutics. He has received research support from Actelion, Gilead, and United Therapeutics, and has been a speaker for Actelion, Bayer, and Gilead.

 

– Pulmonary arterial hypertension (PAH) patients with severely impaired diffusing capacity of the lung for carbon monoxide (DLCO) were much more likely to survive when they received home oxygen therapy, according to a disease registry analysis.

“We all know that supplemental oxygen is widely used with PAH,” said Harrison W. Farber, MD, director of the pulmonary hypertension center at Boston University. But there are practically no data showing that it is successful, and there are even fewer data for patients with PAH who have very low diffusion capacity, he added.

That knowledge gap prompted Dr. Farber and his colleagues to analyze data from the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL), the largest disease registry in the world of patients with PAH.

“Patients in that group – the severe DLCO group – who got oxygen had poorer prognostic features but improved overall survival relative to those who didn’t,” Dr. Farber explained during a presentation at the annual meeting of the American College of Chest Physicians. “Based on this, it makes us think that home oxygen, supplemental oxygen treatment, is associated with improved survival in patients, especially those with severe DLCO and PAH.”

The 3,046 patients analyzed by Dr. Farber and his colleagues had World Health Organization Group 1 PAH with right heart catheterization hemodynamic criteria: a mean pulmonary artery pressure greater than 25 mm Hg, a pulmonary capillary wedge pressure less than or equal to 15 mm Hg, and a pulmonary vascular resistance of at least 3 Wood units (WU). Patients were at least 18 years of age and grouped by oxygen use, which was defined as any use at any time from study enrollment to the end of follow-up, and by DLCO group.

A total of 57% of the patients (1,734) received oxygen, and the remaining 43% of the patients (1,312) did not receive oxygen. Among the patients who received oxygen, 71% (1,227) received the therapy continuously, and 24% (408) received oxygen at night only.

The 424 patients with a DLCO of less than 40% were considered to have a severe DLCO impairment. The other two groups comprised 505 patients with a moderate DLCO impairment (at least 40%, but less than 60%) and 844 patients with a mild to normal DLCO (at least 60%). The DLCOs of 1,273 patients analyzed were unknown.

Among those patients with severe DLCO impairment, the risk of death was significantly lower in those who received oxygen, compared with those who did not receive oxygen (hazard ratio, 0.56; P = .0033). Oxygen use was associated with significant improvements in overall survival in both the newly diagnosed (HR, 0.47; P = .029) and previously diagnosed (HR, 0.59; P = .026) severe DLCO cohorts, Dr. Farber said.

Patients receiving oxygen were more likely to be treated with PAH-specific medications, regardless of their DLCO group.

Among the analysis’s limitations was that the lengths of time patients had been undergoing oxygen treatment were unknown. That prevented adjustments for duration of oxygen treatment, according to Dr. Farber.

Dr. Farber disclosed serving on the steering committees or advisory boards for Actelion, Bayer, Bellerophon, Gilead, and United Therapeutics. He has received research support from Actelion, Gilead, and United Therapeutics, and has been a speaker for Actelion, Bayer, and Gilead.

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Key clinical point: PAH patients with severely impaired DLCO were much more likely to survive when they received home oxygen therapy.

Major finding: PAH patients with severe DLCO impairment who received oxygen had a significantly higher probability of survival than those who didn’t receive oxygen (HR, 0.56; P = .0033).

Data source: An analysis of 3,046 patients in the U.S. multicenter, observational REVEAL disease registry.

Disclosures: Dr. Farber disclosed serving on the steering committees or advisory boards for Actelion, Bayer, Bellerophon, Gilead, and United Therapeutics. He has received research support from Actelion, Gilead, and United Therapeutics, and has been a speaker for Actelion, Bayer, and Gilead.

Wide spectrum of feeding problems poses challenge for clinicians

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– Clinicians are likely to encounter diverse feeding problems in daily practice that will challenge their diagnostic and treatment acumen, Dr. Irene Chatoor told attendees of the annual meeting of the American Academy of Pediatrics.

These problems run the gamut from the most prevalent but least serious picky eating, to the least prevalent but most serious feeding disorders, she noted. Correspondingly, management will range from simple reassurance of parents to more intensive behavioral and medical interventions.

Assessment

Dr. Irene Chatoor
Regardless of their apparent severity, all feeding problems brought to clinicians’ attention can be a source of anxiety for parents and should be carefully evaluated, recommended Dr. Chatoor, who is a professor of psychiatry and pediatrics at George Washington University, and vice chair of the departments of psychiatry and behavioral sciences at Children’s National Medical Center, both in Washington.

“When you assess a feeding problem, you have to look at both the mother and father, and the child,” she advised. The parents are evaluated for their feeding style, while the child is evaluated for three feeding problems: limited appetite, selective intake, and fear of feeding (Pediatrics. 2015;135[2]:344-53).

Clinicians must be alert for organic red flags, such as dysphagia, aspiration, and vomiting, and for behavioral red flags, such as food fixation, abrupt cessation of feeding after a trigger event, and anticipatory gagging. An overarching red flag is failure to thrive.

Sometimes, a child will have both an organic condition and a behavioral feeding disorder at the same time. “It’s very important that you don’t think one excludes the other,” she cautioned.

Diagnosis

“To delineate milder feeding difficulties from feeding disorders, there must be some form of impairment caused by the feeding problem,” Dr. Chatoor commented. “Why is this important? For two reasons. One is for the insurance companies, because they don’t pay unless there is a disorder. And then there is research: you cannot do research unless you clearly define what you are studying.”

Children are considered to have impairment if they have weight loss or growth faltering, considerable nutritional deficiency, or a marked interference with psychosocial functioning.

“When we diagnose feeding problems, it is best done with a multidisciplinary team,” Dr. Chatoor maintained. “I have learned many years ago that I’m not effective in helping parents deal with the feeding disorder if they are still in the back of their mind worried that the child has something organically wrong and that’s why the child does not want to eat.”

Accordingly, various team members perform a medical examination, a nutritional assessment, an oral motor and sensory evaluation, and a psychiatric or psychological assessment to identify the root cause or causes of the problem.

When it comes to behavioral etiologies, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) now groups all feeding and eating disorders together in one section, reflecting the fact that disorders starting early in life can and often do track into adolescence and adulthood, according to Dr. Chatoor.

The manual also features a new diagnosis, avoidant/restrictive food intake disorder (ARFID). Key criteria include the presence of an eating or feeding disturbance that cannot be better explained by lack of available food, culturally sanctioned practices, or a concurrent medical condition or another mental disorder.

The child must have a persistent failure to meet appropriate nutritional and/or energy needs, associated with any of four findings: significant weight loss or failure to achieve expected weight gain or growth, significant nutritional deficiencies, dependence on enteral feeding or oral nutritional supplements, and marked interference with psychosocial functioning.

“You need to have at least one but often you have a combination of nutritional and emotional impairment in the same child,” she commented.

ARFID and its treatment

There are three subtypes of ARFID having different features, treatments, and prognosis, although they all share in common food refusal, according to Dr. Chatoor.

The first subtype – apparent lack of interest in eating or food – emerges by 3 years of age, most often during the transition to self-feeding between 9 and 18 months. Affected children refuse to eat an adequate amount of food for at least 1 month, rarely communicate hunger, lack interest in food, and prefer to play or talk. They typically present with growth deficiency.

“If you have a child who refuses to eat, it generates anxiety in the mother. The mother does things she would not normally do with the child who is eating well. She starts to distract, to cajole, to sometimes even force-feed the child,” Dr. Chatoor explained. “And the more she engages in these behaviors, the more resistant the child becomes. So they become trapped in this vicious cycle.”

Treatment is aimed at removing this conflict with three approaches: explaining to parents the infant’s special temperament (notably, high arousal and difficulty turning off excitement); addressing their background, including any eating issues of their own, and difficulty with setting limits; and providing specific feeding guidelines and a time-out procedure.

The guidelines stress regular feeding, withholding of all snacks, keeping the child at the table for 20 to 30 minutes, and not using any distractions or pressure. Also, importantly, the parents should have dinner with their child. “I always tell the parents what is good for the child is good for you. It’s good for your whole family,” she said. “If they have other children, these rules apply to everybody. Young children learn to eat by watching their parents eating.”

With early and consistent use of these interventions, about two-thirds of children outgrow this eating/feeding disturbance by mid-childhood, according to Dr. Chatoor.

Children with the second subtype of ARFID – avoidance based on the sensory characteristics of food – consistently refuse to eat certain foods having specific tastes, textures, temperatures, smells, and/or appearances. Onset occurs during the toddler years, when a new or different food is introduced.

“Not only do they refuse the same foods that were aversive, but they also generalize it. So these children are afraid to try other foods and they may end up limiting food groups – they don’t eat any vegetables and some of them don’t eat any meats,” she explained. “They are a challenge because this always causes a nutritional deficiency and they also have problems socially as they get older.”

Treatment varies by age, with gradual desensitization for infants and parent modeling of eating new foods for toddlers. A multifaceted approach is used for preschoolers, combining modeling, giving foods attractive shapes and names, having the child participate in food preparation, and using focused play therapy, such as feeding dolls who are “brave” and try new foods.

Clinicians can explain to affected school-aged children that they are “supertasters,” having more taste buds and therefore experiencing food more intensely, and that they can help their taste buds not react so strongly by starting to eat small amounts of new foods and gradually increasing over time. Parents can let the child make a list of 10 foods they would like to eat, and award them points for “courage” for every bite of a new food they try.

Prognosis of this type of ARFID varies, according to Dr. Chatoor. “Through gradual exposure, young children can expand the variety of foods they eat,” she elaborated. However, “some children become very rigid and brand sensitive in regard to the food they are willing to eat and begin to experience social problems during mid-childhood and adolescence. Some children grow up eating a limited diet, but finding ways to compensate nutritionally and socially.”

Children with the third subtype of ARFID – concern about aversive consequences of eating – have an acute onset of consistent food refusal at any age, from infancy onward, after experiencing a traumatic event or repeated traumatic insults to the oropharynx or gastrointestinal tract that trigger distress in the child. These children often have comorbidities such as gastroesophageal reflux, eosinophilic gastroenteritis, or anxiety disorder.

“Treatment involves gradual desensitization to feared objects: the highchair, bib, bottle, or spoon,” Dr. Chatoor explained. “It also involves training of the mother in behavioral techniques to feed the child in spite of the child’s fear and distress.”

Any underlying medical condition causing pain or distress should be treated. Additional measures may include, for example, use of a graduated approach, starting with liquids and progressing to purees, if the child fears solid foods, and prescribing anxiolytic medication in cases of severe anxiety.

Dr. Chatoor disclosed that she has lectured internationally at conferences on feeding disorders that were organized by Abbott Nutrition International and that the company provided a research grant for a study on feeding.

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– Clinicians are likely to encounter diverse feeding problems in daily practice that will challenge their diagnostic and treatment acumen, Dr. Irene Chatoor told attendees of the annual meeting of the American Academy of Pediatrics.

These problems run the gamut from the most prevalent but least serious picky eating, to the least prevalent but most serious feeding disorders, she noted. Correspondingly, management will range from simple reassurance of parents to more intensive behavioral and medical interventions.

Assessment

Dr. Irene Chatoor
Regardless of their apparent severity, all feeding problems brought to clinicians’ attention can be a source of anxiety for parents and should be carefully evaluated, recommended Dr. Chatoor, who is a professor of psychiatry and pediatrics at George Washington University, and vice chair of the departments of psychiatry and behavioral sciences at Children’s National Medical Center, both in Washington.

“When you assess a feeding problem, you have to look at both the mother and father, and the child,” she advised. The parents are evaluated for their feeding style, while the child is evaluated for three feeding problems: limited appetite, selective intake, and fear of feeding (Pediatrics. 2015;135[2]:344-53).

Clinicians must be alert for organic red flags, such as dysphagia, aspiration, and vomiting, and for behavioral red flags, such as food fixation, abrupt cessation of feeding after a trigger event, and anticipatory gagging. An overarching red flag is failure to thrive.

Sometimes, a child will have both an organic condition and a behavioral feeding disorder at the same time. “It’s very important that you don’t think one excludes the other,” she cautioned.

Diagnosis

“To delineate milder feeding difficulties from feeding disorders, there must be some form of impairment caused by the feeding problem,” Dr. Chatoor commented. “Why is this important? For two reasons. One is for the insurance companies, because they don’t pay unless there is a disorder. And then there is research: you cannot do research unless you clearly define what you are studying.”

Children are considered to have impairment if they have weight loss or growth faltering, considerable nutritional deficiency, or a marked interference with psychosocial functioning.

“When we diagnose feeding problems, it is best done with a multidisciplinary team,” Dr. Chatoor maintained. “I have learned many years ago that I’m not effective in helping parents deal with the feeding disorder if they are still in the back of their mind worried that the child has something organically wrong and that’s why the child does not want to eat.”

Accordingly, various team members perform a medical examination, a nutritional assessment, an oral motor and sensory evaluation, and a psychiatric or psychological assessment to identify the root cause or causes of the problem.

When it comes to behavioral etiologies, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) now groups all feeding and eating disorders together in one section, reflecting the fact that disorders starting early in life can and often do track into adolescence and adulthood, according to Dr. Chatoor.

The manual also features a new diagnosis, avoidant/restrictive food intake disorder (ARFID). Key criteria include the presence of an eating or feeding disturbance that cannot be better explained by lack of available food, culturally sanctioned practices, or a concurrent medical condition or another mental disorder.

The child must have a persistent failure to meet appropriate nutritional and/or energy needs, associated with any of four findings: significant weight loss or failure to achieve expected weight gain or growth, significant nutritional deficiencies, dependence on enteral feeding or oral nutritional supplements, and marked interference with psychosocial functioning.

“You need to have at least one but often you have a combination of nutritional and emotional impairment in the same child,” she commented.

ARFID and its treatment

There are three subtypes of ARFID having different features, treatments, and prognosis, although they all share in common food refusal, according to Dr. Chatoor.

The first subtype – apparent lack of interest in eating or food – emerges by 3 years of age, most often during the transition to self-feeding between 9 and 18 months. Affected children refuse to eat an adequate amount of food for at least 1 month, rarely communicate hunger, lack interest in food, and prefer to play or talk. They typically present with growth deficiency.

“If you have a child who refuses to eat, it generates anxiety in the mother. The mother does things she would not normally do with the child who is eating well. She starts to distract, to cajole, to sometimes even force-feed the child,” Dr. Chatoor explained. “And the more she engages in these behaviors, the more resistant the child becomes. So they become trapped in this vicious cycle.”

