Patrice Wendling

CHICAGO – Despite a national downturn in cigarette smoking, a growing number of young Americans are turning to hookah bars to smoke tobacco, a study has shown.

The trend is driven by the social nature of hookah bars and myths about the safety of smoking hookah, also called shisha, narghile, hubble-bubble, and goza, Dr. Srihari Veeraraghavan reported at the annual meeting of the American College of Chest Physicians.

For the first time, a large study showed hookah smoking had eclipsed cigarette smoking for both ever use (46.4% vs. 42.1%) and past-year use (28.4% vs. 19.6%) among 1,203 University of Florida students (BMC Public Health 2013;13:302).

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Patrice Wendling/IMNG Medical Media

More than a third of current cigarette smokers used hookah, but equally worrisome, 29% of current hookah smokers reported never having smoked a cigarette.

"We’ve made impressive strides in the last 40-50 years by reducing smoking in this country," he said in an interview. "And the concern is that students use hookah in their universities, and when they get out in their real life, they’re going to go back to cigarettes because it’s as addictive, if not more [so], than cigarettes."

Myths surrounding hookah/shisha smoking are that it is less addictive, less harmful, and contains less nicotine than conventional cigarettes, said Dr. Veeraraghavan of Emory University in Atlanta.

He highlighted a widely publicized 1997 New York Times article quoting one hookah smoker as saying cigarettes are for "nervous," "competitive" people, but that narghile smoking "teaches you patience and tolerance, and gives you an appreciation of good company."

Some smokers also believe the water in the pipe filters out toxins and that adding molasses or fruit to flavor the tobacco imparts a health benefit.

"Hookah smoking leads to cigarette smoking, and cigarette smokers planning to quit take up hookah thinking that it’s better," Dr. Veeraraghavan said.

Though data in humans are limited, a study found similar peak nicotine concentrations after smoking one cigarette vs. smoking a hookah for a maximum of 45 minutes, but that hookah smoking was associated with greater carbon monoxide levels and 1.7 times the exposure to nicotine (Am. J. Prev. Med. 2009;37:518-23).

A typical hookah session lasts about an hour and may involve 200 puffs. Thus, "in one hookah session, smokers may inhale the equivalent of 100 cigarettes," he said.

This is particularly concerning in light of the recent Canadian Youth Smoking Survey showing that hookah use increased 6% from 2006 through 2010 among kids, grades 9 through 12 (Prev. Chronic Dis. 2013 May 9;10E73). Once again, current cigarette smokers were more likely to use hookahs, but marijuana and alcohol use also predicted hookah use.

Dr. Veeraraghavan suggested that alternative forms of smoking such as hookahs, e-cigarettes, and marijuana should be included in all smoking surveys and that additional research is needed to elucidate the effects on pulmonary function and overall health. Better regulatory mechanisms are also needed, as laws are unclear about hookah smoking in restaurants and other public venues.

Finally, physicians should begin asking patients of all ages about their hookah use since younger adult smokers are less likely to visit the office, but parents will go home and talk to their kids – young or older – about the health risks posed by hookah smoking, he said.

For physicians unaware or uncertain about the emerging popularity of hookah smoking, Dr. Veeraraghavan concluded by showing a slide listing no fewer than 50 hookah bars all in the Chicago area, many not far from CHEST 2013.

Dr. Veeraraghavan reported having no relevant financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Despite a national downturn in cigarette smoking, a growing number of young Americans are turning to hookah bars to smoke tobacco, a study has shown.

The trend is driven by the social nature of hookah bars and myths about the safety of smoking hookah, also called shisha, narghile, hubble-bubble, and goza, Dr. Srihari Veeraraghavan reported at the annual meeting of the American College of Chest Physicians.

For the first time, a large study showed hookah smoking had eclipsed cigarette smoking for both ever use (46.4% vs. 42.1%) and past-year use (28.4% vs. 19.6%) among 1,203 University of Florida students (BMC Public Health 2013;13:302).

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Patrice Wendling/IMNG Medical Media

More than a third of current cigarette smokers used hookah, but equally worrisome, 29% of current hookah smokers reported never having smoked a cigarette.

"We’ve made impressive strides in the last 40-50 years by reducing smoking in this country," he said in an interview. "And the concern is that students use hookah in their universities, and when they get out in their real life, they’re going to go back to cigarettes because it’s as addictive, if not more [so], than cigarettes."

Myths surrounding hookah/shisha smoking are that it is less addictive, less harmful, and contains less nicotine than conventional cigarettes, said Dr. Veeraraghavan of Emory University in Atlanta.

He highlighted a widely publicized 1997 New York Times article quoting one hookah smoker as saying cigarettes are for "nervous," "competitive" people, but that narghile smoking "teaches you patience and tolerance, and gives you an appreciation of good company."

Some smokers also believe the water in the pipe filters out toxins and that adding molasses or fruit to flavor the tobacco imparts a health benefit.

"Hookah smoking leads to cigarette smoking, and cigarette smokers planning to quit take up hookah thinking that it’s better," Dr. Veeraraghavan said.

Though data in humans are limited, a study found similar peak nicotine concentrations after smoking one cigarette vs. smoking a hookah for a maximum of 45 minutes, but that hookah smoking was associated with greater carbon monoxide levels and 1.7 times the exposure to nicotine (Am. J. Prev. Med. 2009;37:518-23).

A typical hookah session lasts about an hour and may involve 200 puffs. Thus, "in one hookah session, smokers may inhale the equivalent of 100 cigarettes," he said.

This is particularly concerning in light of the recent Canadian Youth Smoking Survey showing that hookah use increased 6% from 2006 through 2010 among kids, grades 9 through 12 (Prev. Chronic Dis. 2013 May 9;10E73). Once again, current cigarette smokers were more likely to use hookahs, but marijuana and alcohol use also predicted hookah use.

Dr. Veeraraghavan suggested that alternative forms of smoking such as hookahs, e-cigarettes, and marijuana should be included in all smoking surveys and that additional research is needed to elucidate the effects on pulmonary function and overall health. Better regulatory mechanisms are also needed, as laws are unclear about hookah smoking in restaurants and other public venues.

Finally, physicians should begin asking patients of all ages about their hookah use since younger adult smokers are less likely to visit the office, but parents will go home and talk to their kids – young or older – about the health risks posed by hookah smoking, he said.

For physicians unaware or uncertain about the emerging popularity of hookah smoking, Dr. Veeraraghavan concluded by showing a slide listing no fewer than 50 hookah bars all in the Chicago area, many not far from CHEST 2013.

Dr. Veeraraghavan reported having no relevant financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Despite a national downturn in cigarette smoking, a growing number of young Americans are turning to hookah bars to smoke tobacco, a study has shown.

The trend is driven by the social nature of hookah bars and myths about the safety of smoking hookah, also called shisha, narghile, hubble-bubble, and goza, Dr. Srihari Veeraraghavan reported at the annual meeting of the American College of Chest Physicians.

For the first time, a large study showed hookah smoking had eclipsed cigarette smoking for both ever use (46.4% vs. 42.1%) and past-year use (28.4% vs. 19.6%) among 1,203 University of Florida students (BMC Public Health 2013;13:302).

<

Patrice Wendling/IMNG Medical Media

More than a third of current cigarette smokers used hookah, but equally worrisome, 29% of current hookah smokers reported never having smoked a cigarette.

"We’ve made impressive strides in the last 40-50 years by reducing smoking in this country," he said in an interview. "And the concern is that students use hookah in their universities, and when they get out in their real life, they’re going to go back to cigarettes because it’s as addictive, if not more [so], than cigarettes."

Myths surrounding hookah/shisha smoking are that it is less addictive, less harmful, and contains less nicotine than conventional cigarettes, said Dr. Veeraraghavan of Emory University in Atlanta.

He highlighted a widely publicized 1997 New York Times article quoting one hookah smoker as saying cigarettes are for "nervous," "competitive" people, but that narghile smoking "teaches you patience and tolerance, and gives you an appreciation of good company."

Some smokers also believe the water in the pipe filters out toxins and that adding molasses or fruit to flavor the tobacco imparts a health benefit.

"Hookah smoking leads to cigarette smoking, and cigarette smokers planning to quit take up hookah thinking that it’s better," Dr. Veeraraghavan said.

Though data in humans are limited, a study found similar peak nicotine concentrations after smoking one cigarette vs. smoking a hookah for a maximum of 45 minutes, but that hookah smoking was associated with greater carbon monoxide levels and 1.7 times the exposure to nicotine (Am. J. Prev. Med. 2009;37:518-23).

A typical hookah session lasts about an hour and may involve 200 puffs. Thus, "in one hookah session, smokers may inhale the equivalent of 100 cigarettes," he said.

This is particularly concerning in light of the recent Canadian Youth Smoking Survey showing that hookah use increased 6% from 2006 through 2010 among kids, grades 9 through 12 (Prev. Chronic Dis. 2013 May 9;10E73). Once again, current cigarette smokers were more likely to use hookahs, but marijuana and alcohol use also predicted hookah use.

Dr. Veeraraghavan suggested that alternative forms of smoking such as hookahs, e-cigarettes, and marijuana should be included in all smoking surveys and that additional research is needed to elucidate the effects on pulmonary function and overall health. Better regulatory mechanisms are also needed, as laws are unclear about hookah smoking in restaurants and other public venues.

Finally, physicians should begin asking patients of all ages about their hookah use since younger adult smokers are less likely to visit the office, but parents will go home and talk to their kids – young or older – about the health risks posed by hookah smoking, he said.

For physicians unaware or uncertain about the emerging popularity of hookah smoking, Dr. Veeraraghavan concluded by showing a slide listing no fewer than 50 hookah bars all in the Chicago area, many not far from CHEST 2013.

Dr. Veeraraghavan reported having no relevant financial disclosures.

pwendling@frontlinemedcom.com

AMSTERDAM – PIK3CA mutations were associated with lower pathologic complete responses in women with human epidermal growth factor receptor 2 breast cancer treated with neoadjuvant anti-HER2 therapy in the phase III NeoALTTO trial.

"The lower pCR rate in PIK3CA-mutant tumors is observed in all treatment arms, irrespective of estrogen receptor status," Dr. José Baselga said at the European multidisciplinary European cancer congresses.

Earlier results from NeoALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization) showed that dual HER2 blockade with trastuzumab (Herceptin) and lapatinib (Tykerb) nearly doubled the pCR rate compared with single-agent trastuzumab or lapatinib (51.3% vs. 29.5% vs. 24.7%; P = .0001).

For the analysis, the investigators performed mutational analyses on tumor samples from 355 (78%) of the 455 study participants. Of these, 23% had a PIK3CA mutation, which is highly consistent with other published analyses, said Dr. Baselga, physician-in-chief at Memorial Sloan-Kettering Cancer Center, in New York City.

No BRAF mutations were found, and one patient had a KRAS mutation.

Overall, pCRs occurred in 21% of PIK3CA mutant tumors and 34% of PIK3CA wildtype tumors (P = .03), he said.

The pCR rate was 28.6% in women with a PIK3CA mutation and 55.8% in those without it in the combination trastuzumab/lapatinib arm, 14.8% vs. 20.4% in the lapatinib arm, and 20% vs. 28.4% in the trastuzumab arm. The difference was statistically significant only for the combination arm (P = .012), but Dr. Baselga urged caution in interpreting this because of the small patient numbers.

PIK3CA mutations were also associated with lower pCR rates in both estrogen receptor (ER)–positive (5% vs. 31%) and ER-negative (11% vs. 61%) patients.

In all, PIK3CA mutations were found in 23% of 124 women in the lapatinib arm, 19% of 112 in the trastuzumab arm, 25% of 119 in the combination arm, 23% of 169 ER-positive patients, and 22% of 186 ER-negative patients.

In a logistic regression model that adjusted for treatment arm and ER status, a significant difference was observed in pCR between PIK3CA mutant and wildtype tumors (odds ratio, 0.45; P = .015), by treatment arm (lapatinib vs. trastuzumab: OR, 0.67; P less than .0001 and combination vs. trastuzumab: OR, 2.97; P less than .0001), and by ER status (negative vs. positive: OR, 2.44; P = .0005).

The findings are concordant with two metastatic breast cancer studies, Dr. Baselga said. In the CLEOPATRA trial, women with PIK3CA-mutant tumors had less benefit from first-line trastuzumab with or without pertuzumab (Perjeta), as did those treated with lapatinib plus capecitabine (Xeloda) in the EMILIA trial.

In the FinHER trial, however, PIK3CA mutations were not predictive of resistance to trastuzumab, he said.

"These findings will lead us to analyze carefully PIK3CA mutation status in adjuvant HER2-positive studies. In this setting, PIK3CA status might be both prognostic and predictive," Dr. Baselga concluded.

Invited discussant Prof. Sibylle Loibl, leader of the medicine and research department, University of Frankfurt (Germany)and member of the German Breast Group, observed that ER-positive PIK3CA-mutant tumors achieved the lowest pCR rate of any group in the current analysis and in the NeoSphere trial of pertuzumab/trastuzumab in treatment-naive HER2-positive breast cancer. "This suggests an interaction of the different pathways and a need to better select the HER2-positive patients," she said.

GlaxoSmithKline sponsored the trial. Dr. Baselga reported no relevant financial disclosures.

pwendling@frontlinemedcom.com

AMSTERDAM – PIK3CA mutations were associated with lower pathologic complete responses in women with human epidermal growth factor receptor 2 breast cancer treated with neoadjuvant anti-HER2 therapy in the phase III NeoALTTO trial.

"The lower pCR rate in PIK3CA-mutant tumors is observed in all treatment arms, irrespective of estrogen receptor status," Dr. José Baselga said at the European multidisciplinary European cancer congresses.

