Damian McNamara

MIAMI BEACH – Results of a comprehensive study looking at almost 1.6 million women suggest a small but real elevated risk of thrombotic stroke and myocardial infarction associated with use of hormonal contraception among women who have hypertension.

Even hypertensive women who do not smoke were at increased risk, which suggests that there needs to be a shift in how physicians counsel women regarding use of oral contraception, according to Dr. Keith C. Ferdinand, professor of clinical medicine at Tulane University, New Orleans, and a cardiologist at the Tulane Heart and Vascular Institute in that city.

"Clearly this does suggest that if a patient is on oral contraceptives, you cannot tell them they won’t have a stroke or MI just because they don’t smoke," Dr. Ferdinand said at the meeting, which was sponsored by the International Society on Hypertension in Blacks.

"I was a little surprised by the Danish study," Dr. Ferdinand said (N. Engl. J. Med. 2012;366:2257-66). "The rule of thumb is – if you look at the package insert and at what most clinicians believe – if you’re not over 35 and you don’t smoke, you’re [essentially] okay. That is what we tell patients."

"The Danish registry suggests that although the attributable risk was low (41.5 cases out of 10,000 person-years), it’s really there."

World Health Organization guidelines state that OCs are absolutely contraindicated in women with blood pressure greater than 160 mm Hg/100 mm Hg. "You may say to the patient that if their blood pressure is significantly elevated, they may need another form of contraception." Dr. Ferdinand urged additional caution because even milder blood pressure elevations could be associated with increased risks. The good news, he added, is that the increased risk for MI and stroke does reverse with cessation of OC use.

In the Danish study, researchers assessed 1,626,158 nonpregnant women with no previous cardiovascular disease. This represented essentially the entire Danish female population aged 15-49 years, Dr. Ferdinand said. A total 3,311 thrombotic strokes and 1,725 first MIs occurred out of more than 14 million total person-years of observation in this historical cohort study.

Relative risks increased with hormonal contraceptive use. "Using contraceptive pills with estrogen and progestin did indeed increase the risk of stroke and MI," Dr. Ferdinand said, but the variation by dosage was modest. For example, higher doses of estrogen did appear to increase the relative risk of stroke, but dosing of progestin had little effect, he added.

Specifically, the absolute risks for MI and stroke were increased by a factor of 0.9 to 1.7 with oral contraceptives that included ethinyl estradiol at a dose of 20 mcg, and by a factor of 1.3 to 2.3 with OCs that included ethinyl estradiol at a dose of 30-40 mcg.

Another finding was that if a woman had diabetes, her relative risk of thrombotic stroke was 2.73 and her relative risk for an MI was 4.66. If a woman had hypertension, there was almost an equivalent increased risk of stroke (RR, 2.3), Dr. Ferdinand said. The relative risk of MI associated with hypertension was 2.17.

Dr. Ferdinand is a consultant to Astra Zeneca, Daiichi Sankyo, Forest, and Novartis. He is on the speakers bureau for Astra Zeneca, Forest, Takeda, and Novartis. He also receives grant research support from Eli Lilly, Daiichi Sankyo, Forest, and Novartis.

MIAMI BEACH – Results of a comprehensive study looking at almost 1.6 million women suggest a small but real elevated risk of thrombotic stroke and myocardial infarction associated with use of hormonal contraception among women who have hypertension.

Even hypertensive women who do not smoke were at increased risk, which suggests that there needs to be a shift in how physicians counsel women regarding use of oral contraception, according to Dr. Keith C. Ferdinand, professor of clinical medicine at Tulane University, New Orleans, and a cardiologist at the Tulane Heart and Vascular Institute in that city.

"Clearly this does suggest that if a patient is on oral contraceptives, you cannot tell them they won’t have a stroke or MI just because they don’t smoke," Dr. Ferdinand said at the meeting, which was sponsored by the International Society on Hypertension in Blacks.

"I was a little surprised by the Danish study," Dr. Ferdinand said (N. Engl. J. Med. 2012;366:2257-66). "The rule of thumb is – if you look at the package insert and at what most clinicians believe – if you’re not over 35 and you don’t smoke, you’re [essentially] okay. That is what we tell patients."

"The Danish registry suggests that although the attributable risk was low (41.5 cases out of 10,000 person-years), it’s really there."

World Health Organization guidelines state that OCs are absolutely contraindicated in women with blood pressure greater than 160 mm Hg/100 mm Hg. "You may say to the patient that if their blood pressure is significantly elevated, they may need another form of contraception." Dr. Ferdinand urged additional caution because even milder blood pressure elevations could be associated with increased risks. The good news, he added, is that the increased risk for MI and stroke does reverse with cessation of OC use.

In the Danish study, researchers assessed 1,626,158 nonpregnant women with no previous cardiovascular disease. This represented essentially the entire Danish female population aged 15-49 years, Dr. Ferdinand said. A total 3,311 thrombotic strokes and 1,725 first MIs occurred out of more than 14 million total person-years of observation in this historical cohort study.

Relative risks increased with hormonal contraceptive use. "Using contraceptive pills with estrogen and progestin did indeed increase the risk of stroke and MI," Dr. Ferdinand said, but the variation by dosage was modest. For example, higher doses of estrogen did appear to increase the relative risk of stroke, but dosing of progestin had little effect, he added.

Specifically, the absolute risks for MI and stroke were increased by a factor of 0.9 to 1.7 with oral contraceptives that included ethinyl estradiol at a dose of 20 mcg, and by a factor of 1.3 to 2.3 with OCs that included ethinyl estradiol at a dose of 30-40 mcg.

Another finding was that if a woman had diabetes, her relative risk of thrombotic stroke was 2.73 and her relative risk for an MI was 4.66. If a woman had hypertension, there was almost an equivalent increased risk of stroke (RR, 2.3), Dr. Ferdinand said. The relative risk of MI associated with hypertension was 2.17.

Dr. Ferdinand is a consultant to Astra Zeneca, Daiichi Sankyo, Forest, and Novartis. He is on the speakers bureau for Astra Zeneca, Forest, Takeda, and Novartis. He also receives grant research support from Eli Lilly, Daiichi Sankyo, Forest, and Novartis.

MIAMI BEACH – Results of a comprehensive study looking at almost 1.6 million women suggest a small but real elevated risk of thrombotic stroke and myocardial infarction associated with use of hormonal contraception among women who have hypertension.

Even hypertensive women who do not smoke were at increased risk, which suggests that there needs to be a shift in how physicians counsel women regarding use of oral contraception, according to Dr. Keith C. Ferdinand, professor of clinical medicine at Tulane University, New Orleans, and a cardiologist at the Tulane Heart and Vascular Institute in that city.

"Clearly this does suggest that if a patient is on oral contraceptives, you cannot tell them they won’t have a stroke or MI just because they don’t smoke," Dr. Ferdinand said at the meeting, which was sponsored by the International Society on Hypertension in Blacks.

"I was a little surprised by the Danish study," Dr. Ferdinand said (N. Engl. J. Med. 2012;366:2257-66). "The rule of thumb is – if you look at the package insert and at what most clinicians believe – if you’re not over 35 and you don’t smoke, you’re [essentially] okay. That is what we tell patients."

"The Danish registry suggests that although the attributable risk was low (41.5 cases out of 10,000 person-years), it’s really there."

World Health Organization guidelines state that OCs are absolutely contraindicated in women with blood pressure greater than 160 mm Hg/100 mm Hg. "You may say to the patient that if their blood pressure is significantly elevated, they may need another form of contraception." Dr. Ferdinand urged additional caution because even milder blood pressure elevations could be associated with increased risks. The good news, he added, is that the increased risk for MI and stroke does reverse with cessation of OC use.

In the Danish study, researchers assessed 1,626,158 nonpregnant women with no previous cardiovascular disease. This represented essentially the entire Danish female population aged 15-49 years, Dr. Ferdinand said. A total 3,311 thrombotic strokes and 1,725 first MIs occurred out of more than 14 million total person-years of observation in this historical cohort study.

Relative risks increased with hormonal contraceptive use. "Using contraceptive pills with estrogen and progestin did indeed increase the risk of stroke and MI," Dr. Ferdinand said, but the variation by dosage was modest. For example, higher doses of estrogen did appear to increase the relative risk of stroke, but dosing of progestin had little effect, he added.

Specifically, the absolute risks for MI and stroke were increased by a factor of 0.9 to 1.7 with oral contraceptives that included ethinyl estradiol at a dose of 20 mcg, and by a factor of 1.3 to 2.3 with OCs that included ethinyl estradiol at a dose of 30-40 mcg.

Another finding was that if a woman had diabetes, her relative risk of thrombotic stroke was 2.73 and her relative risk for an MI was 4.66. If a woman had hypertension, there was almost an equivalent increased risk of stroke (RR, 2.3), Dr. Ferdinand said. The relative risk of MI associated with hypertension was 2.17.

Dr. Ferdinand is a consultant to Astra Zeneca, Daiichi Sankyo, Forest, and Novartis. He is on the speakers bureau for Astra Zeneca, Forest, Takeda, and Novartis. He also receives grant research support from Eli Lilly, Daiichi Sankyo, Forest, and Novartis.

How you counsel parents regarding their ultimate decision about male infant circumcision could change based on a new policy statement from the American Academy of Pediatrics.

The academy points to stronger evidence of health benefits that outweigh the risks of the procedure in an updated circumcision policy statement (Pediatrics 2012 Aug. 27;130:585-86). Data support the prevention of urinary tract infections, penile cancer, and transmission of some sexually transmitted infections, including HIV, for example, based on a systematic review of the medical literature.

The final decision lies with parents. However, the evidence is now strong enough to justify access to circumcision and third-party insurance payment for all families who choose the procedure, the American Academy of Pediatrics stated.

"What we suggest is that, having reviewed the literature, especially incorporating the new data on HIV acquisition, we feel that circumcision does have a lot of benefit and some very modest risk," Dr. Andrew Freedman, a member of the AAP Task Force on Circumcision, said in an interview. "Overall, the benefits are probably greater than the risks, or at least great enough that for a family that wishes to have a circumcision, we feel they should be allowed to have a circumcision."

"However, the benefits are not so great that we are advocating a universal recommendation. We’re not suggesting everyone should have a circumcision," added Dr. Freedman, who is vice chair of pediatric surgical services and director of pediatric urology at Cedars-Sinai Medical Center in Los Angeles.

The task force recognized that the medical considerations are just one part of the decision making process, Dr. Freedman said. "For families, this cuts across other paradigms: the ethnic, the religious, and the aesthetic."

Pediatricians play a vital role in counseling families. Dr. Freedman suggested physicians read the technical report that accompanies the policy statement (Pediatrics 2012 Aug. 27;130:e756-85) for "a very robust discussion of the scientific data that I think will be very helpful to pediatricians counseling [families] about circumcision, to provide them with the most relevant data from the literature review."

The health benefits of circumcision include lowering the risk of urinary tract infections in the first 2 years of life (Pediatr. Infect. Dis. J. 2008;27:302-8).The literature review also indicates the procedure lowers the risk of acquiring HIV (PLoS One 2010;5:e8723); genital herpes (CDC fact sheet, Jan. 31, 2012); and human papillomavirus virus (Lancet 2011;377:209-18). To a lesser extent, the evidence also suggests a protective effect against syphilis (Lancet Infect Dis. 2009;9:669-77).