Treatment is aimed at removing this conflict with three approaches: explaining to parents the infant’s special temperament (notably, high arousal and difficulty turning off excitement); addressing their background, including any eating issues of their own, and difficulty with setting limits; and providing specific feeding guidelines and a time-out procedure.

The guidelines stress regular feeding, withholding of all snacks, keeping the child at the table for 20 to 30 minutes, and not using any distractions or pressure. Also, importantly, the parents should have dinner with their child. “I always tell the parents what is good for the child is good for you. It’s good for your whole family,” she said. “If they have other children, these rules apply to everybody. Young children learn to eat by watching their parents eating.”

With early and consistent use of these interventions, about two-thirds of children outgrow this eating/feeding disturbance by mid-childhood, according to Dr. Chatoor.

Children with the second subtype of ARFID – avoidance based on the sensory characteristics of food – consistently refuse to eat certain foods having specific tastes, textures, temperatures, smells, and/or appearances. Onset occurs during the toddler years, when a new or different food is introduced.

“Not only do they refuse the same foods that were aversive, but they also generalize it. So these children are afraid to try other foods and they may end up limiting food groups – they don’t eat any vegetables and some of them don’t eat any meats,” she explained. “They are a challenge because this always causes a nutritional deficiency and they also have problems socially as they get older.”

Treatment varies by age, with gradual desensitization for infants and parent modeling of eating new foods for toddlers. A multifaceted approach is used for preschoolers, combining modeling, giving foods attractive shapes and names, having the child participate in food preparation, and using focused play therapy, such as feeding dolls who are “brave” and try new foods.

Clinicians can explain to affected school-aged children that they are “supertasters,” having more taste buds and therefore experiencing food more intensely, and that they can help their taste buds not react so strongly by starting to eat small amounts of new foods and gradually increasing over time. Parents can let the child make a list of 10 foods they would like to eat, and award them points for “courage” for every bite of a new food they try.

Prognosis of this type of ARFID varies, according to Dr. Chatoor. “Through gradual exposure, young children can expand the variety of foods they eat,” she elaborated. However, “some children become very rigid and brand sensitive in regard to the food they are willing to eat and begin to experience social problems during mid-childhood and adolescence. Some children grow up eating a limited diet, but finding ways to compensate nutritionally and socially.”

Children with the third subtype of ARFID – concern about aversive consequences of eating – have an acute onset of consistent food refusal at any age, from infancy onward, after experiencing a traumatic event or repeated traumatic insults to the oropharynx or gastrointestinal tract that trigger distress in the child. These children often have comorbidities such as gastroesophageal reflux, eosinophilic gastroenteritis, or anxiety disorder.

“Treatment involves gradual desensitization to feared objects: the highchair, bib, bottle, or spoon,” Dr. Chatoor explained. “It also involves training of the mother in behavioral techniques to feed the child in spite of the child’s fear and distress.”

Any underlying medical condition causing pain or distress should be treated. Additional measures may include, for example, use of a graduated approach, starting with liquids and progressing to purees, if the child fears solid foods, and prescribing anxiolytic medication in cases of severe anxiety.

Dr. Chatoor disclosed that she has lectured internationally at conferences on feeding disorders that were organized by Abbott Nutrition International and that the company provided a research grant for a study on feeding.

– Clinicians are likely to encounter diverse feeding problems in daily practice that will challenge their diagnostic and treatment acumen, Dr. Irene Chatoor told attendees of the annual meeting of the American Academy of Pediatrics.

These problems run the gamut from the most prevalent but least serious picky eating, to the least prevalent but most serious feeding disorders, she noted. Correspondingly, management will range from simple reassurance of parents to more intensive behavioral and medical interventions.

Assessment

Dr. Irene Chatoor
Regardless of their apparent severity, all feeding problems brought to clinicians’ attention can be a source of anxiety for parents and should be carefully evaluated, recommended Dr. Chatoor, who is a professor of psychiatry and pediatrics at George Washington University, and vice chair of the departments of psychiatry and behavioral sciences at Children’s National Medical Center, both in Washington.

“When you assess a feeding problem, you have to look at both the mother and father, and the child,” she advised. The parents are evaluated for their feeding style, while the child is evaluated for three feeding problems: limited appetite, selective intake, and fear of feeding (Pediatrics. 2015;135[2]:344-53).

Clinicians must be alert for organic red flags, such as dysphagia, aspiration, and vomiting, and for behavioral red flags, such as food fixation, abrupt cessation of feeding after a trigger event, and anticipatory gagging. An overarching red flag is failure to thrive.

Sometimes, a child will have both an organic condition and a behavioral feeding disorder at the same time. “It’s very important that you don’t think one excludes the other,” she cautioned.

Diagnosis

“To delineate milder feeding difficulties from feeding disorders, there must be some form of impairment caused by the feeding problem,” Dr. Chatoor commented. “Why is this important? For two reasons. One is for the insurance companies, because they don’t pay unless there is a disorder. And then there is research: you cannot do research unless you clearly define what you are studying.”

Children are considered to have impairment if they have weight loss or growth faltering, considerable nutritional deficiency, or a marked interference with psychosocial functioning.

“When we diagnose feeding problems, it is best done with a multidisciplinary team,” Dr. Chatoor maintained. “I have learned many years ago that I’m not effective in helping parents deal with the feeding disorder if they are still in the back of their mind worried that the child has something organically wrong and that’s why the child does not want to eat.”

Accordingly, various team members perform a medical examination, a nutritional assessment, an oral motor and sensory evaluation, and a psychiatric or psychological assessment to identify the root cause or causes of the problem.

When it comes to behavioral etiologies, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) now groups all feeding and eating disorders together in one section, reflecting the fact that disorders starting early in life can and often do track into adolescence and adulthood, according to Dr. Chatoor.

The manual also features a new diagnosis, avoidant/restrictive food intake disorder (ARFID). Key criteria include the presence of an eating or feeding disturbance that cannot be better explained by lack of available food, culturally sanctioned practices, or a concurrent medical condition or another mental disorder.

The child must have a persistent failure to meet appropriate nutritional and/or energy needs, associated with any of four findings: significant weight loss or failure to achieve expected weight gain or growth, significant nutritional deficiencies, dependence on enteral feeding or oral nutritional supplements, and marked interference with psychosocial functioning.

“You need to have at least one but often you have a combination of nutritional and emotional impairment in the same child,” she commented.

ARFID and its treatment

There are three subtypes of ARFID having different features, treatments, and prognosis, although they all share in common food refusal, according to Dr. Chatoor.

The first subtype – apparent lack of interest in eating or food – emerges by 3 years of age, most often during the transition to self-feeding between 9 and 18 months. Affected children refuse to eat an adequate amount of food for at least 1 month, rarely communicate hunger, lack interest in food, and prefer to play or talk. They typically present with growth deficiency.

“If you have a child who refuses to eat, it generates anxiety in the mother. The mother does things she would not normally do with the child who is eating well. She starts to distract, to cajole, to sometimes even force-feed the child,” Dr. Chatoor explained. “And the more she engages in these behaviors, the more resistant the child becomes. So they become trapped in this vicious cycle.”

Treatment is aimed at removing this conflict with three approaches: explaining to parents the infant’s special temperament (notably, high arousal and difficulty turning off excitement); addressing their background, including any eating issues of their own, and difficulty with setting limits; and providing specific feeding guidelines and a time-out procedure.

The guidelines stress regular feeding, withholding of all snacks, keeping the child at the table for 20 to 30 minutes, and not using any distractions or pressure. Also, importantly, the parents should have dinner with their child. “I always tell the parents what is good for the child is good for you. It’s good for your whole family,” she said. “If they have other children, these rules apply to everybody. Young children learn to eat by watching their parents eating.”

With early and consistent use of these interventions, about two-thirds of children outgrow this eating/feeding disturbance by mid-childhood, according to Dr. Chatoor.

Children with the second subtype of ARFID – avoidance based on the sensory characteristics of food – consistently refuse to eat certain foods having specific tastes, textures, temperatures, smells, and/or appearances. Onset occurs during the toddler years, when a new or different food is introduced.

“Not only do they refuse the same foods that were aversive, but they also generalize it. So these children are afraid to try other foods and they may end up limiting food groups – they don’t eat any vegetables and some of them don’t eat any meats,” she explained. “They are a challenge because this always causes a nutritional deficiency and they also have problems socially as they get older.”

Treatment varies by age, with gradual desensitization for infants and parent modeling of eating new foods for toddlers. A multifaceted approach is used for preschoolers, combining modeling, giving foods attractive shapes and names, having the child participate in food preparation, and using focused play therapy, such as feeding dolls who are “brave” and try new foods.

Clinicians can explain to affected school-aged children that they are “supertasters,” having more taste buds and therefore experiencing food more intensely, and that they can help their taste buds not react so strongly by starting to eat small amounts of new foods and gradually increasing over time. Parents can let the child make a list of 10 foods they would like to eat, and award them points for “courage” for every bite of a new food they try.

Prognosis of this type of ARFID varies, according to Dr. Chatoor. “Through gradual exposure, young children can expand the variety of foods they eat,” she elaborated. However, “some children become very rigid and brand sensitive in regard to the food they are willing to eat and begin to experience social problems during mid-childhood and adolescence. Some children grow up eating a limited diet, but finding ways to compensate nutritionally and socially.”

Children with the third subtype of ARFID – concern about aversive consequences of eating – have an acute onset of consistent food refusal at any age, from infancy onward, after experiencing a traumatic event or repeated traumatic insults to the oropharynx or gastrointestinal tract that trigger distress in the child. These children often have comorbidities such as gastroesophageal reflux, eosinophilic gastroenteritis, or anxiety disorder.

“Treatment involves gradual desensitization to feared objects: the highchair, bib, bottle, or spoon,” Dr. Chatoor explained. “It also involves training of the mother in behavioral techniques to feed the child in spite of the child’s fear and distress.”

Any underlying medical condition causing pain or distress should be treated. Additional measures may include, for example, use of a graduated approach, starting with liquids and progressing to purees, if the child fears solid foods, and prescribing anxiolytic medication in cases of severe anxiety.

Dr. Chatoor disclosed that she has lectured internationally at conferences on feeding disorders that were organized by Abbott Nutrition International and that the company provided a research grant for a study on feeding.

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The Robots Are Coming to Vascular Surgery

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Emerging technologies in robotics systems will be the subject of a key session at the 2016 Veithsymposium, entitled “Vascular Robotics and Guidance Systems” and co-chaired by Dr. Kenneth Ouriel, founder of Syntactx, and Dr. Anton N. Sidawy of George Washington University.

Dr. Anton N. Sidawy
“Actual robotic methodologies have not penetrated yet the daily clinical practice of vascular technique,” Dr. Sidawy said in emphasizing the importance of this session. Those who attend will be gaining valuable insight into the importance of such techniques and why they might consider incorporating them into their own practices, he noted..

According to Dr. Sidawy, the major focus of the session will be the Magellan System, which is a steerable catheter system controlled by a remote physician console. The system has two major components: a robotic arm and the aforementioned remote console. This design is meant to keep the operator away from the table, thereby decreasing exposure to the radiation source.

Dr. Kenneth Ouriel
“The steerability allows much easier navigation of tortuous arteries and easier access to smaller arterial and venous branches to deliver therapy,” elaborated Dr. Sidawy.

The promise of such technology is becoming increasingly acknowledged in the field of vascular surgery. The Magellan can be used in a number of endovascular procedures, including – but not necessarily limited to – embolization, endovascular aneurysm repair (EVAR), angioplasty, stenting, crossing total occlusions, and venous procedures. Such applications will be highlighted in-depth during this session, with presentations by some of the most prominent names in the field of vascular robotic surgery.

The session will conclude with a panel discussion involving all the speakers and which will cover the current state and future of robotics in vascular surgery.
 

Thursday, November 17, 2016
Session 53: VASCULAR ROBOTICS AND GUIDANCE SYSTEMS
Moderators: Kenneth Ouriel, MD, MBA / Anton N. Sidawy, MD, MPH
3:52 PM - 4:52 PM

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Emerging technologies in robotics systems will be the subject of a key session at the 2016 Veithsymposium, entitled “Vascular Robotics and Guidance Systems” and co-chaired by Dr. Kenneth Ouriel, founder of Syntactx, and Dr. Anton N. Sidawy of George Washington University.

Dr. Anton N. Sidawy
“Actual robotic methodologies have not penetrated yet the daily clinical practice of vascular technique,” Dr. Sidawy said in emphasizing the importance of this session. Those who attend will be gaining valuable insight into the importance of such techniques and why they might consider incorporating them into their own practices, he noted..

According to Dr. Sidawy, the major focus of the session will be the Magellan System, which is a steerable catheter system controlled by a remote physician console. The system has two major components: a robotic arm and the aforementioned remote console. This design is meant to keep the operator away from the table, thereby decreasing exposure to the radiation source.

Dr. Kenneth Ouriel
“The steerability allows much easier navigation of tortuous arteries and easier access to smaller arterial and venous branches to deliver therapy,” elaborated Dr. Sidawy.

The promise of such technology is becoming increasingly acknowledged in the field of vascular surgery. The Magellan can be used in a number of endovascular procedures, including – but not necessarily limited to – embolization, endovascular aneurysm repair (EVAR), angioplasty, stenting, crossing total occlusions, and venous procedures. Such applications will be highlighted in-depth during this session, with presentations by some of the most prominent names in the field of vascular robotic surgery.

The session will conclude with a panel discussion involving all the speakers and which will cover the current state and future of robotics in vascular surgery.
 

Thursday, November 17, 2016
Session 53: VASCULAR ROBOTICS AND GUIDANCE SYSTEMS
Moderators: Kenneth Ouriel, MD, MBA / Anton N. Sidawy, MD, MPH
3:52 PM - 4:52 PM

Emerging technologies in robotics systems will be the subject of a key session at the 2016 Veithsymposium, entitled “Vascular Robotics and Guidance Systems” and co-chaired by Dr. Kenneth Ouriel, founder of Syntactx, and Dr. Anton N. Sidawy of George Washington University.

Dr. Anton N. Sidawy
“Actual robotic methodologies have not penetrated yet the daily clinical practice of vascular technique,” Dr. Sidawy said in emphasizing the importance of this session. Those who attend will be gaining valuable insight into the importance of such techniques and why they might consider incorporating them into their own practices, he noted..

According to Dr. Sidawy, the major focus of the session will be the Magellan System, which is a steerable catheter system controlled by a remote physician console. The system has two major components: a robotic arm and the aforementioned remote console. This design is meant to keep the operator away from the table, thereby decreasing exposure to the radiation source.

Dr. Kenneth Ouriel
“The steerability allows much easier navigation of tortuous arteries and easier access to smaller arterial and venous branches to deliver therapy,” elaborated Dr. Sidawy.