Earlier results from NeoALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization) showed that dual HER2 blockade with trastuzumab (Herceptin) and lapatinib (Tykerb) nearly doubled the pCR rate compared with single-agent trastuzumab or lapatinib (51.3% vs. 29.5% vs. 24.7%; P = .0001).

For the analysis, the investigators performed mutational analyses on tumor samples from 355 (78%) of the 455 study participants. Of these, 23% had a PIK3CA mutation, which is highly consistent with other published analyses, said Dr. Baselga, physician-in-chief at Memorial Sloan-Kettering Cancer Center, in New York City.

No BRAF mutations were found, and one patient had a KRAS mutation.

Overall, pCRs occurred in 21% of PIK3CA mutant tumors and 34% of PIK3CA wildtype tumors (P = .03), he said.

The pCR rate was 28.6% in women with a PIK3CA mutation and 55.8% in those without it in the combination trastuzumab/lapatinib arm, 14.8% vs. 20.4% in the lapatinib arm, and 20% vs. 28.4% in the trastuzumab arm. The difference was statistically significant only for the combination arm (P = .012), but Dr. Baselga urged caution in interpreting this because of the small patient numbers.

PIK3CA mutations were also associated with lower pCR rates in both estrogen receptor (ER)–positive (5% vs. 31%) and ER-negative (11% vs. 61%) patients.

In all, PIK3CA mutations were found in 23% of 124 women in the lapatinib arm, 19% of 112 in the trastuzumab arm, 25% of 119 in the combination arm, 23% of 169 ER-positive patients, and 22% of 186 ER-negative patients.

In a logistic regression model that adjusted for treatment arm and ER status, a significant difference was observed in pCR between PIK3CA mutant and wildtype tumors (odds ratio, 0.45; P = .015), by treatment arm (lapatinib vs. trastuzumab: OR, 0.67; P less than .0001 and combination vs. trastuzumab: OR, 2.97; P less than .0001), and by ER status (negative vs. positive: OR, 2.44; P = .0005).

The findings are concordant with two metastatic breast cancer studies, Dr. Baselga said. In the CLEOPATRA trial, women with PIK3CA-mutant tumors had less benefit from first-line trastuzumab with or without pertuzumab (Perjeta), as did those treated with lapatinib plus capecitabine (Xeloda) in the EMILIA trial.

In the FinHER trial, however, PIK3CA mutations were not predictive of resistance to trastuzumab, he said.

"These findings will lead us to analyze carefully PIK3CA mutation status in adjuvant HER2-positive studies. In this setting, PIK3CA status might be both prognostic and predictive," Dr. Baselga concluded.

Invited discussant Prof. Sibylle Loibl, leader of the medicine and research department, University of Frankfurt (Germany)and member of the German Breast Group, observed that ER-positive PIK3CA-mutant tumors achieved the lowest pCR rate of any group in the current analysis and in the NeoSphere trial of pertuzumab/trastuzumab in treatment-naive HER2-positive breast cancer. "This suggests an interaction of the different pathways and a need to better select the HER2-positive patients," she said.

GlaxoSmithKline sponsored the trial. Dr. Baselga reported no relevant financial disclosures.

pwendling@frontlinemedcom.com

AMSTERDAM – PIK3CA mutations were associated with lower pathologic complete responses in women with human epidermal growth factor receptor 2 breast cancer treated with neoadjuvant anti-HER2 therapy in the phase III NeoALTTO trial.

"The lower pCR rate in PIK3CA-mutant tumors is observed in all treatment arms, irrespective of estrogen receptor status," Dr. José Baselga said at the European multidisciplinary European cancer congresses.

Earlier results from NeoALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization) showed that dual HER2 blockade with trastuzumab (Herceptin) and lapatinib (Tykerb) nearly doubled the pCR rate compared with single-agent trastuzumab or lapatinib (51.3% vs. 29.5% vs. 24.7%; P = .0001).

For the analysis, the investigators performed mutational analyses on tumor samples from 355 (78%) of the 455 study participants. Of these, 23% had a PIK3CA mutation, which is highly consistent with other published analyses, said Dr. Baselga, physician-in-chief at Memorial Sloan-Kettering Cancer Center, in New York City.

No BRAF mutations were found, and one patient had a KRAS mutation.

Overall, pCRs occurred in 21% of PIK3CA mutant tumors and 34% of PIK3CA wildtype tumors (P = .03), he said.

The pCR rate was 28.6% in women with a PIK3CA mutation and 55.8% in those without it in the combination trastuzumab/lapatinib arm, 14.8% vs. 20.4% in the lapatinib arm, and 20% vs. 28.4% in the trastuzumab arm. The difference was statistically significant only for the combination arm (P = .012), but Dr. Baselga urged caution in interpreting this because of the small patient numbers.

PIK3CA mutations were also associated with lower pCR rates in both estrogen receptor (ER)–positive (5% vs. 31%) and ER-negative (11% vs. 61%) patients.

In all, PIK3CA mutations were found in 23% of 124 women in the lapatinib arm, 19% of 112 in the trastuzumab arm, 25% of 119 in the combination arm, 23% of 169 ER-positive patients, and 22% of 186 ER-negative patients.

In a logistic regression model that adjusted for treatment arm and ER status, a significant difference was observed in pCR between PIK3CA mutant and wildtype tumors (odds ratio, 0.45; P = .015), by treatment arm (lapatinib vs. trastuzumab: OR, 0.67; P less than .0001 and combination vs. trastuzumab: OR, 2.97; P less than .0001), and by ER status (negative vs. positive: OR, 2.44; P = .0005).

The findings are concordant with two metastatic breast cancer studies, Dr. Baselga said. In the CLEOPATRA trial, women with PIK3CA-mutant tumors had less benefit from first-line trastuzumab with or without pertuzumab (Perjeta), as did those treated with lapatinib plus capecitabine (Xeloda) in the EMILIA trial.

In the FinHER trial, however, PIK3CA mutations were not predictive of resistance to trastuzumab, he said.

"These findings will lead us to analyze carefully PIK3CA mutation status in adjuvant HER2-positive studies. In this setting, PIK3CA status might be both prognostic and predictive," Dr. Baselga concluded.

Invited discussant Prof. Sibylle Loibl, leader of the medicine and research department, University of Frankfurt (Germany)and member of the German Breast Group, observed that ER-positive PIK3CA-mutant tumors achieved the lowest pCR rate of any group in the current analysis and in the NeoSphere trial of pertuzumab/trastuzumab in treatment-naive HER2-positive breast cancer. "This suggests an interaction of the different pathways and a need to better select the HER2-positive patients," she said.

GlaxoSmithKline sponsored the trial. Dr. Baselga reported no relevant financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Intensive counseling and other nonpharmacologic strategies to quit smoking dramatically increased abstinence rates among elderly long-term-care residents in a multicenter study.

Among 74 current smokers, 34 residents (46%) successfully quit smoking and 26 (35%) remained tobacco free at 1 year.

Prior research shows that medical advice to quit smoking typically produces 1-year abstinence rates of 5% to 10%.

"With a 46% quit rate, we were successful in showing that pharmacologic therapy isn’t the only way," Dr. Aleksander Shalshin said at the annual meeting of the American College of Chest Physicians.

Smokers over the age of 60 years represent about 23% of current smokers and are at increased risk of dying from disorders related to smoking. A recent prospective study found that the risk of dying from cancer, cardiovascular disease, and respiratory disease was 50% higher among men who continued to smoke into their 70s than for never-smokers.

Further, recent studies in the United States and England have shown that smokers who quit at either age 60 or age 65 years gained 2.7-3.7 years of life, said Dr. Shalshin, a pulmonary and critical care physician with North Shore Long Island Jewish Health System, in Syosset, N.Y.

"I always tell my patients it’s never too late to be a quitter," he said.

For the current study, the investigators prospectively recruited 74 long-term-care residents, aged 65-78 years, who were currently smoking an average of half a pack of cigarettes a day and had a tobacco history of more than 5 years. All were interested in quitting.

The intervention included daily smoking-cessation counseling visits from their primary care physician, nurse, or nurse educator, and regular access to a pulmonary consultant.

Counseling was supplemented with educational self-help, video and printed materials and the facilities set up smoke-free zones within 50 feet of their entrances. Participant’s families were also encouraged to provide support and received education on the benefits of a multifaceted approach to tobacco-addiction treatment.

"For patients in long-term-care facilities, where access is immediate and often easy, you don’t have to wait for the next appointment. It can be done on a daily basis with a little bit of time and effort." Dr. Shalshin said.

Session co-moderator Dr. Linda Efferen, chief medical officer, South Nassau Communities Hospital, Oceanside, N.Y., said targeting this captive audience makes sense and provides a bigger bang for the buck.

"These are our future readmissions, especially if they have underlying COPD [chronic obstructive pulmonary disease], asthma, or heart disease," she said in an interview. "To do this without pharmaceuticals and get these results is just phenomenal. We’re in the antipolypharmacy mode also because most of our patients are already on 20 different medications."

Pharmaceutical options will be used in the next phase of the study, however, to target the remaining patients who were unable to quit with the multidisciplinary nonpharmaceutical approach, Dr. Shalshin said in an interview.

Dr. Shalshin and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Intensive counseling and other nonpharmacologic strategies to quit smoking dramatically increased abstinence rates among elderly long-term-care residents in a multicenter study.

Among 74 current smokers, 34 residents (46%) successfully quit smoking and 26 (35%) remained tobacco free at 1 year.

Prior research shows that medical advice to quit smoking typically produces 1-year abstinence rates of 5% to 10%.

"With a 46% quit rate, we were successful in showing that pharmacologic therapy isn’t the only way," Dr. Aleksander Shalshin said at the annual meeting of the American College of Chest Physicians.

Smokers over the age of 60 years represent about 23% of current smokers and are at increased risk of dying from disorders related to smoking. A recent prospective study found that the risk of dying from cancer, cardiovascular disease, and respiratory disease was 50% higher among men who continued to smoke into their 70s than for never-smokers.

Further, recent studies in the United States and England have shown that smokers who quit at either age 60 or age 65 years gained 2.7-3.7 years of life, said Dr. Shalshin, a pulmonary and critical care physician with North Shore Long Island Jewish Health System, in Syosset, N.Y.

"I always tell my patients it’s never too late to be a quitter," he said.

For the current study, the investigators prospectively recruited 74 long-term-care residents, aged 65-78 years, who were currently smoking an average of half a pack of cigarettes a day and had a tobacco history of more than 5 years. All were interested in quitting.

The intervention included daily smoking-cessation counseling visits from their primary care physician, nurse, or nurse educator, and regular access to a pulmonary consultant.

Counseling was supplemented with educational self-help, video and printed materials and the facilities set up smoke-free zones within 50 feet of their entrances. Participant’s families were also encouraged to provide support and received education on the benefits of a multifaceted approach to tobacco-addiction treatment.

"For patients in long-term-care facilities, where access is immediate and often easy, you don’t have to wait for the next appointment. It can be done on a daily basis with a little bit of time and effort." Dr. Shalshin said.

Session co-moderator Dr. Linda Efferen, chief medical officer, South Nassau Communities Hospital, Oceanside, N.Y., said targeting this captive audience makes sense and provides a bigger bang for the buck.

"These are our future readmissions, especially if they have underlying COPD [chronic obstructive pulmonary disease], asthma, or heart disease," she said in an interview. "To do this without pharmaceuticals and get these results is just phenomenal. We’re in the antipolypharmacy mode also because most of our patients are already on 20 different medications."

Pharmaceutical options will be used in the next phase of the study, however, to target the remaining patients who were unable to quit with the multidisciplinary nonpharmaceutical approach, Dr. Shalshin said in an interview.

Dr. Shalshin and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Intensive counseling and other nonpharmacologic strategies to quit smoking dramatically increased abstinence rates among elderly long-term-care residents in a multicenter study.

Among 74 current smokers, 34 residents (46%) successfully quit smoking and 26 (35%) remained tobacco free at 1 year.

Prior research shows that medical advice to quit smoking typically produces 1-year abstinence rates of 5% to 10%.

"With a 46% quit rate, we were successful in showing that pharmacologic therapy isn’t the only way," Dr. Aleksander Shalshin said at the annual meeting of the American College of Chest Physicians.

Smokers over the age of 60 years represent about 23% of current smokers and are at increased risk of dying from disorders related to smoking. A recent prospective study found that the risk of dying from cancer, cardiovascular disease, and respiratory disease was 50% higher among men who continued to smoke into their 70s than for never-smokers.

Further, recent studies in the United States and England have shown that smokers who quit at either age 60 or age 65 years gained 2.7-3.7 years of life, said Dr. Shalshin, a pulmonary and critical care physician with North Shore Long Island Jewish Health System, in Syosset, N.Y.

"I always tell my patients it’s never too late to be a quitter," he said.

For the current study, the investigators prospectively recruited 74 long-term-care residents, aged 65-78 years, who were currently smoking an average of half a pack of cigarettes a day and had a tobacco history of more than 5 years. All were interested in quitting.

The intervention included daily smoking-cessation counseling visits from their primary care physician, nurse, or nurse educator, and regular access to a pulmonary consultant.

Counseling was supplemented with educational self-help, video and printed materials and the facilities set up smoke-free zones within 50 feet of their entrances. Participant’s families were also encouraged to provide support and received education on the benefits of a multifaceted approach to tobacco-addiction treatment.

"For patients in long-term-care facilities, where access is immediate and often easy, you don’t have to wait for the next appointment. It can be done on a daily basis with a little bit of time and effort." Dr. Shalshin said.

