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International parental attitudes of HPV vaccination have similarities, differences
A study comparing parental attitudes of the human papillomavirus (HPV) vaccine in three countries indicates both low and high HPV knowledge may be associated with lower rates of vaccination, and parents’ country and gender also impact the likelihood of adolescents being immunized, reported Brooke Nickel, of the University of Sydney, and associates.
Of 179 parents with a daughter aged 9-17 years from the United States, United Kingdom, or Australia who took part in an online HPV vaccine opinion survey in 2011, 59% reported that their daughters had received HPV vaccination – 43% in the United States cohort, 63% in the United Kingdom cohort, and 76% in the Australian cohort.
(P less than .001). Parents who had either low knowledge scores or high knowledge scores were less likely to have their daughters vaccinated; U.S. parents and men across all countries also were less likely to vaccinate their daughters.
Among the parents whose daughters did not receive the HPV vaccine, worry about the vaccine’s side effects was significantly more prevalent among the U.S. parents (61%) than among parents in the United Kingdom (36%) or among parents in Australia (15%) (P less than .05). U.S. parents who did not have their daughters get the HPV vaccine also were more likely to agree that getting all three HPV vaccine doses would be a “big hassle” (21%), compared with the United Kingdom cohort (0%) and the Australian cohort (8%) (P less than .05).
Parents from the United States also were significantly more likely to agree that the HPV vaccine was too new so they would want to wait before deciding to get it for their daughters (45%), compared with the parents in the United Kingdom (23%) and those in Australia (8%) (P less than .05).
“This finding was unexpected, given that advertising about HPV contributed to an increased awareness of HPV in the United States at the time of data collection. It is important to note, however, that this survey was conducted in 2011, and therefore attitudes of U.S. parents now may differ,” the researchers wrote.
Nonetheless, parents of unvaccinated daughters with higher knowledge scores overall were more likely to believe that they would want to be on the safe side and vaccinate their daughters at some time (74%) compared with parents who had lower knowledge scores (27%) (P less than .001).
“Parents from the United States with unvaccinated daughters more often believed that getting all three doses of the HPV vaccine would be a significant obstacle, not surprisingly as the HPV vaccine distribution in the United States is predominantly available through physicians’ clinics and medical centers, whereas in the United Kingdom and Australia, free school-based and catch-up programs are offered,” the investigators said.
Read more in Preventive Medicine Reports (2017 Oct 10. doi: 10.1016/j.pmedr.2017.10.005).
A study comparing parental attitudes of the human papillomavirus (HPV) vaccine in three countries indicates both low and high HPV knowledge may be associated with lower rates of vaccination, and parents’ country and gender also impact the likelihood of adolescents being immunized, reported Brooke Nickel, of the University of Sydney, and associates.
Of 179 parents with a daughter aged 9-17 years from the United States, United Kingdom, or Australia who took part in an online HPV vaccine opinion survey in 2011, 59% reported that their daughters had received HPV vaccination – 43% in the United States cohort, 63% in the United Kingdom cohort, and 76% in the Australian cohort.
(P less than .001). Parents who had either low knowledge scores or high knowledge scores were less likely to have their daughters vaccinated; U.S. parents and men across all countries also were less likely to vaccinate their daughters.
Among the parents whose daughters did not receive the HPV vaccine, worry about the vaccine’s side effects was significantly more prevalent among the U.S. parents (61%) than among parents in the United Kingdom (36%) or among parents in Australia (15%) (P less than .05). U.S. parents who did not have their daughters get the HPV vaccine also were more likely to agree that getting all three HPV vaccine doses would be a “big hassle” (21%), compared with the United Kingdom cohort (0%) and the Australian cohort (8%) (P less than .05).
Parents from the United States also were significantly more likely to agree that the HPV vaccine was too new so they would want to wait before deciding to get it for their daughters (45%), compared with the parents in the United Kingdom (23%) and those in Australia (8%) (P less than .05).
“This finding was unexpected, given that advertising about HPV contributed to an increased awareness of HPV in the United States at the time of data collection. It is important to note, however, that this survey was conducted in 2011, and therefore attitudes of U.S. parents now may differ,” the researchers wrote.
Nonetheless, parents of unvaccinated daughters with higher knowledge scores overall were more likely to believe that they would want to be on the safe side and vaccinate their daughters at some time (74%) compared with parents who had lower knowledge scores (27%) (P less than .001).
“Parents from the United States with unvaccinated daughters more often believed that getting all three doses of the HPV vaccine would be a significant obstacle, not surprisingly as the HPV vaccine distribution in the United States is predominantly available through physicians’ clinics and medical centers, whereas in the United Kingdom and Australia, free school-based and catch-up programs are offered,” the investigators said.
Read more in Preventive Medicine Reports (2017 Oct 10. doi: 10.1016/j.pmedr.2017.10.005).
A study comparing parental attitudes of the human papillomavirus (HPV) vaccine in three countries indicates both low and high HPV knowledge may be associated with lower rates of vaccination, and parents’ country and gender also impact the likelihood of adolescents being immunized, reported Brooke Nickel, of the University of Sydney, and associates.
Of 179 parents with a daughter aged 9-17 years from the United States, United Kingdom, or Australia who took part in an online HPV vaccine opinion survey in 2011, 59% reported that their daughters had received HPV vaccination – 43% in the United States cohort, 63% in the United Kingdom cohort, and 76% in the Australian cohort.
(P less than .001). Parents who had either low knowledge scores or high knowledge scores were less likely to have their daughters vaccinated; U.S. parents and men across all countries also were less likely to vaccinate their daughters.
Among the parents whose daughters did not receive the HPV vaccine, worry about the vaccine’s side effects was significantly more prevalent among the U.S. parents (61%) than among parents in the United Kingdom (36%) or among parents in Australia (15%) (P less than .05). U.S. parents who did not have their daughters get the HPV vaccine also were more likely to agree that getting all three HPV vaccine doses would be a “big hassle” (21%), compared with the United Kingdom cohort (0%) and the Australian cohort (8%) (P less than .05).
Parents from the United States also were significantly more likely to agree that the HPV vaccine was too new so they would want to wait before deciding to get it for their daughters (45%), compared with the parents in the United Kingdom (23%) and those in Australia (8%) (P less than .05).
“This finding was unexpected, given that advertising about HPV contributed to an increased awareness of HPV in the United States at the time of data collection. It is important to note, however, that this survey was conducted in 2011, and therefore attitudes of U.S. parents now may differ,” the researchers wrote.
Nonetheless, parents of unvaccinated daughters with higher knowledge scores overall were more likely to believe that they would want to be on the safe side and vaccinate their daughters at some time (74%) compared with parents who had lower knowledge scores (27%) (P less than .001).
“Parents from the United States with unvaccinated daughters more often believed that getting all three doses of the HPV vaccine would be a significant obstacle, not surprisingly as the HPV vaccine distribution in the United States is predominantly available through physicians’ clinics and medical centers, whereas in the United Kingdom and Australia, free school-based and catch-up programs are offered,” the investigators said.
Read more in Preventive Medicine Reports (2017 Oct 10. doi: 10.1016/j.pmedr.2017.10.005).
FROM PREVENTIVE MEDICINE REPORTS
Missed opportunities abound to give HPV vaccine to adolescent girls
, in a study of more than 14,000 fully insured teen girls, reported Claudia M. Espinosa, MD, of the division of pediatric infectious diseases, University of Louisville (Ky.), and her associates.
In a study of 14,588 girls in a fully insured commercial or Medicaid plan who turned 11 years old between Jan. 1, 2010, and Sept. 31, 2015, it was documented whether or not the girls received an HPV vaccine when they were given another adolescent vaccine – one or more doses of the Tdap vaccine and/or one or more doses of the 4-valent meningococcal conjugate vaccine (MenACWY vaccine).
Girls who started HPV vaccination were more likely than those who didn’t to receive the MenACWY (86% vs. 64%, respectively; P less than .0001) and Tdap (86% vs. 73%, respectively; P less than .0001) vaccines.