The promise of such technology is becoming increasingly acknowledged in the field of vascular surgery. The Magellan can be used in a number of endovascular procedures, including – but not necessarily limited to – embolization, endovascular aneurysm repair (EVAR), angioplasty, stenting, crossing total occlusions, and venous procedures. Such applications will be highlighted in-depth during this session, with presentations by some of the most prominent names in the field of vascular robotic surgery.

The session will conclude with a panel discussion involving all the speakers and which will cover the current state and future of robotics in vascular surgery.
 

Thursday, November 17, 2016
Session 53: VASCULAR ROBOTICS AND GUIDANCE SYSTEMS
Moderators: Kenneth Ouriel, MD, MBA / Anton N. Sidawy, MD, MPH
3:52 PM - 4:52 PM

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Addiction potential

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Fri, 01/18/2019 - 16:20

By nature, my wife and I are risk-averse people. Our investment strategy is just a few baby steps short of hiding our money under the mattress. We have never tried marijuana, though to some extent this is because we were out of college and already married when its popularity surged across this country’s campuses. We do drink alcohol, which was so ubiquitous when we were teenagers that it seemed innocuous.

Given my personality, you can understand why I have trouble understanding why anyone would ever try heroin or any opiate. I realize that many of the young addicts don’t follow the news closely enough to realize the risks. But the epidemic of addiction is so entrenched here in rural Maine that they must have known someone who has died of an overdose.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff
However, when I step away from who I am, I can accept the reality that most young people are not as risk averse as my wife and I are. I also realize that not everyone who takes the risk and tries cocaine or heroin becomes addicted. I have always wondered if there was some personality profile that could identify those at risk, especially when they were young enough to be rescued by an intervention.

A recent op-ed piece in the New York Times describes a program that attempts to do just that (“The 4 Traits That Put Kids at Risk for Addiction,” by Maia Szalavitz, Sept. 29, 2016). The program is called Preventure and is the result of some work by Patricia Conrod, a psychiatry professor at the University of Montreal. It has been tried in Britain, Canada, Australia, and the Netherlands with some success in reducing binge drinking. In other studies, it reduced symptoms of depression, panic attacks, and impulsive behavior.

The program begins with testing middle school students and focuses on the traits of hopelessness, sensation-seeking, impulsiveness, and anxiety sensitivity. Hopeless is not a surprising choice given that many of the areas of this country with highest rates of opiate addiction are economically depressed. And it is easy to see why impulsivity and sensation-seeking are related to addiction potential. Anxiety-sensitivity is a less intuitive choice.

With the results of this testing in hand, the program administrators wait several months before approaching the outliers. The next step offers two 90-minute workshops to the entire school with the stated goal of showing how the students can channel their personalities toward success. Although the workshops are advertised as being open to everyone but limited in number of attendees, only the students identified as being at the highest risk are actually selected. It is hoped that this deception will avoid having the participants feel that they have been labeled. However, if a student asks about the selection process, he is given an honest answer. The workshops are targeted to the students’ specific emotional and behavioral vulnerabilities, and teaches cognitive behavioral techniques on how they can be managed.

While I think the deceptive selection process is a clever to wrinkle to avoid labeling, I wonder how long the ruse will survive should the program become more universally adopted. With increased popularity and publicity, every parent and most of the children in a school will realize why the test is being administered and what being selected for the workshop means. There is the threat that being identified as at risk for addiction will become a self-fulfilling prophecy and a trigger for depression.

Preventure sounds like a program worth watching. If larger series and long-term outcomes continue to be favorable, it will remain to be seen whether labeling is a hazard worth worrying about.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].

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By nature, my wife and I are risk-averse people. Our investment strategy is just a few baby steps short of hiding our money under the mattress. We have never tried marijuana, though to some extent this is because we were out of college and already married when its popularity surged across this country’s campuses. We do drink alcohol, which was so ubiquitous when we were teenagers that it seemed innocuous.

Given my personality, you can understand why I have trouble understanding why anyone would ever try heroin or any opiate. I realize that many of the young addicts don’t follow the news closely enough to realize the risks. But the epidemic of addiction is so entrenched here in rural Maine that they must have known someone who has died of an overdose.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff
However, when I step away from who I am, I can accept the reality that most young people are not as risk averse as my wife and I are. I also realize that not everyone who takes the risk and tries cocaine or heroin becomes addicted. I have always wondered if there was some personality profile that could identify those at risk, especially when they were young enough to be rescued by an intervention.

A recent op-ed piece in the New York Times describes a program that attempts to do just that (“The 4 Traits That Put Kids at Risk for Addiction,” by Maia Szalavitz, Sept. 29, 2016). The program is called Preventure and is the result of some work by Patricia Conrod, a psychiatry professor at the University of Montreal. It has been tried in Britain, Canada, Australia, and the Netherlands with some success in reducing binge drinking. In other studies, it reduced symptoms of depression, panic attacks, and impulsive behavior.

The program begins with testing middle school students and focuses on the traits of hopelessness, sensation-seeking, impulsiveness, and anxiety sensitivity. Hopeless is not a surprising choice given that many of the areas of this country with highest rates of opiate addiction are economically depressed. And it is easy to see why impulsivity and sensation-seeking are related to addiction potential. Anxiety-sensitivity is a less intuitive choice.

With the results of this testing in hand, the program administrators wait several months before approaching the outliers. The next step offers two 90-minute workshops to the entire school with the stated goal of showing how the students can channel their personalities toward success. Although the workshops are advertised as being open to everyone but limited in number of attendees, only the students identified as being at the highest risk are actually selected. It is hoped that this deception will avoid having the participants feel that they have been labeled. However, if a student asks about the selection process, he is given an honest answer. The workshops are targeted to the students’ specific emotional and behavioral vulnerabilities, and teaches cognitive behavioral techniques on how they can be managed.

While I think the deceptive selection process is a clever to wrinkle to avoid labeling, I wonder how long the ruse will survive should the program become more universally adopted. With increased popularity and publicity, every parent and most of the children in a school will realize why the test is being administered and what being selected for the workshop means. There is the threat that being identified as at risk for addiction will become a self-fulfilling prophecy and a trigger for depression.

Preventure sounds like a program worth watching. If larger series and long-term outcomes continue to be favorable, it will remain to be seen whether labeling is a hazard worth worrying about.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].

By nature, my wife and I are risk-averse people. Our investment strategy is just a few baby steps short of hiding our money under the mattress. We have never tried marijuana, though to some extent this is because we were out of college and already married when its popularity surged across this country’s campuses. We do drink alcohol, which was so ubiquitous when we were teenagers that it seemed innocuous.

Given my personality, you can understand why I have trouble understanding why anyone would ever try heroin or any opiate. I realize that many of the young addicts don’t follow the news closely enough to realize the risks. But the epidemic of addiction is so entrenched here in rural Maine that they must have known someone who has died of an overdose.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff
However, when I step away from who I am, I can accept the reality that most young people are not as risk averse as my wife and I are. I also realize that not everyone who takes the risk and tries cocaine or heroin becomes addicted. I have always wondered if there was some personality profile that could identify those at risk, especially when they were young enough to be rescued by an intervention.

A recent op-ed piece in the New York Times describes a program that attempts to do just that (“The 4 Traits That Put Kids at Risk for Addiction,” by Maia Szalavitz, Sept. 29, 2016). The program is called Preventure and is the result of some work by Patricia Conrod, a psychiatry professor at the University of Montreal. It has been tried in Britain, Canada, Australia, and the Netherlands with some success in reducing binge drinking. In other studies, it reduced symptoms of depression, panic attacks, and impulsive behavior.

The program begins with testing middle school students and focuses on the traits of hopelessness, sensation-seeking, impulsiveness, and anxiety sensitivity. Hopeless is not a surprising choice given that many of the areas of this country with highest rates of opiate addiction are economically depressed. And it is easy to see why impulsivity and sensation-seeking are related to addiction potential. Anxiety-sensitivity is a less intuitive choice.

With the results of this testing in hand, the program administrators wait several months before approaching the outliers. The next step offers two 90-minute workshops to the entire school with the stated goal of showing how the students can channel their personalities toward success. Although the workshops are advertised as being open to everyone but limited in number of attendees, only the students identified as being at the highest risk are actually selected. It is hoped that this deception will avoid having the participants feel that they have been labeled. However, if a student asks about the selection process, he is given an honest answer. The workshops are targeted to the students’ specific emotional and behavioral vulnerabilities, and teaches cognitive behavioral techniques on how they can be managed.

While I think the deceptive selection process is a clever to wrinkle to avoid labeling, I wonder how long the ruse will survive should the program become more universally adopted. With increased popularity and publicity, every parent and most of the children in a school will realize why the test is being administered and what being selected for the workshop means. There is the threat that being identified as at risk for addiction will become a self-fulfilling prophecy and a trigger for depression.

Preventure sounds like a program worth watching. If larger series and long-term outcomes continue to be favorable, it will remain to be seen whether labeling is a hazard worth worrying about.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].

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Is physician-assisted suicide compatible with the Hippocratic Oath?

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Do we stand by our Hippocratic Oath when providing physician-assisted suicide?

Physician-assisted suicide (PAS) is a form of euthanasia in which a physician provides the patient with the pertinent information, and, in certain cases, a prescription for the necessary lethal drugs, so that the individual can willingly and successfully terminate his or her own life. The justification for PAS is the compassionate relief of intractable human suffering. Euthanasia and PAS are accepted practices in European countries such as the Netherlands, Belgium, and Luxembourg.

Dr. Saeed Ahmed
In the United States, however, PAS is only legal in the states of Oregon, Washington, Montana, Vermont, and California. At this time, euthanasia is not legal in the United States, but there is currently a vigorous debate about its legalization. In states where PAS is legalized, patients are allowed to seek PAS only if they meet certain, strict criteria, including having the mental capacity to make their own decision, and have received a prognosis of less than 6 months of life expectancy. However, the ascertaining of mental capacity raises serious concerns for terminally ill patients who possess concurrent psychiatric illnesses, or are otherwise depressed or in despair about their life circumstances, which may include their loss of autonomy and the perceived burden they might place on their families and caregivers.

Such patients are mentally incapable of making the difficult decision to end their life and therefore should require a psychiatric evaluation to include counseling prior to making a decision to engage in PAS. For patients with mental illness, PAS is even more problematic than for terminally ill patients, because patients may lack the capacity to make rational and responsible decisions. Indeed, there are sizable loopholes where our medical system lacks safeguards and similarly lacks the requirements for a thorough, pre-PAS mental health examination, family notifications, and consultations, and for the minimally necessary legal pressure required to ensure patient cooperation.
 

Critical role of mental health workers

Although PAS has been legalized in those five U.S. states, its support and cases have stalled in recent years, indicating serious ethical concerns, mostly because of multileveled challenges of combating and delineating cultural stereotypes, quantifying mental capacity, gauging quality of life, and deciding where to situate psychiatrists in the PAS decision.

The psychiatrist’s role is being debated. In the United States, opponents take issue with current PAS-legal state’s legislation regarding psychiatric evaluations. For example, Oregon stipulates a psychiatrist referral only in cases where a physician other than a psychiatrist believes the patient’s judgment is impaired. It’s agreed that psychiatrists have the best skill set to assess a patient’s perceptions. Other PAS-legal states require a psychiatrist or psychologist assessment before making the decision. Unfortunately, though, physicians have rarely referred these patients to psychiatrists before offering PAS as an option.

PAS opponents target standards by which concepts like “quality of life” or “contributing member of society” are judged – specifically, that “unbearable suffering” and its ramifications are ill defined – people whose lives are deemed “not worth living” (including the terminally ill) would be susceptible to “sympathetic death” via PAS that might result from PAS legalization. Opponents also argue that recognizing a suicide “right” contradicts that a significant number of suicide attempters have mental illness and need help. They say that legalizing PAS would enable mentally incapacitated people to commit the irreversible act based on their distorted perceptions without providing them the expected assistance from their profession.1

The use of euthanasia or PAS gradually is trending from physically terminally ill patients toward psychiatrically complex patients. There are cases in which euthanasia or PAS was requested by psychiatric patients who had chronic psychiatric, medical, and psychosocial histories rather than purely physical ailment histories. In one study, Scott Y. H. Kim, MD, PhD, and his associates reviewed cases in the Netherlands in which either euthanasia or PAS for psychiatric disorders was deployed. The granted PAS requests appeared to involve physician judgment without psychiatric input.

The study reviewed 66 cases: 55% of patients had chronic severe conditions with extensive histories of attempted suicides and psychiatric hospitalizations, demonstrating that the granted euthanasia and PAS requests had involved extensive evaluations. However, 11% of cases had no independent psychiatric input, and 24% involved disagreement among the physicians.2 PAS proponents and opponents support the involvement and expertise of psychiatrists in all of this.

Psychiatrists have long contended that suicide attempts are often a “cry for help,” not an earnest act to end one’s life. Legalizing PAS tells suicidal individuals that society does not care whether they live or die – a truly un-Hippocratic stance. The stereotypes tossed around in the PAS debate, which could mean life or death, need to be unpacked with specific criteria attached, rather than preconceptions.
 

 

 

Autonomy of patients and implications of PAS

In the PAS debate, there are serious life concerns exhibited by terminally ill/psychiatrically ill patients over losing their autonomy and becoming a burden to their families and caregivers. Stereotypes must be deconstructed, yes, but such patients generally have been considered to be rendered, by the sum effect of their illnesses, mentally incapable of making the decision to end their lives. Addressing this order of patient life concerns generally has been the realm of social workers, psychologists, and, in the most desirable cases, psychiatrists. Therefore, even in keeping with established practice, some form of competent psychiatric evaluation should be required before considering PAS as a viable option.

The call for this requirement is backed up by a study, which reported that 47% of patients who had considered or committed suicide previously were diagnosed with psychiatric disorders, and 15% had undiagnosed psychiatric disorders.3 Also, inventories of thwarted suicide attempters reveal that most lack the conviction to end their lives, and this obverse phenomenon is backed by a study that revealed that 75% of 96 suicidal patients were found to be ambivalent in their intent to end their lives. Suicide attempters simply may be trying to communicate with people in their lives in order to test their love and care.4 This indicates that those who attempt suicide are predominantly psychiatrically ill and prone to distorted perceptions, impaired judgment, frustration, escapism, and manipulative guilt.