Session co-moderator Dr. Linda Efferen, chief medical officer, South Nassau Communities Hospital, Oceanside, N.Y., said targeting this captive audience makes sense and provides a bigger bang for the buck.

"These are our future readmissions, especially if they have underlying COPD [chronic obstructive pulmonary disease], asthma, or heart disease," she said in an interview. "To do this without pharmaceuticals and get these results is just phenomenal. We’re in the antipolypharmacy mode also because most of our patients are already on 20 different medications."

Pharmaceutical options will be used in the next phase of the study, however, to target the remaining patients who were unable to quit with the multidisciplinary nonpharmaceutical approach, Dr. Shalshin said in an interview.

Dr. Shalshin and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

AMSTERDAM – Countries with widespread colorectal cancer screening are reaping the benefits of their efforts.

An analysis involving 11 European countries found that the greater the proportion of people screened, the bigger the reduction in colorectal cancer (CRC) deaths for both males and females. Countries with low rates of CRC screening had sluggish declines or actual increases in CRC mortality over the 22-year study period, despite having health care services that were comparable to those of high-screening countries, Dr. Philippe Autier reported at the European Cancer Congress 2013.

For example, CRC deaths fell 39% for men and 47% for women in Austria, where 35% of men and 36% of women aged 50 years or more had an endoscopic examination of the large bowel between 1989 and 2010. In contrast, CRC mortality rose by 30% among men and 2% among women in Greece, where endoscopic examinations reached a low of 8% for both sexes over the same period.

Patrice Wendling/IMNG Medical Media

Fecal occult blood test screening over the past 10 years reached a high of 61% for both sexes in Austria versus a low of 4% in the Netherlands. CRC mortality declined by 4% for men and 10% for women in the Netherlands, the lowest declines posted in the study (Ab. 1405).

A history of at least one endoscopic exam explained 73% of the decrease in CRC mortality in men and 82% of the decrease in women, according to Dr. Autier, research director at the International Prevention Research Institute, Lyon, France.

The investigators based their calculations on CRC screening data collected from participants, aged 50 years or more, in the Survey of Health, Aging, and Retirement in Europe (SHARE) project and on data from the World Health Organization mortality database. The team is planning to collect additional data from Europe, and to gather data from the United States, Canada, and Australia.

CRC screening is more cost-effective than either mammography or prostate-specific antigen (PSA) testing, and the risk of overdiagnosis is very low since endoscopy involves systematic removal of polyps or precancerous lesions, Dr. Autier said at a press briefing.

Prof. Jack Cuzick, with the Centre for Cancer Prevention at Queen Mary, University of London, commented that "the real challenge now is to get this information out into the public enough and to find ways to get compliance rates up, because this is probably the single most important screening modality we have in terms of a highly effective screening test that actually has an impact on a major cancer."

Future research will also need to determine whether countries can actually build preventive activities into their CRC screening programs.

"We do know how to prevent about 30% of colorectal cancer incidence and mortality by something as simple as a daily aspirin," Prof. Cuzick said. "Whether we should focus that on people just at high risk, because they have an adenoma or other factors, or not, is important."

European CanCer Organisation President Prof. Cornelis van de Velde said in a statement that "it is very disappointing that there are so many differences in outcome due to limitations in the use of screening. People over 50 should be informed of the availability of the test, and pressure should be put on national health services to put more effort into organizing screening programs."

As for whether one screening test should be advocated over another, he told reporters that the American Cancer Society has the right message: "Do something, you have the choice."

Dr. Autier reported having no financial disclosures.

pwendling@frontlinemedcom.com

AMSTERDAM – Countries with widespread colorectal cancer screening are reaping the benefits of their efforts.

An analysis involving 11 European countries found that the greater the proportion of people screened, the bigger the reduction in colorectal cancer (CRC) deaths for both males and females. Countries with low rates of CRC screening had sluggish declines or actual increases in CRC mortality over the 22-year study period, despite having health care services that were comparable to those of high-screening countries, Dr. Philippe Autier reported at the European Cancer Congress 2013.

For example, CRC deaths fell 39% for men and 47% for women in Austria, where 35% of men and 36% of women aged 50 years or more had an endoscopic examination of the large bowel between 1989 and 2010. In contrast, CRC mortality rose by 30% among men and 2% among women in Greece, where endoscopic examinations reached a low of 8% for both sexes over the same period.

Patrice Wendling/IMNG Medical Media

Fecal occult blood test screening over the past 10 years reached a high of 61% for both sexes in Austria versus a low of 4% in the Netherlands. CRC mortality declined by 4% for men and 10% for women in the Netherlands, the lowest declines posted in the study (Ab. 1405).

A history of at least one endoscopic exam explained 73% of the decrease in CRC mortality in men and 82% of the decrease in women, according to Dr. Autier, research director at the International Prevention Research Institute, Lyon, France.

The investigators based their calculations on CRC screening data collected from participants, aged 50 years or more, in the Survey of Health, Aging, and Retirement in Europe (SHARE) project and on data from the World Health Organization mortality database. The team is planning to collect additional data from Europe, and to gather data from the United States, Canada, and Australia.

CRC screening is more cost-effective than either mammography or prostate-specific antigen (PSA) testing, and the risk of overdiagnosis is very low since endoscopy involves systematic removal of polyps or precancerous lesions, Dr. Autier said at a press briefing.

Prof. Jack Cuzick, with the Centre for Cancer Prevention at Queen Mary, University of London, commented that "the real challenge now is to get this information out into the public enough and to find ways to get compliance rates up, because this is probably the single most important screening modality we have in terms of a highly effective screening test that actually has an impact on a major cancer."

Future research will also need to determine whether countries can actually build preventive activities into their CRC screening programs.

"We do know how to prevent about 30% of colorectal cancer incidence and mortality by something as simple as a daily aspirin," Prof. Cuzick said. "Whether we should focus that on people just at high risk, because they have an adenoma or other factors, or not, is important."

European CanCer Organisation President Prof. Cornelis van de Velde said in a statement that "it is very disappointing that there are so many differences in outcome due to limitations in the use of screening. People over 50 should be informed of the availability of the test, and pressure should be put on national health services to put more effort into organizing screening programs."

As for whether one screening test should be advocated over another, he told reporters that the American Cancer Society has the right message: "Do something, you have the choice."

Dr. Autier reported having no financial disclosures.

pwendling@frontlinemedcom.com

AMSTERDAM – Countries with widespread colorectal cancer screening are reaping the benefits of their efforts.

An analysis involving 11 European countries found that the greater the proportion of people screened, the bigger the reduction in colorectal cancer (CRC) deaths for both males and females. Countries with low rates of CRC screening had sluggish declines or actual increases in CRC mortality over the 22-year study period, despite having health care services that were comparable to those of high-screening countries, Dr. Philippe Autier reported at the European Cancer Congress 2013.

For example, CRC deaths fell 39% for men and 47% for women in Austria, where 35% of men and 36% of women aged 50 years or more had an endoscopic examination of the large bowel between 1989 and 2010. In contrast, CRC mortality rose by 30% among men and 2% among women in Greece, where endoscopic examinations reached a low of 8% for both sexes over the same period.

Patrice Wendling/IMNG Medical Media

Fecal occult blood test screening over the past 10 years reached a high of 61% for both sexes in Austria versus a low of 4% in the Netherlands. CRC mortality declined by 4% for men and 10% for women in the Netherlands, the lowest declines posted in the study (Ab. 1405).

A history of at least one endoscopic exam explained 73% of the decrease in CRC mortality in men and 82% of the decrease in women, according to Dr. Autier, research director at the International Prevention Research Institute, Lyon, France.

The investigators based their calculations on CRC screening data collected from participants, aged 50 years or more, in the Survey of Health, Aging, and Retirement in Europe (SHARE) project and on data from the World Health Organization mortality database. The team is planning to collect additional data from Europe, and to gather data from the United States, Canada, and Australia.

CRC screening is more cost-effective than either mammography or prostate-specific antigen (PSA) testing, and the risk of overdiagnosis is very low since endoscopy involves systematic removal of polyps or precancerous lesions, Dr. Autier said at a press briefing.

Prof. Jack Cuzick, with the Centre for Cancer Prevention at Queen Mary, University of London, commented that "the real challenge now is to get this information out into the public enough and to find ways to get compliance rates up, because this is probably the single most important screening modality we have in terms of a highly effective screening test that actually has an impact on a major cancer."

Future research will also need to determine whether countries can actually build preventive activities into their CRC screening programs.

"We do know how to prevent about 30% of colorectal cancer incidence and mortality by something as simple as a daily aspirin," Prof. Cuzick said. "Whether we should focus that on people just at high risk, because they have an adenoma or other factors, or not, is important."

European CanCer Organisation President Prof. Cornelis van de Velde said in a statement that "it is very disappointing that there are so many differences in outcome due to limitations in the use of screening. People over 50 should be informed of the availability of the test, and pressure should be put on national health services to put more effort into organizing screening programs."

As for whether one screening test should be advocated over another, he told reporters that the American Cancer Society has the right message: "Do something, you have the choice."

Dr. Autier reported having no financial disclosures.

pwendling@frontlinemedcom.com

AMSTERDAM – Immunotherapy with ipilimumab provides a durable, long-term survival benefit in patients with metastatic or locally advanced melanoma, a pooled analysis confirms.

Median overall survival was 11.4 months and 3-year survival 22% among 1,861 patients receiving ipilimumab (Yervoy) in a mixture of 12 clinical trials.

When data from 2,985 additional patients in the expanded access program were included, median overall survival was 9.5 months and 3-year survival 21%, Dr. F. Stephen Hodi Jr., director of the Melanoma Center at the Dana-Farber Cancer Institute, Boston, said at the European Cancer Congress 2013.

The pooled analysis, involving eight prospective phase II, two prospective phase III, and two retrospective, observational trials, is the largest survival analysis of ipilimumab to date and provides the most precise estimate yet of its survival benefit.

Patrice Wendling/IMNG Medical Media

The analysis (LBA24) also confirms the observation that the survival benefit of ipilimumab plateaus around 3 years and that patients who are alive at this point maintain a long-term survival benefit, Dr. Hodi said. No deaths have been reported after 7 years, with some patients surviving for up to 10 years.

"A few years ago, we would never imagine using the ‘C’ word, cure, and to see some patients living long term," he said at a press briefing. "Our goal as clinical investigators is to find something that cures patients of their disease, but at least what we’re showing here is that we’re having a great paradigm shift of maybe curing a subset of patients; it’s hard to use that term, but at least turning their disease into a chronic illness, which is a huge paradigm shift from where we were just a few years ago."

The survival benefit was not affected by prior therapy, ipilimumab dose (3 mg vs. 10 mg), or inclusion of the expanded access program (EAP) data, Dr. Hodi said.

Prof. Martin Gore, medical director of the Royal Marsden Hospital and professor of cancer medicine at the Institute of Cancer Research, both in London, who was invited to discuss the study, disagreed with this conclusion. He highlighted a 6% difference in 3-year overall survival between treatment-naïve and previously treated patients (20% vs. 26%) and a 3% difference in 3-year overall survival between those receiving the licensed 3-mg/kg and 10-mg/kg doses (21% vs. 24%). While these differences probably don’t make a difference in the clinic, they could be relevant with large numbers of patients in clinical trials, he said.

The EAP data would have been better utilized as a validation set to evaluate "real world" toxicity with ipilimumab, rather than being included in the pooled analysis, he said.

Prefacing further remarks with the comment, "I have not treated a patient with IL-2 [interleukin-2] for 15 years, so I’m not an apologist for it," Prof. Gore also pointed out that the 9.5-month median survival in the pooled analysis is "within the bounds" of what IL-2 provided 20 years ago when it posted a median survival of 10.5 months and 3-year survival of 15% in 631 patients with stage IV melanoma (J. Clin. Oncol. 1998;16:2921-9).

Still, Prof. Gore said clinicians should advise their patients that ipilimumab produces a 10% improvement in survival over conventional therapy and to say "that if you reach 3 years, you may well be home and dry ...

"I think there’s a potential cure for some patients, I think we can say that," he added. "But it’s not a competition with targeted agents. That’s really, really important. This is an adjunctive treatment in the same way as targeted agents are an adjunctive treatment for those with BRAF mutations. We have to learn to put these together."

The big question going forward is who may be unsuitable for ipilimumab and whether the "old rules for immunotherapy" apply, such as poor performance status, high disease volume, and rapidly progressive disease, Prof. Gore concluded.

It’s currently not possible to predict which patients will respond to ipilimumab, but this issue is an area of very active investigation, along with how to combine or sequence immunotherapy and targeted agents, Dr. Hodi said.

Prof. Alexander Eggermont, past president of the European Cancer Organization and director of the Institut Gustave Roussy Comprehensive Cancer Center in Villejuif, France, said in a statement that the pooled analysis demonstrates that with a response rate of only 10%-15%, one can achieve survival of more than 3-10 years in 17%-25% of patients who have received only a few doses of ipilimumab.

"These survival results could even double or triple with anti-PD1/PDL1 [programmed death 1 protein and its ligand] monoclonal antibodies; and metastatic melanoma could become a curable disease for perhaps more than 50% of patients over the coming 5 to 10 years," he commented.

Dr. Hodi reported having no financial disclosures and no outside funding for the pooled analysis. The National Cancer Institute conducted three of the phase II studies, and Bristol-Myers Squibb conducted the remaining studies. Prof. Gore reported serving on the speakers bureaus for Pfizer, Roche, Novartis, and Bristol-Myers Squibb, and on the advisory boards for Pfizer, Roche, and Astellas.

pwendling@frontlinemedcom.com

AMSTERDAM – Immunotherapy with ipilimumab provides a durable, long-term survival benefit in patients with metastatic or locally advanced melanoma, a pooled analysis confirms.