The task force also considered evidence that circumcision can lower the risk of penile cancer over a lifetime (Int. J. Cancer. 2005;116:606-116); and the risk of cervical cancer in sexual partners (N. Engl. J. Med. 2002;346:1105-12).

There is a lot of partisanship regarding circumcision, Dr. Freedman said. "People are for it or against it, and they don’t recognize the AAP is not in that game. We are just trying to do a fair, scientific review of the data and put the medical aspect into context."

"What we’ve tried to do is add clarification because it’s a nuanced policy. The old policy was as well, but people did not appreciate that," he said. "People tended to want to see the policy as a ‘yes or no’ vote on circumcision."

"Everyone [on the task force] approached it from the standpoint that we should start without any preconceived bias. Let the data drive where it goes." Once task force members identified the relevant issues, accumulated the research, presented it to each other, and discussed the findings, "we reached consensus pretty easily," he said.

The policy statement updates the previous policy on circumcision that the AAP published in 1999 and reaffirmed in 2005.

The Circumcision Resource Center, a critic of circumcision, responded to the AAP policy statement by saying, "The circumcision literature reflects the pro-circumcision bias of circumcised American researchers who seek to find benefits and avoid studying the harms of circumcision. ... The United States is the only country in the world that circumcises many of its male infants for nonreligious reasons." It then counters some specific points covered in the AAP policy with its own views in a statement on its website.*

The American College of Obstetricians and Gynecologists endorsed the AAP policy statement and the technical report. ACOG provided a liaison member to the task force, as did the American Academy of Family Physicians and the Centers for Disease Control and Prevention.

The Agency for Healthcare Research and Quality’s National Inpatient Sample data from 1988 to 2008 reveal that the rate of circumcision performed during newborn male delivery hospitalizations rose from 48% in 1988-1991, to 61% in 1997-2000, then fell to 56% in 2000-2008. This does not include out-of hospital circumcisions and thus underestimates the rate of male circumcisions in the first month of life.

Dr. Freedman said that he had no relevant financial disclosures. 

* This story was updated with new information on 8/29/2012.

How you counsel parents regarding their ultimate decision about male infant circumcision could change based on a new policy statement from the American Academy of Pediatrics.

The academy points to stronger evidence of health benefits that outweigh the risks of the procedure in an updated circumcision policy statement (Pediatrics 2012 Aug. 27;130:585-86). Data support the prevention of urinary tract infections, penile cancer, and transmission of some sexually transmitted infections, including HIV, for example, based on a systematic review of the medical literature.

The final decision lies with parents. However, the evidence is now strong enough to justify access to circumcision and third-party insurance payment for all families who choose the procedure, the American Academy of Pediatrics stated.

"What we suggest is that, having reviewed the literature, especially incorporating the new data on HIV acquisition, we feel that circumcision does have a lot of benefit and some very modest risk," Dr. Andrew Freedman, a member of the AAP Task Force on Circumcision, said in an interview. "Overall, the benefits are probably greater than the risks, or at least great enough that for a family that wishes to have a circumcision, we feel they should be allowed to have a circumcision."

"However, the benefits are not so great that we are advocating a universal recommendation. We’re not suggesting everyone should have a circumcision," added Dr. Freedman, who is vice chair of pediatric surgical services and director of pediatric urology at Cedars-Sinai Medical Center in Los Angeles.

The task force recognized that the medical considerations are just one part of the decision making process, Dr. Freedman said. "For families, this cuts across other paradigms: the ethnic, the religious, and the aesthetic."

Pediatricians play a vital role in counseling families. Dr. Freedman suggested physicians read the technical report that accompanies the policy statement (Pediatrics 2012 Aug. 27;130:e756-85) for "a very robust discussion of the scientific data that I think will be very helpful to pediatricians counseling [families] about circumcision, to provide them with the most relevant data from the literature review."

The health benefits of circumcision include lowering the risk of urinary tract infections in the first 2 years of life (Pediatr. Infect. Dis. J. 2008;27:302-8).The literature review also indicates the procedure lowers the risk of acquiring HIV (PLoS One 2010;5:e8723); genital herpes (CDC fact sheet, Jan. 31, 2012); and human papillomavirus virus (Lancet 2011;377:209-18). To a lesser extent, the evidence also suggests a protective effect against syphilis (Lancet Infect Dis. 2009;9:669-77).

The task force also considered evidence that circumcision can lower the risk of penile cancer over a lifetime (Int. J. Cancer. 2005;116:606-116); and the risk of cervical cancer in sexual partners (N. Engl. J. Med. 2002;346:1105-12).

There is a lot of partisanship regarding circumcision, Dr. Freedman said. "People are for it or against it, and they don’t recognize the AAP is not in that game. We are just trying to do a fair, scientific review of the data and put the medical aspect into context."

"What we’ve tried to do is add clarification because it’s a nuanced policy. The old policy was as well, but people did not appreciate that," he said. "People tended to want to see the policy as a ‘yes or no’ vote on circumcision."

"Everyone [on the task force] approached it from the standpoint that we should start without any preconceived bias. Let the data drive where it goes." Once task force members identified the relevant issues, accumulated the research, presented it to each other, and discussed the findings, "we reached consensus pretty easily," he said.

The policy statement updates the previous policy on circumcision that the AAP published in 1999 and reaffirmed in 2005.

The Circumcision Resource Center, a critic of circumcision, responded to the AAP policy statement by saying, "The circumcision literature reflects the pro-circumcision bias of circumcised American researchers who seek to find benefits and avoid studying the harms of circumcision. ... The United States is the only country in the world that circumcises many of its male infants for nonreligious reasons." It then counters some specific points covered in the AAP policy with its own views in a statement on its website.*

The American College of Obstetricians and Gynecologists endorsed the AAP policy statement and the technical report. ACOG provided a liaison member to the task force, as did the American Academy of Family Physicians and the Centers for Disease Control and Prevention.

The Agency for Healthcare Research and Quality’s National Inpatient Sample data from 1988 to 2008 reveal that the rate of circumcision performed during newborn male delivery hospitalizations rose from 48% in 1988-1991, to 61% in 1997-2000, then fell to 56% in 2000-2008. This does not include out-of hospital circumcisions and thus underestimates the rate of male circumcisions in the first month of life.

Dr. Freedman said that he had no relevant financial disclosures. 

* This story was updated with new information on 8/29/2012.

How you counsel parents regarding their ultimate decision about male infant circumcision could change based on a new policy statement from the American Academy of Pediatrics.

The academy points to stronger evidence of health benefits that outweigh the risks of the procedure in an updated circumcision policy statement (Pediatrics 2012 Aug. 27;130:585-86). Data support the prevention of urinary tract infections, penile cancer, and transmission of some sexually transmitted infections, including HIV, for example, based on a systematic review of the medical literature.

The final decision lies with parents. However, the evidence is now strong enough to justify access to circumcision and third-party insurance payment for all families who choose the procedure, the American Academy of Pediatrics stated.

"What we suggest is that, having reviewed the literature, especially incorporating the new data on HIV acquisition, we feel that circumcision does have a lot of benefit and some very modest risk," Dr. Andrew Freedman, a member of the AAP Task Force on Circumcision, said in an interview. "Overall, the benefits are probably greater than the risks, or at least great enough that for a family that wishes to have a circumcision, we feel they should be allowed to have a circumcision."

"However, the benefits are not so great that we are advocating a universal recommendation. We’re not suggesting everyone should have a circumcision," added Dr. Freedman, who is vice chair of pediatric surgical services and director of pediatric urology at Cedars-Sinai Medical Center in Los Angeles.

The task force recognized that the medical considerations are just one part of the decision making process, Dr. Freedman said. "For families, this cuts across other paradigms: the ethnic, the religious, and the aesthetic."

Pediatricians play a vital role in counseling families. Dr. Freedman suggested physicians read the technical report that accompanies the policy statement (Pediatrics 2012 Aug. 27;130:e756-85) for "a very robust discussion of the scientific data that I think will be very helpful to pediatricians counseling [families] about circumcision, to provide them with the most relevant data from the literature review."

The health benefits of circumcision include lowering the risk of urinary tract infections in the first 2 years of life (Pediatr. Infect. Dis. J. 2008;27:302-8).The literature review also indicates the procedure lowers the risk of acquiring HIV (PLoS One 2010;5:e8723); genital herpes (CDC fact sheet, Jan. 31, 2012); and human papillomavirus virus (Lancet 2011;377:209-18). To a lesser extent, the evidence also suggests a protective effect against syphilis (Lancet Infect Dis. 2009;9:669-77).

The task force also considered evidence that circumcision can lower the risk of penile cancer over a lifetime (Int. J. Cancer. 2005;116:606-116); and the risk of cervical cancer in sexual partners (N. Engl. J. Med. 2002;346:1105-12).

There is a lot of partisanship regarding circumcision, Dr. Freedman said. "People are for it or against it, and they don’t recognize the AAP is not in that game. We are just trying to do a fair, scientific review of the data and put the medical aspect into context."

"What we’ve tried to do is add clarification because it’s a nuanced policy. The old policy was as well, but people did not appreciate that," he said. "People tended to want to see the policy as a ‘yes or no’ vote on circumcision."

"Everyone [on the task force] approached it from the standpoint that we should start without any preconceived bias. Let the data drive where it goes." Once task force members identified the relevant issues, accumulated the research, presented it to each other, and discussed the findings, "we reached consensus pretty easily," he said.

The policy statement updates the previous policy on circumcision that the AAP published in 1999 and reaffirmed in 2005.

The Circumcision Resource Center, a critic of circumcision, responded to the AAP policy statement by saying, "The circumcision literature reflects the pro-circumcision bias of circumcised American researchers who seek to find benefits and avoid studying the harms of circumcision. ... The United States is the only country in the world that circumcises many of its male infants for nonreligious reasons." It then counters some specific points covered in the AAP policy with its own views in a statement on its website.*

The American College of Obstetricians and Gynecologists endorsed the AAP policy statement and the technical report. ACOG provided a liaison member to the task force, as did the American Academy of Family Physicians and the Centers for Disease Control and Prevention.

The Agency for Healthcare Research and Quality’s National Inpatient Sample data from 1988 to 2008 reveal that the rate of circumcision performed during newborn male delivery hospitalizations rose from 48% in 1988-1991, to 61% in 1997-2000, then fell to 56% in 2000-2008. This does not include out-of hospital circumcisions and thus underestimates the rate of male circumcisions in the first month of life.

Dr. Freedman said that he had no relevant financial disclosures. 

* This story was updated with new information on 8/29/2012.

MIAMI BEACH – Just slightly more than half of black patients with hypertension attained their systolic and diastolic blood pressure goals at 1 year in a large, cross-sectional study, which suggests that more aggressive intervention is needed.

"There is a perception among some ... that hypertension is not an issue, that patients are well controlled. The ultimate goal of this research is to vet that," Michael Hagan, Dr.P.H., said at a meeting sponsored by the International Society on Hypertension in Blacks.

Damian McNamara/IMNG Medical Media

Another prominent finding is that combination drug therapy outperformed the use of only one agent at a time, according to this General Electric electronic medical record database study of 9,251 hypertensive blacks. In addition, notable differences in efficacy emerged among 16 different treatment strategies, Dr. Hagan reported.

Despite at least 1 year of treatment, only 53% of the study subjects achieved a blood pressure goal below 140/90 mm Hg (or below 130/80 mmHg if they had diabetes or chronic kidney disease). "So far, we’ve found a large, unmet need in terms of getting patients to goal."