“A missed opportunity was defined as the absence of an HPV vaccine dose administered during any visit with a Tdap or MenACWY vaccine claim, any well-adolescent visit, or any encounter with a primary care provider, regardless of visit type,” the investigators said.
Of 10,987 visits when a Tdap or MenACWY vaccine dose was given, HPV vaccine was given at the same visit in only 37% of cases. An HPV vaccine was administered at only 26% of 12,621 of well-adolescent visits, and 42% of 14,195 other visits with primary care providers.
“The data also suggest that pediatricians and nonpediatricians alike are missing opportunities to administer the HPV vaccine when other adolescent vaccines are given,” Dr. Espinosa and her associates noted. “Future research should focus on communication strategies that might facilitate the conceptual ‘bundling’ of HPV vaccine with other adolescent vaccines in the provider’s office.”
Read more in the Journal of the Pediatric Infectious Diseases Society (2017 Sep 23. doi: 10.1093/jpids/pix067).
, in a study of more than 14,000 fully insured teen girls, reported Claudia M. Espinosa, MD, of the division of pediatric infectious diseases, University of Louisville (Ky.), and her associates.
In a study of 14,588 girls in a fully insured commercial or Medicaid plan who turned 11 years old between Jan. 1, 2010, and Sept. 31, 2015, it was documented whether or not the girls received an HPV vaccine when they were given another adolescent vaccine – one or more doses of the Tdap vaccine and/or one or more doses of the 4-valent meningococcal conjugate vaccine (MenACWY vaccine).
Girls who started HPV vaccination were more likely than those who didn’t to receive the MenACWY (86% vs. 64%, respectively; P less than .0001) and Tdap (86% vs. 73%, respectively; P less than .0001) vaccines.
“A missed opportunity was defined as the absence of an HPV vaccine dose administered during any visit with a Tdap or MenACWY vaccine claim, any well-adolescent visit, or any encounter with a primary care provider, regardless of visit type,” the investigators said.
Of 10,987 visits when a Tdap or MenACWY vaccine dose was given, HPV vaccine was given at the same visit in only 37% of cases. An HPV vaccine was administered at only 26% of 12,621 of well-adolescent visits, and 42% of 14,195 other visits with primary care providers.
“The data also suggest that pediatricians and nonpediatricians alike are missing opportunities to administer the HPV vaccine when other adolescent vaccines are given,” Dr. Espinosa and her associates noted. “Future research should focus on communication strategies that might facilitate the conceptual ‘bundling’ of HPV vaccine with other adolescent vaccines in the provider’s office.”
Read more in the Journal of the Pediatric Infectious Diseases Society (2017 Sep 23. doi: 10.1093/jpids/pix067).
, in a study of more than 14,000 fully insured teen girls, reported Claudia M. Espinosa, MD, of the division of pediatric infectious diseases, University of Louisville (Ky.), and her associates.
In a study of 14,588 girls in a fully insured commercial or Medicaid plan who turned 11 years old between Jan. 1, 2010, and Sept. 31, 2015, it was documented whether or not the girls received an HPV vaccine when they were given another adolescent vaccine – one or more doses of the Tdap vaccine and/or one or more doses of the 4-valent meningococcal conjugate vaccine (MenACWY vaccine).
Girls who started HPV vaccination were more likely than those who didn’t to receive the MenACWY (86% vs. 64%, respectively; P less than .0001) and Tdap (86% vs. 73%, respectively; P less than .0001) vaccines.
“A missed opportunity was defined as the absence of an HPV vaccine dose administered during any visit with a Tdap or MenACWY vaccine claim, any well-adolescent visit, or any encounter with a primary care provider, regardless of visit type,” the investigators said.
Of 10,987 visits when a Tdap or MenACWY vaccine dose was given, HPV vaccine was given at the same visit in only 37% of cases. An HPV vaccine was administered at only 26% of 12,621 of well-adolescent visits, and 42% of 14,195 other visits with primary care providers.
“The data also suggest that pediatricians and nonpediatricians alike are missing opportunities to administer the HPV vaccine when other adolescent vaccines are given,” Dr. Espinosa and her associates noted. “Future research should focus on communication strategies that might facilitate the conceptual ‘bundling’ of HPV vaccine with other adolescent vaccines in the provider’s office.”
Read more in the Journal of the Pediatric Infectious Diseases Society (2017 Sep 23. doi: 10.1093/jpids/pix067).
FROM THE JOURNAL OF THE PEDIATRIC INFECTIOUS DISEASES SOCIETY
What to do about the problem of non-FDA approved compounded bioidentical hormones
VIDEO: Intermittent furosemide during acute HFpEF favors kidneys
DALLAS – Patients with heart failure with preserved ejection fraction who were hospitalized for acute decompensation had a significantly smaller rise in serum creatinine when treated with intermittent, bolus doses of furosemide, compared with patients who received a continuous furosemide infusion in a single-center, randomized trial with 90 patients.
Intermittent furosemide also resulted in many fewer episodes of worsening renal function. In the trial, 12% of patients who received bolus furosemide doses developed worsening renal function during hospitalization compared with 36% of patients treated with a continuous furosemide infusion, Kavita Sharma, MD, said at the annual scientific meeting of the Heart Failure Society of America.
While acknowledging that this finding is preliminary because it was made in a relatively small, single-center study, “I’d be cautious about continuous infusion” in acute decompensated patients with heart failure with preserved ejection fraction (HFpEF); “bolus is preferred,” Dr. Sharma said in a video interview.
Results from the prior Diuretic Optimization Strategies Evaluation (DOSE) trial, published in 2011, had shown no significant difference in renal function in hospitalized heart failure patients randomized to receive either bolus or continuous furosemide, but that study largely enrolled patients with heart failure with reduced ejection fraction (HFrEF) (N Engl J Med. 2011 Mar 3;364[9]:797-805).
“When patients with HFpEF are hospitalized with acute heart failure there is a high rate of kidney injury, that often results in slowing diuresis leading to longer hospital stays. With adjustment for changes in blood pressure and volume of diuresis we saw a fourfold increase in worsening renal failure [with continuous infusion], so you should think twice before using continuous dosing,” said Dr. Sharma, a heart failure cardiologist at Johns Hopkins Medicine in Baltimore.
She presented results from Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction (ROPA-DOP), which randomized 90 hospitalized heart failure patients with a left ventricular ejection fraction of at least 50% and an estimated glomerular filtration rate of more than 15 mL/min/1.73 m2. The enrolled patients averaged 66 years old, 61% were women, their average body mass index was 41 kg/m2, and their average estimated glomerular filtration rate was 58 mL/min/1.73 m2.
The study’s primary endpoint was percent change in creatinine during hospitalization, which rose by an average 5% in the patients who received intermittent bolus furosemide and by an average 16% in patient who received a continuous infusion, a statistically significant difference. In a regression analysis that controlled for between-group differences in patient’s age, sex, race, body mass index, smoking status, changes in systolic blood pressure, heart rate, fluid balance after 72 hours, and other variables, patients treated with continuous furosemide infusion averaged an 11% greater increase in serum creatinine, Dr. Sharma reported. After similar adjustments, the secondary endpoint rate of worsening renal function was more than four times more likely to occur in the patients on continuous infusion compared with those who received intermittent bolus treatment, she said.
A second aspect of the ROPA-DOP trial randomized the same patients to received either low dose (3 mcg/kg per min) dopamine or placebo during hospitalization. The results showed that low-dose dopamine had no significant impact on either change in creatinine levels or on the incidence of worsening renal function compared with placebo, though dopamine treatment did link with a nonsignificant trend toward somewhat greater diuresis. These results were consistent with prior findings in the Renal Optimization Strategies Evaluation (ROSE) trial (JAMA. 2013 Nov 18;310[23]:2533-43), which used a mixed population of patients with HFpEF or HFrEF but predominantly patients with HFrEF, Dr. Sharma noted.