Median overall survival was 11.4 months and 3-year survival 22% among 1,861 patients receiving ipilimumab (Yervoy) in a mixture of 12 clinical trials.

When data from 2,985 additional patients in the expanded access program were included, median overall survival was 9.5 months and 3-year survival 21%, Dr. F. Stephen Hodi Jr., director of the Melanoma Center at the Dana-Farber Cancer Institute, Boston, said at the European Cancer Congress 2013.

The pooled analysis, involving eight prospective phase II, two prospective phase III, and two retrospective, observational trials, is the largest survival analysis of ipilimumab to date and provides the most precise estimate yet of its survival benefit.

Patrice Wendling/IMNG Medical Media

The analysis (LBA24) also confirms the observation that the survival benefit of ipilimumab plateaus around 3 years and that patients who are alive at this point maintain a long-term survival benefit, Dr. Hodi said. No deaths have been reported after 7 years, with some patients surviving for up to 10 years.

"A few years ago, we would never imagine using the ‘C’ word, cure, and to see some patients living long term," he said at a press briefing. "Our goal as clinical investigators is to find something that cures patients of their disease, but at least what we’re showing here is that we’re having a great paradigm shift of maybe curing a subset of patients; it’s hard to use that term, but at least turning their disease into a chronic illness, which is a huge paradigm shift from where we were just a few years ago."

The survival benefit was not affected by prior therapy, ipilimumab dose (3 mg vs. 10 mg), or inclusion of the expanded access program (EAP) data, Dr. Hodi said.

Prof. Martin Gore, medical director of the Royal Marsden Hospital and professor of cancer medicine at the Institute of Cancer Research, both in London, who was invited to discuss the study, disagreed with this conclusion. He highlighted a 6% difference in 3-year overall survival between treatment-naïve and previously treated patients (20% vs. 26%) and a 3% difference in 3-year overall survival between those receiving the licensed 3-mg/kg and 10-mg/kg doses (21% vs. 24%). While these differences probably don’t make a difference in the clinic, they could be relevant with large numbers of patients in clinical trials, he said.

The EAP data would have been better utilized as a validation set to evaluate "real world" toxicity with ipilimumab, rather than being included in the pooled analysis, he said.

Prefacing further remarks with the comment, "I have not treated a patient with IL-2 [interleukin-2] for 15 years, so I’m not an apologist for it," Prof. Gore also pointed out that the 9.5-month median survival in the pooled analysis is "within the bounds" of what IL-2 provided 20 years ago when it posted a median survival of 10.5 months and 3-year survival of 15% in 631 patients with stage IV melanoma (J. Clin. Oncol. 1998;16:2921-9).

Still, Prof. Gore said clinicians should advise their patients that ipilimumab produces a 10% improvement in survival over conventional therapy and to say "that if you reach 3 years, you may well be home and dry ...

"I think there’s a potential cure for some patients, I think we can say that," he added. "But it’s not a competition with targeted agents. That’s really, really important. This is an adjunctive treatment in the same way as targeted agents are an adjunctive treatment for those with BRAF mutations. We have to learn to put these together."

The big question going forward is who may be unsuitable for ipilimumab and whether the "old rules for immunotherapy" apply, such as poor performance status, high disease volume, and rapidly progressive disease, Prof. Gore concluded.

It’s currently not possible to predict which patients will respond to ipilimumab, but this issue is an area of very active investigation, along with how to combine or sequence immunotherapy and targeted agents, Dr. Hodi said.

Prof. Alexander Eggermont, past president of the European Cancer Organization and director of the Institut Gustave Roussy Comprehensive Cancer Center in Villejuif, France, said in a statement that the pooled analysis demonstrates that with a response rate of only 10%-15%, one can achieve survival of more than 3-10 years in 17%-25% of patients who have received only a few doses of ipilimumab.

"These survival results could even double or triple with anti-PD1/PDL1 [programmed death 1 protein and its ligand] monoclonal antibodies; and metastatic melanoma could become a curable disease for perhaps more than 50% of patients over the coming 5 to 10 years," he commented.

Dr. Hodi reported having no financial disclosures and no outside funding for the pooled analysis. The National Cancer Institute conducted three of the phase II studies, and Bristol-Myers Squibb conducted the remaining studies. Prof. Gore reported serving on the speakers bureaus for Pfizer, Roche, Novartis, and Bristol-Myers Squibb, and on the advisory boards for Pfizer, Roche, and Astellas.

pwendling@frontlinemedcom.com

AMSTERDAM – Immunotherapy with ipilimumab provides a durable, long-term survival benefit in patients with metastatic or locally advanced melanoma, a pooled analysis confirms.

Median overall survival was 11.4 months and 3-year survival 22% among 1,861 patients receiving ipilimumab (Yervoy) in a mixture of 12 clinical trials.

When data from 2,985 additional patients in the expanded access program were included, median overall survival was 9.5 months and 3-year survival 21%, Dr. F. Stephen Hodi Jr., director of the Melanoma Center at the Dana-Farber Cancer Institute, Boston, said at the European Cancer Congress 2013.

The pooled analysis, involving eight prospective phase II, two prospective phase III, and two retrospective, observational trials, is the largest survival analysis of ipilimumab to date and provides the most precise estimate yet of its survival benefit.

Patrice Wendling/IMNG Medical Media

The analysis (LBA24) also confirms the observation that the survival benefit of ipilimumab plateaus around 3 years and that patients who are alive at this point maintain a long-term survival benefit, Dr. Hodi said. No deaths have been reported after 7 years, with some patients surviving for up to 10 years.

"A few years ago, we would never imagine using the ‘C’ word, cure, and to see some patients living long term," he said at a press briefing. "Our goal as clinical investigators is to find something that cures patients of their disease, but at least what we’re showing here is that we’re having a great paradigm shift of maybe curing a subset of patients; it’s hard to use that term, but at least turning their disease into a chronic illness, which is a huge paradigm shift from where we were just a few years ago."

The survival benefit was not affected by prior therapy, ipilimumab dose (3 mg vs. 10 mg), or inclusion of the expanded access program (EAP) data, Dr. Hodi said.

Prof. Martin Gore, medical director of the Royal Marsden Hospital and professor of cancer medicine at the Institute of Cancer Research, both in London, who was invited to discuss the study, disagreed with this conclusion. He highlighted a 6% difference in 3-year overall survival between treatment-naïve and previously treated patients (20% vs. 26%) and a 3% difference in 3-year overall survival between those receiving the licensed 3-mg/kg and 10-mg/kg doses (21% vs. 24%). While these differences probably don’t make a difference in the clinic, they could be relevant with large numbers of patients in clinical trials, he said.

The EAP data would have been better utilized as a validation set to evaluate "real world" toxicity with ipilimumab, rather than being included in the pooled analysis, he said.

Prefacing further remarks with the comment, "I have not treated a patient with IL-2 [interleukin-2] for 15 years, so I’m not an apologist for it," Prof. Gore also pointed out that the 9.5-month median survival in the pooled analysis is "within the bounds" of what IL-2 provided 20 years ago when it posted a median survival of 10.5 months and 3-year survival of 15% in 631 patients with stage IV melanoma (J. Clin. Oncol. 1998;16:2921-9).

Still, Prof. Gore said clinicians should advise their patients that ipilimumab produces a 10% improvement in survival over conventional therapy and to say "that if you reach 3 years, you may well be home and dry ...

"I think there’s a potential cure for some patients, I think we can say that," he added. "But it’s not a competition with targeted agents. That’s really, really important. This is an adjunctive treatment in the same way as targeted agents are an adjunctive treatment for those with BRAF mutations. We have to learn to put these together."

The big question going forward is who may be unsuitable for ipilimumab and whether the "old rules for immunotherapy" apply, such as poor performance status, high disease volume, and rapidly progressive disease, Prof. Gore concluded.

It’s currently not possible to predict which patients will respond to ipilimumab, but this issue is an area of very active investigation, along with how to combine or sequence immunotherapy and targeted agents, Dr. Hodi said.

Prof. Alexander Eggermont, past president of the European Cancer Organization and director of the Institut Gustave Roussy Comprehensive Cancer Center in Villejuif, France, said in a statement that the pooled analysis demonstrates that with a response rate of only 10%-15%, one can achieve survival of more than 3-10 years in 17%-25% of patients who have received only a few doses of ipilimumab.

"These survival results could even double or triple with anti-PD1/PDL1 [programmed death 1 protein and its ligand] monoclonal antibodies; and metastatic melanoma could become a curable disease for perhaps more than 50% of patients over the coming 5 to 10 years," he commented.

Dr. Hodi reported having no financial disclosures and no outside funding for the pooled analysis. The National Cancer Institute conducted three of the phase II studies, and Bristol-Myers Squibb conducted the remaining studies. Prof. Gore reported serving on the speakers bureaus for Pfizer, Roche, Novartis, and Bristol-Myers Squibb, and on the advisory boards for Pfizer, Roche, and Astellas.

pwendling@frontlinemedcom.com

CHICAGO – Penetration of the inferior vena cava and adjacent organs occurred with 46% of IVC filters placed among 262 patients, an award-winning analysis shows.

Grade 2 or 3 penetration was significantly associated with filter type (49% temporary vs. 5.3% permanent; P = .0001) and length of time in place (18.2% less than 30 days vs. 57.3% 30 days or more; P less than .0001).

"The majority of filters were placed for prophylaxis or relative indications and were temporary," Dr. Michael Go said at the annual meeting of the Midwestern Vascular Surgical Society.

The filter penetrated the aorta in 12 cases; duodenum in 26; and spine, colon, or kidney in 6; and simultaneously penetrated two organs in 7. Another 100 filters had struts immediately adjacent to the external aspect of the IVC, possibly indicating tenting of the cava.

Patrice Wendling/IMNG Medical Media

Only 1.6% of temporary filters, however, were retrieved during the 3-year study period, he said.

A filter retrieval rate between 1.2% and 5.1% was cited in a recent Medicare data analysis, which reported an alarming 111% increase in the rate of IVC filter placement from 1999 through 2008 (J. Am. Coll. Radio. 2011;8:483-9).

"IVC filter placement is an epidemic because of the ever-increasing number of risk factors being identified for VTE [venous thromboembolism]," said Dr. Go, with the division of vascular diseases and surgery, Ohio State University Medical Center, Columbus.

Other culprits behind the explosive growth of IVC filters are that angiography suites and catheter labs are now commonplace, the skill needed to insert a filter is easily disseminated, and temporary filters have decreased the threshold for placement.

"Concern over filter complications is increasing, as are referrals for removal, but little long-term data exist," he remarked.

A total of 591 patients had an IVC filter placed at Ohio State University between January 2006 and December 2009, with an adequate postfilter computed tomography (CT) scan available in 262. CT findings were graded, based on a modified, previously published scale (J. Vasc. Interv. Radiol. 2011;22:70-4), ranging from 0 (struts confined entirely within the IVC) to 3 (strut interacts with aorta, duodenum, or other organs).

Indications for filter placement were prophylaxis in 16.4% and VTE in 83.6%. Among the filters placed for VTE, 44.7% were for absolute indications (inability/failure of anticoagulation) and 55.3% for relative indications.

Grade 0 penetration occurred in 42 filters, grade 1 in 100, grade 2 in 83, and grade 3 in 37, Dr. Go said.

Grade 2 or 3 penetration was present in 44.6% of Tulip filters, 74.4% of Celect, 5.3% of Greenfield, and 0% of Optease (P = .0000), according to the analysis, which won this year’s Pfeifer Venous Award from the society.

There was a trend toward increased grade 2 or 3 penetration with uniconical filters vs. biconical filters (46.7% vs. 0%; P = .0645).

In all, 32 patients sought clinical follow-up for abdominal or back pain, but none were conclusively tied to filter problems or penetration.

"It remains unclear if most penetrations caused clinically significant problems," he said. "Monitoring of penetrations with CT, or some other follow-up, may be important to understand the natural history of this condition."

Audience members remarked that the retrieval rate in the series was extremely low and asked whether efforts, such as percutaneous retrieval, were being undertaken.

"We have attempted to remove some of these filters, sometimes successfully, sometimes not," Dr. Go responded. "As far as our retrieval rate, I agree 1.6% is dismal. Vascular surgery put in 19% of the filters. We don’t have a specific protocol in place, other than hyperawareness amongst all of us partners about who has a filter in place and to bring them back when appropriate."

He also observed that even when retrieval is undertaken, technical failure rates are high at about 8.5% in the recent literature (Eur. J. Vasc. Endovasc. Surg. 2013;46:353-9).

Dr. Go and his coauthors reported no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Penetration of the inferior vena cava and adjacent organs occurred with 46% of IVC filters placed among 262 patients, an award-winning analysis shows.

Grade 2 or 3 penetration was significantly associated with filter type (49% temporary vs. 5.3% permanent; P = .0001) and length of time in place (18.2% less than 30 days vs. 57.3% 30 days or more; P less than .0001).

"The majority of filters were placed for prophylaxis or relative indications and were temporary," Dr. Michael Go said at the annual meeting of the Midwestern Vascular Surgical Society.

The filter penetrated the aorta in 12 cases; duodenum in 26; and spine, colon, or kidney in 6; and simultaneously penetrated two organs in 7. Another 100 filters had struts immediately adjacent to the external aspect of the IVC, possibly indicating tenting of the cava.

Patrice Wendling/IMNG Medical Media

Only 1.6% of temporary filters, however, were retrieved during the 3-year study period, he said.