Goal attainment varied by therapy, with combination therapy outshining monotherapy in general. Goals were met by 67% of patients taking a beta-blocker plus diuretic, by 65% of those taking a thiazide or thiazidelike diuretic, by 57% of those taking an ACE inhibitor plus hydrochlorothiazide, by 54% of those taking a calcium channel blocker, by 51% of patients taking an angiotensin receptor blocker plus hydrochlorothiazide, by 46% of those on ACE inhibitor monotherapy, and by 45% of those prescribed an angiotensin receptor blocker alone.

The study also reveals differences in systolic and diastolic blood pressure decreases after 6 months and 1 year. "The combination of beta-blocker plus diuretic had the largest effect," said Dr. Hagan, director of global health economics and outcomes research at Takeda Pharmaceuticals North America.

At both 6 months and 1 year, patients taking a beta-blocker and diuretic experienced the greatest decrease in systolic blood pressure (about 13%) compared with baseline measures. This combination also was associated with the greatest decrease in diastolic blood pressure at 6 months (12%). Patients taking an ACE inhibitor plus hydrochlorothiazide experienced the greatest drop in diastolic pressure at 1 year (11%).

Interestingly, only 1% of the study population was prescribed the most effective combination. In contrast, 21% were prescribed the most common treatment: an ACE inhibitor. Next most common were calcium channel blockers (17%); thiazide or thiazidelike diuretics (15%); an ACE inhibitor plus hydrochlorothiazide (15%); an ARB plus hydrochlorothiazide; and an ARB alone (7%).

Overall mean baseline blood pressure was 146/87 mm Hg. A significant decrease to 132/79 mm Hg was observed at 1 year, Dr. Hagan reported.

This potential limitation stems from the retrospective, cross-sectional design of the study, which limits investigating why patients were prescribed a certain regimen, for example. Additional findings are forthcoming, Dr. Hagan added, and could include assessment of antihypertensive use and efficacy in the general hypertensive population, as well as the treatment profile of certain higher risk subgroups.

Mean patient age in the study was 58 years and 68% were women. The most prevalent risk factors for hypertension were obesity (65%), stage 2 hypertension (50%), and diabetes (43%).

Takeda Pharmaceuticals sponsored this study.

MIAMI BEACH – Just slightly more than half of black patients with hypertension attained their systolic and diastolic blood pressure goals at 1 year in a large, cross-sectional study, which suggests that more aggressive intervention is needed.

"There is a perception among some ... that hypertension is not an issue, that patients are well controlled. The ultimate goal of this research is to vet that," Michael Hagan, Dr.P.H., said at a meeting sponsored by the International Society on Hypertension in Blacks.

Damian McNamara/IMNG Medical Media

Another prominent finding is that combination drug therapy outperformed the use of only one agent at a time, according to this General Electric electronic medical record database study of 9,251 hypertensive blacks. In addition, notable differences in efficacy emerged among 16 different treatment strategies, Dr. Hagan reported.

Despite at least 1 year of treatment, only 53% of the study subjects achieved a blood pressure goal below 140/90 mm Hg (or below 130/80 mmHg if they had diabetes or chronic kidney disease). "So far, we’ve found a large, unmet need in terms of getting patients to goal."

Goal attainment varied by therapy, with combination therapy outshining monotherapy in general. Goals were met by 67% of patients taking a beta-blocker plus diuretic, by 65% of those taking a thiazide or thiazidelike diuretic, by 57% of those taking an ACE inhibitor plus hydrochlorothiazide, by 54% of those taking a calcium channel blocker, by 51% of patients taking an angiotensin receptor blocker plus hydrochlorothiazide, by 46% of those on ACE inhibitor monotherapy, and by 45% of those prescribed an angiotensin receptor blocker alone.

The study also reveals differences in systolic and diastolic blood pressure decreases after 6 months and 1 year. "The combination of beta-blocker plus diuretic had the largest effect," said Dr. Hagan, director of global health economics and outcomes research at Takeda Pharmaceuticals North America.

At both 6 months and 1 year, patients taking a beta-blocker and diuretic experienced the greatest decrease in systolic blood pressure (about 13%) compared with baseline measures. This combination also was associated with the greatest decrease in diastolic blood pressure at 6 months (12%). Patients taking an ACE inhibitor plus hydrochlorothiazide experienced the greatest drop in diastolic pressure at 1 year (11%).

Interestingly, only 1% of the study population was prescribed the most effective combination. In contrast, 21% were prescribed the most common treatment: an ACE inhibitor. Next most common were calcium channel blockers (17%); thiazide or thiazidelike diuretics (15%); an ACE inhibitor plus hydrochlorothiazide (15%); an ARB plus hydrochlorothiazide; and an ARB alone (7%).

Overall mean baseline blood pressure was 146/87 mm Hg. A significant decrease to 132/79 mm Hg was observed at 1 year, Dr. Hagan reported.

This potential limitation stems from the retrospective, cross-sectional design of the study, which limits investigating why patients were prescribed a certain regimen, for example. Additional findings are forthcoming, Dr. Hagan added, and could include assessment of antihypertensive use and efficacy in the general hypertensive population, as well as the treatment profile of certain higher risk subgroups.

Mean patient age in the study was 58 years and 68% were women. The most prevalent risk factors for hypertension were obesity (65%), stage 2 hypertension (50%), and diabetes (43%).

Takeda Pharmaceuticals sponsored this study.

MIAMI BEACH – Just slightly more than half of black patients with hypertension attained their systolic and diastolic blood pressure goals at 1 year in a large, cross-sectional study, which suggests that more aggressive intervention is needed.

"There is a perception among some ... that hypertension is not an issue, that patients are well controlled. The ultimate goal of this research is to vet that," Michael Hagan, Dr.P.H., said at a meeting sponsored by the International Society on Hypertension in Blacks.

Damian McNamara/IMNG Medical Media

Another prominent finding is that combination drug therapy outperformed the use of only one agent at a time, according to this General Electric electronic medical record database study of 9,251 hypertensive blacks. In addition, notable differences in efficacy emerged among 16 different treatment strategies, Dr. Hagan reported.

Despite at least 1 year of treatment, only 53% of the study subjects achieved a blood pressure goal below 140/90 mm Hg (or below 130/80 mmHg if they had diabetes or chronic kidney disease). "So far, we’ve found a large, unmet need in terms of getting patients to goal."

Goal attainment varied by therapy, with combination therapy outshining monotherapy in general. Goals were met by 67% of patients taking a beta-blocker plus diuretic, by 65% of those taking a thiazide or thiazidelike diuretic, by 57% of those taking an ACE inhibitor plus hydrochlorothiazide, by 54% of those taking a calcium channel blocker, by 51% of patients taking an angiotensin receptor blocker plus hydrochlorothiazide, by 46% of those on ACE inhibitor monotherapy, and by 45% of those prescribed an angiotensin receptor blocker alone.

The study also reveals differences in systolic and diastolic blood pressure decreases after 6 months and 1 year. "The combination of beta-blocker plus diuretic had the largest effect," said Dr. Hagan, director of global health economics and outcomes research at Takeda Pharmaceuticals North America.

At both 6 months and 1 year, patients taking a beta-blocker and diuretic experienced the greatest decrease in systolic blood pressure (about 13%) compared with baseline measures. This combination also was associated with the greatest decrease in diastolic blood pressure at 6 months (12%). Patients taking an ACE inhibitor plus hydrochlorothiazide experienced the greatest drop in diastolic pressure at 1 year (11%).

Interestingly, only 1% of the study population was prescribed the most effective combination. In contrast, 21% were prescribed the most common treatment: an ACE inhibitor. Next most common were calcium channel blockers (17%); thiazide or thiazidelike diuretics (15%); an ACE inhibitor plus hydrochlorothiazide (15%); an ARB plus hydrochlorothiazide; and an ARB alone (7%).

Overall mean baseline blood pressure was 146/87 mm Hg. A significant decrease to 132/79 mm Hg was observed at 1 year, Dr. Hagan reported.

This potential limitation stems from the retrospective, cross-sectional design of the study, which limits investigating why patients were prescribed a certain regimen, for example. Additional findings are forthcoming, Dr. Hagan added, and could include assessment of antihypertensive use and efficacy in the general hypertensive population, as well as the treatment profile of certain higher risk subgroups.

Mean patient age in the study was 58 years and 68% were women. The most prevalent risk factors for hypertension were obesity (65%), stage 2 hypertension (50%), and diabetes (43%).

Takeda Pharmaceuticals sponsored this study.

One day, when Dr. George E. Kikano was taking care of a patient he’d known for years, the unexpected occurred – 25 million unexpecteds, to be exact.

The patient was Albert J. Weatherhead, a major philanthropist. Through their foundation, Mr. Weatherhead and his wife Celia have given more than $100 million to Harvard University, pledged another $100 million to Tulane University, and supported many other institutions nationwide.

Courtesy University Hospitals Cleveland

They also happen to live in the Cleveland area, where family physician Dr. Kikano had launched a number of innovative community health outreach programs in recent years.

"Mr. Weatherhead came in one day when he was sick," Dr. Kikano recalls. "He said: ‘George, I appreciate all the good programs you are doing to help in the community. This is something my wife and I have decided to support with $25 million.’

"This was not money to name a building or put a billboard out there," Dr. Kikano said. "This is just going to go to develop programs to help the community."

The Weatherheads’ gift will bolster existing health care and disease prevention outreach programs. A multidisciplinary house-calls program, now in its seventh year and run by family physician Dr. Peter DeGolia, is an example. The money also will allow Dr. Kikano and his colleagues to devise new ways to address the needs of underserved residents in Cleveland.

Prior to the Weatherheads’ gift, outreach services were funded through smaller grants from other individuals and foundations. "This is completely mission driven. You don’t make money doing this, but you do it for people," Dr. Kikano said in an interview.

Courtesy University Hospitals Cleveland

No one would fault Dr. Kikano if he chose to focus solely on inpatient care. He is the Dorothy Jones Weatherhead Professor of Family Medicine & Community Health at Case Western Reserve University School of Medicine. However, Dr. Kikano saw a great need outside the walls of the institution as well.

"We have great hospitals [in Cleveland], but health care is not the best in our county in Ohio, Cuyahoga County," Dr. Kikano said during a presentation at the annual meeting of the International Society on Hypertension in Blacks in Miami Beach. "I see two different populations. There is more than 20 years’ difference in life expectancy [in communities] 6 miles apart. It’s amazing."

The $25 million grant establishes the Weatherhead Institute for Family Medicine & Community Health. The institute’s priorities include fighting the childhood obesity epidemic; supplying fresh fruit and other healthy foods to residents who can shop only at inner-city grocery stores; and targeting the high rates of hypertension, diabetes, and other chronic health conditions.

Mapping of seniors in the local communities around university hospitals is another project. "I have 20,000 seniors living in poverty with no primary care," Dr. Kikano said. "When they get sick, they go to the ER or they see me for an appointment, with the next available appointment at 2-3 months."

Nearly one-third of noninstitutionalized seniors in the community live alone. Many are medically complex. The typical house-call patient is an older woman with five or more comorbid chronic conditions and eight or more prescribed medications.