“It was a neutral finding [for dopamine in ROPA-DOP], and while there was no harm from dopamine there was clearly no benefit,” she said. It is possible that HFpEF patients with right ventricular dysfunction secondary to pulmonary hypertension might benefit from low-dose dopamine, but this needs further study, Dr. Sharma said.
[email protected]
On Twitter @mitchelzoler
In the Diuretic Optimization Strategies Evaluation (DOSE) trial, we enrolled heart failure patients with a mix of reduced ejection fraction and preserved ejection fraction. The DOSE results showed no relationship between ejection fraction and the response to furosemide treatment by intermittent bolus or by continuous infusion in patients hospitalized with acute decompensated heart failure. The results also showed that continuous infusion was no better than intermittent bolus treatment, and following our report in 2011 (N Engl J Med. 2011 Mar 3;364[9]:797-805), many centers that had previously relied on continuous furosemide switched to use of bolus doses primarily because continuous infusion is much less convenient.
But it is important to keep in mind that trial results focus on averages and populations of patients. Anecdotally, we see some acute heart failure patients who seem to respond better to continuous infusion, and so some clinicians switch patients who do not respond well to bolus treatment to continuous infusion. In DOSE, we only tested the efficacy of the initial strategy; we have no evidence on whether or not changing the dosing strategy helps patients who do not respond adequately to an initial strategy of intermittent bolus doses.
G. Michael Felker, MD , professor of medicine at Duke University, Durham, N.C., made these comments in an interview. He has been a consultant to Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, MyoKardia, Novartis, Stealth, and Trevena.
In the Diuretic Optimization Strategies Evaluation (DOSE) trial, we enrolled heart failure patients with a mix of reduced ejection fraction and preserved ejection fraction. The DOSE results showed no relationship between ejection fraction and the response to furosemide treatment by intermittent bolus or by continuous infusion in patients hospitalized with acute decompensated heart failure. The results also showed that continuous infusion was no better than intermittent bolus treatment, and following our report in 2011 (N Engl J Med. 2011 Mar 3;364[9]:797-805), many centers that had previously relied on continuous furosemide switched to use of bolus doses primarily because continuous infusion is much less convenient.
But it is important to keep in mind that trial results focus on averages and populations of patients. Anecdotally, we see some acute heart failure patients who seem to respond better to continuous infusion, and so some clinicians switch patients who do not respond well to bolus treatment to continuous infusion. In DOSE, we only tested the efficacy of the initial strategy; we have no evidence on whether or not changing the dosing strategy helps patients who do not respond adequately to an initial strategy of intermittent bolus doses.
G. Michael Felker, MD , professor of medicine at Duke University, Durham, N.C., made these comments in an interview. He has been a consultant to Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, MyoKardia, Novartis, Stealth, and Trevena.
In the Diuretic Optimization Strategies Evaluation (DOSE) trial, we enrolled heart failure patients with a mix of reduced ejection fraction and preserved ejection fraction. The DOSE results showed no relationship between ejection fraction and the response to furosemide treatment by intermittent bolus or by continuous infusion in patients hospitalized with acute decompensated heart failure. The results also showed that continuous infusion was no better than intermittent bolus treatment, and following our report in 2011 (N Engl J Med. 2011 Mar 3;364[9]:797-805), many centers that had previously relied on continuous furosemide switched to use of bolus doses primarily because continuous infusion is much less convenient.
But it is important to keep in mind that trial results focus on averages and populations of patients. Anecdotally, we see some acute heart failure patients who seem to respond better to continuous infusion, and so some clinicians switch patients who do not respond well to bolus treatment to continuous infusion. In DOSE, we only tested the efficacy of the initial strategy; we have no evidence on whether or not changing the dosing strategy helps patients who do not respond adequately to an initial strategy of intermittent bolus doses.
G. Michael Felker, MD , professor of medicine at Duke University, Durham, N.C., made these comments in an interview. He has been a consultant to Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, MyoKardia, Novartis, Stealth, and Trevena.
DALLAS – Patients with heart failure with preserved ejection fraction who were hospitalized for acute decompensation had a significantly smaller rise in serum creatinine when treated with intermittent, bolus doses of furosemide, compared with patients who received a continuous furosemide infusion in a single-center, randomized trial with 90 patients.
Intermittent furosemide also resulted in many fewer episodes of worsening renal function. In the trial, 12% of patients who received bolus furosemide doses developed worsening renal function during hospitalization compared with 36% of patients treated with a continuous furosemide infusion, Kavita Sharma, MD, said at the annual scientific meeting of the Heart Failure Society of America.
While acknowledging that this finding is preliminary because it was made in a relatively small, single-center study, “I’d be cautious about continuous infusion” in acute decompensated patients with heart failure with preserved ejection fraction (HFpEF); “bolus is preferred,” Dr. Sharma said in a video interview.
Results from the prior Diuretic Optimization Strategies Evaluation (DOSE) trial, published in 2011, had shown no significant difference in renal function in hospitalized heart failure patients randomized to receive either bolus or continuous furosemide, but that study largely enrolled patients with heart failure with reduced ejection fraction (HFrEF) (N Engl J Med. 2011 Mar 3;364[9]:797-805).
“When patients with HFpEF are hospitalized with acute heart failure there is a high rate of kidney injury, that often results in slowing diuresis leading to longer hospital stays. With adjustment for changes in blood pressure and volume of diuresis we saw a fourfold increase in worsening renal failure [with continuous infusion], so you should think twice before using continuous dosing,” said Dr. Sharma, a heart failure cardiologist at Johns Hopkins Medicine in Baltimore.
She presented results from Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction (ROPA-DOP), which randomized 90 hospitalized heart failure patients with a left ventricular ejection fraction of at least 50% and an estimated glomerular filtration rate of more than 15 mL/min/1.73 m2. The enrolled patients averaged 66 years old, 61% were women, their average body mass index was 41 kg/m2, and their average estimated glomerular filtration rate was 58 mL/min/1.73 m2.
The study’s primary endpoint was percent change in creatinine during hospitalization, which rose by an average 5% in the patients who received intermittent bolus furosemide and by an average 16% in patient who received a continuous infusion, a statistically significant difference. In a regression analysis that controlled for between-group differences in patient’s age, sex, race, body mass index, smoking status, changes in systolic blood pressure, heart rate, fluid balance after 72 hours, and other variables, patients treated with continuous furosemide infusion averaged an 11% greater increase in serum creatinine, Dr. Sharma reported. After similar adjustments, the secondary endpoint rate of worsening renal function was more than four times more likely to occur in the patients on continuous infusion compared with those who received intermittent bolus treatment, she said.
A second aspect of the ROPA-DOP trial randomized the same patients to received either low dose (3 mcg/kg per min) dopamine or placebo during hospitalization. The results showed that low-dose dopamine had no significant impact on either change in creatinine levels or on the incidence of worsening renal function compared with placebo, though dopamine treatment did link with a nonsignificant trend toward somewhat greater diuresis. These results were consistent with prior findings in the Renal Optimization Strategies Evaluation (ROSE) trial (JAMA. 2013 Nov 18;310[23]:2533-43), which used a mixed population of patients with HFpEF or HFrEF but predominantly patients with HFrEF, Dr. Sharma noted.
“It was a neutral finding [for dopamine in ROPA-DOP], and while there was no harm from dopamine there was clearly no benefit,” she said. It is possible that HFpEF patients with right ventricular dysfunction secondary to pulmonary hypertension might benefit from low-dose dopamine, but this needs further study, Dr. Sharma said.
[email protected]
On Twitter @mitchelzoler
DALLAS – Patients with heart failure with preserved ejection fraction who were hospitalized for acute decompensation had a significantly smaller rise in serum creatinine when treated with intermittent, bolus doses of furosemide, compared with patients who received a continuous furosemide infusion in a single-center, randomized trial with 90 patients.