A filter retrieval rate between 1.2% and 5.1% was cited in a recent Medicare data analysis, which reported an alarming 111% increase in the rate of IVC filter placement from 1999 through 2008 (J. Am. Coll. Radio. 2011;8:483-9).

"IVC filter placement is an epidemic because of the ever-increasing number of risk factors being identified for VTE [venous thromboembolism]," said Dr. Go, with the division of vascular diseases and surgery, Ohio State University Medical Center, Columbus.

Other culprits behind the explosive growth of IVC filters are that angiography suites and catheter labs are now commonplace, the skill needed to insert a filter is easily disseminated, and temporary filters have decreased the threshold for placement.

"Concern over filter complications is increasing, as are referrals for removal, but little long-term data exist," he remarked.

A total of 591 patients had an IVC filter placed at Ohio State University between January 2006 and December 2009, with an adequate postfilter computed tomography (CT) scan available in 262. CT findings were graded, based on a modified, previously published scale (J. Vasc. Interv. Radiol. 2011;22:70-4), ranging from 0 (struts confined entirely within the IVC) to 3 (strut interacts with aorta, duodenum, or other organs).

Indications for filter placement were prophylaxis in 16.4% and VTE in 83.6%. Among the filters placed for VTE, 44.7% were for absolute indications (inability/failure of anticoagulation) and 55.3% for relative indications.

Grade 0 penetration occurred in 42 filters, grade 1 in 100, grade 2 in 83, and grade 3 in 37, Dr. Go said.

Grade 2 or 3 penetration was present in 44.6% of Tulip filters, 74.4% of Celect, 5.3% of Greenfield, and 0% of Optease (P = .0000), according to the analysis, which won this year’s Pfeifer Venous Award from the society.

There was a trend toward increased grade 2 or 3 penetration with uniconical filters vs. biconical filters (46.7% vs. 0%; P = .0645).

In all, 32 patients sought clinical follow-up for abdominal or back pain, but none were conclusively tied to filter problems or penetration.

"It remains unclear if most penetrations caused clinically significant problems," he said. "Monitoring of penetrations with CT, or some other follow-up, may be important to understand the natural history of this condition."

Audience members remarked that the retrieval rate in the series was extremely low and asked whether efforts, such as percutaneous retrieval, were being undertaken.

"We have attempted to remove some of these filters, sometimes successfully, sometimes not," Dr. Go responded. "As far as our retrieval rate, I agree 1.6% is dismal. Vascular surgery put in 19% of the filters. We don’t have a specific protocol in place, other than hyperawareness amongst all of us partners about who has a filter in place and to bring them back when appropriate."

He also observed that even when retrieval is undertaken, technical failure rates are high at about 8.5% in the recent literature (Eur. J. Vasc. Endovasc. Surg. 2013;46:353-9).

Dr. Go and his coauthors reported no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Penetration of the inferior vena cava and adjacent organs occurred with 46% of IVC filters placed among 262 patients, an award-winning analysis shows.

Grade 2 or 3 penetration was significantly associated with filter type (49% temporary vs. 5.3% permanent; P = .0001) and length of time in place (18.2% less than 30 days vs. 57.3% 30 days or more; P less than .0001).

"The majority of filters were placed for prophylaxis or relative indications and were temporary," Dr. Michael Go said at the annual meeting of the Midwestern Vascular Surgical Society.

The filter penetrated the aorta in 12 cases; duodenum in 26; and spine, colon, or kidney in 6; and simultaneously penetrated two organs in 7. Another 100 filters had struts immediately adjacent to the external aspect of the IVC, possibly indicating tenting of the cava.

Patrice Wendling/IMNG Medical Media

Only 1.6% of temporary filters, however, were retrieved during the 3-year study period, he said.

A filter retrieval rate between 1.2% and 5.1% was cited in a recent Medicare data analysis, which reported an alarming 111% increase in the rate of IVC filter placement from 1999 through 2008 (J. Am. Coll. Radio. 2011;8:483-9).

"IVC filter placement is an epidemic because of the ever-increasing number of risk factors being identified for VTE [venous thromboembolism]," said Dr. Go, with the division of vascular diseases and surgery, Ohio State University Medical Center, Columbus.

Other culprits behind the explosive growth of IVC filters are that angiography suites and catheter labs are now commonplace, the skill needed to insert a filter is easily disseminated, and temporary filters have decreased the threshold for placement.

"Concern over filter complications is increasing, as are referrals for removal, but little long-term data exist," he remarked.

A total of 591 patients had an IVC filter placed at Ohio State University between January 2006 and December 2009, with an adequate postfilter computed tomography (CT) scan available in 262. CT findings were graded, based on a modified, previously published scale (J. Vasc. Interv. Radiol. 2011;22:70-4), ranging from 0 (struts confined entirely within the IVC) to 3 (strut interacts with aorta, duodenum, or other organs).

Indications for filter placement were prophylaxis in 16.4% and VTE in 83.6%. Among the filters placed for VTE, 44.7% were for absolute indications (inability/failure of anticoagulation) and 55.3% for relative indications.

Grade 0 penetration occurred in 42 filters, grade 1 in 100, grade 2 in 83, and grade 3 in 37, Dr. Go said.

Grade 2 or 3 penetration was present in 44.6% of Tulip filters, 74.4% of Celect, 5.3% of Greenfield, and 0% of Optease (P = .0000), according to the analysis, which won this year’s Pfeifer Venous Award from the society.

There was a trend toward increased grade 2 or 3 penetration with uniconical filters vs. biconical filters (46.7% vs. 0%; P = .0645).

In all, 32 patients sought clinical follow-up for abdominal or back pain, but none were conclusively tied to filter problems or penetration.

"It remains unclear if most penetrations caused clinically significant problems," he said. "Monitoring of penetrations with CT, or some other follow-up, may be important to understand the natural history of this condition."

Audience members remarked that the retrieval rate in the series was extremely low and asked whether efforts, such as percutaneous retrieval, were being undertaken.

"We have attempted to remove some of these filters, sometimes successfully, sometimes not," Dr. Go responded. "As far as our retrieval rate, I agree 1.6% is dismal. Vascular surgery put in 19% of the filters. We don’t have a specific protocol in place, other than hyperawareness amongst all of us partners about who has a filter in place and to bring them back when appropriate."

He also observed that even when retrieval is undertaken, technical failure rates are high at about 8.5% in the recent literature (Eur. J. Vasc. Endovasc. Surg. 2013;46:353-9).

Dr. Go and his coauthors reported no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Lower-extremity revascularization or amputation was among the strongest predictors of 30-day vascular surgery readmission in what is being described as the largest single-center review in this setting to date.

Lower-extremity revascularization and amputations made up 63% of unplanned readmissions, though rates for endovascular lower-extremity revascularization were almost half that of open revascularization (8.2% vs. 15%).

Notably, below-knee amputations fared the worst, with a 30-day unplanned readmission rate of 24%, compared with 13.3% for above-knee amputations and 16.4% for foot amputation.

"Amputations and open lower-extremity revascularization had the highest rates of readmission in this analysis and therefore we need to focus our efforts and find additional postoperative [management] strategies for these two subgroups," Dr. Travis L. Engelbert said at the annual meeting of the annual meeting of the Midwestern Vascular Surgical Society.*

Patrice Wendling/IMNG Medical Media

The analysis involved 2,505 patients who underwent vascular surgery at the University of Wisconsin Hospitals and Clinics in Madison from 2009 to mid-2013. The overall readmission rate was 9.7% (n = 244).

Of these, 147 patients (60.2%) were readmitted to the vascular surgery service.

The most common readmitting diagnosis was wound complication or infection in 37%, said Dr. Engelbert, a vascular surgeon at the university.

Patients whose index admission was urgent rather than elective had significantly higher readmission rates (14.6% vs. 6.9%; P less than .001), as did those living remotely rather than inside Dane County, where the university is located (12% vs. 8.8%; P = .02).

Not surprisingly, higher illness severity, as calculated using the 3M APR DRG software, was significantly associated with readmission (15.6% high vs. 4.3% low severity; P less than .001).

Patients who were readmitted had a longer initial length of stay (LOS) (8.5 days vs. 6.1 days; P less than .01), and were more likely to have an ICU admission (18.3% vs. 9.5% without ICU stay; P less than .05), he reported.

Based on insurance status, patients covered by Medicaid (16.8%) and Medicare (10%) were most likely to have an unplanned readmission, followed by fee-for-service patients (9.5%), self-pay (8%), and HMO (5.5%) patients (P = .02).

Dr. Engelbert observed that vascular surgery outcomes have come under scrutiny and that there has been some discussion of cutbacks in Medicare reimbursement given its high rates of readmission.

"This is already starting to happen for certain medical patient populations and if this were to happen, it would significantly affect a vascular service’s practice because a majority of our patients are covered by Medicare and have a higher readmission rate," he said.

The analysis suggests that vascular surgeons may also want to pay closer attention to discharge destination for their patients. Readmission rates were about three times higher for patients discharged to a rehabilitation facility or skilled nursing facility than for those discharged home (19.2% and 16.2% vs. 6.2%; P less than .01).

"The discharge destination matters," Dr. Engelbert said. "... we need to have improved coordination between hospitals and postdischarge destinations. And, we also might need to look at how these patients are cared for and if they are discharged to the appropriate level of care when they’re discharged to these skilled nursing and rehabilitation facilities."

The effects of discharge destination (odds ratio, 1.54 skilled nursing facility), index length of stay (OR, 1.03), insurance (OR, 0.43 HMO), and lower-extremity revascularization or amputation (OR, 2.35) persisted in multivariable logistic regression analysis that controlled for age, sex, race, proximity to hospital, clinic follow-up time, urgent vs. elective admission, insurance type, procedure type, length of stay, and discharge destination.

When asked by the audience what the university has done to reduce its vascular readmission rates, Dr. Engelbert said they have looked at using in-patient swabs to reduce infection and dedicated vascular nurse practitioners or case managers to ensure patients are being discharged to the appropriate level of care.

"I think further efforts need to focus on how we can reduce outpatient complications, through closer and quicker follow-up perhaps, as well as ways to use technology to monitor patients," he said.

One example of this is the use of outpatient remote wound analysis using smartphone photograph technology.

"Wound complications and subsequent readmissions are frequent, costly, and a significant burden to the patients," Dr. Engelbert said in an interview. "Hopefully, this method will reduce the severity of wound complications if they can be caught and treated at an earlier stage with digital photograph analysis."

One audience member argued that the vast majority of vascular problems could be cared for outpatient, but that vascular surgeons frequently aren’t told their patients have been readmitted until after they’ve been in the hospital for 2 or 3 days.

Dr. Engelbert reported having no financial disclosures. A coauthor reported grant funding from Abbott, Cook, Covidien, Endologix, Gore, and the National Institutes of Health.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

CHICAGO – Lower-extremity revascularization or amputation was among the strongest predictors of 30-day vascular surgery readmission in what is being described as the largest single-center review in this setting to date.

Lower-extremity revascularization and amputations made up 63% of unplanned readmissions, though rates for endovascular lower-extremity revascularization were almost half that of open revascularization (8.2% vs. 15%).

Notably, below-knee amputations fared the worst, with a 30-day unplanned readmission rate of 24%, compared with 13.3% for above-knee amputations and 16.4% for foot amputation.

"Amputations and open lower-extremity revascularization had the highest rates of readmission in this analysis and therefore we need to focus our efforts and find additional postoperative [management] strategies for these two subgroups," Dr. Travis L. Engelbert said at the annual meeting of the annual meeting of the Midwestern Vascular Surgical Society.*

Patrice Wendling/IMNG Medical Media

The analysis involved 2,505 patients who underwent vascular surgery at the University of Wisconsin Hospitals and Clinics in Madison from 2009 to mid-2013. The overall readmission rate was 9.7% (n = 244).

Of these, 147 patients (60.2%) were readmitted to the vascular surgery service.

The most common readmitting diagnosis was wound complication or infection in 37%, said Dr. Engelbert, a vascular surgeon at the university.

Patients whose index admission was urgent rather than elective had significantly higher readmission rates (14.6% vs. 6.9%; P less than .001), as did those living remotely rather than inside Dane County, where the university is located (12% vs. 8.8%; P = .02).

Not surprisingly, higher illness severity, as calculated using the 3M APR DRG software, was significantly associated with readmission (15.6% high vs. 4.3% low severity; P less than .001).

Patients who were readmitted had a longer initial length of stay (LOS) (8.5 days vs. 6.1 days; P less than .01), and were more likely to have an ICU admission (18.3% vs. 9.5% without ICU stay; P less than .05), he reported.

Based on insurance status, patients covered by Medicaid (16.8%) and Medicare (10%) were most likely to have an unplanned readmission, followed by fee-for-service patients (9.5%), self-pay (8%), and HMO (5.5%) patients (P = .02).

Dr. Engelbert observed that vascular surgery outcomes have come under scrutiny and that there has been some discussion of cutbacks in Medicare reimbursement given its high rates of readmission.

"This is already starting to happen for certain medical patient populations and if this were to happen, it would significantly affect a vascular service’s practice because a majority of our patients are covered by Medicare and have a higher readmission rate," he said.

The analysis suggests that vascular surgeons may also want to pay closer attention to discharge destination for their patients. Readmission rates were about three times higher for patients discharged to a rehabilitation facility or skilled nursing facility than for those discharged home (19.2% and 16.2% vs. 6.2%; P less than .01).

"The discharge destination matters," Dr. Engelbert said. "... we need to have improved coordination between hospitals and postdischarge destinations. And, we also might need to look at how these patients are cared for and if they are discharged to the appropriate level of care when they’re discharged to these skilled nursing and rehabilitation facilities."