Suicide is abhorrent to most human beings’ sensibilities, because humanity has an innate will to live.5 It is wrong to offer patients life-ending options when they might rejuvenate or ease into death naturally. With the debilitated or elderly, PAS could violate their human rights. If the attitude that they are a burden to society persists, then a certain segment of society might be tempted to avoid their intergenerational obligations to elders, particularly those elders presenting with concurrent mental illnesses. PAS would additionally fuel that problem. This would represent a profound injustice and gross violation of human dignity, while also serving as a denial of basic human rights, particularly the right to life and care.6

Conclusion

The complex physical, psychological, and social challenges associated with PAS and the difficulty in enforcing its laws necessitate more adept alternatives. Instead of conditionally legalizing suicide, we should ease patient suffering with compassion and calibrated treatment.6,7

Terminally ill patients often suffer from depression, affecting their rationality. Adequate counseling, medical care, and psychological care should be the response to terminally ill patients considering suicide. If society accepts that ending a life is a reasonable response to human suffering that could otherwise be treated or reversed, then those with the most serious psychiatric conditions are destined to become more vulnerable. Therefore, physicians and psychiatrists should instead work harder to help patients recover, rather than participating in their quest for death.

Simplistic legal and regulatory oversight is insufficient, because the questions evoked by PAS are complicated by life, death, and ethics. Further research is needed to look into the mechanisms and morality of how psychiatrists and other physicians will make judgments and recommendations that are vital elements in developing regulatory oversight on PAS. Finally, future studies should look at which practices have been successful and which might be deemed unethical.
 

References

1. Clin Med (Lond). 2010 Aug;109(4):323-5.

2. JAMA Psychiatry. 2016;73(4):362-8.

3. “The Final Months: A Study of the Lives of 134 Persons Who Committed Suicide,” New York: Oxford University Press, 1981.

4. “Why We Shouldn’t Legalize Assisting Suicide, Part I.” Department of Medical Ethics, National Right to Life Committee.

5. “Working with Suicidal Individuals: A Guide to Providing Understanding, Assessment and Support,” Philadelphia: Jessica Kingsley Publishers, 2010.

6. “Always Care, Never Kill: How Physician-Assisted Suicide Endangers the Weak, Corrupts Medicine, Compromises the Family, and Violates Human Dignity and Equality,” Washington: The Heritage Foundation, 2015.

7. Ann Intern Med. 2012 Jan 3;156(1 Pt 2):73-104.

Dr. Ahmed is a 2nd-year resident in the psychiatry & behavioral sciences department at the Nassau University Medical Center, New York. Over the last 3 years, he has published and presented papers at national and international forums. His interests include public social psychiatry, health care policy, health disparities, mental health stigma, and undiagnosed and overdiagnosed psychiatric illnesses in children. Dr. Ahmed is a member of the American Psychiatric Association, the American Society of Clinical Psychopharmacology, and the American Association for Social Psychiatry.

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Do we stand by our Hippocratic Oath when providing physician-assisted suicide?

Physician-assisted suicide (PAS) is a form of euthanasia in which a physician provides the patient with the pertinent information, and, in certain cases, a prescription for the necessary lethal drugs, so that the individual can willingly and successfully terminate his or her own life. The justification for PAS is the compassionate relief of intractable human suffering. Euthanasia and PAS are accepted practices in European countries such as the Netherlands, Belgium, and Luxembourg.

Dr. Saeed Ahmed
In the United States, however, PAS is only legal in the states of Oregon, Washington, Montana, Vermont, and California. At this time, euthanasia is not legal in the United States, but there is currently a vigorous debate about its legalization. In states where PAS is legalized, patients are allowed to seek PAS only if they meet certain, strict criteria, including having the mental capacity to make their own decision, and have received a prognosis of less than 6 months of life expectancy. However, the ascertaining of mental capacity raises serious concerns for terminally ill patients who possess concurrent psychiatric illnesses, or are otherwise depressed or in despair about their life circumstances, which may include their loss of autonomy and the perceived burden they might place on their families and caregivers.

Such patients are mentally incapable of making the difficult decision to end their life and therefore should require a psychiatric evaluation to include counseling prior to making a decision to engage in PAS. For patients with mental illness, PAS is even more problematic than for terminally ill patients, because patients may lack the capacity to make rational and responsible decisions. Indeed, there are sizable loopholes where our medical system lacks safeguards and similarly lacks the requirements for a thorough, pre-PAS mental health examination, family notifications, and consultations, and for the minimally necessary legal pressure required to ensure patient cooperation.
 

Critical role of mental health workers

Although PAS has been legalized in those five U.S. states, its support and cases have stalled in recent years, indicating serious ethical concerns, mostly because of multileveled challenges of combating and delineating cultural stereotypes, quantifying mental capacity, gauging quality of life, and deciding where to situate psychiatrists in the PAS decision.

The psychiatrist’s role is being debated. In the United States, opponents take issue with current PAS-legal state’s legislation regarding psychiatric evaluations. For example, Oregon stipulates a psychiatrist referral only in cases where a physician other than a psychiatrist believes the patient’s judgment is impaired. It’s agreed that psychiatrists have the best skill set to assess a patient’s perceptions. Other PAS-legal states require a psychiatrist or psychologist assessment before making the decision. Unfortunately, though, physicians have rarely referred these patients to psychiatrists before offering PAS as an option.

PAS opponents target standards by which concepts like “quality of life” or “contributing member of society” are judged – specifically, that “unbearable suffering” and its ramifications are ill defined – people whose lives are deemed “not worth living” (including the terminally ill) would be susceptible to “sympathetic death” via PAS that might result from PAS legalization. Opponents also argue that recognizing a suicide “right” contradicts that a significant number of suicide attempters have mental illness and need help. They say that legalizing PAS would enable mentally incapacitated people to commit the irreversible act based on their distorted perceptions without providing them the expected assistance from their profession.1

The use of euthanasia or PAS gradually is trending from physically terminally ill patients toward psychiatrically complex patients. There are cases in which euthanasia or PAS was requested by psychiatric patients who had chronic psychiatric, medical, and psychosocial histories rather than purely physical ailment histories. In one study, Scott Y. H. Kim, MD, PhD, and his associates reviewed cases in the Netherlands in which either euthanasia or PAS for psychiatric disorders was deployed. The granted PAS requests appeared to involve physician judgment without psychiatric input.

The study reviewed 66 cases: 55% of patients had chronic severe conditions with extensive histories of attempted suicides and psychiatric hospitalizations, demonstrating that the granted euthanasia and PAS requests had involved extensive evaluations. However, 11% of cases had no independent psychiatric input, and 24% involved disagreement among the physicians.2 PAS proponents and opponents support the involvement and expertise of psychiatrists in all of this.

Psychiatrists have long contended that suicide attempts are often a “cry for help,” not an earnest act to end one’s life. Legalizing PAS tells suicidal individuals that society does not care whether they live or die – a truly un-Hippocratic stance. The stereotypes tossed around in the PAS debate, which could mean life or death, need to be unpacked with specific criteria attached, rather than preconceptions.
 

 

 

Autonomy of patients and implications of PAS

In the PAS debate, there are serious life concerns exhibited by terminally ill/psychiatrically ill patients over losing their autonomy and becoming a burden to their families and caregivers. Stereotypes must be deconstructed, yes, but such patients generally have been considered to be rendered, by the sum effect of their illnesses, mentally incapable of making the decision to end their lives. Addressing this order of patient life concerns generally has been the realm of social workers, psychologists, and, in the most desirable cases, psychiatrists. Therefore, even in keeping with established practice, some form of competent psychiatric evaluation should be required before considering PAS as a viable option.

The call for this requirement is backed up by a study, which reported that 47% of patients who had considered or committed suicide previously were diagnosed with psychiatric disorders, and 15% had undiagnosed psychiatric disorders.3 Also, inventories of thwarted suicide attempters reveal that most lack the conviction to end their lives, and this obverse phenomenon is backed by a study that revealed that 75% of 96 suicidal patients were found to be ambivalent in their intent to end their lives. Suicide attempters simply may be trying to communicate with people in their lives in order to test their love and care.4 This indicates that those who attempt suicide are predominantly psychiatrically ill and prone to distorted perceptions, impaired judgment, frustration, escapism, and manipulative guilt.

Suicide is abhorrent to most human beings’ sensibilities, because humanity has an innate will to live.5 It is wrong to offer patients life-ending options when they might rejuvenate or ease into death naturally. With the debilitated or elderly, PAS could violate their human rights. If the attitude that they are a burden to society persists, then a certain segment of society might be tempted to avoid their intergenerational obligations to elders, particularly those elders presenting with concurrent mental illnesses. PAS would additionally fuel that problem. This would represent a profound injustice and gross violation of human dignity, while also serving as a denial of basic human rights, particularly the right to life and care.6

Conclusion

The complex physical, psychological, and social challenges associated with PAS and the difficulty in enforcing its laws necessitate more adept alternatives. Instead of conditionally legalizing suicide, we should ease patient suffering with compassion and calibrated treatment.6,7

Terminally ill patients often suffer from depression, affecting their rationality. Adequate counseling, medical care, and psychological care should be the response to terminally ill patients considering suicide. If society accepts that ending a life is a reasonable response to human suffering that could otherwise be treated or reversed, then those with the most serious psychiatric conditions are destined to become more vulnerable. Therefore, physicians and psychiatrists should instead work harder to help patients recover, rather than participating in their quest for death.

Simplistic legal and regulatory oversight is insufficient, because the questions evoked by PAS are complicated by life, death, and ethics. Further research is needed to look into the mechanisms and morality of how psychiatrists and other physicians will make judgments and recommendations that are vital elements in developing regulatory oversight on PAS. Finally, future studies should look at which practices have been successful and which might be deemed unethical.
 

References

1. Clin Med (Lond). 2010 Aug;109(4):323-5.

2. JAMA Psychiatry. 2016;73(4):362-8.

3. “The Final Months: A Study of the Lives of 134 Persons Who Committed Suicide,” New York: Oxford University Press, 1981.

4. “Why We Shouldn’t Legalize Assisting Suicide, Part I.” Department of Medical Ethics, National Right to Life Committee.

5. “Working with Suicidal Individuals: A Guide to Providing Understanding, Assessment and Support,” Philadelphia: Jessica Kingsley Publishers, 2010.

6. “Always Care, Never Kill: How Physician-Assisted Suicide Endangers the Weak, Corrupts Medicine, Compromises the Family, and Violates Human Dignity and Equality,” Washington: The Heritage Foundation, 2015.

7. Ann Intern Med. 2012 Jan 3;156(1 Pt 2):73-104.

Dr. Ahmed is a 2nd-year resident in the psychiatry & behavioral sciences department at the Nassau University Medical Center, New York. Over the last 3 years, he has published and presented papers at national and international forums. His interests include public social psychiatry, health care policy, health disparities, mental health stigma, and undiagnosed and overdiagnosed psychiatric illnesses in children. Dr. Ahmed is a member of the American Psychiatric Association, the American Society of Clinical Psychopharmacology, and the American Association for Social Psychiatry.

 



Do we stand by our Hippocratic Oath when providing physician-assisted suicide?

Physician-assisted suicide (PAS) is a form of euthanasia in which a physician provides the patient with the pertinent information, and, in certain cases, a prescription for the necessary lethal drugs, so that the individual can willingly and successfully terminate his or her own life. The justification for PAS is the compassionate relief of intractable human suffering. Euthanasia and PAS are accepted practices in European countries such as the Netherlands, Belgium, and Luxembourg.

Dr. Saeed Ahmed
In the United States, however, PAS is only legal in the states of Oregon, Washington, Montana, Vermont, and California. At this time, euthanasia is not legal in the United States, but there is currently a vigorous debate about its legalization. In states where PAS is legalized, patients are allowed to seek PAS only if they meet certain, strict criteria, including having the mental capacity to make their own decision, and have received a prognosis of less than 6 months of life expectancy. However, the ascertaining of mental capacity raises serious concerns for terminally ill patients who possess concurrent psychiatric illnesses, or are otherwise depressed or in despair about their life circumstances, which may include their loss of autonomy and the perceived burden they might place on their families and caregivers.

Such patients are mentally incapable of making the difficult decision to end their life and therefore should require a psychiatric evaluation to include counseling prior to making a decision to engage in PAS. For patients with mental illness, PAS is even more problematic than for terminally ill patients, because patients may lack the capacity to make rational and responsible decisions. Indeed, there are sizable loopholes where our medical system lacks safeguards and similarly lacks the requirements for a thorough, pre-PAS mental health examination, family notifications, and consultations, and for the minimally necessary legal pressure required to ensure patient cooperation.
 

Critical role of mental health workers

Although PAS has been legalized in those five U.S. states, its support and cases have stalled in recent years, indicating serious ethical concerns, mostly because of multileveled challenges of combating and delineating cultural stereotypes, quantifying mental capacity, gauging quality of life, and deciding where to situate psychiatrists in the PAS decision.

The psychiatrist’s role is being debated. In the United States, opponents take issue with current PAS-legal state’s legislation regarding psychiatric evaluations. For example, Oregon stipulates a psychiatrist referral only in cases where a physician other than a psychiatrist believes the patient’s judgment is impaired. It’s agreed that psychiatrists have the best skill set to assess a patient’s perceptions. Other PAS-legal states require a psychiatrist or psychologist assessment before making the decision. Unfortunately, though, physicians have rarely referred these patients to psychiatrists before offering PAS as an option.

PAS opponents target standards by which concepts like “quality of life” or “contributing member of society” are judged – specifically, that “unbearable suffering” and its ramifications are ill defined – people whose lives are deemed “not worth living” (including the terminally ill) would be susceptible to “sympathetic death” via PAS that might result from PAS legalization. Opponents also argue that recognizing a suicide “right” contradicts that a significant number of suicide attempters have mental illness and need help. They say that legalizing PAS would enable mentally incapacitated people to commit the irreversible act based on their distorted perceptions without providing them the expected assistance from their profession.1

The use of euthanasia or PAS gradually is trending from physically terminally ill patients toward psychiatrically complex patients. There are cases in which euthanasia or PAS was requested by psychiatric patients who had chronic psychiatric, medical, and psychosocial histories rather than purely physical ailment histories. In one study, Scott Y. H. Kim, MD, PhD, and his associates reviewed cases in the Netherlands in which either euthanasia or PAS for psychiatric disorders was deployed. The granted PAS requests appeared to involve physician judgment without psychiatric input.

The study reviewed 66 cases: 55% of patients had chronic severe conditions with extensive histories of attempted suicides and psychiatric hospitalizations, demonstrating that the granted euthanasia and PAS requests had involved extensive evaluations. However, 11% of cases had no independent psychiatric input, and 24% involved disagreement among the physicians.2 PAS proponents and opponents support the involvement and expertise of psychiatrists in all of this.

Psychiatrists have long contended that suicide attempts are often a “cry for help,” not an earnest act to end one’s life. Legalizing PAS tells suicidal individuals that society does not care whether they live or die – a truly un-Hippocratic stance. The stereotypes tossed around in the PAS debate, which could mean life or death, need to be unpacked with specific criteria attached, rather than preconceptions.
 