Intermittent furosemide also resulted in many fewer episodes of worsening renal function. In the trial, 12% of patients who received bolus furosemide doses developed worsening renal function during hospitalization compared with 36% of patients treated with a continuous furosemide infusion, Kavita Sharma, MD, said at the annual scientific meeting of the Heart Failure Society of America.
While acknowledging that this finding is preliminary because it was made in a relatively small, single-center study, “I’d be cautious about continuous infusion” in acute decompensated patients with heart failure with preserved ejection fraction (HFpEF); “bolus is preferred,” Dr. Sharma said in a video interview.
Results from the prior Diuretic Optimization Strategies Evaluation (DOSE) trial, published in 2011, had shown no significant difference in renal function in hospitalized heart failure patients randomized to receive either bolus or continuous furosemide, but that study largely enrolled patients with heart failure with reduced ejection fraction (HFrEF) (N Engl J Med. 2011 Mar 3;364[9]:797-805).
“When patients with HFpEF are hospitalized with acute heart failure there is a high rate of kidney injury, that often results in slowing diuresis leading to longer hospital stays. With adjustment for changes in blood pressure and volume of diuresis we saw a fourfold increase in worsening renal failure [with continuous infusion], so you should think twice before using continuous dosing,” said Dr. Sharma, a heart failure cardiologist at Johns Hopkins Medicine in Baltimore.
She presented results from Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction (ROPA-DOP), which randomized 90 hospitalized heart failure patients with a left ventricular ejection fraction of at least 50% and an estimated glomerular filtration rate of more than 15 mL/min/1.73 m2. The enrolled patients averaged 66 years old, 61% were women, their average body mass index was 41 kg/m2, and their average estimated glomerular filtration rate was 58 mL/min/1.73 m2.
The study’s primary endpoint was percent change in creatinine during hospitalization, which rose by an average 5% in the patients who received intermittent bolus furosemide and by an average 16% in patient who received a continuous infusion, a statistically significant difference. In a regression analysis that controlled for between-group differences in patient’s age, sex, race, body mass index, smoking status, changes in systolic blood pressure, heart rate, fluid balance after 72 hours, and other variables, patients treated with continuous furosemide infusion averaged an 11% greater increase in serum creatinine, Dr. Sharma reported. After similar adjustments, the secondary endpoint rate of worsening renal function was more than four times more likely to occur in the patients on continuous infusion compared with those who received intermittent bolus treatment, she said.
A second aspect of the ROPA-DOP trial randomized the same patients to received either low dose (3 mcg/kg per min) dopamine or placebo during hospitalization. The results showed that low-dose dopamine had no significant impact on either change in creatinine levels or on the incidence of worsening renal function compared with placebo, though dopamine treatment did link with a nonsignificant trend toward somewhat greater diuresis. These results were consistent with prior findings in the Renal Optimization Strategies Evaluation (ROSE) trial (JAMA. 2013 Nov 18;310[23]:2533-43), which used a mixed population of patients with HFpEF or HFrEF but predominantly patients with HFrEF, Dr. Sharma noted.
“It was a neutral finding [for dopamine in ROPA-DOP], and while there was no harm from dopamine there was clearly no benefit,” she said. It is possible that HFpEF patients with right ventricular dysfunction secondary to pulmonary hypertension might benefit from low-dose dopamine, but this needs further study, Dr. Sharma said.
[email protected]
On Twitter @mitchelzoler
AT THE HFSA ANNUAL SCIENTIFIC MEETING
Key clinical point:
Major finding: Serum creatinine rose by an average 5% with intermittent bolus furosemide and by 16% with continuous infusion.
Data source: ROPA-DOP, a single-center randomized trial with 90 patients.
Disclosures: Dr. Sharma had no disclosures.
Physical inactivity in youth is an independent risk factor for schizophrenia
PARIS – Low physical activity in childhood and adolescence was independently associated with later development of schizophrenia and other nonaffective psychotic disorders in the large, prospective, population-based Cardiovascular Risk in Young Finns cohort study, Jarmo Hietala, MD, PhD, reported at the annual congress of the European College of Neuropsychopharmacology.
The key question now: Is this risk factor remediable? That is, will a pediatric exercise intervention that results in improved physical fitness also reduce the risk of later nonaffective psychosis? Given that there are really no downsides to physical activity, the Finnish data make a strong case for including exercise and physical activity interventions in investigational psychosis prevention programs targeting high-risk youth, according to Dr. Hietala, professor of psychiatry at the University of Turku (Finland).
Dr. Hietala and his coinvestigators tapped into comprehensive national registries in order to identify all study participants with a psychiatric diagnosis of sufficient severity to have resulted in hospitalization up to 2012. Forty-one patients were hospitalized for schizophrenia spectrum disorders, 47 for other forms of nonaffective psychosis, 43 for personality disorders, 111 for affective disorders, and 49 with alcohol and other substance use disorders.
In a multivariate analysis adjusted for sex, age, body mass index, birth weight, non-preterm birth, and maternal mental disorders, each 1-point decrement in the pediatric physical activity index was associated with a 26% increase in the risk of developing any nonaffective psychosis and, more specifically, a 43% increased risk of schizophrenia.
Moreover, nonparticipation in organized sports competitions was independently associated with a 2.58-fold increased risk of any nonaffective psychosis and a 4.88-fold increased risk of schizophrenia. And social isolation as reflected in spending less time in common activities with friends during leisure time was associated with a 71% increased risk of nonaffective psychosis and a 76% increased risk of schizophrenia.
Of note, schizophrenia was the only psychiatric disorder associated with low physical activity in childhood and adolescence. Sedentary youths were not at increased risk of later hospitalization for affective disorders or other forms of mental illness.
“Our results have relevance for preemptive psychiatry and provide rationale for including exercise in early interventions for psychosis,” the psychiatrist said.
Current programs aimed at preventing schizophrenia in youth at high risk because of family history typically emphasize avoidance of street drugs, the importance of seeking out constructive social interactions, stress reduction techniques, and cognitive-behavioral therapy aimed at promoting a positive world view.
Formal evaluation of physical activity as part of a preventive approach has a sound theoretic basis, according to Dr. Hietala. He cited an influential essay called “Rethinking Schizophrenia” by the then-director of the National Institute of Mental Health, Thomas R. Insel, MD. In that article, Dr. Insel highlights the past half-century of largely unsatisfactory results with pharmacotherapy and goes on to make the case for considering schizophrenia as a neurodevelopmental disorder in which, he argues, “psychosis is a late, potentially preventable stage of the illness” (Nature. 2010 Nov 11;468[7321]:187-93).
This view of schizophrenia as a neurodevelopmental disorder has quickly come to dominate thinking within the field. Dr. Hietala noted that the schizophrenia spectrum chapter in the DSM-5 includes a greater focus on abnormal behavior and catatonia as a core domain alongside classic features, such as delusions, hallucinations, negative symptoms, and disorganized speech.
“My view of schizophrenia is that the psychotic symptoms are a secondary phenomenon, a complication of the disease that has been going on for a while. It’s a pity that we focus so much on the psychotic symptoms rather than the cognitive or negative or affective symptoms,” he said.
The hope is that a long-term physical activity intervention in at-risk youth will stimulate neurodevelopmental catch-up, thereby thwarting their predisposition to schizophrenia.
“Human development is not a linear process; it happens in spurts of rapid growth followed by consolidation periods,” Dr. Hietala said.
However, even if it turns out that an early physical activity intervention does not reduce the risk of developing schizophrenia, it might favorably alter its course in important ways, according to Dr. Hietala.
Individuals with schizophrenia are known to be at increased risk for metabolic syndrome and premature death tied to cardiovascular disease. A recent meta-analysis of 16 prospective cohort studies totaling more than 1 million men and women found that mortality during follow-up was 59% greater in those who sat for more than 8 hours per day and were in the lowest quartile of physical activity, compared with those sitting for less than 4 hours per day who were in the top quartile of physical activity, at more than 35.5 metabolic equivalent hours per week.