"Most of what we see is hypertension, heart failure, diabetes, osteoarthritis, and dementia," Dr. Kikano said. He described ‘Jamie,’ a 97-year-old woman with all five of these conditions who "lives, essentially, across the street from the Cleveland Clinic." Taking her two blocks by ambulance to the emergency department costs the county $1,000 each time.

In contrast, Medicare reimburses the house call program $85 for each monthly visit to her home.

In addition to identifying challenges in the community, Dr. Kikano and his colleagues devise solutions as well. For example, after they discovered a lack of pharmacies in Cleveland’s inner-city neighborhoods, they found a local pharmacy willing to deliver with no extra fee or kickback. "This made a huge difference."

Although you may not count major philanthropists among your patients, Dr. Kikano has a message for other physicians: "The message is do the right things for the right reasons, and the money will follow."

In September 2011, shortly after surprising Dr. Kikano with his $25 million gift, Albert Weatherhead died from cancer and pneumonia. He was 86 years old.

Mr. McNamara is Miami Bureau Chief. Follow him on Twitter@MedReporter on Twitter.

Courtesy University Hospitals Cleveland

Courtesy University Hospitals Cleveland

One day, when Dr. George E. Kikano was taking care of a patient he’d known for years, the unexpected occurred – 25 million unexpecteds, to be exact.

The patient was Albert J. Weatherhead, a major philanthropist. Through their foundation, Mr. Weatherhead and his wife Celia have given more than $100 million to Harvard University, pledged another $100 million to Tulane University, and supported many other institutions nationwide.

Courtesy University Hospitals Cleveland

They also happen to live in the Cleveland area, where family physician Dr. Kikano had launched a number of innovative community health outreach programs in recent years.

"Mr. Weatherhead came in one day when he was sick," Dr. Kikano recalls. "He said: ‘George, I appreciate all the good programs you are doing to help in the community. This is something my wife and I have decided to support with $25 million.’

"This was not money to name a building or put a billboard out there," Dr. Kikano said. "This is just going to go to develop programs to help the community."

The Weatherheads’ gift will bolster existing health care and disease prevention outreach programs. A multidisciplinary house-calls program, now in its seventh year and run by family physician Dr. Peter DeGolia, is an example. The money also will allow Dr. Kikano and his colleagues to devise new ways to address the needs of underserved residents in Cleveland.

Prior to the Weatherheads’ gift, outreach services were funded through smaller grants from other individuals and foundations. "This is completely mission driven. You don’t make money doing this, but you do it for people," Dr. Kikano said in an interview.

Courtesy University Hospitals Cleveland

No one would fault Dr. Kikano if he chose to focus solely on inpatient care. He is the Dorothy Jones Weatherhead Professor of Family Medicine & Community Health at Case Western Reserve University School of Medicine. However, Dr. Kikano saw a great need outside the walls of the institution as well.

"We have great hospitals [in Cleveland], but health care is not the best in our county in Ohio, Cuyahoga County," Dr. Kikano said during a presentation at the annual meeting of the International Society on Hypertension in Blacks in Miami Beach. "I see two different populations. There is more than 20 years’ difference in life expectancy [in communities] 6 miles apart. It’s amazing."

The $25 million grant establishes the Weatherhead Institute for Family Medicine & Community Health. The institute’s priorities include fighting the childhood obesity epidemic; supplying fresh fruit and other healthy foods to residents who can shop only at inner-city grocery stores; and targeting the high rates of hypertension, diabetes, and other chronic health conditions.

Mapping of seniors in the local communities around university hospitals is another project. "I have 20,000 seniors living in poverty with no primary care," Dr. Kikano said. "When they get sick, they go to the ER or they see me for an appointment, with the next available appointment at 2-3 months."

Nearly one-third of noninstitutionalized seniors in the community live alone. Many are medically complex. The typical house-call patient is an older woman with five or more comorbid chronic conditions and eight or more prescribed medications.

"Most of what we see is hypertension, heart failure, diabetes, osteoarthritis, and dementia," Dr. Kikano said. He described ‘Jamie,’ a 97-year-old woman with all five of these conditions who "lives, essentially, across the street from the Cleveland Clinic." Taking her two blocks by ambulance to the emergency department costs the county $1,000 each time.

In contrast, Medicare reimburses the house call program $85 for each monthly visit to her home.

In addition to identifying challenges in the community, Dr. Kikano and his colleagues devise solutions as well. For example, after they discovered a lack of pharmacies in Cleveland’s inner-city neighborhoods, they found a local pharmacy willing to deliver with no extra fee or kickback. "This made a huge difference."

Although you may not count major philanthropists among your patients, Dr. Kikano has a message for other physicians: "The message is do the right things for the right reasons, and the money will follow."

In September 2011, shortly after surprising Dr. Kikano with his $25 million gift, Albert Weatherhead died from cancer and pneumonia. He was 86 years old.

Mr. McNamara is Miami Bureau Chief. Follow him on Twitter@MedReporter on Twitter.

Courtesy University Hospitals Cleveland

Courtesy University Hospitals Cleveland

One day, when Dr. George E. Kikano was taking care of a patient he’d known for years, the unexpected occurred – 25 million unexpecteds, to be exact.

The patient was Albert J. Weatherhead, a major philanthropist. Through their foundation, Mr. Weatherhead and his wife Celia have given more than $100 million to Harvard University, pledged another $100 million to Tulane University, and supported many other institutions nationwide.

Courtesy University Hospitals Cleveland

They also happen to live in the Cleveland area, where family physician Dr. Kikano had launched a number of innovative community health outreach programs in recent years.

"Mr. Weatherhead came in one day when he was sick," Dr. Kikano recalls. "He said: ‘George, I appreciate all the good programs you are doing to help in the community. This is something my wife and I have decided to support with $25 million.’

"This was not money to name a building or put a billboard out there," Dr. Kikano said. "This is just going to go to develop programs to help the community."

The Weatherheads’ gift will bolster existing health care and disease prevention outreach programs. A multidisciplinary house-calls program, now in its seventh year and run by family physician Dr. Peter DeGolia, is an example. The money also will allow Dr. Kikano and his colleagues to devise new ways to address the needs of underserved residents in Cleveland.

Prior to the Weatherheads’ gift, outreach services were funded through smaller grants from other individuals and foundations. "This is completely mission driven. You don’t make money doing this, but you do it for people," Dr. Kikano said in an interview.

Courtesy University Hospitals Cleveland

No one would fault Dr. Kikano if he chose to focus solely on inpatient care. He is the Dorothy Jones Weatherhead Professor of Family Medicine & Community Health at Case Western Reserve University School of Medicine. However, Dr. Kikano saw a great need outside the walls of the institution as well.

"We have great hospitals [in Cleveland], but health care is not the best in our county in Ohio, Cuyahoga County," Dr. Kikano said during a presentation at the annual meeting of the International Society on Hypertension in Blacks in Miami Beach. "I see two different populations. There is more than 20 years’ difference in life expectancy [in communities] 6 miles apart. It’s amazing."

The $25 million grant establishes the Weatherhead Institute for Family Medicine & Community Health. The institute’s priorities include fighting the childhood obesity epidemic; supplying fresh fruit and other healthy foods to residents who can shop only at inner-city grocery stores; and targeting the high rates of hypertension, diabetes, and other chronic health conditions.

Mapping of seniors in the local communities around university hospitals is another project. "I have 20,000 seniors living in poverty with no primary care," Dr. Kikano said. "When they get sick, they go to the ER or they see me for an appointment, with the next available appointment at 2-3 months."

Nearly one-third of noninstitutionalized seniors in the community live alone. Many are medically complex. The typical house-call patient is an older woman with five or more comorbid chronic conditions and eight or more prescribed medications.

"Most of what we see is hypertension, heart failure, diabetes, osteoarthritis, and dementia," Dr. Kikano said. He described ‘Jamie,’ a 97-year-old woman with all five of these conditions who "lives, essentially, across the street from the Cleveland Clinic." Taking her two blocks by ambulance to the emergency department costs the county $1,000 each time.

In contrast, Medicare reimburses the house call program $85 for each monthly visit to her home.

In addition to identifying challenges in the community, Dr. Kikano and his colleagues devise solutions as well. For example, after they discovered a lack of pharmacies in Cleveland’s inner-city neighborhoods, they found a local pharmacy willing to deliver with no extra fee or kickback. "This made a huge difference."

Although you may not count major philanthropists among your patients, Dr. Kikano has a message for other physicians: "The message is do the right things for the right reasons, and the money will follow."

In September 2011, shortly after surprising Dr. Kikano with his $25 million gift, Albert Weatherhead died from cancer and pneumonia. He was 86 years old.

Mr. McNamara is Miami Bureau Chief. Follow him on Twitter@MedReporter on Twitter.

Courtesy University Hospitals Cleveland

Courtesy University Hospitals Cleveland

MIAMI BEACH – When it comes to heart failure, women tend to respond better to cardiac resynchronization therapy than do men, but for a long time no one knew why.

Turns out women have some distinct physiologic advantages, specifically more left bundle branch block and more nonischemic cardiomyopathy. Each drives a better response to cardiac resynchronization therapy (CRT), said Dr. David G. Strauss, a medical officer at the Food and Drug Administration’s Center for Devices and Radiologic Health in Silver Spring, Md.

In addition, timing of a specific electrical component within the heart triggers a third important distinction. Women benefit significantly from CRT even when their QRS duration is shorter than 150 msec. This supports the need for new gender-specific criteria for left bundle branch block and, ultimately, better identification of patients most likely to benefit from CRT device placement, Dr. Strauss said at the annual meeting of the International Society on Hypertension in Blacks.

"This is important because different professional societies recently have recommended that CRT be given to patients with QRS duration of 150 msec or more, and primarily in class II heart failure," he said. However, this cutoff "would exclude women with left bundle branch block and QRS duration 130-149 msec that derived significant benefit in MADIT-CRT" (Circulation 2011;123:1061-72).

In MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial–Cardiac Resynchronization Therapy), 1,820 patients were randomly assigned to receive CRT with an implantable cardioverter-defibrillator (ICD) or an ICD alone. In men with QRS duration of 130-140 msec in the study, there was no benefit from CRT and a trend toward harm associated with the device (hazard ratio, 1.69), Dr. Strauss said.

In contrast, women with QRS durations of 130-140 msec "had very significant benefit from CRT with a hazard ratio of 0.20, indicating 80% decrease in heart failure hospitalization or death," Dr. Strauss said.

More nonischemic cardiomyopathy among women translates to less myocardial scar and, ultimately, to a better CRT response. Scar tissue, no matter how it is electrically activated, does not contract, Dr. Strauss said.

Presence of left bundle branch block conferred a significant benefit in terms of reduced heart failure hospitalizations and deaths with use of CRT in the MADIT-CRT research. Conversely, participants without left bundle branch block realized no clinical advantage with CRT.

Be careful, however, to correctly identify left bundle branch block, Dr. Strauss said. Research suggests that one third of patients diagnosed with left bundle branch block by conventional electrocardiographic criteria are misdiagnosed (Am. J. Cardiol. 2011;107:927-34). Patients with intraventricular conduction delays, such as those caused by left ventricular hypertrophy and left ventricular dilation who do not have a blocked left bundle branch, can still display a prolonged QRS duration. This duration can be in the range generally considered diagnostic of left bundle branch block.

New criteria could parlay into better patient selection in the future, Dr. Strauss said. "CRT has been shown to improve heart failure symptoms, reduce heart failure hospitalization, and reduce mortality. However, not all patients benefit and significant risks exist." For example, addition of a CRT device with a left ventricular lead is associated with more complications, compared with ICD alone. "Thus there is a need for better patient risk stratification and patient identification criteria."