 

 

Autonomy of patients and implications of PAS

In the PAS debate, there are serious life concerns exhibited by terminally ill/psychiatrically ill patients over losing their autonomy and becoming a burden to their families and caregivers. Stereotypes must be deconstructed, yes, but such patients generally have been considered to be rendered, by the sum effect of their illnesses, mentally incapable of making the decision to end their lives. Addressing this order of patient life concerns generally has been the realm of social workers, psychologists, and, in the most desirable cases, psychiatrists. Therefore, even in keeping with established practice, some form of competent psychiatric evaluation should be required before considering PAS as a viable option.

The call for this requirement is backed up by a study, which reported that 47% of patients who had considered or committed suicide previously were diagnosed with psychiatric disorders, and 15% had undiagnosed psychiatric disorders.3 Also, inventories of thwarted suicide attempters reveal that most lack the conviction to end their lives, and this obverse phenomenon is backed by a study that revealed that 75% of 96 suicidal patients were found to be ambivalent in their intent to end their lives. Suicide attempters simply may be trying to communicate with people in their lives in order to test their love and care.4 This indicates that those who attempt suicide are predominantly psychiatrically ill and prone to distorted perceptions, impaired judgment, frustration, escapism, and manipulative guilt.

Suicide is abhorrent to most human beings’ sensibilities, because humanity has an innate will to live.5 It is wrong to offer patients life-ending options when they might rejuvenate or ease into death naturally. With the debilitated or elderly, PAS could violate their human rights. If the attitude that they are a burden to society persists, then a certain segment of society might be tempted to avoid their intergenerational obligations to elders, particularly those elders presenting with concurrent mental illnesses. PAS would additionally fuel that problem. This would represent a profound injustice and gross violation of human dignity, while also serving as a denial of basic human rights, particularly the right to life and care.6

Conclusion

The complex physical, psychological, and social challenges associated with PAS and the difficulty in enforcing its laws necessitate more adept alternatives. Instead of conditionally legalizing suicide, we should ease patient suffering with compassion and calibrated treatment.6,7

Terminally ill patients often suffer from depression, affecting their rationality. Adequate counseling, medical care, and psychological care should be the response to terminally ill patients considering suicide. If society accepts that ending a life is a reasonable response to human suffering that could otherwise be treated or reversed, then those with the most serious psychiatric conditions are destined to become more vulnerable. Therefore, physicians and psychiatrists should instead work harder to help patients recover, rather than participating in their quest for death.

Simplistic legal and regulatory oversight is insufficient, because the questions evoked by PAS are complicated by life, death, and ethics. Further research is needed to look into the mechanisms and morality of how psychiatrists and other physicians will make judgments and recommendations that are vital elements in developing regulatory oversight on PAS. Finally, future studies should look at which practices have been successful and which might be deemed unethical.
 

References

1. Clin Med (Lond). 2010 Aug;109(4):323-5.

2. JAMA Psychiatry. 2016;73(4):362-8.

3. “The Final Months: A Study of the Lives of 134 Persons Who Committed Suicide,” New York: Oxford University Press, 1981.

4. “Why We Shouldn’t Legalize Assisting Suicide, Part I.” Department of Medical Ethics, National Right to Life Committee.

5. “Working with Suicidal Individuals: A Guide to Providing Understanding, Assessment and Support,” Philadelphia: Jessica Kingsley Publishers, 2010.

6. “Always Care, Never Kill: How Physician-Assisted Suicide Endangers the Weak, Corrupts Medicine, Compromises the Family, and Violates Human Dignity and Equality,” Washington: The Heritage Foundation, 2015.

7. Ann Intern Med. 2012 Jan 3;156(1 Pt 2):73-104.

Dr. Ahmed is a 2nd-year resident in the psychiatry & behavioral sciences department at the Nassau University Medical Center, New York. Over the last 3 years, he has published and presented papers at national and international forums. His interests include public social psychiatry, health care policy, health disparities, mental health stigma, and undiagnosed and overdiagnosed psychiatric illnesses in children. Dr. Ahmed is a member of the American Psychiatric Association, the American Society of Clinical Psychopharmacology, and the American Association for Social Psychiatry.

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Lower Extremity Occlusive Disease and Alternative Graft Options

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Tue, 12/13/2016 - 10:27

Vascular surgeons spend much of their clinical time taking care of patients with lower extremity occlusive disease, so the “New Devices and Techniques for Treating Lower Extremity Occlusive Disease; Prosthetic Grafts and Heparin Bonding” session on Thursday afternoon will be particularly useful for the practicing surgeon, according to Dr. Russell Samson who will co-moderate the session along with Dr. Ali F. AbuRahma of West Virginia University.

Dr. Russell Samson
“Currently, the gold standard graft material for lower extremity occlusive disease is still considered to be autogenous saphenous vein. However, suitable saphenous vein may not always be available,” said Dr. Samson of Sarasota Vascular Specialists and Florida State University. “Accordingly, other graft options will sometimes be required.”

Two recent advances with respect to such alternative graft options, which will be addressed during the session, are heparin-bonded ePTFE and spiral laminar flow grafts.

“Whether these two modalities improve patency rates compared to standard ePTFE grafts remains controversial,” Dr. Samson said.

Heparin-bonded ePTFE will be the topic of a debate presented by Dr. Richard Neville of George Washington University Hospital, and Dr. Jonathan Beard of Sheffield Vascular Institute, in the United Kingdom. These two experts will conduct a debate. Dr. Neville will discuss long-term patency data suggesting that heparin bonding is valuable in PTFE Fempop Bypass Grafts, and Dr. Beard will argue that it does not improve results.

Additionally, Dr. Yann Gouëffic of the University of Nantes, France, will address the cost-efficiency of heparin bonding.

“In an age where surgeons are becoming more cost conscious, new graft configurations, which are often more costly, need to offer significant improvement in long-term outcomes,” Dr. Samson said.

As for spiral laminar flow grafts, Dr. Hosam F. El Sayed of Ohio State University will provide insight into a specific format of PTFE that creates a spiral laminar flow that more accurately represents flow within the arterial system, Dr. Samson noted.

Dr. Ali F. AbuRahma
“However, no matter what graft material is ultimately chosen, highly calcified arteries pose a technical challenge,” he said.

Therefore, Dr. Enrico Ascher of Lutheran Medical Center, who is highly regarded for his experience in performing distal tibial bypass, will provide insight into how to deal with “pipe-like” calcified arteries that some surgeons may consider inoperable, Dr. Samson added.

Further, since many surgeons may prefer an endovascular procedure as a first-line alternative to bypass, this session will also include a talk by Dr. Hiroyoshi Yokoi of Fukuoka Sanno Hospital in Japan on advanced guidewire techniques to open these distal vessels, and another by noted inventor, Dr. Timothy A.M. Chuter of the University of California, San Francisco, who will discuss advantages and early clinical experience with a novel balloon that does not straighten when it inflates.

Another talk during the session, which will be given by Dr. Joseph L. Mills of Baylor College of Medicine, will focus on the impact of foot infections on leg bypass outcomes in CLI patients and what can be done to offset that impact.

“Dr. Mills will remind us that no matter what treatment we choose, the final result can be spoiled by an infection, so managing foot infections in patients requiring surgical bypass becomes a preeminent consideration,” Dr. Samson said.

“The practicing vascular surgeon deals with challenging infrainguinal atherosclerotic conditions on a daily basis. Therefore, information gained from attending this program should enhance their ability to offer long-lasting therapies,” he added.


Session 59
“New Devices and Techniques for Treating Lower Extremity Occlusive Disease; Prosthetic Grafts and Heparin Bonding”
Thursday, 1:00 p.m. – 1:54 p.m.
Grand Ballroom West, 3rd Floor


 

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Vascular surgeons spend much of their clinical time taking care of patients with lower extremity occlusive disease, so the “New Devices and Techniques for Treating Lower Extremity Occlusive Disease; Prosthetic Grafts and Heparin Bonding” session on Thursday afternoon will be particularly useful for the practicing surgeon, according to Dr. Russell Samson who will co-moderate the session along with Dr. Ali F. AbuRahma of West Virginia University.

Dr. Russell Samson
“Currently, the gold standard graft material for lower extremity occlusive disease is still considered to be autogenous saphenous vein. However, suitable saphenous vein may not always be available,” said Dr. Samson of Sarasota Vascular Specialists and Florida State University. “Accordingly, other graft options will sometimes be required.”

Two recent advances with respect to such alternative graft options, which will be addressed during the session, are heparin-bonded ePTFE and spiral laminar flow grafts.

“Whether these two modalities improve patency rates compared to standard ePTFE grafts remains controversial,” Dr. Samson said.

Heparin-bonded ePTFE will be the topic of a debate presented by Dr. Richard Neville of George Washington University Hospital, and Dr. Jonathan Beard of Sheffield Vascular Institute, in the United Kingdom. These two experts will conduct a debate. Dr. Neville will discuss long-term patency data suggesting that heparin bonding is valuable in PTFE Fempop Bypass Grafts, and Dr. Beard will argue that it does not improve results.

Additionally, Dr. Yann Gouëffic of the University of Nantes, France, will address the cost-efficiency of heparin bonding.

“In an age where surgeons are becoming more cost conscious, new graft configurations, which are often more costly, need to offer significant improvement in long-term outcomes,” Dr. Samson said.

As for spiral laminar flow grafts, Dr. Hosam F. El Sayed of Ohio State University will provide insight into a specific format of PTFE that creates a spiral laminar flow that more accurately represents flow within the arterial system, Dr. Samson noted.

Dr. Ali F. AbuRahma
“However, no matter what graft material is ultimately chosen, highly calcified arteries pose a technical challenge,” he said.

Therefore, Dr. Enrico Ascher of Lutheran Medical Center, who is highly regarded for his experience in performing distal tibial bypass, will provide insight into how to deal with “pipe-like” calcified arteries that some surgeons may consider inoperable, Dr. Samson added.

Further, since many surgeons may prefer an endovascular procedure as a first-line alternative to bypass, this session will also include a talk by Dr. Hiroyoshi Yokoi of Fukuoka Sanno Hospital in Japan on advanced guidewire techniques to open these distal vessels, and another by noted inventor, Dr. Timothy A.M. Chuter of the University of California, San Francisco, who will discuss advantages and early clinical experience with a novel balloon that does not straighten when it inflates.

Another talk during the session, which will be given by Dr. Joseph L. Mills of Baylor College of Medicine, will focus on the impact of foot infections on leg bypass outcomes in CLI patients and what can be done to offset that impact.

“Dr. Mills will remind us that no matter what treatment we choose, the final result can be spoiled by an infection, so managing foot infections in patients requiring surgical bypass becomes a preeminent consideration,” Dr. Samson said.

“The practicing vascular surgeon deals with challenging infrainguinal atherosclerotic conditions on a daily basis. Therefore, information gained from attending this program should enhance their ability to offer long-lasting therapies,” he added.


Session 59
“New Devices and Techniques for Treating Lower Extremity Occlusive Disease; Prosthetic Grafts and Heparin Bonding”
Thursday, 1:00 p.m. – 1:54 p.m.
Grand Ballroom West, 3rd Floor


 

Vascular surgeons spend much of their clinical time taking care of patients with lower extremity occlusive disease, so the “New Devices and Techniques for Treating Lower Extremity Occlusive Disease; Prosthetic Grafts and Heparin Bonding” session on Thursday afternoon will be particularly useful for the practicing surgeon, according to Dr. Russell Samson who will co-moderate the session along with Dr. Ali F. AbuRahma of West Virginia University.

Dr. Russell Samson
“Currently, the gold standard graft material for lower extremity occlusive disease is still considered to be autogenous saphenous vein. However, suitable saphenous vein may not always be available,” said Dr. Samson of Sarasota Vascular Specialists and Florida State University. “Accordingly, other graft options will sometimes be required.”

Two recent advances with respect to such alternative graft options, which will be addressed during the session, are heparin-bonded ePTFE and spiral laminar flow grafts.

“Whether these two modalities improve patency rates compared to standard ePTFE grafts remains controversial,” Dr. Samson said.

Heparin-bonded ePTFE will be the topic of a debate presented by Dr. Richard Neville of George Washington University Hospital, and Dr. Jonathan Beard of Sheffield Vascular Institute, in the United Kingdom. These two experts will conduct a debate. Dr. Neville will discuss long-term patency data suggesting that heparin bonding is valuable in PTFE Fempop Bypass Grafts, and Dr. Beard will argue that it does not improve results.

Additionally, Dr. Yann Gouëffic of the University of Nantes, France, will address the cost-efficiency of heparin bonding.

“In an age where surgeons are becoming more cost conscious, new graft configurations, which are often more costly, need to offer significant improvement in long-term outcomes,” Dr. Samson said.

As for spiral laminar flow grafts, Dr. Hosam F. El Sayed of Ohio State University will provide insight into a specific format of PTFE that creates a spiral laminar flow that more accurately represents flow within the arterial system, Dr. Samson noted.

Dr. Ali F. AbuRahma
“However, no matter what graft material is ultimately chosen, highly calcified arteries pose a technical challenge,” he said.

Therefore, Dr. Enrico Ascher of Lutheran Medical Center, who is highly regarded for his experience in performing distal tibial bypass, will provide insight into how to deal with “pipe-like” calcified arteries that some surgeons may consider inoperable, Dr. Samson added.

Further, since many surgeons may prefer an endovascular procedure as a first-line alternative to bypass, this session will also include a talk by Dr. Hiroyoshi Yokoi of Fukuoka Sanno Hospital in Japan on advanced guidewire techniques to open these distal vessels, and another by noted inventor, Dr. Timothy A.M. Chuter of the University of California, San Francisco, who will discuss advantages and early clinical experience with a novel balloon that does not straighten when it inflates.

Another talk during the session, which will be given by Dr. Joseph L. Mills of Baylor College of Medicine, will focus on the impact of foot infections on leg bypass outcomes in CLI patients and what can be done to offset that impact.

“Dr. Mills will remind us that no matter what treatment we choose, the final result can be spoiled by an infection, so managing foot infections in patients requiring surgical bypass becomes a preeminent consideration,” Dr. Samson said.

“The practicing vascular surgeon deals with challenging infrainguinal atherosclerotic conditions on a daily basis. Therefore, information gained from attending this program should enhance their ability to offer long-lasting therapies,” he added.