But there was no increased risk of mortality among those who sat for more than 8 hours per day and were also in the highest quartile of physical activity. The implication is that high levels of moderate-intensity physical activity eliminates the increased risk of death associated with high sitting time (Lancet. 2016 Sep 24;388[10051]:1302-10). That’s a finding that could be applicable to patients with schizophrenia.
Dr. Hietala reported having no financial conflicts regarding the Cardiovascular Risk in Young Finns study, which is supported by the Academy of Finland, the Social Insurance Institution of Finland, and grants from nonprofit foundations.
PARIS – Low physical activity in childhood and adolescence was independently associated with later development of schizophrenia and other nonaffective psychotic disorders in the large, prospective, population-based Cardiovascular Risk in Young Finns cohort study, Jarmo Hietala, MD, PhD, reported at the annual congress of the European College of Neuropsychopharmacology.
The key question now: Is this risk factor remediable? That is, will a pediatric exercise intervention that results in improved physical fitness also reduce the risk of later nonaffective psychosis? Given that there are really no downsides to physical activity, the Finnish data make a strong case for including exercise and physical activity interventions in investigational psychosis prevention programs targeting high-risk youth, according to Dr. Hietala, professor of psychiatry at the University of Turku (Finland).
Dr. Hietala and his coinvestigators tapped into comprehensive national registries in order to identify all study participants with a psychiatric diagnosis of sufficient severity to have resulted in hospitalization up to 2012. Forty-one patients were hospitalized for schizophrenia spectrum disorders, 47 for other forms of nonaffective psychosis, 43 for personality disorders, 111 for affective disorders, and 49 with alcohol and other substance use disorders.
In a multivariate analysis adjusted for sex, age, body mass index, birth weight, non-preterm birth, and maternal mental disorders, each 1-point decrement in the pediatric physical activity index was associated with a 26% increase in the risk of developing any nonaffective psychosis and, more specifically, a 43% increased risk of schizophrenia.
Moreover, nonparticipation in organized sports competitions was independently associated with a 2.58-fold increased risk of any nonaffective psychosis and a 4.88-fold increased risk of schizophrenia. And social isolation as reflected in spending less time in common activities with friends during leisure time was associated with a 71% increased risk of nonaffective psychosis and a 76% increased risk of schizophrenia.
Of note, schizophrenia was the only psychiatric disorder associated with low physical activity in childhood and adolescence. Sedentary youths were not at increased risk of later hospitalization for affective disorders or other forms of mental illness.
“Our results have relevance for preemptive psychiatry and provide rationale for including exercise in early interventions for psychosis,” the psychiatrist said.
Current programs aimed at preventing schizophrenia in youth at high risk because of family history typically emphasize avoidance of street drugs, the importance of seeking out constructive social interactions, stress reduction techniques, and cognitive-behavioral therapy aimed at promoting a positive world view.
Formal evaluation of physical activity as part of a preventive approach has a sound theoretic basis, according to Dr. Hietala. He cited an influential essay called “Rethinking Schizophrenia” by the then-director of the National Institute of Mental Health, Thomas R. Insel, MD. In that article, Dr. Insel highlights the past half-century of largely unsatisfactory results with pharmacotherapy and goes on to make the case for considering schizophrenia as a neurodevelopmental disorder in which, he argues, “psychosis is a late, potentially preventable stage of the illness” (Nature. 2010 Nov 11;468[7321]:187-93).
This view of schizophrenia as a neurodevelopmental disorder has quickly come to dominate thinking within the field. Dr. Hietala noted that the schizophrenia spectrum chapter in the DSM-5 includes a greater focus on abnormal behavior and catatonia as a core domain alongside classic features, such as delusions, hallucinations, negative symptoms, and disorganized speech.
“My view of schizophrenia is that the psychotic symptoms are a secondary phenomenon, a complication of the disease that has been going on for a while. It’s a pity that we focus so much on the psychotic symptoms rather than the cognitive or negative or affective symptoms,” he said.
The hope is that a long-term physical activity intervention in at-risk youth will stimulate neurodevelopmental catch-up, thereby thwarting their predisposition to schizophrenia.
“Human development is not a linear process; it happens in spurts of rapid growth followed by consolidation periods,” Dr. Hietala said.
However, even if it turns out that an early physical activity intervention does not reduce the risk of developing schizophrenia, it might favorably alter its course in important ways, according to Dr. Hietala.
Individuals with schizophrenia are known to be at increased risk for metabolic syndrome and premature death tied to cardiovascular disease. A recent meta-analysis of 16 prospective cohort studies totaling more than 1 million men and women found that mortality during follow-up was 59% greater in those who sat for more than 8 hours per day and were in the lowest quartile of physical activity, compared with those sitting for less than 4 hours per day who were in the top quartile of physical activity, at more than 35.5 metabolic equivalent hours per week.
But there was no increased risk of mortality among those who sat for more than 8 hours per day and were also in the highest quartile of physical activity. The implication is that high levels of moderate-intensity physical activity eliminates the increased risk of death associated with high sitting time (Lancet. 2016 Sep 24;388[10051]:1302-10). That’s a finding that could be applicable to patients with schizophrenia.
Dr. Hietala reported having no financial conflicts regarding the Cardiovascular Risk in Young Finns study, which is supported by the Academy of Finland, the Social Insurance Institution of Finland, and grants from nonprofit foundations.
PARIS – Low physical activity in childhood and adolescence was independently associated with later development of schizophrenia and other nonaffective psychotic disorders in the large, prospective, population-based Cardiovascular Risk in Young Finns cohort study, Jarmo Hietala, MD, PhD, reported at the annual congress of the European College of Neuropsychopharmacology.
The key question now: Is this risk factor remediable? That is, will a pediatric exercise intervention that results in improved physical fitness also reduce the risk of later nonaffective psychosis? Given that there are really no downsides to physical activity, the Finnish data make a strong case for including exercise and physical activity interventions in investigational psychosis prevention programs targeting high-risk youth, according to Dr. Hietala, professor of psychiatry at the University of Turku (Finland).
Dr. Hietala and his coinvestigators tapped into comprehensive national registries in order to identify all study participants with a psychiatric diagnosis of sufficient severity to have resulted in hospitalization up to 2012. Forty-one patients were hospitalized for schizophrenia spectrum disorders, 47 for other forms of nonaffective psychosis, 43 for personality disorders, 111 for affective disorders, and 49 with alcohol and other substance use disorders.
In a multivariate analysis adjusted for sex, age, body mass index, birth weight, non-preterm birth, and maternal mental disorders, each 1-point decrement in the pediatric physical activity index was associated with a 26% increase in the risk of developing any nonaffective psychosis and, more specifically, a 43% increased risk of schizophrenia.
Moreover, nonparticipation in organized sports competitions was independently associated with a 2.58-fold increased risk of any nonaffective psychosis and a 4.88-fold increased risk of schizophrenia. And social isolation as reflected in spending less time in common activities with friends during leisure time was associated with a 71% increased risk of nonaffective psychosis and a 76% increased risk of schizophrenia.
Of note, schizophrenia was the only psychiatric disorder associated with low physical activity in childhood and adolescence. Sedentary youths were not at increased risk of later hospitalization for affective disorders or other forms of mental illness.
“Our results have relevance for preemptive psychiatry and provide rationale for including exercise in early interventions for psychosis,” the psychiatrist said.
Current programs aimed at preventing schizophrenia in youth at high risk because of family history typically emphasize avoidance of street drugs, the importance of seeking out constructive social interactions, stress reduction techniques, and cognitive-behavioral therapy aimed at promoting a positive world view.