The effects of discharge destination (odds ratio, 1.54 skilled nursing facility), index length of stay (OR, 1.03), insurance (OR, 0.43 HMO), and lower-extremity revascularization or amputation (OR, 2.35) persisted in multivariable logistic regression analysis that controlled for age, sex, race, proximity to hospital, clinic follow-up time, urgent vs. elective admission, insurance type, procedure type, length of stay, and discharge destination.

When asked by the audience what the university has done to reduce its vascular readmission rates, Dr. Engelbert said they have looked at using in-patient swabs to reduce infection and dedicated vascular nurse practitioners or case managers to ensure patients are being discharged to the appropriate level of care.

"I think further efforts need to focus on how we can reduce outpatient complications, through closer and quicker follow-up perhaps, as well as ways to use technology to monitor patients," he said.

One example of this is the use of outpatient remote wound analysis using smartphone photograph technology.

"Wound complications and subsequent readmissions are frequent, costly, and a significant burden to the patients," Dr. Engelbert said in an interview. "Hopefully, this method will reduce the severity of wound complications if they can be caught and treated at an earlier stage with digital photograph analysis."

One audience member argued that the vast majority of vascular problems could be cared for outpatient, but that vascular surgeons frequently aren’t told their patients have been readmitted until after they’ve been in the hospital for 2 or 3 days.

Dr. Engelbert reported having no financial disclosures. A coauthor reported grant funding from Abbott, Cook, Covidien, Endologix, Gore, and the National Institutes of Health.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

CHICAGO – Lower-extremity revascularization or amputation was among the strongest predictors of 30-day vascular surgery readmission in what is being described as the largest single-center review in this setting to date.

Lower-extremity revascularization and amputations made up 63% of unplanned readmissions, though rates for endovascular lower-extremity revascularization were almost half that of open revascularization (8.2% vs. 15%).

Notably, below-knee amputations fared the worst, with a 30-day unplanned readmission rate of 24%, compared with 13.3% for above-knee amputations and 16.4% for foot amputation.

"Amputations and open lower-extremity revascularization had the highest rates of readmission in this analysis and therefore we need to focus our efforts and find additional postoperative [management] strategies for these two subgroups," Dr. Travis L. Engelbert said at the annual meeting of the annual meeting of the Midwestern Vascular Surgical Society.*

Patrice Wendling/IMNG Medical Media

The analysis involved 2,505 patients who underwent vascular surgery at the University of Wisconsin Hospitals and Clinics in Madison from 2009 to mid-2013. The overall readmission rate was 9.7% (n = 244).

Of these, 147 patients (60.2%) were readmitted to the vascular surgery service.

The most common readmitting diagnosis was wound complication or infection in 37%, said Dr. Engelbert, a vascular surgeon at the university.

Patients whose index admission was urgent rather than elective had significantly higher readmission rates (14.6% vs. 6.9%; P less than .001), as did those living remotely rather than inside Dane County, where the university is located (12% vs. 8.8%; P = .02).

Not surprisingly, higher illness severity, as calculated using the 3M APR DRG software, was significantly associated with readmission (15.6% high vs. 4.3% low severity; P less than .001).

Patients who were readmitted had a longer initial length of stay (LOS) (8.5 days vs. 6.1 days; P less than .01), and were more likely to have an ICU admission (18.3% vs. 9.5% without ICU stay; P less than .05), he reported.

Based on insurance status, patients covered by Medicaid (16.8%) and Medicare (10%) were most likely to have an unplanned readmission, followed by fee-for-service patients (9.5%), self-pay (8%), and HMO (5.5%) patients (P = .02).

Dr. Engelbert observed that vascular surgery outcomes have come under scrutiny and that there has been some discussion of cutbacks in Medicare reimbursement given its high rates of readmission.

"This is already starting to happen for certain medical patient populations and if this were to happen, it would significantly affect a vascular service’s practice because a majority of our patients are covered by Medicare and have a higher readmission rate," he said.

The analysis suggests that vascular surgeons may also want to pay closer attention to discharge destination for their patients. Readmission rates were about three times higher for patients discharged to a rehabilitation facility or skilled nursing facility than for those discharged home (19.2% and 16.2% vs. 6.2%; P less than .01).

"The discharge destination matters," Dr. Engelbert said. "... we need to have improved coordination between hospitals and postdischarge destinations. And, we also might need to look at how these patients are cared for and if they are discharged to the appropriate level of care when they’re discharged to these skilled nursing and rehabilitation facilities."

The effects of discharge destination (odds ratio, 1.54 skilled nursing facility), index length of stay (OR, 1.03), insurance (OR, 0.43 HMO), and lower-extremity revascularization or amputation (OR, 2.35) persisted in multivariable logistic regression analysis that controlled for age, sex, race, proximity to hospital, clinic follow-up time, urgent vs. elective admission, insurance type, procedure type, length of stay, and discharge destination.

When asked by the audience what the university has done to reduce its vascular readmission rates, Dr. Engelbert said they have looked at using in-patient swabs to reduce infection and dedicated vascular nurse practitioners or case managers to ensure patients are being discharged to the appropriate level of care.

"I think further efforts need to focus on how we can reduce outpatient complications, through closer and quicker follow-up perhaps, as well as ways to use technology to monitor patients," he said.

One example of this is the use of outpatient remote wound analysis using smartphone photograph technology.

"Wound complications and subsequent readmissions are frequent, costly, and a significant burden to the patients," Dr. Engelbert said in an interview. "Hopefully, this method will reduce the severity of wound complications if they can be caught and treated at an earlier stage with digital photograph analysis."

One audience member argued that the vast majority of vascular problems could be cared for outpatient, but that vascular surgeons frequently aren’t told their patients have been readmitted until after they’ve been in the hospital for 2 or 3 days.

Dr. Engelbert reported having no financial disclosures. A coauthor reported grant funding from Abbott, Cook, Covidien, Endologix, Gore, and the National Institutes of Health.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

CHICAGO – Endovascular coiling should be offered to women with pelvic congestion syndrome as an effective treatment.

"The technical success rate is high, pain scores were significantly improved, and most importantly, the patient satisfaction with resolution of their symptoms is very high," Dr. Axel Thors said at the annual meeting of the Midwestern Vascular Surgical Society*.

He reported on a 4-year review involving 15 women with pelvic congestion syndrome (PCS) who underwent endovenous coil embolization (n = 14) or stenting of the iliac vein (n = 1).

The diagnosis of PCS was made clinically by the presence of chronic pelvic pain for 6 months or more, sensations of pelvic fullness, dyspareunia, or perineal varicosities. There was no evidence of nutcracker syndrome or perirenal varicosities. Other pathologies had been previously ruled out.

Patrice Wendling/IMNG Medical Media

"By the time these women got to us, we were probably the last provider they had seen and they had all undergone extensive evaluation for their pelvic pain, all the way from their primary providers to the ob.gyns.," said Dr. Thors of Ohio State University, Columbus.

Their average age was 36 years. Fourteen patients had a previous pregnancy, with an average parity of two.

Twelve patients presented with symptomatic vulvar varices and three with imaging or laproscopic findings of tubo-ovarian varices. All had complaints of chronic pelvic pain.

"Lower extremity venous insufficiency was closely associated with the incidence [of PCS], as was chronic dyspareunia," Dr. Thors said.

Gonadal vein venograms were performed during normal breath and the Valsalva maneuver. Embolization was performed if there was gonadal vein incompetence, congestion of the ovarian venous plexus, uterine venous congestion, cross-pelvic congestion, or marked enlargement of gonadal veins (minimum 6 mm). The average venality size was 7.3 mm.

In all, 13 gonadal veins were embolized with an average of three coils, ranging in size from 6 mm to 12 mm, Dr. Thors said.

Four gonadal veins were occluded using an Amplatzer plug (range 12-18 mm). One iliac vein was stented with a 16 mm by 60 mm stent.

Lower-extremity venous insufficiency was treated with ablation and subsequently followed clinically, he said.

Pain scores on a 10-point visual analog scale declined significantly from baseline for eight evaluable patients for pelvic pain (9.3 vs. 1.8), dyspareunia (8.875 vs. 1.5), painful vulvar varices (9.2 vs. 1.2), and lower extremity venous insufficiency (7 vs. 1), he said.

Two patients had recurrence, and their baseline pain score of 1.2 increased to 4.0 after a mean of 21 months.

All eight patients reported that they were "satisfied" or "very satisfied" with their procedure.

"Patients with chronic pelvic pain, vulvar varices, multiparity, and lower extremity venous insufficiency should be offered endovascular evaluation and treatment," Dr. Thors concluded.

Audience members said that the study represents an important concept in the management of these patients. It is a validation of a very old treatment that sometimes is not offered because of a lack of knowledge or perceived lack of data. A 2012 Agency for Healthcare Research and Quality review estimated that outpatient management of chronic pelvic pain cost $1.2 billion annually. The AHRQ review of 36 studies concluded that there is insufficient evidence to demonstrate the effectiveness of surgical approaches for chronic pelvic pain.

Dr. Thors and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

CHICAGO – Endovascular coiling should be offered to women with pelvic congestion syndrome as an effective treatment.

"The technical success rate is high, pain scores were significantly improved, and most importantly, the patient satisfaction with resolution of their symptoms is very high," Dr. Axel Thors said at the annual meeting of the Midwestern Vascular Surgical Society*.

He reported on a 4-year review involving 15 women with pelvic congestion syndrome (PCS) who underwent endovenous coil embolization (n = 14) or stenting of the iliac vein (n = 1).

The diagnosis of PCS was made clinically by the presence of chronic pelvic pain for 6 months or more, sensations of pelvic fullness, dyspareunia, or perineal varicosities. There was no evidence of nutcracker syndrome or perirenal varicosities. Other pathologies had been previously ruled out.

Patrice Wendling/IMNG Medical Media

"By the time these women got to us, we were probably the last provider they had seen and they had all undergone extensive evaluation for their pelvic pain, all the way from their primary providers to the ob.gyns.," said Dr. Thors of Ohio State University, Columbus.

Their average age was 36 years. Fourteen patients had a previous pregnancy, with an average parity of two.

Twelve patients presented with symptomatic vulvar varices and three with imaging or laproscopic findings of tubo-ovarian varices. All had complaints of chronic pelvic pain.

"Lower extremity venous insufficiency was closely associated with the incidence [of PCS], as was chronic dyspareunia," Dr. Thors said.

Gonadal vein venograms were performed during normal breath and the Valsalva maneuver. Embolization was performed if there was gonadal vein incompetence, congestion of the ovarian venous plexus, uterine venous congestion, cross-pelvic congestion, or marked enlargement of gonadal veins (minimum 6 mm). The average venality size was 7.3 mm.

In all, 13 gonadal veins were embolized with an average of three coils, ranging in size from 6 mm to 12 mm, Dr. Thors said.

Four gonadal veins were occluded using an Amplatzer plug (range 12-18 mm). One iliac vein was stented with a 16 mm by 60 mm stent.

Lower-extremity venous insufficiency was treated with ablation and subsequently followed clinically, he said.

Pain scores on a 10-point visual analog scale declined significantly from baseline for eight evaluable patients for pelvic pain (9.3 vs. 1.8), dyspareunia (8.875 vs. 1.5), painful vulvar varices (9.2 vs. 1.2), and lower extremity venous insufficiency (7 vs. 1), he said.

Two patients had recurrence, and their baseline pain score of 1.2 increased to 4.0 after a mean of 21 months.

All eight patients reported that they were "satisfied" or "very satisfied" with their procedure.

"Patients with chronic pelvic pain, vulvar varices, multiparity, and lower extremity venous insufficiency should be offered endovascular evaluation and treatment," Dr. Thors concluded.

Audience members said that the study represents an important concept in the management of these patients. It is a validation of a very old treatment that sometimes is not offered because of a lack of knowledge or perceived lack of data. A 2012 Agency for Healthcare Research and Quality review estimated that outpatient management of chronic pelvic pain cost $1.2 billion annually. The AHRQ review of 36 studies concluded that there is insufficient evidence to demonstrate the effectiveness of surgical approaches for chronic pelvic pain.

Dr. Thors and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

CHICAGO – Endovascular coiling should be offered to women with pelvic congestion syndrome as an effective treatment.

"The technical success rate is high, pain scores were significantly improved, and most importantly, the patient satisfaction with resolution of their symptoms is very high," Dr. Axel Thors said at the annual meeting of the Midwestern Vascular Surgical Society*.

He reported on a 4-year review involving 15 women with pelvic congestion syndrome (PCS) who underwent endovenous coil embolization (n = 14) or stenting of the iliac vein (n = 1).

The diagnosis of PCS was made clinically by the presence of chronic pelvic pain for 6 months or more, sensations of pelvic fullness, dyspareunia, or perineal varicosities. There was no evidence of nutcracker syndrome or perirenal varicosities. Other pathologies had been previously ruled out.

Patrice Wendling/IMNG Medical Media

"By the time these women got to us, we were probably the last provider they had seen and they had all undergone extensive evaluation for their pelvic pain, all the way from their primary providers to the ob.gyns.," said Dr. Thors of Ohio State University, Columbus.

Their average age was 36 years. Fourteen patients had a previous pregnancy, with an average parity of two.

Twelve patients presented with symptomatic vulvar varices and three with imaging or laproscopic findings of tubo-ovarian varices. All had complaints of chronic pelvic pain.

"Lower extremity venous insufficiency was closely associated with the incidence [of PCS], as was chronic dyspareunia," Dr. Thors said.