Session 59
“New Devices and Techniques for Treating Lower Extremity Occlusive Disease; Prosthetic Grafts and Heparin Bonding”
Thursday, 1:00 p.m. – 1:54 p.m.
Grand Ballroom West, 3rd Floor


 

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Highlight on Innovative Devices for Embolectomy, Clot Retrieval, and Embolization

Article Type
Changed
Tue, 12/13/2016 - 10:27

With the development of ever-more-sophisticated endovascular intervention systems, limb ischemia need no longer be an automatic sentence of lifelong pain or amputation.

But the burgeoning supply of these specialized devices brings its own challenge to the area of endovascular intervention. Which device is best for which patient? And which have strong data to back up their claims of effectiveness? Thursday’s session, “New Devices for Embolectomy, Clot Removal, and Embolization,” will offer some guidance.

Dr. Thomas McNamara
During the session, eight presentations will examine these new systems and their supporting studies. The session will also feature expert guidance for getting the most of the technology and maximizing patient outcomes, said session moderator Dr. Thomas McNamara of the Unviersity of California, Los Angeles.

“The presentations represent significant further advances in methods and technology that can treat patients with severe, limb-threatening, and life-altering vascular diseases,” said Dr. McNamara. “Also, comparisons are made between competing new technologies. This will be very helpful in deciding which method and/or technology to use. And it will, I think, be very helpful in deciding whether to use interventional or open surgical treatments.“These presentations will not only guide the vascular specialist, but help to substantiate that the interventional techniques continue to be more and more effective. This information could, and should, be shared with primary care physicians.”

This point can’t be underestimated, Dr. McNamara noted. Primary care physicians are on the front line of venous disorders, and should know that there are good treatment options for many patients – treatments than can save limbs and vastly improve pain and function.

“An increasing percentage of patients should be referred for consultation and possible treatments for arterial and venous disease. This will result in decreased morbidity and improved quality of life for an increasing number of patients.”

Surgeons should expect to see more and more such patients as the U.S. population continues to age – and effective treatment not only benefits each individual, but society as a whole.

“The disease significantly decreases the quality of life, and reduces the independence of our aging population. This significantly increases the costs, and increases the burden to society and families of the growing percentage of our population in their ‘Golden Years.’”

The session opens with a lecture by Dr. Ali Amin, a vascular surgeon from West Reading, Pa. He will discuss the role of mechanical thrombectomy and thrombolysis in acute limb ischemia, and when open surgery rather than endovascular intervention is indicated

Dr. Jos C. van den Berg of the University of Bern, Switzerland, will then tackle how to utilize suction techniques and devices to deal with the embolic complications of peripheral vascular interventions.

Rotarex and Aspirex, two mechanical debulking devices created by Straub Med, will be the topic of a presentation by Dr. Michael K.W. Lichtenberg chief of the Angiology Clinic and Venous Center at Klinikum Arnsberg, Germany.

There will be three presentations on thrombectomy with the Indigo System by Penumbra. Indigo provides mechanical clot engagement and vacuum extraction and can be used in both arteries and veins.

Dr. James F. Benenati, of Florida International University Herbert Wertheim College of Medicine, and Dr. Richard R. Saxon of San Diego Imaging, will discuss the PRISM Registry data. The registry recently reported that mechanical aspiration with the Indigo device is a safe and effective option for the treatment of peripheral or visceral arterial occlusions either as a frontline therapy or in patients who failed thrombolysis.

Dr. Frank R. Arko of Carolinas Healthcare System, will share his thoughts on why the Indigo system is an excellent choice for clot removal, and how it decreases the need for lytic therapy.

Dr. George L. Adams, MD, Director of Cardiovascular and Peripheral Vascular Research will make the case for why the Indigo system could be a “game-changer” in the treatment of acute limb ischemia and visceral artery thomboses and emboli.

Dr. Andrej Schmidt of the University Clinic of Leipzig, Germany, will discuss the advantages and limitations of several other Penumbra products, including the Ruby Coil for peripheral embolization, and the Penumbra Occlusion Device (POD). He will also touch on the Lantern microcatheter, Penumbra’s newest product, launched in April. The low-profile, high-flow microcatheter can pass through the distal vasculature, but can also be used for high-flow contrast injections.

Finally, Dr. Aaron Fischman of Mount Sinai Medical Center, will speak on the challenge of endovascular rescue procedures for acute visceral ischemia from thromboembolism.
 

Session 62
“New Devices for Embolectomy, Clot Removal, and Embolization”
4:32 p.m. – 5:30 p.m.
Grand Ballroom West, 3rd Floor

 

Publications
Topics
Sections

With the development of ever-more-sophisticated endovascular intervention systems, limb ischemia need no longer be an automatic sentence of lifelong pain or amputation.

But the burgeoning supply of these specialized devices brings its own challenge to the area of endovascular intervention. Which device is best for which patient? And which have strong data to back up their claims of effectiveness? Thursday’s session, “New Devices for Embolectomy, Clot Removal, and Embolization,” will offer some guidance.

Dr. Thomas McNamara
During the session, eight presentations will examine these new systems and their supporting studies. The session will also feature expert guidance for getting the most of the technology and maximizing patient outcomes, said session moderator Dr. Thomas McNamara of the Unviersity of California, Los Angeles.

“The presentations represent significant further advances in methods and technology that can treat patients with severe, limb-threatening, and life-altering vascular diseases,” said Dr. McNamara. “Also, comparisons are made between competing new technologies. This will be very helpful in deciding which method and/or technology to use. And it will, I think, be very helpful in deciding whether to use interventional or open surgical treatments.“These presentations will not only guide the vascular specialist, but help to substantiate that the interventional techniques continue to be more and more effective. This information could, and should, be shared with primary care physicians.”

This point can’t be underestimated, Dr. McNamara noted. Primary care physicians are on the front line of venous disorders, and should know that there are good treatment options for many patients – treatments than can save limbs and vastly improve pain and function.

“An increasing percentage of patients should be referred for consultation and possible treatments for arterial and venous disease. This will result in decreased morbidity and improved quality of life for an increasing number of patients.”

Surgeons should expect to see more and more such patients as the U.S. population continues to age – and effective treatment not only benefits each individual, but society as a whole.

“The disease significantly decreases the quality of life, and reduces the independence of our aging population. This significantly increases the costs, and increases the burden to society and families of the growing percentage of our population in their ‘Golden Years.’”

The session opens with a lecture by Dr. Ali Amin, a vascular surgeon from West Reading, Pa. He will discuss the role of mechanical thrombectomy and thrombolysis in acute limb ischemia, and when open surgery rather than endovascular intervention is indicated

Dr. Jos C. van den Berg of the University of Bern, Switzerland, will then tackle how to utilize suction techniques and devices to deal with the embolic complications of peripheral vascular interventions.

Rotarex and Aspirex, two mechanical debulking devices created by Straub Med, will be the topic of a presentation by Dr. Michael K.W. Lichtenberg chief of the Angiology Clinic and Venous Center at Klinikum Arnsberg, Germany.

There will be three presentations on thrombectomy with the Indigo System by Penumbra. Indigo provides mechanical clot engagement and vacuum extraction and can be used in both arteries and veins.

Dr. James F. Benenati, of Florida International University Herbert Wertheim College of Medicine, and Dr. Richard R. Saxon of San Diego Imaging, will discuss the PRISM Registry data. The registry recently reported that mechanical aspiration with the Indigo device is a safe and effective option for the treatment of peripheral or visceral arterial occlusions either as a frontline therapy or in patients who failed thrombolysis.

Dr. Frank R. Arko of Carolinas Healthcare System, will share his thoughts on why the Indigo system is an excellent choice for clot removal, and how it decreases the need for lytic therapy.

Dr. George L. Adams, MD, Director of Cardiovascular and Peripheral Vascular Research will make the case for why the Indigo system could be a “game-changer” in the treatment of acute limb ischemia and visceral artery thomboses and emboli.

Dr. Andrej Schmidt of the University Clinic of Leipzig, Germany, will discuss the advantages and limitations of several other Penumbra products, including the Ruby Coil for peripheral embolization, and the Penumbra Occlusion Device (POD). He will also touch on the Lantern microcatheter, Penumbra’s newest product, launched in April. The low-profile, high-flow microcatheter can pass through the distal vasculature, but can also be used for high-flow contrast injections.

Finally, Dr. Aaron Fischman of Mount Sinai Medical Center, will speak on the challenge of endovascular rescue procedures for acute visceral ischemia from thromboembolism.
 

Session 62
“New Devices for Embolectomy, Clot Removal, and Embolization”
4:32 p.m. – 5:30 p.m.
Grand Ballroom West, 3rd Floor

 

With the development of ever-more-sophisticated endovascular intervention systems, limb ischemia need no longer be an automatic sentence of lifelong pain or amputation.

But the burgeoning supply of these specialized devices brings its own challenge to the area of endovascular intervention. Which device is best for which patient? And which have strong data to back up their claims of effectiveness? Thursday’s session, “New Devices for Embolectomy, Clot Removal, and Embolization,” will offer some guidance.

Dr. Thomas McNamara
During the session, eight presentations will examine these new systems and their supporting studies. The session will also feature expert guidance for getting the most of the technology and maximizing patient outcomes, said session moderator Dr. Thomas McNamara of the Unviersity of California, Los Angeles.

“The presentations represent significant further advances in methods and technology that can treat patients with severe, limb-threatening, and life-altering vascular diseases,” said Dr. McNamara. “Also, comparisons are made between competing new technologies. This will be very helpful in deciding which method and/or technology to use. And it will, I think, be very helpful in deciding whether to use interventional or open surgical treatments.“These presentations will not only guide the vascular specialist, but help to substantiate that the interventional techniques continue to be more and more effective. This information could, and should, be shared with primary care physicians.”

This point can’t be underestimated, Dr. McNamara noted. Primary care physicians are on the front line of venous disorders, and should know that there are good treatment options for many patients – treatments than can save limbs and vastly improve pain and function.

“An increasing percentage of patients should be referred for consultation and possible treatments for arterial and venous disease. This will result in decreased morbidity and improved quality of life for an increasing number of patients.”

Surgeons should expect to see more and more such patients as the U.S. population continues to age – and effective treatment not only benefits each individual, but society as a whole.

“The disease significantly decreases the quality of life, and reduces the independence of our aging population. This significantly increases the costs, and increases the burden to society and families of the growing percentage of our population in their ‘Golden Years.’”

The session opens with a lecture by Dr. Ali Amin, a vascular surgeon from West Reading, Pa. He will discuss the role of mechanical thrombectomy and thrombolysis in acute limb ischemia, and when open surgery rather than endovascular intervention is indicated

Dr. Jos C. van den Berg of the University of Bern, Switzerland, will then tackle how to utilize suction techniques and devices to deal with the embolic complications of peripheral vascular interventions.

Rotarex and Aspirex, two mechanical debulking devices created by Straub Med, will be the topic of a presentation by Dr. Michael K.W. Lichtenberg chief of the Angiology Clinic and Venous Center at Klinikum Arnsberg, Germany.

There will be three presentations on thrombectomy with the Indigo System by Penumbra. Indigo provides mechanical clot engagement and vacuum extraction and can be used in both arteries and veins.

Dr. James F. Benenati, of Florida International University Herbert Wertheim College of Medicine, and Dr. Richard R. Saxon of San Diego Imaging, will discuss the PRISM Registry data. The registry recently reported that mechanical aspiration with the Indigo device is a safe and effective option for the treatment of peripheral or visceral arterial occlusions either as a frontline therapy or in patients who failed thrombolysis.

Dr. Frank R. Arko of Carolinas Healthcare System, will share his thoughts on why the Indigo system is an excellent choice for clot removal, and how it decreases the need for lytic therapy.

Dr. George L. Adams, MD, Director of Cardiovascular and Peripheral Vascular Research will make the case for why the Indigo system could be a “game-changer” in the treatment of acute limb ischemia and visceral artery thomboses and emboli.

Dr. Andrej Schmidt of the University Clinic of Leipzig, Germany, will discuss the advantages and limitations of several other Penumbra products, including the Ruby Coil for peripheral embolization, and the Penumbra Occlusion Device (POD). He will also touch on the Lantern microcatheter, Penumbra’s newest product, launched in April. The low-profile, high-flow microcatheter can pass through the distal vasculature, but can also be used for high-flow contrast injections.

Finally, Dr. Aaron Fischman of Mount Sinai Medical Center, will speak on the challenge of endovascular rescue procedures for acute visceral ischemia from thromboembolism.
 

Session 62
“New Devices for Embolectomy, Clot Removal, and Embolization”
4:32 p.m. – 5:30 p.m.
Grand Ballroom West, 3rd Floor

 

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Bioactive lipid shows promise in atopic dermatitis

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Fri, 01/18/2019 - 16:20

– A novel oral agent known as DS107 showed promise as a safe and effective treatment for moderate-to-severe atopic dermatitis in a phase IIa proof-of-concept study, Diamant Thaçi, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

“Clear efficacy signals in the reduction of clinical symptoms of atopic dermatitis were detected within 2 weeks of treatment, with the maximum improvement in the endpoints observed between weeks 4 and 8,” said Dr. Thaçi, professor of dermatology and head of the Comprehensive Center for Inflammation Medicine at University Hospital Schleswig-Holstein, in Lübeck, Germany.

Dr. Diamant Thaçi
The active compound in DS107 is dihomo gamma linolenic acid (DGLA), which is present in healthy skin but depleted in patients with atopic dermatitis (AD).

Dr. Thaçi presented the results of an 8-week, double-blind, randomized, placebo-controlled, multicenter phase IIa study that included 102 patients with moderate-to-severe AD. Participants averaged a baseline Investigator Global Assessment (IGA) score of 3.5 on the 0-5 scale. They were randomized to 2 g of oral DS107 once daily or an equal quantity of mineral oil as a placebo control.

Based upon the encouraging findings, a 300-patient phase IIb study will get underway soon. It will examine the effects of 1 g of DS107 per day as well as 2 g in the hope that the lower dose will cut down on the high rate of minor GI side effects seen at 2 g/day while preserving the efficacy of the higher dose.

The primary efficacy endpoint in the phase IIa study was at least a 2-point drop from baseline in IGA plus an end-of-treatment IGA of 0 or 1, meaning clear or almost clear. In the intent-to-treat analysis, this was achieved in 21.6% of the group assigned to DS107, compared with 11.8% of controls. In the 71 participants who actually completed 8 weeks of treatment – 35 in the DS107 arm, 36 controls – the composite efficacy endpoint was achieved in 31.4% of those on active treatment and 16.7% on mineral oil.

Significant separation between the active treatment and control arms in terms of itch visual analog scores was seen by week 4. This was a particularly encouraging finding, since patients report pruritis to be the most troublesome symptom of AD, Dr. Thaçi noted.

Significantly greater improvement in quality of life as measured by the Patient-Oriented Eczema Measure (POEM) was also seen by week 4 in the DS107 group as compared with controls.