Formal evaluation of physical activity as part of a preventive approach has a sound theoretic basis, according to Dr. Hietala. He cited an influential essay called “Rethinking Schizophrenia” by the then-director of the National Institute of Mental Health, Thomas R. Insel, MD. In that article, Dr. Insel highlights the past half-century of largely unsatisfactory results with pharmacotherapy and goes on to make the case for considering schizophrenia as a neurodevelopmental disorder in which, he argues, “psychosis is a late, potentially preventable stage of the illness” (Nature. 2010 Nov 11;468[7321]:187-93).
This view of schizophrenia as a neurodevelopmental disorder has quickly come to dominate thinking within the field. Dr. Hietala noted that the schizophrenia spectrum chapter in the DSM-5 includes a greater focus on abnormal behavior and catatonia as a core domain alongside classic features, such as delusions, hallucinations, negative symptoms, and disorganized speech.
“My view of schizophrenia is that the psychotic symptoms are a secondary phenomenon, a complication of the disease that has been going on for a while. It’s a pity that we focus so much on the psychotic symptoms rather than the cognitive or negative or affective symptoms,” he said.
The hope is that a long-term physical activity intervention in at-risk youth will stimulate neurodevelopmental catch-up, thereby thwarting their predisposition to schizophrenia.
“Human development is not a linear process; it happens in spurts of rapid growth followed by consolidation periods,” Dr. Hietala said.
However, even if it turns out that an early physical activity intervention does not reduce the risk of developing schizophrenia, it might favorably alter its course in important ways, according to Dr. Hietala.
Individuals with schizophrenia are known to be at increased risk for metabolic syndrome and premature death tied to cardiovascular disease. A recent meta-analysis of 16 prospective cohort studies totaling more than 1 million men and women found that mortality during follow-up was 59% greater in those who sat for more than 8 hours per day and were in the lowest quartile of physical activity, compared with those sitting for less than 4 hours per day who were in the top quartile of physical activity, at more than 35.5 metabolic equivalent hours per week.
But there was no increased risk of mortality among those who sat for more than 8 hours per day and were also in the highest quartile of physical activity. The implication is that high levels of moderate-intensity physical activity eliminates the increased risk of death associated with high sitting time (Lancet. 2016 Sep 24;388[10051]:1302-10). That’s a finding that could be applicable to patients with schizophrenia.
Dr. Hietala reported having no financial conflicts regarding the Cardiovascular Risk in Young Finns study, which is supported by the Academy of Finland, the Social Insurance Institution of Finland, and grants from nonprofit foundations.
AT THE ECNP CONGRESS
Key clinical point:
Major finding: Each 1-point decrement on a physical activity score recorded during childhood and adolescence was independently associated with a 43% increased risk of later development of schizophrenia.
Data source: The Cardiovascular Risk in Young Finns study is an ongoing prospective, population-based study of nearly 3,600 Finns who were aged 3-18 years old when the study began in 1980.
Disclosures: The presenter reported having no financial conflicts regarding the study, which is supported by the Academy of Finland, the Social Insurance Institution of Finland, and grants from nonprofit foundations.
Contraception coverage rollback is discriminatory
On Oct. 6, the Trump administration rolled back a crucial piece of the Affordable Care Act so that any employer can now claim a moral or religious objection to providing contraception coverage, thus denying their employees access to critical health care – contraception.
Nearly all women – 99% – who have had sex have used some form of contraception at some point during their reproductive lives, regardless of faith or religion (National health statistics reports. 2013 Feb 14[62]). Most women spend the majority of their fertile life span, approximately 35-40 years, avoiding pregnancy, and only a few years actively trying to become pregnant. A desired pregnancy is a gift, but unplanned pregnancies may have a negative impact on women, families, and society.
In the United States, our rising maternal mortality ratio is currently at 26.4 per 100,000 live births (Lancet. 2016 Oct 8;388[10053]:1775-812). Given the risks of pregnancy, especially to those with medical conditions that make pregnancy more dangerous, women need access to methods to avoid pregnancy until they actively seek it. If employers of for-profit businesses now choose to claim a moral or religious objection to providing coverage for contraception, millions of women could become unable to access affordable, effective contraception.
Since the Affordable Care Act mandate that provided coverage for contraceptive methods with no cost-sharing, thousands of women have had improved access to contraception, including IUDs and contraceptive implants, the most effective and longest-lasting reversible methods available. Since President Trump took office, many women have presented to clinics across the country to get long-acting contraception, like an IUD or implant, before the Trump administration could pull the plug on the contraceptive mandate. That scenario has now occurred, leaving millions of women up in the air about the future of their contraceptive coverage.
By allowing employers to deny coverage of contraception, the Trump administration is demonstrating its lack of concern for women’s health and its denial of the most fundamental principles of public health. 
Rolling back the contraceptive mandate is rolling back on vital women’s preventive health services. It is counter to society’s interest in public health and is discriminatory against women.
Dr. Prager is associate professor of obstetrics and gynecology at the University of Washington, Seattle. She is also the director of the family planning division and family planning fellowship. Dr. Prager is an unpaid trainer for Nexplanon (Merck). Dr. Espey is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. Dr. Espey reported having no relevant disclosures.
On Oct. 6, the Trump administration rolled back a crucial piece of the Affordable Care Act so that any employer can now claim a moral or religious objection to providing contraception coverage, thus denying their employees access to critical health care – contraception.
Nearly all women – 99% – who have had sex have used some form of contraception at some point during their reproductive lives, regardless of faith or religion (National health statistics reports. 2013 Feb 14[62]). Most women spend the majority of their fertile life span, approximately 35-40 years, avoiding pregnancy, and only a few years actively trying to become pregnant. A desired pregnancy is a gift, but unplanned pregnancies may have a negative impact on women, families, and society.
In the United States, our rising maternal mortality ratio is currently at 26.4 per 100,000 live births (Lancet. 2016 Oct 8;388[10053]:1775-812). Given the risks of pregnancy, especially to those with medical conditions that make pregnancy more dangerous, women need access to methods to avoid pregnancy until they actively seek it. If employers of for-profit businesses now choose to claim a moral or religious objection to providing coverage for contraception, millions of women could become unable to access affordable, effective contraception.
Since the Affordable Care Act mandate that provided coverage for contraceptive methods with no cost-sharing, thousands of women have had improved access to contraception, including IUDs and contraceptive implants, the most effective and longest-lasting reversible methods available. Since President Trump took office, many women have presented to clinics across the country to get long-acting contraception, like an IUD or implant, before the Trump administration could pull the plug on the contraceptive mandate. That scenario has now occurred, leaving millions of women up in the air about the future of their contraceptive coverage.
By allowing employers to deny coverage of contraception, the Trump administration is demonstrating its lack of concern for women’s health and its denial of the most fundamental principles of public health.
Rolling back the contraceptive mandate is rolling back on vital women’s preventive health services. It is counter to society’s interest in public health and is discriminatory against women.
Dr. Prager is associate professor of obstetrics and gynecology at the University of Washington, Seattle. She is also the director of the family planning division and family planning fellowship. Dr. Prager is an unpaid trainer for Nexplanon (Merck). Dr. Espey is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. Dr. Espey reported having no relevant disclosures.
On Oct. 6, the Trump administration rolled back a crucial piece of the Affordable Care Act so that any employer can now claim a moral or religious objection to providing contraception coverage, thus denying their employees access to critical health care – contraception.
Nearly all women – 99% – who have had sex have used some form of contraception at some point during their reproductive lives, regardless of faith or religion (National health statistics reports. 2013 Feb 14[62]). Most women spend the majority of their fertile life span, approximately 35-40 years, avoiding pregnancy, and only a few years actively trying to become pregnant. A desired pregnancy is a gift, but unplanned pregnancies may have a negative impact on women, families, and society.
In the United States, our rising maternal mortality ratio is currently at 26.4 per 100,000 live births (Lancet. 2016 Oct 8;388[10053]:1775-812). Given the risks of pregnancy, especially to those with medical conditions that make pregnancy more dangerous, women need access to methods to avoid pregnancy until they actively seek it. If employers of for-profit businesses now choose to claim a moral or religious objection to providing coverage for contraception, millions of women could become unable to access affordable, effective contraception.