Gonadal vein venograms were performed during normal breath and the Valsalva maneuver. Embolization was performed if there was gonadal vein incompetence, congestion of the ovarian venous plexus, uterine venous congestion, cross-pelvic congestion, or marked enlargement of gonadal veins (minimum 6 mm). The average venality size was 7.3 mm.

In all, 13 gonadal veins were embolized with an average of three coils, ranging in size from 6 mm to 12 mm, Dr. Thors said.

Four gonadal veins were occluded using an Amplatzer plug (range 12-18 mm). One iliac vein was stented with a 16 mm by 60 mm stent.

Lower-extremity venous insufficiency was treated with ablation and subsequently followed clinically, he said.

Pain scores on a 10-point visual analog scale declined significantly from baseline for eight evaluable patients for pelvic pain (9.3 vs. 1.8), dyspareunia (8.875 vs. 1.5), painful vulvar varices (9.2 vs. 1.2), and lower extremity venous insufficiency (7 vs. 1), he said.

Two patients had recurrence, and their baseline pain score of 1.2 increased to 4.0 after a mean of 21 months.

All eight patients reported that they were "satisfied" or "very satisfied" with their procedure.

"Patients with chronic pelvic pain, vulvar varices, multiparity, and lower extremity venous insufficiency should be offered endovascular evaluation and treatment," Dr. Thors concluded.

Audience members said that the study represents an important concept in the management of these patients. It is a validation of a very old treatment that sometimes is not offered because of a lack of knowledge or perceived lack of data. A 2012 Agency for Healthcare Research and Quality review estimated that outpatient management of chronic pelvic pain cost $1.2 billion annually. The AHRQ review of 36 studies concluded that there is insufficient evidence to demonstrate the effectiveness of surgical approaches for chronic pelvic pain.

Dr. Thors and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

CHICAGO – Patients undergoing carotid endarterectomy with cervical block anesthesia had fewer hemodynamic fluctuations and required less vasoactive medications than those under general anesthesia in a retrospective evaluation.

"Under cervical block anesthesia, carotid endarterectomy can be performed with a better hemodynamic profile," Dr. Marika Y. Gassner, a resident with Henry Ford Macomb Hospital, Clinton Township, Mich., said at the annual meeting of the Midwestern Vascular Surgical Society*.

Patrice Wendling/IMNG Medical Media

The practice switched in 2003 from using general anesthesia for the majority of carotid endarterectomy to performing more than 90% of cases under local cervical block anesthesia (CBA). Exceptions include patients who are extremely nervous, unable to communicate in English, or who have plaque extending above C2.

The investigators organized the retrospective cohort study after initial observations suggested patients under CBA had less intraoperative hypotension or fluctuations in mean arterial pressure below 65 mm Hg. Vasoactive therapy demands were also lower. For example, anesthesia records showed that several doses of beta-blockers and ephedrine were required for a patient under general anesthesia, while a patient under CBA had only a single dose of midazolam (Versed) early in the procedure, she said.

Other advantages of CBA include continuous feedback on neurologic status/cerebral perfusion, endotracheal intubation not required, shorter operative times, and reduced use of shunts, Dr. Gassner said.

The analysis included 651 patients who underwent carotid endarterectomy by a single surgeon at two suburban teaching hospitals, with 397 under general anesthesia (GA) and 254 under CBA.

The CBA and GA groups were similar in age (71.26 vs. 70.97 years) and incidence of coronary artery disease (57% vs. 56%), hypertension (77% vs. 75%), and renal failure (3.5% vs. 4.0%). The GA group, however, had significantly more females (39% vs. 46.6%), and a higher incidence of chronic obstructive pulmonary disease (16% vs. 23%), nicotine abuse, (50% vs. 63%), and symptomatic patients (41.3% vs. 54%).

The incidence of intraoperative hypotension (systolic BP less than 100 mm HG) was 0.52% with CBA and 17.84% with GA (P less than .001), Dr. Gassner said.

Mean arterial pressure changes of 20% or more per patient occurred in 20% and 41%, respectively (P less than .001).

Vasopressors were required during surgery in 51.13% of the GA group and 36.22% of the CBA group (P = .0002), and antihypertensive medications in 64% and 73.6% (P = .0085). Drugs from both categories were required by significantly fewer CBA patients (22.5% vs. 33.75%; P = .045), she said.

There were no deaths in either group. Postoperative complications were higher in the GA than the CBA group including myocardial infarction (4 vs. 0 events), stroke (6 vs. 0 events), hematoma (7 vs. 2 events), and return to the OR (7 vs. 0 events). The difference did not reach statistical significance because of the sample size, Dr. Gassner said.

Earlier in the presentation, she observed that there was no difference in the primary composite endpoint of stroke, myocardial infarction, or death at 30 days in the randomized GALA (general anaesthesia vs. local anaesthesia for carotid surgery) trial conducted at 95 centers in 24 countries (Lancet 2008;372:2132-42).

"If they couldn’t find it [a survival advantage] in GALA with 3,500 patients, we couldn’t find it here," Dr. Gassner said, adding that a randomized trial powered to look at late mortality is needed.

The group has no current plans to conduct such a study or perform a cost analysis, although a subsequent analysis of the GALA data revealed a cost savings of about $283 favoring carotid endarterectomy using local anesthesia (Br. J. Surg. 2010;97:1218-25).

Dr. Gassner and her coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

CHICAGO – Patients undergoing carotid endarterectomy with cervical block anesthesia had fewer hemodynamic fluctuations and required less vasoactive medications than those under general anesthesia in a retrospective evaluation.

"Under cervical block anesthesia, carotid endarterectomy can be performed with a better hemodynamic profile," Dr. Marika Y. Gassner, a resident with Henry Ford Macomb Hospital, Clinton Township, Mich., said at the annual meeting of the Midwestern Vascular Surgical Society*.

Patrice Wendling/IMNG Medical Media

The practice switched in 2003 from using general anesthesia for the majority of carotid endarterectomy to performing more than 90% of cases under local cervical block anesthesia (CBA). Exceptions include patients who are extremely nervous, unable to communicate in English, or who have plaque extending above C2.

The investigators organized the retrospective cohort study after initial observations suggested patients under CBA had less intraoperative hypotension or fluctuations in mean arterial pressure below 65 mm Hg. Vasoactive therapy demands were also lower. For example, anesthesia records showed that several doses of beta-blockers and ephedrine were required for a patient under general anesthesia, while a patient under CBA had only a single dose of midazolam (Versed) early in the procedure, she said.

Other advantages of CBA include continuous feedback on neurologic status/cerebral perfusion, endotracheal intubation not required, shorter operative times, and reduced use of shunts, Dr. Gassner said.

The analysis included 651 patients who underwent carotid endarterectomy by a single surgeon at two suburban teaching hospitals, with 397 under general anesthesia (GA) and 254 under CBA.

The CBA and GA groups were similar in age (71.26 vs. 70.97 years) and incidence of coronary artery disease (57% vs. 56%), hypertension (77% vs. 75%), and renal failure (3.5% vs. 4.0%). The GA group, however, had significantly more females (39% vs. 46.6%), and a higher incidence of chronic obstructive pulmonary disease (16% vs. 23%), nicotine abuse, (50% vs. 63%), and symptomatic patients (41.3% vs. 54%).

The incidence of intraoperative hypotension (systolic BP less than 100 mm HG) was 0.52% with CBA and 17.84% with GA (P less than .001), Dr. Gassner said.

Mean arterial pressure changes of 20% or more per patient occurred in 20% and 41%, respectively (P less than .001).

Vasopressors were required during surgery in 51.13% of the GA group and 36.22% of the CBA group (P = .0002), and antihypertensive medications in 64% and 73.6% (P = .0085). Drugs from both categories were required by significantly fewer CBA patients (22.5% vs. 33.75%; P = .045), she said.

There were no deaths in either group. Postoperative complications were higher in the GA than the CBA group including myocardial infarction (4 vs. 0 events), stroke (6 vs. 0 events), hematoma (7 vs. 2 events), and return to the OR (7 vs. 0 events). The difference did not reach statistical significance because of the sample size, Dr. Gassner said.

Earlier in the presentation, she observed that there was no difference in the primary composite endpoint of stroke, myocardial infarction, or death at 30 days in the randomized GALA (general anaesthesia vs. local anaesthesia for carotid surgery) trial conducted at 95 centers in 24 countries (Lancet 2008;372:2132-42).

"If they couldn’t find it [a survival advantage] in GALA with 3,500 patients, we couldn’t find it here," Dr. Gassner said, adding that a randomized trial powered to look at late mortality is needed.

The group has no current plans to conduct such a study or perform a cost analysis, although a subsequent analysis of the GALA data revealed a cost savings of about $283 favoring carotid endarterectomy using local anesthesia (Br. J. Surg. 2010;97:1218-25).

Dr. Gassner and her coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

CHICAGO – Patients undergoing carotid endarterectomy with cervical block anesthesia had fewer hemodynamic fluctuations and required less vasoactive medications than those under general anesthesia in a retrospective evaluation.

"Under cervical block anesthesia, carotid endarterectomy can be performed with a better hemodynamic profile," Dr. Marika Y. Gassner, a resident with Henry Ford Macomb Hospital, Clinton Township, Mich., said at the annual meeting of the Midwestern Vascular Surgical Society*.

Patrice Wendling/IMNG Medical Media

The practice switched in 2003 from using general anesthesia for the majority of carotid endarterectomy to performing more than 90% of cases under local cervical block anesthesia (CBA). Exceptions include patients who are extremely nervous, unable to communicate in English, or who have plaque extending above C2.

The investigators organized the retrospective cohort study after initial observations suggested patients under CBA had less intraoperative hypotension or fluctuations in mean arterial pressure below 65 mm Hg. Vasoactive therapy demands were also lower. For example, anesthesia records showed that several doses of beta-blockers and ephedrine were required for a patient under general anesthesia, while a patient under CBA had only a single dose of midazolam (Versed) early in the procedure, she said.

Other advantages of CBA include continuous feedback on neurologic status/cerebral perfusion, endotracheal intubation not required, shorter operative times, and reduced use of shunts, Dr. Gassner said.

The analysis included 651 patients who underwent carotid endarterectomy by a single surgeon at two suburban teaching hospitals, with 397 under general anesthesia (GA) and 254 under CBA.

The CBA and GA groups were similar in age (71.26 vs. 70.97 years) and incidence of coronary artery disease (57% vs. 56%), hypertension (77% vs. 75%), and renal failure (3.5% vs. 4.0%). The GA group, however, had significantly more females (39% vs. 46.6%), and a higher incidence of chronic obstructive pulmonary disease (16% vs. 23%), nicotine abuse, (50% vs. 63%), and symptomatic patients (41.3% vs. 54%).

The incidence of intraoperative hypotension (systolic BP less than 100 mm HG) was 0.52% with CBA and 17.84% with GA (P less than .001), Dr. Gassner said.

Mean arterial pressure changes of 20% or more per patient occurred in 20% and 41%, respectively (P less than .001).

Vasopressors were required during surgery in 51.13% of the GA group and 36.22% of the CBA group (P = .0002), and antihypertensive medications in 64% and 73.6% (P = .0085). Drugs from both categories were required by significantly fewer CBA patients (22.5% vs. 33.75%; P = .045), she said.

There were no deaths in either group. Postoperative complications were higher in the GA than the CBA group including myocardial infarction (4 vs. 0 events), stroke (6 vs. 0 events), hematoma (7 vs. 2 events), and return to the OR (7 vs. 0 events). The difference did not reach statistical significance because of the sample size, Dr. Gassner said.

Earlier in the presentation, she observed that there was no difference in the primary composite endpoint of stroke, myocardial infarction, or death at 30 days in the randomized GALA (general anaesthesia vs. local anaesthesia for carotid surgery) trial conducted at 95 centers in 24 countries (Lancet 2008;372:2132-42).

"If they couldn’t find it [a survival advantage] in GALA with 3,500 patients, we couldn’t find it here," Dr. Gassner said, adding that a randomized trial powered to look at late mortality is needed.

The group has no current plans to conduct such a study or perform a cost analysis, although a subsequent analysis of the GALA data revealed a cost savings of about $283 favoring carotid endarterectomy using local anesthesia (Br. J. Surg. 2010;97:1218-25).

Dr. Gassner and her coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

CHICAGO – A novel bifurcated covered stent graft limb that uses an off-the-shelf graft can treat large common iliac aneurysms, while preserving good pelvic blood flow.

The alternative endovascular approach has been performed on 15 patients since April 2011, with a success rate of 100%. Bilateral stent grafts were placed in four patients.

The all-male cohort has been able to maintain appropriate exercise tolerance and remains free from erectile dysfunction, pelvic ischemia, buttock claudication, and paralysis.

"These people do well," extremely well, Dr. Patrick Kelly said at the annual meeting of the Midwestern Vascular Surgical Society*.

Several iliac branch grafts are currently under investigation, including the Cook Zenith Branch iliac endovascular graft. They promise to preserve flow to the internal iliac artery and thus reduce the potential for ischemic sequelae resulting from iliac embolization. Depending on patient anatomy, however, the internal iliac may become jailed upon deployment of the main body graft, said Dr. Kelly of Sanford Health, Sioux Falls, S.D. The fenestrated systems are also limited by bridging stent technology and the relatively short bridging stent.

Patrice Wendling/IMNG Medical Media

His alternative modified bifurcated limb divides the common iliac flow into the internal and external iliac arteries, while excluding the common iliac artery aneurysm.

"The pros are that it uses an off the shelf [graft], should be able to handle virtually any anatomy, can be used to treat either existing EVAR [endovascular aneurysm repair] or previous open repairs, and has multiple off-ramps, so you don’t jail yourself," he said. "The cons: It requires arm access – although I’m not sure that’s a con – and it requires three stents."