No severe adverse events occurred in the study. However, more than one-quarter of subjects interrupted or discontinued participation because of mild nausea, loose stools, and/or abdominal pain. These issues were equally common in the DS107 and mineral oil groups, and Dr. Thaçi and his coinvestigators suspect that for many patients it was simply a matter of too much oil in the stomach. The GI symptoms resolved quickly without intervention after a brief halt of therapy, but some patients never returned to participation.

“This problem can be solved in the future with a different dosing design or even a different method of delivering the DGLA,” the dermatologist added.

Asked about the significant placebo response seen in the study, Dr. Thaçi shrugged it off as “quite understandable.”

“Placebo is not always a placebo. There is the feeling of fullness in the stomach, there is some emollient effect, the continuous contact with the physician. You see this in all the clinical trials in atopic dermatitis: in the beginning, the first 2-3 weeks, you have some influence of placebo,” he said.

The placebo effect was greatly diminished in patients with more severe AD. In the subset with a baseline IGA of 4 or 5, none of the control subjects achieved the primary efficacy endpoint, while more than 20% on DS107 did, Dr. Thaçi noted.

The mechanism of benefit of DGLA is not fully understood as yet. Animal studies point to an antibacterial effect, and DGLA also reduces levels of inflammatory cytokines. Eosinophilia was reduced to a much greater extent in the DS107 group than controls.

Dr. Thaçi reported serving as a consultant to DS Pharma, the privately held biopharmaceutical company that is developing oral DS107, as well as to numerous other pharmaceutical companies.

[email protected]

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– A novel oral agent known as DS107 showed promise as a safe and effective treatment for moderate-to-severe atopic dermatitis in a phase IIa proof-of-concept study, Diamant Thaçi, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

“Clear efficacy signals in the reduction of clinical symptoms of atopic dermatitis were detected within 2 weeks of treatment, with the maximum improvement in the endpoints observed between weeks 4 and 8,” said Dr. Thaçi, professor of dermatology and head of the Comprehensive Center for Inflammation Medicine at University Hospital Schleswig-Holstein, in Lübeck, Germany.

Dr. Diamant Thaçi
The active compound in DS107 is dihomo gamma linolenic acid (DGLA), which is present in healthy skin but depleted in patients with atopic dermatitis (AD).

Dr. Thaçi presented the results of an 8-week, double-blind, randomized, placebo-controlled, multicenter phase IIa study that included 102 patients with moderate-to-severe AD. Participants averaged a baseline Investigator Global Assessment (IGA) score of 3.5 on the 0-5 scale. They were randomized to 2 g of oral DS107 once daily or an equal quantity of mineral oil as a placebo control.

Based upon the encouraging findings, a 300-patient phase IIb study will get underway soon. It will examine the effects of 1 g of DS107 per day as well as 2 g in the hope that the lower dose will cut down on the high rate of minor GI side effects seen at 2 g/day while preserving the efficacy of the higher dose.

The primary efficacy endpoint in the phase IIa study was at least a 2-point drop from baseline in IGA plus an end-of-treatment IGA of 0 or 1, meaning clear or almost clear. In the intent-to-treat analysis, this was achieved in 21.6% of the group assigned to DS107, compared with 11.8% of controls. In the 71 participants who actually completed 8 weeks of treatment – 35 in the DS107 arm, 36 controls – the composite efficacy endpoint was achieved in 31.4% of those on active treatment and 16.7% on mineral oil.

Significant separation between the active treatment and control arms in terms of itch visual analog scores was seen by week 4. This was a particularly encouraging finding, since patients report pruritis to be the most troublesome symptom of AD, Dr. Thaçi noted.

Significantly greater improvement in quality of life as measured by the Patient-Oriented Eczema Measure (POEM) was also seen by week 4 in the DS107 group as compared with controls.

No severe adverse events occurred in the study. However, more than one-quarter of subjects interrupted or discontinued participation because of mild nausea, loose stools, and/or abdominal pain. These issues were equally common in the DS107 and mineral oil groups, and Dr. Thaçi and his coinvestigators suspect that for many patients it was simply a matter of too much oil in the stomach. The GI symptoms resolved quickly without intervention after a brief halt of therapy, but some patients never returned to participation.

“This problem can be solved in the future with a different dosing design or even a different method of delivering the DGLA,” the dermatologist added.

Asked about the significant placebo response seen in the study, Dr. Thaçi shrugged it off as “quite understandable.”

“Placebo is not always a placebo. There is the feeling of fullness in the stomach, there is some emollient effect, the continuous contact with the physician. You see this in all the clinical trials in atopic dermatitis: in the beginning, the first 2-3 weeks, you have some influence of placebo,” he said.

The placebo effect was greatly diminished in patients with more severe AD. In the subset with a baseline IGA of 4 or 5, none of the control subjects achieved the primary efficacy endpoint, while more than 20% on DS107 did, Dr. Thaçi noted.

The mechanism of benefit of DGLA is not fully understood as yet. Animal studies point to an antibacterial effect, and DGLA also reduces levels of inflammatory cytokines. Eosinophilia was reduced to a much greater extent in the DS107 group than controls.

Dr. Thaçi reported serving as a consultant to DS Pharma, the privately held biopharmaceutical company that is developing oral DS107, as well as to numerous other pharmaceutical companies.

[email protected]

– A novel oral agent known as DS107 showed promise as a safe and effective treatment for moderate-to-severe atopic dermatitis in a phase IIa proof-of-concept study, Diamant Thaçi, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

“Clear efficacy signals in the reduction of clinical symptoms of atopic dermatitis were detected within 2 weeks of treatment, with the maximum improvement in the endpoints observed between weeks 4 and 8,” said Dr. Thaçi, professor of dermatology and head of the Comprehensive Center for Inflammation Medicine at University Hospital Schleswig-Holstein, in Lübeck, Germany.

Dr. Diamant Thaçi
The active compound in DS107 is dihomo gamma linolenic acid (DGLA), which is present in healthy skin but depleted in patients with atopic dermatitis (AD).

Dr. Thaçi presented the results of an 8-week, double-blind, randomized, placebo-controlled, multicenter phase IIa study that included 102 patients with moderate-to-severe AD. Participants averaged a baseline Investigator Global Assessment (IGA) score of 3.5 on the 0-5 scale. They were randomized to 2 g of oral DS107 once daily or an equal quantity of mineral oil as a placebo control.

Based upon the encouraging findings, a 300-patient phase IIb study will get underway soon. It will examine the effects of 1 g of DS107 per day as well as 2 g in the hope that the lower dose will cut down on the high rate of minor GI side effects seen at 2 g/day while preserving the efficacy of the higher dose.

The primary efficacy endpoint in the phase IIa study was at least a 2-point drop from baseline in IGA plus an end-of-treatment IGA of 0 or 1, meaning clear or almost clear. In the intent-to-treat analysis, this was achieved in 21.6% of the group assigned to DS107, compared with 11.8% of controls. In the 71 participants who actually completed 8 weeks of treatment – 35 in the DS107 arm, 36 controls – the composite efficacy endpoint was achieved in 31.4% of those on active treatment and 16.7% on mineral oil.

Significant separation between the active treatment and control arms in terms of itch visual analog scores was seen by week 4. This was a particularly encouraging finding, since patients report pruritis to be the most troublesome symptom of AD, Dr. Thaçi noted.

Significantly greater improvement in quality of life as measured by the Patient-Oriented Eczema Measure (POEM) was also seen by week 4 in the DS107 group as compared with controls.

No severe adverse events occurred in the study. However, more than one-quarter of subjects interrupted or discontinued participation because of mild nausea, loose stools, and/or abdominal pain. These issues were equally common in the DS107 and mineral oil groups, and Dr. Thaçi and his coinvestigators suspect that for many patients it was simply a matter of too much oil in the stomach. The GI symptoms resolved quickly without intervention after a brief halt of therapy, but some patients never returned to participation.

“This problem can be solved in the future with a different dosing design or even a different method of delivering the DGLA,” the dermatologist added.

Asked about the significant placebo response seen in the study, Dr. Thaçi shrugged it off as “quite understandable.”

“Placebo is not always a placebo. There is the feeling of fullness in the stomach, there is some emollient effect, the continuous contact with the physician. You see this in all the clinical trials in atopic dermatitis: in the beginning, the first 2-3 weeks, you have some influence of placebo,” he said.

The placebo effect was greatly diminished in patients with more severe AD. In the subset with a baseline IGA of 4 or 5, none of the control subjects achieved the primary efficacy endpoint, while more than 20% on DS107 did, Dr. Thaçi noted.

The mechanism of benefit of DGLA is not fully understood as yet. Animal studies point to an antibacterial effect, and DGLA also reduces levels of inflammatory cytokines. Eosinophilia was reduced to a much greater extent in the DS107 group than controls.

Dr. Thaçi reported serving as a consultant to DS Pharma, the privately held biopharmaceutical company that is developing oral DS107, as well as to numerous other pharmaceutical companies.

[email protected]

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Key clinical point: The bioactive lipid known as DGLA showed promise as a novel oral therapy for moderate-to-severe atopic dermatitis in a phase IIa study.

Major finding: Once-daily oral DS107, which contains a bioactive lipid, achieved significant improvement in moderate-to-severe atopic dermatitis in 31.4% of patients, compared with 16.7% on placebo.

Data source: This phase IIa, double-blind, randomized, placebo-controlled, multicenter 8-week trial included 102 adults with moderate-to-severe atopic dermatitis.

Disclosures: The study presenter reported serving as a consultant to DS Pharma, the privately held biopharmaceutical company that is developing oral DS107, as well as to numerous other pharmaceutical companies.

Study of Bioengineered Vessels for Dialysis Vascular Access Promising

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Tue, 12/13/2016 - 10:27

The idea of using bioengineered human acellular vessels for dialysis vascular access used to be a pie-in-the-sky notion, but research presented today will demonstrate just how close they are to becoming a realistic option.

Dr. Jeffrey H. Lawson will present results from two Phase II single-arm trials of bioengineered human acellular vessels for dialysis access in 60 patients with end-stage renal disease conducted in six hospitals: three in the United States and three in Poland. His presentation is entitled “Tissue Engineered Blood Vessels for Arterial Bypass and Dialysis Access: Midterm Results n Patients.” To date, the early clinical experience with these vessels “suggests that they are safe to implant as a dialysis access vessel and lower leg bypass graft,” said Dr. Lawson, chief medical officer at Humacyte and professor of surgery and pathology in the department of surgery at Duke University, Durham, N.C. “They enjoy enduring patency, tolerate needed interventions, appear durable and have a low risk of infection.”

Dr. Jeffrey Lawson
Currently, expanded polytetrafluoroethylene (ePTFE) grafts are used in patients receiving hemodialysis who are not candidates for autologous fistula creation or whose fistula has failed. “However, infection, intimal hyperplasia, and thrombosis of implanted grafts often lead to failure and abandonment, and contribute to the high cost of renal replacement therapy,” Dr. Lawson and his associates wrote in a published article describing the two studies (Lancet 2016;387:2026-34). “Indeed, 90% of patients with graft thrombosis have intimal hyperplasia that contributes to stenosis, and infection is reported in up to 17% of synthetic arteriovenous grafts.” For the trials, which are the first of their kind, researchers implanted a novel bioengineered human acellular vessel developed by Humacyte into the arms of patients for hemodialysis access. Primary endpoints were safety (defined as freedom from immune response or infection, aneurysm, or mechanical failure, and incidence of adverse events), and efficacy as assessed by primary, primary assisted, and secondary patencies at 6 months. All patients were followed up a mean of 16 months, or had a censoring event.

The researchers observed that during 82 patient-years of follow-up, only one vessel became infected. The vessels had no dilatation and rarely had postcannulation bleeding. At 6 months, 63% of patients had primary patency, 73% had primary assisted patency, and 97% had secondary patency, with most loss of primary patency because of thrombosis. At 1 year, 28% had primary patency, 38% had primary assisted patency, and 89% had secondary patency. “Following implantation into patients, the human acellular vessel (HAV) appears to completely repopulate with the host’s (recipient’s) own vascular tissue,” Dr. Lawson said. “The vessel is filled with cells that look like vascular smooth muscle cells and the implanted vessel is lined with endothelial cells from the host, suggesting that the manufactured acellular vessel becomes repopulated with the hosts own cells making it part of their own body. I will also be discussing some unpublished work that we have done for lower leg arterial bypass work in 20 patients to date.”

Dr. Lawson acknowledged that the Phase II experience at a few clinical sites is a limitation of the current analysis. “These findings need to be confirmed and validated in a large Phase III clinical trial, which is now underway,” he said.

Session 60
“New Developments in Arterial Grafts; Stents and Stent-Grafts; Concepts and Techniques to Improve Their Use and Results”
Thursday, 1:54 p.m.– 3:24 p.m.
Grand Ballroom East, 3rd Floor

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The idea of using bioengineered human acellular vessels for dialysis vascular access used to be a pie-in-the-sky notion, but research presented today will demonstrate just how close they are to becoming a realistic option.

Dr. Jeffrey H. Lawson will present results from two Phase II single-arm trials of bioengineered human acellular vessels for dialysis access in 60 patients with end-stage renal disease conducted in six hospitals: three in the United States and three in Poland. His presentation is entitled “Tissue Engineered Blood Vessels for Arterial Bypass and Dialysis Access: Midterm Results n Patients.” To date, the early clinical experience with these vessels “suggests that they are safe to implant as a dialysis access vessel and lower leg bypass graft,” said Dr. Lawson, chief medical officer at Humacyte and professor of surgery and pathology in the department of surgery at Duke University, Durham, N.C. “They enjoy enduring patency, tolerate needed interventions, appear durable and have a low risk of infection.”

Dr. Jeffrey Lawson
Currently, expanded polytetrafluoroethylene (ePTFE) grafts are used in patients receiving hemodialysis who are not candidates for autologous fistula creation or whose fistula has failed. “However, infection, intimal hyperplasia, and thrombosis of implanted grafts often lead to failure and abandonment, and contribute to the high cost of renal replacement therapy,” Dr. Lawson and his associates wrote in a published article describing the two studies (Lancet 2016;387:2026-34). “Indeed, 90% of patients with graft thrombosis have intimal hyperplasia that contributes to stenosis, and infection is reported in up to 17% of synthetic arteriovenous grafts.” For the trials, which are the first of their kind, researchers implanted a novel bioengineered human acellular vessel developed by Humacyte into the arms of patients for hemodialysis access. Primary endpoints were safety (defined as freedom from immune response or infection, aneurysm, or mechanical failure, and incidence of adverse events), and efficacy as assessed by primary, primary assisted, and secondary patencies at 6 months. All patients were followed up a mean of 16 months, or had a censoring event.