Based on results of electrical activation mapping and simulation studies, "My colleagues and I proposed stricter left bundle branch block criteria," he said. For example, they propose QRS duration of 130 msec or greater in women and 140 msec greater in men to replace the conventional 120 msec definition of left bundle branch block in either gender.

Another proposed new requirement is mid-QRS notching in at least two of the electrocardiographic leads of I, aVL, V1, V2, V5, or V6. This is important for diagnosing left bundle branch block because it reflects two events, Dr. Strauss said. There is an initial notch when electrical activation reaches the endocardium of the left ventricle and a second notch when activation reaches the lateral wall opposite the septum.

Other researchers support changing the current criteria for left bundle branch block. In a study of 111 patients, researchers found meeting what they termed "false" criteria was associated with a fourfold higher rate of heart failure hospitalization or death, compared with those meeting strict criteria (Pacing Clin. Electrophysiol. 2012;35:927-34).

CRT is FDA approved for class 3 or 4 heart failure, both of ischemic and nonischemic etiology, with a left ventricular ejection fraction less than 35% and a QRS duration over 120 msec. The FDA also approved CRT for class I ischemic or class II (ischemic or nonischemic) heart failure with an ejection fraction less than 30%, a QRS duration over 130 msec, and left bundle branch block.

Dr. Strauss reported no relevant financial disclosures.

MIAMI BEACH – When it comes to heart failure, women tend to respond better to cardiac resynchronization therapy than do men, but for a long time no one knew why.

Turns out women have some distinct physiologic advantages, specifically more left bundle branch block and more nonischemic cardiomyopathy. Each drives a better response to cardiac resynchronization therapy (CRT), said Dr. David G. Strauss, a medical officer at the Food and Drug Administration’s Center for Devices and Radiologic Health in Silver Spring, Md.

In addition, timing of a specific electrical component within the heart triggers a third important distinction. Women benefit significantly from CRT even when their QRS duration is shorter than 150 msec. This supports the need for new gender-specific criteria for left bundle branch block and, ultimately, better identification of patients most likely to benefit from CRT device placement, Dr. Strauss said at the annual meeting of the International Society on Hypertension in Blacks.

"This is important because different professional societies recently have recommended that CRT be given to patients with QRS duration of 150 msec or more, and primarily in class II heart failure," he said. However, this cutoff "would exclude women with left bundle branch block and QRS duration 130-149 msec that derived significant benefit in MADIT-CRT" (Circulation 2011;123:1061-72).

In MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial–Cardiac Resynchronization Therapy), 1,820 patients were randomly assigned to receive CRT with an implantable cardioverter-defibrillator (ICD) or an ICD alone. In men with QRS duration of 130-140 msec in the study, there was no benefit from CRT and a trend toward harm associated with the device (hazard ratio, 1.69), Dr. Strauss said.

In contrast, women with QRS durations of 130-140 msec "had very significant benefit from CRT with a hazard ratio of 0.20, indicating 80% decrease in heart failure hospitalization or death," Dr. Strauss said.

More nonischemic cardiomyopathy among women translates to less myocardial scar and, ultimately, to a better CRT response. Scar tissue, no matter how it is electrically activated, does not contract, Dr. Strauss said.

Presence of left bundle branch block conferred a significant benefit in terms of reduced heart failure hospitalizations and deaths with use of CRT in the MADIT-CRT research. Conversely, participants without left bundle branch block realized no clinical advantage with CRT.

Be careful, however, to correctly identify left bundle branch block, Dr. Strauss said. Research suggests that one third of patients diagnosed with left bundle branch block by conventional electrocardiographic criteria are misdiagnosed (Am. J. Cardiol. 2011;107:927-34). Patients with intraventricular conduction delays, such as those caused by left ventricular hypertrophy and left ventricular dilation who do not have a blocked left bundle branch, can still display a prolonged QRS duration. This duration can be in the range generally considered diagnostic of left bundle branch block.

New criteria could parlay into better patient selection in the future, Dr. Strauss said. "CRT has been shown to improve heart failure symptoms, reduce heart failure hospitalization, and reduce mortality. However, not all patients benefit and significant risks exist." For example, addition of a CRT device with a left ventricular lead is associated with more complications, compared with ICD alone. "Thus there is a need for better patient risk stratification and patient identification criteria."

Based on results of electrical activation mapping and simulation studies, "My colleagues and I proposed stricter left bundle branch block criteria," he said. For example, they propose QRS duration of 130 msec or greater in women and 140 msec greater in men to replace the conventional 120 msec definition of left bundle branch block in either gender.

Another proposed new requirement is mid-QRS notching in at least two of the electrocardiographic leads of I, aVL, V1, V2, V5, or V6. This is important for diagnosing left bundle branch block because it reflects two events, Dr. Strauss said. There is an initial notch when electrical activation reaches the endocardium of the left ventricle and a second notch when activation reaches the lateral wall opposite the septum.

Other researchers support changing the current criteria for left bundle branch block. In a study of 111 patients, researchers found meeting what they termed "false" criteria was associated with a fourfold higher rate of heart failure hospitalization or death, compared with those meeting strict criteria (Pacing Clin. Electrophysiol. 2012;35:927-34).

CRT is FDA approved for class 3 or 4 heart failure, both of ischemic and nonischemic etiology, with a left ventricular ejection fraction less than 35% and a QRS duration over 120 msec. The FDA also approved CRT for class I ischemic or class II (ischemic or nonischemic) heart failure with an ejection fraction less than 30%, a QRS duration over 130 msec, and left bundle branch block.

Dr. Strauss reported no relevant financial disclosures.

MIAMI BEACH – When it comes to heart failure, women tend to respond better to cardiac resynchronization therapy than do men, but for a long time no one knew why.

Turns out women have some distinct physiologic advantages, specifically more left bundle branch block and more nonischemic cardiomyopathy. Each drives a better response to cardiac resynchronization therapy (CRT), said Dr. David G. Strauss, a medical officer at the Food and Drug Administration’s Center for Devices and Radiologic Health in Silver Spring, Md.

In addition, timing of a specific electrical component within the heart triggers a third important distinction. Women benefit significantly from CRT even when their QRS duration is shorter than 150 msec. This supports the need for new gender-specific criteria for left bundle branch block and, ultimately, better identification of patients most likely to benefit from CRT device placement, Dr. Strauss said at the annual meeting of the International Society on Hypertension in Blacks.

"This is important because different professional societies recently have recommended that CRT be given to patients with QRS duration of 150 msec or more, and primarily in class II heart failure," he said. However, this cutoff "would exclude women with left bundle branch block and QRS duration 130-149 msec that derived significant benefit in MADIT-CRT" (Circulation 2011;123:1061-72).

In MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial–Cardiac Resynchronization Therapy), 1,820 patients were randomly assigned to receive CRT with an implantable cardioverter-defibrillator (ICD) or an ICD alone. In men with QRS duration of 130-140 msec in the study, there was no benefit from CRT and a trend toward harm associated with the device (hazard ratio, 1.69), Dr. Strauss said.

In contrast, women with QRS durations of 130-140 msec "had very significant benefit from CRT with a hazard ratio of 0.20, indicating 80% decrease in heart failure hospitalization or death," Dr. Strauss said.

More nonischemic cardiomyopathy among women translates to less myocardial scar and, ultimately, to a better CRT response. Scar tissue, no matter how it is electrically activated, does not contract, Dr. Strauss said.

Presence of left bundle branch block conferred a significant benefit in terms of reduced heart failure hospitalizations and deaths with use of CRT in the MADIT-CRT research. Conversely, participants without left bundle branch block realized no clinical advantage with CRT.

Be careful, however, to correctly identify left bundle branch block, Dr. Strauss said. Research suggests that one third of patients diagnosed with left bundle branch block by conventional electrocardiographic criteria are misdiagnosed (Am. J. Cardiol. 2011;107:927-34). Patients with intraventricular conduction delays, such as those caused by left ventricular hypertrophy and left ventricular dilation who do not have a blocked left bundle branch, can still display a prolonged QRS duration. This duration can be in the range generally considered diagnostic of left bundle branch block.

New criteria could parlay into better patient selection in the future, Dr. Strauss said. "CRT has been shown to improve heart failure symptoms, reduce heart failure hospitalization, and reduce mortality. However, not all patients benefit and significant risks exist." For example, addition of a CRT device with a left ventricular lead is associated with more complications, compared with ICD alone. "Thus there is a need for better patient risk stratification and patient identification criteria."

Based on results of electrical activation mapping and simulation studies, "My colleagues and I proposed stricter left bundle branch block criteria," he said. For example, they propose QRS duration of 130 msec or greater in women and 140 msec greater in men to replace the conventional 120 msec definition of left bundle branch block in either gender.

Another proposed new requirement is mid-QRS notching in at least two of the electrocardiographic leads of I, aVL, V1, V2, V5, or V6. This is important for diagnosing left bundle branch block because it reflects two events, Dr. Strauss said. There is an initial notch when electrical activation reaches the endocardium of the left ventricle and a second notch when activation reaches the lateral wall opposite the septum.

Other researchers support changing the current criteria for left bundle branch block. In a study of 111 patients, researchers found meeting what they termed "false" criteria was associated with a fourfold higher rate of heart failure hospitalization or death, compared with those meeting strict criteria (Pacing Clin. Electrophysiol. 2012;35:927-34).

CRT is FDA approved for class 3 or 4 heart failure, both of ischemic and nonischemic etiology, with a left ventricular ejection fraction less than 35% and a QRS duration over 120 msec. The FDA also approved CRT for class I ischemic or class II (ischemic or nonischemic) heart failure with an ejection fraction less than 30%, a QRS duration over 130 msec, and left bundle branch block.

Dr. Strauss reported no relevant financial disclosures.

ORLANDO – Patients who express a KIT genetic abnormality represent a small minority of those with melanoma, but there is a lot of interest in the development of specific inhibitors, said Dr. Richard D. Carvajal at the annual meeting of the Florida Society of Dermatology and Dermatologic Surgery.

Studies from Dr. Carvajal and other researchers indicate that inhibitors could significantly prolong median progression-free survival for patients who have amplification, overexpression, or a mutation of this genetic driver of melanoma.

In his phase II study of Novartis’ imatinib (Gleevec) for patients with melanoma and KIT alterations, 4 of 25 evaluable patients responded, for an overall durable response rate of 16%. Median progression-free survival was "pretty modest at 3 to 3.5 months," Dr. Carvajal said. Two patients had a complete response to therapy, and another two achieved a partial response (JAMA 2011;305:2327-34).

"So the question is: Can we better select patients likely to respond?" Dr. Carvajal asked at the meeting. "Certainly this is not vemurafenib [Zelboraf], where we get a response in 50% of patients. It could be due to variability in KIT mutations," said Dr. Carvajal, a medical oncologist specializing in melanoma and sarcomas at Memorial Sloan-Kettering Cancer Center in New York.

Only 3% of patients with melanoma harbor a KIT mutation. "You have to have a mutation in KIT; otherwise, the patient is not going to respond to imatinib," he said. The study was preceded by three negative clinical trials in unselected patients (before the mutation was identified).