Operative details

The bifurcated limb is created by sewing an 8-mm and 10-mm covered stent graft to the distal end of a standard 16 x 20 x 82-mm stent graft limb. The distal ends of both the 8-mm and 10-mm grafts are left free, allowing flexibility and easier selection of the internal iliac artery, he said.

Once the graft is resheathed using a spiral wire technique, a traditional infrarenal abdominal aneurysm repair is performed. In order to exclude the common iliac aneurysm, the graft is oriented with the 8-mm limb toward the internal iliac and with the distal end of the 8-mm limb being deployed 2-3 cm above the origin of the internal iliac artery. The internal iliac artery is selected from an arm approach, through the 8-mm limb of the bifurcated stent graft limb.

Angiograms are performed and a 3-cm covered, self-expanding bridge stent graft is deployed. The 10-mm limb is used to extend the graft into the external iliac, thus completing exclusion of the common iliac aneurysm, while preserving both the internal and external iliac arteries, Dr. Kelly said.

Thus far, occlusion of the external iliac artery has been reported in one patient, and there were no recurring endoleaks. There was a type-3 endoleak between the main body and bridging stent that was visible on diagnostic angiography, but it resolved after being reballooned and patent flow was established upon completion angiography, Dr. Kelly explained. There was also a retrograde fill that was fixed 1 year postoperatively by extending the limb to obtain a healthy seal.

The average patient age was 65.4 years (range, 46-87 years); fluoroscopy time, 46 minutes (range, 29-91 minutes); and average length of stay 3.1 days (range, 1-9 days).

This compares with an average hospital stay of 4-7 days for the tried-and-true method of open aneurysm repair, which has bleeding rates of 30% or more, colonic ischemia in 20%-30%, and paraplegia in 2%-3%, Dr. Kelly noted.

Audience reaction

Dr. Rebecca Kelso of the Cleveland Clinic, who comoderated the session, was enthusiastic about the novel approach.

"The potential for it is quite significant, because the other main competitive device he mentioned that’s on the market still has anatomic limitations for use," she said in an interview. "So if he has something that can be used in any patient, no matter what the circumstances, well then that has significant implications for being available commercially for everyone."

Fellow moderator Dr. Patrick J. Geraghty of Washington University, St. Louis, remarked that while the approach uses a standardized graft, it is somewhat tailored since the length and the diameter of the Bivon grafts extending into the external and internal iliac arteries can be chosen separately. That said, the one-size-fits-all approach is particularly appealing because it could simplify treatment planning and reduce treatment delays.

"If you have a patient who is symptomatic and you have an off-the-shelf component, you could potentially treat them within the next 24 hours," he said in an interview. "The current turnaround time for the fenestrated system is about a month or so, so it would shorten treatment delays and might lead to a broader application of the technology."

A potentially shorter hospital length of stay could also reduce hospital costs, Dr. Kelso noted.

While the audience appeared equally enthusiastic about the results, some members questioned whether results on a physician-modified graft without an Investigational Device Exemption (IDE) should be presented at the meeting in light of recent warnings by the U.S. Food and Drug Administration that such interventions involve the use of significant-risk devices and need to be conducted under an IDE. Dr. Kelly responded that he is currently working with the FDA to obtain an IDE.

Earlier this year, the Society of Thoracic Surgeons and the American College of Cardiology became the first medical societies to receive an IDE to study alternative access for transcatheter aortic valve replacement using the STS/ACC TVT Registry

Dr. Kelly and Dr. Kelso reported having no financial disclosures. Dr. Geraghty disclosed relationships with Cook Medical and Bard/Lutonix.

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

CHICAGO – A novel bifurcated covered stent graft limb that uses an off-the-shelf graft can treat large common iliac aneurysms, while preserving good pelvic blood flow.

The alternative endovascular approach has been performed on 15 patients since April 2011, with a success rate of 100%. Bilateral stent grafts were placed in four patients.

The all-male cohort has been able to maintain appropriate exercise tolerance and remains free from erectile dysfunction, pelvic ischemia, buttock claudication, and paralysis.

"These people do well," extremely well, Dr. Patrick Kelly said at the annual meeting of the Midwestern Vascular Surgical Society*.

Several iliac branch grafts are currently under investigation, including the Cook Zenith Branch iliac endovascular graft. They promise to preserve flow to the internal iliac artery and thus reduce the potential for ischemic sequelae resulting from iliac embolization. Depending on patient anatomy, however, the internal iliac may become jailed upon deployment of the main body graft, said Dr. Kelly of Sanford Health, Sioux Falls, S.D. The fenestrated systems are also limited by bridging stent technology and the relatively short bridging stent.

Patrice Wendling/IMNG Medical Media

His alternative modified bifurcated limb divides the common iliac flow into the internal and external iliac arteries, while excluding the common iliac artery aneurysm.

"The pros are that it uses an off the shelf [graft], should be able to handle virtually any anatomy, can be used to treat either existing EVAR [endovascular aneurysm repair] or previous open repairs, and has multiple off-ramps, so you don’t jail yourself," he said. "The cons: It requires arm access – although I’m not sure that’s a con – and it requires three stents."

Operative details

The bifurcated limb is created by sewing an 8-mm and 10-mm covered stent graft to the distal end of a standard 16 x 20 x 82-mm stent graft limb. The distal ends of both the 8-mm and 10-mm grafts are left free, allowing flexibility and easier selection of the internal iliac artery, he said.

Once the graft is resheathed using a spiral wire technique, a traditional infrarenal abdominal aneurysm repair is performed. In order to exclude the common iliac aneurysm, the graft is oriented with the 8-mm limb toward the internal iliac and with the distal end of the 8-mm limb being deployed 2-3 cm above the origin of the internal iliac artery. The internal iliac artery is selected from an arm approach, through the 8-mm limb of the bifurcated stent graft limb.

Angiograms are performed and a 3-cm covered, self-expanding bridge stent graft is deployed. The 10-mm limb is used to extend the graft into the external iliac, thus completing exclusion of the common iliac aneurysm, while preserving both the internal and external iliac arteries, Dr. Kelly said.

Thus far, occlusion of the external iliac artery has been reported in one patient, and there were no recurring endoleaks. There was a type-3 endoleak between the main body and bridging stent that was visible on diagnostic angiography, but it resolved after being reballooned and patent flow was established upon completion angiography, Dr. Kelly explained. There was also a retrograde fill that was fixed 1 year postoperatively by extending the limb to obtain a healthy seal.

The average patient age was 65.4 years (range, 46-87 years); fluoroscopy time, 46 minutes (range, 29-91 minutes); and average length of stay 3.1 days (range, 1-9 days).

This compares with an average hospital stay of 4-7 days for the tried-and-true method of open aneurysm repair, which has bleeding rates of 30% or more, colonic ischemia in 20%-30%, and paraplegia in 2%-3%, Dr. Kelly noted.

Audience reaction

Dr. Rebecca Kelso of the Cleveland Clinic, who comoderated the session, was enthusiastic about the novel approach.

"The potential for it is quite significant, because the other main competitive device he mentioned that’s on the market still has anatomic limitations for use," she said in an interview. "So if he has something that can be used in any patient, no matter what the circumstances, well then that has significant implications for being available commercially for everyone."

Fellow moderator Dr. Patrick J. Geraghty of Washington University, St. Louis, remarked that while the approach uses a standardized graft, it is somewhat tailored since the length and the diameter of the Bivon grafts extending into the external and internal iliac arteries can be chosen separately. That said, the one-size-fits-all approach is particularly appealing because it could simplify treatment planning and reduce treatment delays.

"If you have a patient who is symptomatic and you have an off-the-shelf component, you could potentially treat them within the next 24 hours," he said in an interview. "The current turnaround time for the fenestrated system is about a month or so, so it would shorten treatment delays and might lead to a broader application of the technology."

A potentially shorter hospital length of stay could also reduce hospital costs, Dr. Kelso noted.

While the audience appeared equally enthusiastic about the results, some members questioned whether results on a physician-modified graft without an Investigational Device Exemption (IDE) should be presented at the meeting in light of recent warnings by the U.S. Food and Drug Administration that such interventions involve the use of significant-risk devices and need to be conducted under an IDE. Dr. Kelly responded that he is currently working with the FDA to obtain an IDE.

Earlier this year, the Society of Thoracic Surgeons and the American College of Cardiology became the first medical societies to receive an IDE to study alternative access for transcatheter aortic valve replacement using the STS/ACC TVT Registry

Dr. Kelly and Dr. Kelso reported having no financial disclosures. Dr. Geraghty disclosed relationships with Cook Medical and Bard/Lutonix.

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

CHICAGO – A novel bifurcated covered stent graft limb that uses an off-the-shelf graft can treat large common iliac aneurysms, while preserving good pelvic blood flow.

The alternative endovascular approach has been performed on 15 patients since April 2011, with a success rate of 100%. Bilateral stent grafts were placed in four patients.

The all-male cohort has been able to maintain appropriate exercise tolerance and remains free from erectile dysfunction, pelvic ischemia, buttock claudication, and paralysis.

"These people do well," extremely well, Dr. Patrick Kelly said at the annual meeting of the Midwestern Vascular Surgical Society*.

Several iliac branch grafts are currently under investigation, including the Cook Zenith Branch iliac endovascular graft. They promise to preserve flow to the internal iliac artery and thus reduce the potential for ischemic sequelae resulting from iliac embolization. Depending on patient anatomy, however, the internal iliac may become jailed upon deployment of the main body graft, said Dr. Kelly of Sanford Health, Sioux Falls, S.D. The fenestrated systems are also limited by bridging stent technology and the relatively short bridging stent.

Patrice Wendling/IMNG Medical Media

His alternative modified bifurcated limb divides the common iliac flow into the internal and external iliac arteries, while excluding the common iliac artery aneurysm.

"The pros are that it uses an off the shelf [graft], should be able to handle virtually any anatomy, can be used to treat either existing EVAR [endovascular aneurysm repair] or previous open repairs, and has multiple off-ramps, so you don’t jail yourself," he said. "The cons: It requires arm access – although I’m not sure that’s a con – and it requires three stents."

Operative details

The bifurcated limb is created by sewing an 8-mm and 10-mm covered stent graft to the distal end of a standard 16 x 20 x 82-mm stent graft limb. The distal ends of both the 8-mm and 10-mm grafts are left free, allowing flexibility and easier selection of the internal iliac artery, he said.

Once the graft is resheathed using a spiral wire technique, a traditional infrarenal abdominal aneurysm repair is performed. In order to exclude the common iliac aneurysm, the graft is oriented with the 8-mm limb toward the internal iliac and with the distal end of the 8-mm limb being deployed 2-3 cm above the origin of the internal iliac artery. The internal iliac artery is selected from an arm approach, through the 8-mm limb of the bifurcated stent graft limb.

Angiograms are performed and a 3-cm covered, self-expanding bridge stent graft is deployed. The 10-mm limb is used to extend the graft into the external iliac, thus completing exclusion of the common iliac aneurysm, while preserving both the internal and external iliac arteries, Dr. Kelly said.

Thus far, occlusion of the external iliac artery has been reported in one patient, and there were no recurring endoleaks. There was a type-3 endoleak between the main body and bridging stent that was visible on diagnostic angiography, but it resolved after being reballooned and patent flow was established upon completion angiography, Dr. Kelly explained. There was also a retrograde fill that was fixed 1 year postoperatively by extending the limb to obtain a healthy seal.

The average patient age was 65.4 years (range, 46-87 years); fluoroscopy time, 46 minutes (range, 29-91 minutes); and average length of stay 3.1 days (range, 1-9 days).

This compares with an average hospital stay of 4-7 days for the tried-and-true method of open aneurysm repair, which has bleeding rates of 30% or more, colonic ischemia in 20%-30%, and paraplegia in 2%-3%, Dr. Kelly noted.

Audience reaction

Dr. Rebecca Kelso of the Cleveland Clinic, who comoderated the session, was enthusiastic about the novel approach.

"The potential for it is quite significant, because the other main competitive device he mentioned that’s on the market still has anatomic limitations for use," she said in an interview. "So if he has something that can be used in any patient, no matter what the circumstances, well then that has significant implications for being available commercially for everyone."

Fellow moderator Dr. Patrick J. Geraghty of Washington University, St. Louis, remarked that while the approach uses a standardized graft, it is somewhat tailored since the length and the diameter of the Bivon grafts extending into the external and internal iliac arteries can be chosen separately. That said, the one-size-fits-all approach is particularly appealing because it could simplify treatment planning and reduce treatment delays.

"If you have a patient who is symptomatic and you have an off-the-shelf component, you could potentially treat them within the next 24 hours," he said in an interview. "The current turnaround time for the fenestrated system is about a month or so, so it would shorten treatment delays and might lead to a broader application of the technology."

A potentially shorter hospital length of stay could also reduce hospital costs, Dr. Kelso noted.

While the audience appeared equally enthusiastic about the results, some members questioned whether results on a physician-modified graft without an Investigational Device Exemption (IDE) should be presented at the meeting in light of recent warnings by the U.S. Food and Drug Administration that such interventions involve the use of significant-risk devices and need to be conducted under an IDE. Dr. Kelly responded that he is currently working with the FDA to obtain an IDE.

Earlier this year, the Society of Thoracic Surgeons and the American College of Cardiology became the first medical societies to receive an IDE to study alternative access for transcatheter aortic valve replacement using the STS/ACC TVT Registry

Dr. Kelly and Dr. Kelso reported having no financial disclosures. Dr. Geraghty disclosed relationships with Cook Medical and Bard/Lutonix.

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.