The researchers observed that during 82 patient-years of follow-up, only one vessel became infected. The vessels had no dilatation and rarely had postcannulation bleeding. At 6 months, 63% of patients had primary patency, 73% had primary assisted patency, and 97% had secondary patency, with most loss of primary patency because of thrombosis. At 1 year, 28% had primary patency, 38% had primary assisted patency, and 89% had secondary patency. “Following implantation into patients, the human acellular vessel (HAV) appears to completely repopulate with the host’s (recipient’s) own vascular tissue,” Dr. Lawson said. “The vessel is filled with cells that look like vascular smooth muscle cells and the implanted vessel is lined with endothelial cells from the host, suggesting that the manufactured acellular vessel becomes repopulated with the hosts own cells making it part of their own body. I will also be discussing some unpublished work that we have done for lower leg arterial bypass work in 20 patients to date.”

Dr. Lawson acknowledged that the Phase II experience at a few clinical sites is a limitation of the current analysis. “These findings need to be confirmed and validated in a large Phase III clinical trial, which is now underway,” he said.

Session 60
“New Developments in Arterial Grafts; Stents and Stent-Grafts; Concepts and Techniques to Improve Their Use and Results”
Thursday, 1:54 p.m.– 3:24 p.m.
Grand Ballroom East, 3rd Floor

The idea of using bioengineered human acellular vessels for dialysis vascular access used to be a pie-in-the-sky notion, but research presented today will demonstrate just how close they are to becoming a realistic option.

Dr. Jeffrey H. Lawson will present results from two Phase II single-arm trials of bioengineered human acellular vessels for dialysis access in 60 patients with end-stage renal disease conducted in six hospitals: three in the United States and three in Poland. His presentation is entitled “Tissue Engineered Blood Vessels for Arterial Bypass and Dialysis Access: Midterm Results n Patients.” To date, the early clinical experience with these vessels “suggests that they are safe to implant as a dialysis access vessel and lower leg bypass graft,” said Dr. Lawson, chief medical officer at Humacyte and professor of surgery and pathology in the department of surgery at Duke University, Durham, N.C. “They enjoy enduring patency, tolerate needed interventions, appear durable and have a low risk of infection.”

Dr. Jeffrey Lawson
Currently, expanded polytetrafluoroethylene (ePTFE) grafts are used in patients receiving hemodialysis who are not candidates for autologous fistula creation or whose fistula has failed. “However, infection, intimal hyperplasia, and thrombosis of implanted grafts often lead to failure and abandonment, and contribute to the high cost of renal replacement therapy,” Dr. Lawson and his associates wrote in a published article describing the two studies (Lancet 2016;387:2026-34). “Indeed, 90% of patients with graft thrombosis have intimal hyperplasia that contributes to stenosis, and infection is reported in up to 17% of synthetic arteriovenous grafts.” For the trials, which are the first of their kind, researchers implanted a novel bioengineered human acellular vessel developed by Humacyte into the arms of patients for hemodialysis access. Primary endpoints were safety (defined as freedom from immune response or infection, aneurysm, or mechanical failure, and incidence of adverse events), and efficacy as assessed by primary, primary assisted, and secondary patencies at 6 months. All patients were followed up a mean of 16 months, or had a censoring event.

The researchers observed that during 82 patient-years of follow-up, only one vessel became infected. The vessels had no dilatation and rarely had postcannulation bleeding. At 6 months, 63% of patients had primary patency, 73% had primary assisted patency, and 97% had secondary patency, with most loss of primary patency because of thrombosis. At 1 year, 28% had primary patency, 38% had primary assisted patency, and 89% had secondary patency. “Following implantation into patients, the human acellular vessel (HAV) appears to completely repopulate with the host’s (recipient’s) own vascular tissue,” Dr. Lawson said. “The vessel is filled with cells that look like vascular smooth muscle cells and the implanted vessel is lined with endothelial cells from the host, suggesting that the manufactured acellular vessel becomes repopulated with the hosts own cells making it part of their own body. I will also be discussing some unpublished work that we have done for lower leg arterial bypass work in 20 patients to date.”

Dr. Lawson acknowledged that the Phase II experience at a few clinical sites is a limitation of the current analysis. “These findings need to be confirmed and validated in a large Phase III clinical trial, which is now underway,” he said.

Session 60
“New Developments in Arterial Grafts; Stents and Stent-Grafts; Concepts and Techniques to Improve Their Use and Results”
Thursday, 1:54 p.m.– 3:24 p.m.
Grand Ballroom East, 3rd Floor

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ASVAL Can Save Refluxing Saphenous Veins

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Tue, 12/13/2016 - 10:27

Ambulatory selective varicose vein ablation under local anesthesia (ASVAL) can abolish reflux while preserving the great saphenous vein, and benefits can last at least a decade, said Dr. Silvain Chastanet, who helped create the technique and will discuss it Thursday morning.

Historically, a refluxing great saphenous vein was treated by removing it. The ASVAL method preserves the vein by using microphlebotomy to instead remove the varicose reservoir, said Dr. Chastanet of the Riviera Vein Institute in Monaco. “Because each patient is different, this strategy offers tailored, à la carte treatment, as opposed to systematic ablation,” he said. “Doing precise and thorough microphlebectomies is not as simple as one might think, but we will share tips and tricks for performing saphenous sparing venous surgery in an easy and elegant way.”

Dr. Silvain Chastanet
Dr. Chastanet recently evaluated more than 300 saphenous-sparing ASVAL procedures at his institute and found that 10 years later, 64% of patients remained reflux free, 70% continued to have symptomatic relief, and 66% remained improved cosmetically. Notably, fewer than 1 in 10 patients needed repeat phlebectomy or ablation.

The ASVAL technique is based on the premise that reflux usually ascends from the tributaries toward the saphenous trunk, rather than following the opposite path, said Dr. Chastanet. Although the ascending pattern is not universal, increasing evidence suggests that it is most common. For example, a study of more than 700 consecutive patients with chronic venous disease showed that patients of CEAP category C4-C6 had significantly greater involvement of the saphenofemoral junction and saphenopopliteal trunk than patients with less advanced venous disease. The authors concluded that reflux usually ascends up from the tributaries and accessory saphenous veins (J Vasc Surg. 2010;51(1):96-103).

Thus, when evaluating a patient with saphenous reflux, surgeons should always ask whether they can spare the great saphenous vein, Dr. Chastanet said. Evidence indicates that if the patient is classified as C2 (varicose veins) and the great saphenous vein is dilated less than 10 mm, ASVAL may be a valid option, especially if reflux is localized above the knee, with the varices localized to the thigh.

Techniques such as ASVAL are a major advance, but questions persist about surgically treating varicose disease, Dr. Chastanet noted. For example, although ascending disease appears to be most common, it can convert to descending disease or patients can have a refluxing saphenous trunk without tributaries. “We still do not know which patients are likely to have descending or ascending disease, and why,” Dr. Chastanet said. Likewise, experts continue to debate whether phlebectomy should be performed together with saphenous ablation. “Considering that some varicosities will disappear after endothermal ablation of the saphenous vein, some surgeons consider concomitant phlebectomy to be overtreatment,” Dr. Chastenet noted. “Conversely, if we consider that the disease begins at the tributary level according to the ascending theory, it seems obvious to focus treatment on the varicose tributaries, which are the main concern for the majority of patients.”

Bringing techniques such as ASVAL into community practice involves practical challenges, too. Microphlebectomy is “clearly” the best cosmetic option, but is not taught during surgical or phlebology training, Dr. Chastanet said. “There is a need to develop new tools for treating the varicose tributaries in an easier and faster way.” Such advances could help transition procedures such as ASVAL to outpatient settings, which is not now the norm in most countries, he noted. “Using local anesthesia, mini-invasive surgical procedures with immediate ambulation will enable us to reach this goal.”

Session 63
“Venous Clinical Examination and Hemodynamics”
Thursday 8:13 a.m. – 8:18 a.m.
Trianon Ballroom, 3rd Floor

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Ambulatory selective varicose vein ablation under local anesthesia (ASVAL) can abolish reflux while preserving the great saphenous vein, and benefits can last at least a decade, said Dr. Silvain Chastanet, who helped create the technique and will discuss it Thursday morning.

Historically, a refluxing great saphenous vein was treated by removing it. The ASVAL method preserves the vein by using microphlebotomy to instead remove the varicose reservoir, said Dr. Chastanet of the Riviera Vein Institute in Monaco. “Because each patient is different, this strategy offers tailored, à la carte treatment, as opposed to systematic ablation,” he said. “Doing precise and thorough microphlebectomies is not as simple as one might think, but we will share tips and tricks for performing saphenous sparing venous surgery in an easy and elegant way.”

Dr. Silvain Chastanet
Dr. Chastanet recently evaluated more than 300 saphenous-sparing ASVAL procedures at his institute and found that 10 years later, 64% of patients remained reflux free, 70% continued to have symptomatic relief, and 66% remained improved cosmetically. Notably, fewer than 1 in 10 patients needed repeat phlebectomy or ablation.

The ASVAL technique is based on the premise that reflux usually ascends from the tributaries toward the saphenous trunk, rather than following the opposite path, said Dr. Chastanet. Although the ascending pattern is not universal, increasing evidence suggests that it is most common. For example, a study of more than 700 consecutive patients with chronic venous disease showed that patients of CEAP category C4-C6 had significantly greater involvement of the saphenofemoral junction and saphenopopliteal trunk than patients with less advanced venous disease. The authors concluded that reflux usually ascends up from the tributaries and accessory saphenous veins (J Vasc Surg. 2010;51(1):96-103).

Thus, when evaluating a patient with saphenous reflux, surgeons should always ask whether they can spare the great saphenous vein, Dr. Chastanet said. Evidence indicates that if the patient is classified as C2 (varicose veins) and the great saphenous vein is dilated less than 10 mm, ASVAL may be a valid option, especially if reflux is localized above the knee, with the varices localized to the thigh.

Techniques such as ASVAL are a major advance, but questions persist about surgically treating varicose disease, Dr. Chastanet noted. For example, although ascending disease appears to be most common, it can convert to descending disease or patients can have a refluxing saphenous trunk without tributaries. “We still do not know which patients are likely to have descending or ascending disease, and why,” Dr. Chastanet said. Likewise, experts continue to debate whether phlebectomy should be performed together with saphenous ablation. “Considering that some varicosities will disappear after endothermal ablation of the saphenous vein, some surgeons consider concomitant phlebectomy to be overtreatment,” Dr. Chastenet noted. “Conversely, if we consider that the disease begins at the tributary level according to the ascending theory, it seems obvious to focus treatment on the varicose tributaries, which are the main concern for the majority of patients.”

Bringing techniques such as ASVAL into community practice involves practical challenges, too. Microphlebectomy is “clearly” the best cosmetic option, but is not taught during surgical or phlebology training, Dr. Chastanet said. “There is a need to develop new tools for treating the varicose tributaries in an easier and faster way.” Such advances could help transition procedures such as ASVAL to outpatient settings, which is not now the norm in most countries, he noted. “Using local anesthesia, mini-invasive surgical procedures with immediate ambulation will enable us to reach this goal.”

Session 63
“Venous Clinical Examination and Hemodynamics”
Thursday 8:13 a.m. – 8:18 a.m.
Trianon Ballroom, 3rd Floor

Ambulatory selective varicose vein ablation under local anesthesia (ASVAL) can abolish reflux while preserving the great saphenous vein, and benefits can last at least a decade, said Dr. Silvain Chastanet, who helped create the technique and will discuss it Thursday morning.

Historically, a refluxing great saphenous vein was treated by removing it. The ASVAL method preserves the vein by using microphlebotomy to instead remove the varicose reservoir, said Dr. Chastanet of the Riviera Vein Institute in Monaco. “Because each patient is different, this strategy offers tailored, à la carte treatment, as opposed to systematic ablation,” he said. “Doing precise and thorough microphlebectomies is not as simple as one might think, but we will share tips and tricks for performing saphenous sparing venous surgery in an easy and elegant way.”

Dr. Silvain Chastanet
Dr. Chastanet recently evaluated more than 300 saphenous-sparing ASVAL procedures at his institute and found that 10 years later, 64% of patients remained reflux free, 70% continued to have symptomatic relief, and 66% remained improved cosmetically. Notably, fewer than 1 in 10 patients needed repeat phlebectomy or ablation.

The ASVAL technique is based on the premise that reflux usually ascends from the tributaries toward the saphenous trunk, rather than following the opposite path, said Dr. Chastanet. Although the ascending pattern is not universal, increasing evidence suggests that it is most common. For example, a study of more than 700 consecutive patients with chronic venous disease showed that patients of CEAP category C4-C6 had significantly greater involvement of the saphenofemoral junction and saphenopopliteal trunk than patients with less advanced venous disease. The authors concluded that reflux usually ascends up from the tributaries and accessory saphenous veins (J Vasc Surg. 2010;51(1):96-103).

Thus, when evaluating a patient with saphenous reflux, surgeons should always ask whether they can spare the great saphenous vein, Dr. Chastanet said. Evidence indicates that if the patient is classified as C2 (varicose veins) and the great saphenous vein is dilated less than 10 mm, ASVAL may be a valid option, especially if reflux is localized above the knee, with the varices localized to the thigh.

Techniques such as ASVAL are a major advance, but questions persist about surgically treating varicose disease, Dr. Chastanet noted. For example, although ascending disease appears to be most common, it can convert to descending disease or patients can have a refluxing saphenous trunk without tributaries. “We still do not know which patients are likely to have descending or ascending disease, and why,” Dr. Chastanet said. Likewise, experts continue to debate whether phlebectomy should be performed together with saphenous ablation. “Considering that some varicosities will disappear after endothermal ablation of the saphenous vein, some surgeons consider concomitant phlebectomy to be overtreatment,” Dr. Chastenet noted. “Conversely, if we consider that the disease begins at the tributary level according to the ascending theory, it seems obvious to focus treatment on the varicose tributaries, which are the main concern for the majority of patients.”

Bringing techniques such as ASVAL into community practice involves practical challenges, too. Microphlebectomy is “clearly” the best cosmetic option, but is not taught during surgical or phlebology training, Dr. Chastanet said. “There is a need to develop new tools for treating the varicose tributaries in an easier and faster way.” Such advances could help transition procedures such as ASVAL to outpatient settings, which is not now the norm in most countries, he noted. “Using local anesthesia, mini-invasive surgical procedures with immediate ambulation will enable us to reach this goal.”

Session 63
“Venous Clinical Examination and Hemodynamics”
Thursday 8:13 a.m. – 8:18 a.m.
Trianon Ballroom, 3rd Floor

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