In another phase II study enrolling only patients with KIT alterations, investigators reported that 10 of 43 patients responded to treatment with imatinib, for a 23% overall response rate (J. Clin. Oncol. 2011;29:2904-9).

Studies are underway with potential KIT inhibitors other than imatinib, including Pfizer’s sunitinib (Sutent), Novartis’ nilotinib (Tasigna), and Bristol-Myers Squibb’s dasatinib (Sprycel).

Sunitinib

Sunitinib is "reasonably promising" for melanoma patients with KIT mutations, said Dr. David Minor, of the California Pacific Center for Melanoma Research and Treatment at the University of California, San Francisco.

He and his colleagues conducted gene sequencing of tumors from 90 patients with advanced melanoma. The findings revealed that 11% featured a KIT mutation (Clin. Cancer Res. 2012:18:1457-63).

Ten of 12 patients treated with sunitinib were evaluable – 4 with KIT mutations and 6 with KIT amplification or overexpression. Although the mutation was a significant predictor of shortened survival time, treatment with sunitinib was associated with complete remission in 1 patient for 15 months and 2 partial responses for 1 and 7 months, he noted. A KIT mutation might be more clinically relevant because there were no complete responses and only one partial response in patients with KIT amplification or overexpression. Dr. Minor is director of inpatient oncology at the California Pacific Medical Center.

Nilotinib

Because only a small percentage of melanoma patients harbor a KIT mutation, conducting large efficacy studies remains a challenge, Dr. Carvajal said. "Indeed, a randomized, phase III trial of nilotinib versus DTIC [dacarbazine] in KIT-mutant melanoma was designed to be the definitive study demonstrating improved outcomes with nilotinib versus DTIC," he said. However, after patient accrual began for the TEAM (Tasigna Efficacy in Advanced Melanoma) trial in 2010, researchers reported difficulty enrolling a sufficient number of patients with metastatic or inoperable melanoma and a KIT mutation. Therefore, they redesigned the study into a single-arm phase II trial of nilotinib alone.

Researchers at the University of Pittsburgh also termed nilotinib a promising agent for melanoma patients with relevant KIT mutations in a review article (Expert Opin. Investig. Drugs 2012;21:861-9).

Dasatinib

Dr. Harriet Kluger and her colleagues at Yale University in New Haven, Conn., reported mixed efficacy for dasatinib in a phase II study (Cancer 2011;117:2202-8).

"At this point I would say that other than in the setting of patients with c-KIT mutations in their tumors, which is still being studied, dasatinib is not a promising agent for this disease," Dr. Kluger said in an interview. She is on the medical oncology faculty at Yale.

She and her colleagues studied 36 evaluable patients with stage 3 or 4 unresectable melanoma. Dasatinib was associated with two partial responses (24 weeks and 64 weeks) and three minor responses. Another patient who initially responded discontinued because of noncompliance. The median progression-free survival was 8 weeks, and the 6-month progression-free survival was 13%. Some activity of dasatinib was observed in a small subset of patients without KIT mutations, suggesting that more research is needed to identify predictive biomarkers for response to this inhibitor.

The KIT gene is located on chromosome 4 and codes for a family of proteins, the receptor tyrosine kinases. KIT function is essential for normal melanocyte genesis and migration. KIT protein signaling also is important for the development of reproductive germ cells, early hematopoietic stem cells, immune mast cells, and interstitial cells of Cajal located in the gastrointestinal tract.

Available data suggest that patients with mutations affecting exons 11 or 13 of KIT may be more likely to achieve clinical benefit with KIT inhibition, Dr. Carvajal said. He added that greater expression of the mutant KIT allele, compared with the wild type, may be a marker of tumors more "addicted" to KIT activation and that may be more susceptible to inhibition.

"This work is still fairly new," he said.

Dr. Carvajal is a consultant to Novartis. Dr. Minor and Dr. Kluger said that they had no relevant disclosures.

ORLANDO – Patients who express a KIT genetic abnormality represent a small minority of those with melanoma, but there is a lot of interest in the development of specific inhibitors, said Dr. Richard D. Carvajal at the annual meeting of the Florida Society of Dermatology and Dermatologic Surgery.

Studies from Dr. Carvajal and other researchers indicate that inhibitors could significantly prolong median progression-free survival for patients who have amplification, overexpression, or a mutation of this genetic driver of melanoma.

In his phase II study of Novartis’ imatinib (Gleevec) for patients with melanoma and KIT alterations, 4 of 25 evaluable patients responded, for an overall durable response rate of 16%. Median progression-free survival was "pretty modest at 3 to 3.5 months," Dr. Carvajal said. Two patients had a complete response to therapy, and another two achieved a partial response (JAMA 2011;305:2327-34).

"So the question is: Can we better select patients likely to respond?" Dr. Carvajal asked at the meeting. "Certainly this is not vemurafenib [Zelboraf], where we get a response in 50% of patients. It could be due to variability in KIT mutations," said Dr. Carvajal, a medical oncologist specializing in melanoma and sarcomas at Memorial Sloan-Kettering Cancer Center in New York.

Only 3% of patients with melanoma harbor a KIT mutation. "You have to have a mutation in KIT; otherwise, the patient is not going to respond to imatinib," he said. The study was preceded by three negative clinical trials in unselected patients (before the mutation was identified).

In another phase II study enrolling only patients with KIT alterations, investigators reported that 10 of 43 patients responded to treatment with imatinib, for a 23% overall response rate (J. Clin. Oncol. 2011;29:2904-9).

Studies are underway with potential KIT inhibitors other than imatinib, including Pfizer’s sunitinib (Sutent), Novartis’ nilotinib (Tasigna), and Bristol-Myers Squibb’s dasatinib (Sprycel).

Sunitinib

Sunitinib is "reasonably promising" for melanoma patients with KIT mutations, said Dr. David Minor, of the California Pacific Center for Melanoma Research and Treatment at the University of California, San Francisco.

He and his colleagues conducted gene sequencing of tumors from 90 patients with advanced melanoma. The findings revealed that 11% featured a KIT mutation (Clin. Cancer Res. 2012:18:1457-63).

Ten of 12 patients treated with sunitinib were evaluable – 4 with KIT mutations and 6 with KIT amplification or overexpression. Although the mutation was a significant predictor of shortened survival time, treatment with sunitinib was associated with complete remission in 1 patient for 15 months and 2 partial responses for 1 and 7 months, he noted. A KIT mutation might be more clinically relevant because there were no complete responses and only one partial response in patients with KIT amplification or overexpression. Dr. Minor is director of inpatient oncology at the California Pacific Medical Center.

Nilotinib

Because only a small percentage of melanoma patients harbor a KIT mutation, conducting large efficacy studies remains a challenge, Dr. Carvajal said. "Indeed, a randomized, phase III trial of nilotinib versus DTIC [dacarbazine] in KIT-mutant melanoma was designed to be the definitive study demonstrating improved outcomes with nilotinib versus DTIC," he said. However, after patient accrual began for the TEAM (Tasigna Efficacy in Advanced Melanoma) trial in 2010, researchers reported difficulty enrolling a sufficient number of patients with metastatic or inoperable melanoma and a KIT mutation. Therefore, they redesigned the study into a single-arm phase II trial of nilotinib alone.

Researchers at the University of Pittsburgh also termed nilotinib a promising agent for melanoma patients with relevant KIT mutations in a review article (Expert Opin. Investig. Drugs 2012;21:861-9).

Dasatinib

Dr. Harriet Kluger and her colleagues at Yale University in New Haven, Conn., reported mixed efficacy for dasatinib in a phase II study (Cancer 2011;117:2202-8).

"At this point I would say that other than in the setting of patients with c-KIT mutations in their tumors, which is still being studied, dasatinib is not a promising agent for this disease," Dr. Kluger said in an interview. She is on the medical oncology faculty at Yale.

She and her colleagues studied 36 evaluable patients with stage 3 or 4 unresectable melanoma. Dasatinib was associated with two partial responses (24 weeks and 64 weeks) and three minor responses. Another patient who initially responded discontinued because of noncompliance. The median progression-free survival was 8 weeks, and the 6-month progression-free survival was 13%. Some activity of dasatinib was observed in a small subset of patients without KIT mutations, suggesting that more research is needed to identify predictive biomarkers for response to this inhibitor.

The KIT gene is located on chromosome 4 and codes for a family of proteins, the receptor tyrosine kinases. KIT function is essential for normal melanocyte genesis and migration. KIT protein signaling also is important for the development of reproductive germ cells, early hematopoietic stem cells, immune mast cells, and interstitial cells of Cajal located in the gastrointestinal tract.

Available data suggest that patients with mutations affecting exons 11 or 13 of KIT may be more likely to achieve clinical benefit with KIT inhibition, Dr. Carvajal said. He added that greater expression of the mutant KIT allele, compared with the wild type, may be a marker of tumors more "addicted" to KIT activation and that may be more susceptible to inhibition.

"This work is still fairly new," he said.

Dr. Carvajal is a consultant to Novartis. Dr. Minor and Dr. Kluger said that they had no relevant disclosures.

ORLANDO – Patients who express a KIT genetic abnormality represent a small minority of those with melanoma, but there is a lot of interest in the development of specific inhibitors, said Dr. Richard D. Carvajal at the annual meeting of the Florida Society of Dermatology and Dermatologic Surgery.

Studies from Dr. Carvajal and other researchers indicate that inhibitors could significantly prolong median progression-free survival for patients who have amplification, overexpression, or a mutation of this genetic driver of melanoma.

In his phase II study of Novartis’ imatinib (Gleevec) for patients with melanoma and KIT alterations, 4 of 25 evaluable patients responded, for an overall durable response rate of 16%. Median progression-free survival was "pretty modest at 3 to 3.5 months," Dr. Carvajal said. Two patients had a complete response to therapy, and another two achieved a partial response (JAMA 2011;305:2327-34).

"So the question is: Can we better select patients likely to respond?" Dr. Carvajal asked at the meeting. "Certainly this is not vemurafenib [Zelboraf], where we get a response in 50% of patients. It could be due to variability in KIT mutations," said Dr. Carvajal, a medical oncologist specializing in melanoma and sarcomas at Memorial Sloan-Kettering Cancer Center in New York.

Only 3% of patients with melanoma harbor a KIT mutation. "You have to have a mutation in KIT; otherwise, the patient is not going to respond to imatinib," he said. The study was preceded by three negative clinical trials in unselected patients (before the mutation was identified).

In another phase II study enrolling only patients with KIT alterations, investigators reported that 10 of 43 patients responded to treatment with imatinib, for a 23% overall response rate (J. Clin. Oncol. 2011;29:2904-9).

Studies are underway with potential KIT inhibitors other than imatinib, including Pfizer’s sunitinib (Sutent), Novartis’ nilotinib (Tasigna), and Bristol-Myers Squibb’s dasatinib (Sprycel).

Sunitinib

Sunitinib is "reasonably promising" for melanoma patients with KIT mutations, said Dr. David Minor, of the California Pacific Center for Melanoma Research and Treatment at the University of California, San Francisco.

He and his colleagues conducted gene sequencing of tumors from 90 patients with advanced melanoma. The findings revealed that 11% featured a KIT mutation (Clin. Cancer Res. 2012:18:1457-63).

Ten of 12 patients treated with sunitinib were evaluable – 4 with KIT mutations and 6 with KIT amplification or overexpression. Although the mutation was a significant predictor of shortened survival time, treatment with sunitinib was associated with complete remission in 1 patient for 15 months and 2 partial responses for 1 and 7 months, he noted. A KIT mutation might be more clinically relevant because there were no complete responses and only one partial response in patients with KIT amplification or overexpression. Dr. Minor is director of inpatient oncology at the California Pacific Medical Center.