Since the Affordable Care Act mandate that provided coverage for contraceptive methods with no cost-sharing, thousands of women have had improved access to contraception, including IUDs and contraceptive implants, the most effective and longest-lasting reversible methods available. Since President Trump took office, many women have presented to clinics across the country to get long-acting contraception, like an IUD or implant, before the Trump administration could pull the plug on the contraceptive mandate. That scenario has now occurred, leaving millions of women up in the air about the future of their contraceptive coverage.
By allowing employers to deny coverage of contraception, the Trump administration is demonstrating its lack of concern for women’s health and its denial of the most fundamental principles of public health.
Rolling back the contraceptive mandate is rolling back on vital women’s preventive health services. It is counter to society’s interest in public health and is discriminatory against women.
Dr. Prager is associate professor of obstetrics and gynecology at the University of Washington, Seattle. She is also the director of the family planning division and family planning fellowship. Dr. Prager is an unpaid trainer for Nexplanon (Merck). Dr. Espey is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. Dr. Espey reported having no relevant disclosures.
New antiviral combination for HCV infection in kidney disease
The combination of glecaprevir and pibrentasvir has been found to be both safe and effective as a treatment for hepatitis C virus (HCV) infection in patients with end-stage kidney disease, according to a paper published in the New England Journal of Medicine.
There are few treatment options available for these patients, as ribavirin can accumulate systemically in patients with severe renal impairment with serious adverse consequences such as hemolytic anemia and pruritus, and interferon has a negative side-effect profile in this population.
In this open-label phase 3 trial, 104 patients with hepatitis C infection and either compensated liver disease with severe renal impairment, dependence on dialysis, or both received 300 mg glecaprevir and 120 mg pibrentasvir daily for 12 weeks (N Engl J Med. 2017 Oct 12. doi: 10.1056/NEJMoa1704053).
The treatment was associated with a sustained virologic response in 102 patients (98%) at 12 weeks and 100 patients (96%) at 24 weeks, with no cases of virologic failure.
Of the two patients who did not have a sustained virologic response at 12 weeks, one was undergoing hemodialysis at baseline and had both compensated cirrhosis and underlying hypertension, while the other had a history of gastrointestinal tract telangiectasia and discontinued after a nonserious adverse event of diarrhea.
One-quarter of patients experienced serious adverse events, but none were deemed drug related, and there were no reports of liver decompensation. Five patients reported grade 3 hemoglobin abnormalities, but none showed abnormalities in alanine aminotransferase of grade 2 or higher.
The most common adverse events were pruritus, fatigue, and nausea, which were each reported in more than 10% of patients. The authors described this as an acceptable safety profile in a population of patients with numerous coexisting conditions. However, they noted that the absence of a placebo control group made it difficult to compare treatment-related adverse events with the underlying adverse event profile of this group of patients.
“Glecaprevir–pibrentasvir may fulfill an important unmet need; the absence of ribavirin as part of the treatment regimen minimizes the risks of treatment discontinuation and of adverse events due to anemia, which represents a considerable benefit for patients with severe renal insufficiency, since they are at increased risk for life-threatening anemia and cardiac events,” they wrote.
The study was supported by AbbVie. Twelve authors declared speakers bureau, advisory board positions, grants, or other support from AbbVie, as well as grants and funding from other pharmaceutical companies outside this work. Five authors were employees and stockholders of AbbVie.
The combination of glecaprevir and pibrentasvir has been found to be both safe and effective as a treatment for hepatitis C virus (HCV) infection in patients with end-stage kidney disease, according to a paper published in the New England Journal of Medicine.
There are few treatment options available for these patients, as ribavirin can accumulate systemically in patients with severe renal impairment with serious adverse consequences such as hemolytic anemia and pruritus, and interferon has a negative side-effect profile in this population.
In this open-label phase 3 trial, 104 patients with hepatitis C infection and either compensated liver disease with severe renal impairment, dependence on dialysis, or both received 300 mg glecaprevir and 120 mg pibrentasvir daily for 12 weeks (N Engl J Med. 2017 Oct 12. doi: 10.1056/NEJMoa1704053).
The treatment was associated with a sustained virologic response in 102 patients (98%) at 12 weeks and 100 patients (96%) at 24 weeks, with no cases of virologic failure.
Of the two patients who did not have a sustained virologic response at 12 weeks, one was undergoing hemodialysis at baseline and had both compensated cirrhosis and underlying hypertension, while the other had a history of gastrointestinal tract telangiectasia and discontinued after a nonserious adverse event of diarrhea.
One-quarter of patients experienced serious adverse events, but none were deemed drug related, and there were no reports of liver decompensation. Five patients reported grade 3 hemoglobin abnormalities, but none showed abnormalities in alanine aminotransferase of grade 2 or higher.
The most common adverse events were pruritus, fatigue, and nausea, which were each reported in more than 10% of patients. The authors described this as an acceptable safety profile in a population of patients with numerous coexisting conditions. However, they noted that the absence of a placebo control group made it difficult to compare treatment-related adverse events with the underlying adverse event profile of this group of patients.
“Glecaprevir–pibrentasvir may fulfill an important unmet need; the absence of ribavirin as part of the treatment regimen minimizes the risks of treatment discontinuation and of adverse events due to anemia, which represents a considerable benefit for patients with severe renal insufficiency, since they are at increased risk for life-threatening anemia and cardiac events,” they wrote.
The study was supported by AbbVie. Twelve authors declared speakers bureau, advisory board positions, grants, or other support from AbbVie, as well as grants and funding from other pharmaceutical companies outside this work. Five authors were employees and stockholders of AbbVie.
The combination of glecaprevir and pibrentasvir has been found to be both safe and effective as a treatment for hepatitis C virus (HCV) infection in patients with end-stage kidney disease, according to a paper published in the New England Journal of Medicine.
There are few treatment options available for these patients, as ribavirin can accumulate systemically in patients with severe renal impairment with serious adverse consequences such as hemolytic anemia and pruritus, and interferon has a negative side-effect profile in this population.
In this open-label phase 3 trial, 104 patients with hepatitis C infection and either compensated liver disease with severe renal impairment, dependence on dialysis, or both received 300 mg glecaprevir and 120 mg pibrentasvir daily for 12 weeks (N Engl J Med. 2017 Oct 12. doi: 10.1056/NEJMoa1704053).
The treatment was associated with a sustained virologic response in 102 patients (98%) at 12 weeks and 100 patients (96%) at 24 weeks, with no cases of virologic failure.
Of the two patients who did not have a sustained virologic response at 12 weeks, one was undergoing hemodialysis at baseline and had both compensated cirrhosis and underlying hypertension, while the other had a history of gastrointestinal tract telangiectasia and discontinued after a nonserious adverse event of diarrhea.
One-quarter of patients experienced serious adverse events, but none were deemed drug related, and there were no reports of liver decompensation. Five patients reported grade 3 hemoglobin abnormalities, but none showed abnormalities in alanine aminotransferase of grade 2 or higher.
The most common adverse events were pruritus, fatigue, and nausea, which were each reported in more than 10% of patients. The authors described this as an acceptable safety profile in a population of patients with numerous coexisting conditions. However, they noted that the absence of a placebo control group made it difficult to compare treatment-related adverse events with the underlying adverse event profile of this group of patients.
“Glecaprevir–pibrentasvir may fulfill an important unmet need; the absence of ribavirin as part of the treatment regimen minimizes the risks of treatment discontinuation and of adverse events due to anemia, which represents a considerable benefit for patients with severe renal insufficiency, since they are at increased risk for life-threatening anemia and cardiac events,” they wrote.
The study was supported by AbbVie. Twelve authors declared speakers bureau, advisory board positions, grants, or other support from AbbVie, as well as grants and funding from other pharmaceutical companies outside this work. Five authors were employees and stockholders of AbbVie.