Nilotinib

Because only a small percentage of melanoma patients harbor a KIT mutation, conducting large efficacy studies remains a challenge, Dr. Carvajal said. "Indeed, a randomized, phase III trial of nilotinib versus DTIC [dacarbazine] in KIT-mutant melanoma was designed to be the definitive study demonstrating improved outcomes with nilotinib versus DTIC," he said. However, after patient accrual began for the TEAM (Tasigna Efficacy in Advanced Melanoma) trial in 2010, researchers reported difficulty enrolling a sufficient number of patients with metastatic or inoperable melanoma and a KIT mutation. Therefore, they redesigned the study into a single-arm phase II trial of nilotinib alone.

Researchers at the University of Pittsburgh also termed nilotinib a promising agent for melanoma patients with relevant KIT mutations in a review article (Expert Opin. Investig. Drugs 2012;21:861-9).

Dasatinib

Dr. Harriet Kluger and her colleagues at Yale University in New Haven, Conn., reported mixed efficacy for dasatinib in a phase II study (Cancer 2011;117:2202-8).

"At this point I would say that other than in the setting of patients with c-KIT mutations in their tumors, which is still being studied, dasatinib is not a promising agent for this disease," Dr. Kluger said in an interview. She is on the medical oncology faculty at Yale.

She and her colleagues studied 36 evaluable patients with stage 3 or 4 unresectable melanoma. Dasatinib was associated with two partial responses (24 weeks and 64 weeks) and three minor responses. Another patient who initially responded discontinued because of noncompliance. The median progression-free survival was 8 weeks, and the 6-month progression-free survival was 13%. Some activity of dasatinib was observed in a small subset of patients without KIT mutations, suggesting that more research is needed to identify predictive biomarkers for response to this inhibitor.

The KIT gene is located on chromosome 4 and codes for a family of proteins, the receptor tyrosine kinases. KIT function is essential for normal melanocyte genesis and migration. KIT protein signaling also is important for the development of reproductive germ cells, early hematopoietic stem cells, immune mast cells, and interstitial cells of Cajal located in the gastrointestinal tract.

Available data suggest that patients with mutations affecting exons 11 or 13 of KIT may be more likely to achieve clinical benefit with KIT inhibition, Dr. Carvajal said. He added that greater expression of the mutant KIT allele, compared with the wild type, may be a marker of tumors more "addicted" to KIT activation and that may be more susceptible to inhibition.

"This work is still fairly new," he said.

Dr. Carvajal is a consultant to Novartis. Dr. Minor and Dr. Kluger said that they had no relevant disclosures.

ORLANDO – A recent study that found a high prevalence of undiagnosed or untreated cardiovascular risk factors among patients with moderate to severe psoriasis reinforces the need for routine screening, said Dr. Jeffrey P. Callen.

Cardiovascular disease risk "seems to be increased in our patients with moderate to severe psoriasis, the kinds of patients who require systemic therapy," said Dr. Callen.

In the study, a total 59% of patients had at least two established cardiovascular risk factors, and 29% had three or more. Importantly, using Framingham risk scores, the investigators found 19% were at high risk for a cardiovascular event (J. Am. Acad. Dermatol. 2012;67:76-85).

Although comorbidities of psoriasis have garnered a lot of research, "what is relatively new is some of our systemic therapies might moderate or lessen these comorbidities and lessen patient risks in the future," said Dr. Callen, chief of the division of dermatology at the University of Louisville (Ky.).

Methotrexate therapy, for example, reduced the incidence of vascular disease in veterans with psoriasis or rheumatoid arthritis (J. Am. Acad. Dermatol. 2005;52:262-7). A lower to moderate cumulative dose appeared to be more beneficial than higher dose methotrexate, he said at the annual meeting of the Florida Society of Dermatology and Dermatologic Surgery.

In a more recent study, tumor necrosis factor (TNF) antagonist therapy improved aortic stiffness among 60 patients with inflammatory arthropathies, including psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis (Hypertension 2010;55:333-8). "Those treated had a decrease in aortic stiffness, suggesting there is something we are doing with our systemic therapies," Dr. Callen said. "At least in the short run, this intervention might have some impact on cardiovascular disease."

How much of a concern is aortic stiffness? A comparison of 58 normotensive patients with psoriasis and 36 controls found significantly higher rates of abnormal aortic stiffness in the psoriasis group (Blood Press. 2010:19:351-8).

Another study suggests that treatment with a TNF inhibitor or hydroxychloroquine reduces the risk for new-onset diabetes mellitus among patients with psoriasis or rheumatoid arthritis (JAMA 2011;305:2525-31). The decrease was statistically significant, compared with treatment with other nonbiologic disease-modifying antirheumatic drugs.

"Dermatologists often overlook systemic aspects of skin disease, including psoriasis," said Dr. Callen.

For this reason, Dr. Callen recommends a comprehensive comorbidity monitoring plan, especially for patients with severe psoriasis. Assess blood pressure, heart rate, and body mass index every 2 years, for example. Order a lipid profile and check fasting blood glucose every 5 years (or more frequently in the presence of other risk factors). Ask patients questions about arthritis symptoms regularly, as well. He adapted these recommendations from a report in the British Medical Journal (2010;340:b5666).

Also ask your psoriasis patients about the other medical professionals they consult. "There are patients with severe psoriasis who are not seeing other doctors. I see patients who come in and list me as their primary care physician. I’m not a PCP," he said.

Dr. Callen said he is a consultant to Amgen and a member of the safety monitoring committee for Celgene.

ORLANDO – A recent study that found a high prevalence of undiagnosed or untreated cardiovascular risk factors among patients with moderate to severe psoriasis reinforces the need for routine screening, said Dr. Jeffrey P. Callen.

Cardiovascular disease risk "seems to be increased in our patients with moderate to severe psoriasis, the kinds of patients who require systemic therapy," said Dr. Callen.

In the study, a total 59% of patients had at least two established cardiovascular risk factors, and 29% had three or more. Importantly, using Framingham risk scores, the investigators found 19% were at high risk for a cardiovascular event (J. Am. Acad. Dermatol. 2012;67:76-85).

Although comorbidities of psoriasis have garnered a lot of research, "what is relatively new is some of our systemic therapies might moderate or lessen these comorbidities and lessen patient risks in the future," said Dr. Callen, chief of the division of dermatology at the University of Louisville (Ky.).

Methotrexate therapy, for example, reduced the incidence of vascular disease in veterans with psoriasis or rheumatoid arthritis (J. Am. Acad. Dermatol. 2005;52:262-7). A lower to moderate cumulative dose appeared to be more beneficial than higher dose methotrexate, he said at the annual meeting of the Florida Society of Dermatology and Dermatologic Surgery.

In a more recent study, tumor necrosis factor (TNF) antagonist therapy improved aortic stiffness among 60 patients with inflammatory arthropathies, including psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis (Hypertension 2010;55:333-8). "Those treated had a decrease in aortic stiffness, suggesting there is something we are doing with our systemic therapies," Dr. Callen said. "At least in the short run, this intervention might have some impact on cardiovascular disease."

How much of a concern is aortic stiffness? A comparison of 58 normotensive patients with psoriasis and 36 controls found significantly higher rates of abnormal aortic stiffness in the psoriasis group (Blood Press. 2010:19:351-8).

Another study suggests that treatment with a TNF inhibitor or hydroxychloroquine reduces the risk for new-onset diabetes mellitus among patients with psoriasis or rheumatoid arthritis (JAMA 2011;305:2525-31). The decrease was statistically significant, compared with treatment with other nonbiologic disease-modifying antirheumatic drugs.

"Dermatologists often overlook systemic aspects of skin disease, including psoriasis," said Dr. Callen.

For this reason, Dr. Callen recommends a comprehensive comorbidity monitoring plan, especially for patients with severe psoriasis. Assess blood pressure, heart rate, and body mass index every 2 years, for example. Order a lipid profile and check fasting blood glucose every 5 years (or more frequently in the presence of other risk factors). Ask patients questions about arthritis symptoms regularly, as well. He adapted these recommendations from a report in the British Medical Journal (2010;340:b5666).

Also ask your psoriasis patients about the other medical professionals they consult. "There are patients with severe psoriasis who are not seeing other doctors. I see patients who come in and list me as their primary care physician. I’m not a PCP," he said.

Dr. Callen said he is a consultant to Amgen and a member of the safety monitoring committee for Celgene.

ORLANDO – A recent study that found a high prevalence of undiagnosed or untreated cardiovascular risk factors among patients with moderate to severe psoriasis reinforces the need for routine screening, said Dr. Jeffrey P. Callen.

Cardiovascular disease risk "seems to be increased in our patients with moderate to severe psoriasis, the kinds of patients who require systemic therapy," said Dr. Callen.

In the study, a total 59% of patients had at least two established cardiovascular risk factors, and 29% had three or more. Importantly, using Framingham risk scores, the investigators found 19% were at high risk for a cardiovascular event (J. Am. Acad. Dermatol. 2012;67:76-85).

Although comorbidities of psoriasis have garnered a lot of research, "what is relatively new is some of our systemic therapies might moderate or lessen these comorbidities and lessen patient risks in the future," said Dr. Callen, chief of the division of dermatology at the University of Louisville (Ky.).

Methotrexate therapy, for example, reduced the incidence of vascular disease in veterans with psoriasis or rheumatoid arthritis (J. Am. Acad. Dermatol. 2005;52:262-7). A lower to moderate cumulative dose appeared to be more beneficial than higher dose methotrexate, he said at the annual meeting of the Florida Society of Dermatology and Dermatologic Surgery.

In a more recent study, tumor necrosis factor (TNF) antagonist therapy improved aortic stiffness among 60 patients with inflammatory arthropathies, including psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis (Hypertension 2010;55:333-8). "Those treated had a decrease in aortic stiffness, suggesting there is something we are doing with our systemic therapies," Dr. Callen said. "At least in the short run, this intervention might have some impact on cardiovascular disease."

How much of a concern is aortic stiffness? A comparison of 58 normotensive patients with psoriasis and 36 controls found significantly higher rates of abnormal aortic stiffness in the psoriasis group (Blood Press. 2010:19:351-8).

Another study suggests that treatment with a TNF inhibitor or hydroxychloroquine reduces the risk for new-onset diabetes mellitus among patients with psoriasis or rheumatoid arthritis (JAMA 2011;305:2525-31). The decrease was statistically significant, compared with treatment with other nonbiologic disease-modifying antirheumatic drugs.

"Dermatologists often overlook systemic aspects of skin disease, including psoriasis," said Dr. Callen.

For this reason, Dr. Callen recommends a comprehensive comorbidity monitoring plan, especially for patients with severe psoriasis. Assess blood pressure, heart rate, and body mass index every 2 years, for example. Order a lipid profile and check fasting blood glucose every 5 years (or more frequently in the presence of other risk factors). Ask patients questions about arthritis symptoms regularly, as well. He adapted these recommendations from a report in the British Medical Journal (2010;340:b5666).

Also ask your psoriasis patients about the other medical professionals they consult. "There are patients with severe psoriasis who are not seeing other doctors. I see patients who come in and list me as their primary care physician. I’m not a PCP," he said.

Dr. Callen said he is a consultant to Amgen and a member of the safety monitoring committee for Celgene.

SAN FRANCISCO – Thoracic surgeons should not shy away from segmentectomy in select patients with NSCLC, an expert advises, because the technique confers specific advantages.

In addition, it is as feasible as lobectomy. "If you can do a lobectomy, you can do a segmentectomy. There is no doubt about it," Dr. Matthew J. Schuchert said at the annual meeting of the American Association for Thoracic Surgery.

He shared patient selection criteria and technique tips based on experience with the more than 800 segmentectomies performed at the University of Pittsburgh Medical Center/UPMC Cancer Institute, where he is a general and thoracic surgeon.

Anatomic segmentectomy accomplishes the fundamental surgical tenets achieved by lobectomy, including R0 resection, adequate margins, and an opportunity for systematic nodal staging in early lung cancer, Dr. Schuchert said.

Lung preservation is another potential benefit of segmentectomy and the procedure is particularly useful for tumors with low malignancy potential where you may not have to take out an entire lobe to gain oncologic control, he said.

Equivalent survival to lobectomy has been demonstrated for stage 1A disease, especially for lesions smaller than 2 cm. In addition, "there may be decreased morbidity and mortality risk, especially among the elderly, a population we are going to be seeing more and more of."

Patient selection is paramount. In addition to the elderly, segmentectomy is particularly suitable for patients with marginal pulmonary function; those with "ground glass opacity" that may have low nodal positivity rates; and those who had prior lobectomy seeking parenchymal preservation.

"If you are contemplating the use of segmentectomy, it all really comes down to evaluation of the case," he said. Preoperative imaging ideally reveals a small tumor (less than 2 cm) in the outer one third of the lung. In addition, tumors should be confined to a discrete segmental boundary. "That’s critical. That’s the ticket for success," he said.

Surgeons can use the same anatomic approach they employ for lobectomy, only direct it at one segment. It is important to know segmental vascular and segmental bronchial anatomy, Dr. Schuchert noted.

"All of the same anatomic concerns, exposure concerns, and dissection concerns and techniques really apply." Segmentectomy can be performed through video-assisted thoracic surgery (VATS) or an open approach; the majority of cases at the University of Pittsburgh are VATS.

"We typically position the camera at about the seventh interspace in the mid-axillary line. Along the same interspace, a little more posteriorly, we will utilize a 10-mm incision for retraction and stapling. The access incision is pretty much the same as it is for a VATS lobectomy, usually somewhere along the line of the inframammary crease, and we place it right over the anterior hilum." This incision is usually around the level of the minor fissure on the right and slightly above the major fissure on the left, he added. Next, a 5-mm incision is made for retraction; it can also be particularly useful during node dissection, Dr. Schuchert said.

Preservation of the remaining lung is always a goal. "If you devitalize the remaining lung or impinge upon the bronchial supply, that patient is going to be doomed to have some perioperative issues." Remember that segmentectomy is a functional operation as well, he pointed out. "We are not just taking things out; what we leave behind still has to work."

Dissection assisted by an energy device is a more recent development in their hands. "We have now utilized energy in well over 100 patients undergoing both segmentectomy and lobectomy," he said.

Another essential goal of segmentectomy is to achieve a margin-to-tumor ratio greater than the size of the tumor itself, he said. As an example, he cited the case of a 71-year-old man with a history of diverticulitis with a pulmonary nodule picked up on an abdominal CT scan. The nodule was 1.7 cm, well confined in the outer third of the lung, and well centered within the basilar segment. Fine-needle aspiration of the nodule revealed adenocarcinoma. "He was considered to be an excellent candidate for segmentectomy. In this case, the margin was about 5 cm for a 1.7-cm tumor."

He and his colleagues published additional details of the segmentectomies they performed between 2002 and 2010 at UPMC in a retrospective study (Ann. Thorac. Surg. 2012:93:1780-7).

He said that he had no disclosures.

SAN FRANCISCO – Thoracic surgeons should not shy away from segmentectomy in select patients with NSCLC, an expert advises, because the technique confers specific advantages.

In addition, it is as feasible as lobectomy. "If you can do a lobectomy, you can do a segmentectomy. There is no doubt about it," Dr. Matthew J. Schuchert said at the annual meeting of the American Association for Thoracic Surgery.

He shared patient selection criteria and technique tips based on experience with the more than 800 segmentectomies performed at the University of Pittsburgh Medical Center/UPMC Cancer Institute, where he is a general and thoracic surgeon.

Anatomic segmentectomy accomplishes the fundamental surgical tenets achieved by lobectomy, including R0 resection, adequate margins, and an opportunity for systematic nodal staging in early lung cancer, Dr. Schuchert said.

Lung preservation is another potential benefit of segmentectomy and the procedure is particularly useful for tumors with low malignancy potential where you may not have to take out an entire lobe to gain oncologic control, he said.

Equivalent survival to lobectomy has been demonstrated for stage 1A disease, especially for lesions smaller than 2 cm. In addition, "there may be decreased morbidity and mortality risk, especially among the elderly, a population we are going to be seeing more and more of."

Patient selection is paramount. In addition to the elderly, segmentectomy is particularly suitable for patients with marginal pulmonary function; those with "ground glass opacity" that may have low nodal positivity rates; and those who had prior lobectomy seeking parenchymal preservation.

"If you are contemplating the use of segmentectomy, it all really comes down to evaluation of the case," he said. Preoperative imaging ideally reveals a small tumor (less than 2 cm) in the outer one third of the lung. In addition, tumors should be confined to a discrete segmental boundary. "That’s critical. That’s the ticket for success," he said.

Surgeons can use the same anatomic approach they employ for lobectomy, only direct it at one segment. It is important to know segmental vascular and segmental bronchial anatomy, Dr. Schuchert noted.

"All of the same anatomic concerns, exposure concerns, and dissection concerns and techniques really apply." Segmentectomy can be performed through video-assisted thoracic surgery (VATS) or an open approach; the majority of cases at the University of Pittsburgh are VATS.

"We typically position the camera at about the seventh interspace in the mid-axillary line. Along the same interspace, a little more posteriorly, we will utilize a 10-mm incision for retraction and stapling. The access incision is pretty much the same as it is for a VATS lobectomy, usually somewhere along the line of the inframammary crease, and we place it right over the anterior hilum." This incision is usually around the level of the minor fissure on the right and slightly above the major fissure on the left, he added. Next, a 5-mm incision is made for retraction; it can also be particularly useful during node dissection, Dr. Schuchert said.

Preservation of the remaining lung is always a goal. "If you devitalize the remaining lung or impinge upon the bronchial supply, that patient is going to be doomed to have some perioperative issues." Remember that segmentectomy is a functional operation as well, he pointed out. "We are not just taking things out; what we leave behind still has to work."

Dissection assisted by an energy device is a more recent development in their hands. "We have now utilized energy in well over 100 patients undergoing both segmentectomy and lobectomy," he said.

Another essential goal of segmentectomy is to achieve a margin-to-tumor ratio greater than the size of the tumor itself, he said. As an example, he cited the case of a 71-year-old man with a history of diverticulitis with a pulmonary nodule picked up on an abdominal CT scan. The nodule was 1.7 cm, well confined in the outer third of the lung, and well centered within the basilar segment. Fine-needle aspiration of the nodule revealed adenocarcinoma. "He was considered to be an excellent candidate for segmentectomy. In this case, the margin was about 5 cm for a 1.7-cm tumor."

He and his colleagues published additional details of the segmentectomies they performed between 2002 and 2010 at UPMC in a retrospective study (Ann. Thorac. Surg. 2012:93:1780-7).

He said that he had no disclosures.

SAN FRANCISCO – Thoracic surgeons should not shy away from segmentectomy in select patients with NSCLC, an expert advises, because the technique confers specific advantages.

In addition, it is as feasible as lobectomy. "If you can do a lobectomy, you can do a segmentectomy. There is no doubt about it," Dr. Matthew J. Schuchert said at the annual meeting of the American Association for Thoracic Surgery.

He shared patient selection criteria and technique tips based on experience with the more than 800 segmentectomies performed at the University of Pittsburgh Medical Center/UPMC Cancer Institute, where he is a general and thoracic surgeon.

Anatomic segmentectomy accomplishes the fundamental surgical tenets achieved by lobectomy, including R0 resection, adequate margins, and an opportunity for systematic nodal staging in early lung cancer, Dr. Schuchert said.

Lung preservation is another potential benefit of segmentectomy and the procedure is particularly useful for tumors with low malignancy potential where you may not have to take out an entire lobe to gain oncologic control, he said.

Equivalent survival to lobectomy has been demonstrated for stage 1A disease, especially for lesions smaller than 2 cm. In addition, "there may be decreased morbidity and mortality risk, especially among the elderly, a population we are going to be seeing more and more of."

Patient selection is paramount. In addition to the elderly, segmentectomy is particularly suitable for patients with marginal pulmonary function; those with "ground glass opacity" that may have low nodal positivity rates; and those who had prior lobectomy seeking parenchymal preservation.

"If you are contemplating the use of segmentectomy, it all really comes down to evaluation of the case," he said. Preoperative imaging ideally reveals a small tumor (less than 2 cm) in the outer one third of the lung. In addition, tumors should be confined to a discrete segmental boundary. "That’s critical. That’s the ticket for success," he said.

Surgeons can use the same anatomic approach they employ for lobectomy, only direct it at one segment. It is important to know segmental vascular and segmental bronchial anatomy, Dr. Schuchert noted.

"All of the same anatomic concerns, exposure concerns, and dissection concerns and techniques really apply." Segmentectomy can be performed through video-assisted thoracic surgery (VATS) or an open approach; the majority of cases at the University of Pittsburgh are VATS.

"We typically position the camera at about the seventh interspace in the mid-axillary line. Along the same interspace, a little more posteriorly, we will utilize a 10-mm incision for retraction and stapling. The access incision is pretty much the same as it is for a VATS lobectomy, usually somewhere along the line of the inframammary crease, and we place it right over the anterior hilum." This incision is usually around the level of the minor fissure on the right and slightly above the major fissure on the left, he added. Next, a 5-mm incision is made for retraction; it can also be particularly useful during node dissection, Dr. Schuchert said.

Preservation of the remaining lung is always a goal. "If you devitalize the remaining lung or impinge upon the bronchial supply, that patient is going to be doomed to have some perioperative issues." Remember that segmentectomy is a functional operation as well, he pointed out. "We are not just taking things out; what we leave behind still has to work."

Dissection assisted by an energy device is a more recent development in their hands. "We have now utilized energy in well over 100 patients undergoing both segmentectomy and lobectomy," he said.

Another essential goal of segmentectomy is to achieve a margin-to-tumor ratio greater than the size of the tumor itself, he said. As an example, he cited the case of a 71-year-old man with a history of diverticulitis with a pulmonary nodule picked up on an abdominal CT scan. The nodule was 1.7 cm, well confined in the outer third of the lung, and well centered within the basilar segment. Fine-needle aspiration of the nodule revealed adenocarcinoma. "He was considered to be an excellent candidate for segmentectomy. In this case, the margin was about 5 cm for a 1.7-cm tumor."

He and his colleagues published additional details of the segmentectomies they performed between 2002 and 2010 at UPMC in a retrospective study (Ann. Thorac. Surg. 2012:93:1780-7).

He said that he had no disclosures.