FROM NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: The combination of glecaprevir and pibrentasvir has been found to be both safe and effective as a treatment for hepatitis C infection in patients with end-stage kidney disease.
Major finding:
Data source: Open-label phase 3 trial in 104 patients with hepatitis C infection and renal failure.
Disclosures: The study was supported by AbbVie. Twelve authors declared speakers bureau, advisory board positions, grants, or other support from AbbVie, as well as grants and funding from other pharmaceutical companies outside this work. Five authors were employees and stockholders of AbbVie.
PBC linked to low BMD, increased risk of osteoporosis
Patients with primary biliary cholangitis (PBC) have lower lumbar spine and hip bone mineral density (BMD) and are at an increased risk of osteoporosis and fracture, according to Junyu Fan, MD, and associates.
In a meta-analysis of 210 potentially relevant articles, only 8 met the study’s criteria. Of those, five studies were pooled and the overall relationship between PBC and osteoporosis risk was assessed. Results found a significant association between PBC (n = 504) and the prevalence of osteoporosis (P = .01), compared with the control group (n = 2,052).
The study additionally examined possible connection between PBC and bone fractures; more fracture events were reported in PBC patients (n = 929) than in controls (n = 8,699; P less than .00001). It is noted that there was no publication bias (P = .476).
“Further clinical management, follow-up, and surveillance issues should be addressed with caution,” researchers concluded. “Given the limited number of studies included, more high-quality studies will be required to determine the mechanisms underpinning the relationship between PBC and osteoporosis risk.”
Find the full study in Clinical Rheumatology (2017. doi: 10.1007/s10067-017-3844-x).
Patients with primary biliary cholangitis (PBC) have lower lumbar spine and hip bone mineral density (BMD) and are at an increased risk of osteoporosis and fracture, according to Junyu Fan, MD, and associates.
In a meta-analysis of 210 potentially relevant articles, only 8 met the study’s criteria. Of those, five studies were pooled and the overall relationship between PBC and osteoporosis risk was assessed. Results found a significant association between PBC (n = 504) and the prevalence of osteoporosis (P = .01), compared with the control group (n = 2,052).
The study additionally examined possible connection between PBC and bone fractures; more fracture events were reported in PBC patients (n = 929) than in controls (n = 8,699; P less than .00001). It is noted that there was no publication bias (P = .476).
“Further clinical management, follow-up, and surveillance issues should be addressed with caution,” researchers concluded. “Given the limited number of studies included, more high-quality studies will be required to determine the mechanisms underpinning the relationship between PBC and osteoporosis risk.”
Find the full study in Clinical Rheumatology (2017. doi: 10.1007/s10067-017-3844-x).
Patients with primary biliary cholangitis (PBC) have lower lumbar spine and hip bone mineral density (BMD) and are at an increased risk of osteoporosis and fracture, according to Junyu Fan, MD, and associates.
In a meta-analysis of 210 potentially relevant articles, only 8 met the study’s criteria. Of those, five studies were pooled and the overall relationship between PBC and osteoporosis risk was assessed. Results found a significant association between PBC (n = 504) and the prevalence of osteoporosis (P = .01), compared with the control group (n = 2,052).
The study additionally examined possible connection between PBC and bone fractures; more fracture events were reported in PBC patients (n = 929) than in controls (n = 8,699; P less than .00001). It is noted that there was no publication bias (P = .476).
“Further clinical management, follow-up, and surveillance issues should be addressed with caution,” researchers concluded. “Given the limited number of studies included, more high-quality studies will be required to determine the mechanisms underpinning the relationship between PBC and osteoporosis risk.”
Find the full study in Clinical Rheumatology (2017. doi: 10.1007/s10067-017-3844-x).
FROM CLINICAL RHEUMATOLOGY
Minimal residual disease measures not yet impactful for AML patients
SAN FRANCISCO – Routine testing for minimal residual disease is probably not of value in acute myeloid leukemia, as there is no evidence that changing treatment based on MRD status currently makes a difference in patient outcomes, experts said at the annual congress on Hematologic Malignancies held by the National Comprehensive Cancer Network.
“If we find minimal residual disease, we don’t always have a better therapy to offer our patients,” Jessica Altman, MD, associate professor of hematology and oncology at the Northwestern University Feinberg School of Medicine, said.
Beyond that therapeutic reality, there are no clear guidelines and standards for MRD testing. The optimal timing for MRD testing and a standard threshold for an MRD classification are not yet established, she said.
“Having MRD is bad, not having it is better,” Richard Stone, MD, PhD, clinical director of the adult leukemia program at the Dana-Farber Cancer Institute, said. The problem in AML, he said, is, “So?” There is no reliable “MRD eraser” in AML, he said. Until then, there is not much point in knowing whether a patient is MRD positive or not.
A recent survey conducted by researchers at Moffitt Cancer Center, Tampa, addressed MRD testing at 13 major cancer centers. While most centers reported that they test for MRD, many physicians said that they are unsure about what to do with the results.
A 2013 study by the HOVON group found that patients who were in complete remission but MRD positive after their first course of therapy, subsequently became MRD negative after their second course of therapy. But the second regimen would not have been different based on knowledge of MRD status, according to the HOVON/SAKK AML 42A study (J Clin Oncol. 2013; 31:3889-97).
The AML community is awaiting guidelines on MRD use from the NCCN and other groups, Dr. Altman said. An option for using NPM1 mutations to assess MRD should be available soon, and could be an improvement on existing options (N Engl J Med 2016; 374:422-33).
Given the treatment limitations, knowing about MRD status can have a negative mental toll on patients, Dr. Stone said. “I would not underplay the psychological burden.” Nevertheless, MRD should be measured in clinical trials, and it could be a valuable surrogate marker by which to compare drug efficacy.
One of the biggest hopes is that MRD status could eventually be useful in determining the need for allogeneic stem cell transplant in patients deemed intermediate risk, Dr. Altman said. “I think we are finally on the brink of this being actionable.”
Dr. Altman reports financial relationships with Astellas, Bristol-Myers Squibb, Celgene, Janssen, Novartis, and Syros. Dr. Stone reports financial relationships with AbbVie, Actinium, Agios, Amgen and many other companies.
SAN FRANCISCO – Routine testing for minimal residual disease is probably not of value in acute myeloid leukemia, as there is no evidence that changing treatment based on MRD status currently makes a difference in patient outcomes, experts said at the annual congress on Hematologic Malignancies held by the National Comprehensive Cancer Network.
“If we find minimal residual disease, we don’t always have a better therapy to offer our patients,” Jessica Altman, MD, associate professor of hematology and oncology at the Northwestern University Feinberg School of Medicine, said.
Beyond that therapeutic reality, there are no clear guidelines and standards for MRD testing. The optimal timing for MRD testing and a standard threshold for an MRD classification are not yet established, she said.
“Having MRD is bad, not having it is better,” Richard Stone, MD, PhD, clinical director of the adult leukemia program at the Dana-Farber Cancer Institute, said. The problem in AML, he said, is, “So?” There is no reliable “MRD eraser” in AML, he said. Until then, there is not much point in knowing whether a patient is MRD positive or not.
A recent survey conducted by researchers at Moffitt Cancer Center, Tampa, addressed MRD testing at 13 major cancer centers. While most centers reported that they test for MRD, many physicians said that they are unsure about what to do with the results.
A 2013 study by the HOVON group found that patients who were in complete remission but MRD positive after their first course of therapy, subsequently became MRD negative after their second course of therapy. But the second regimen would not have been different based on knowledge of MRD status, according to the HOVON/SAKK AML 42A study (J Clin Oncol. 2013; 31:3889-97).
The AML community is awaiting guidelines on MRD use from the NCCN and other groups, Dr. Altman said. An option for using NPM1 mutations to assess MRD should be available soon, and could be an improvement on existing options (N Engl J Med 2016; 374:422-33).
Given the treatment limitations, knowing about MRD status can have a negative mental toll on patients, Dr. Stone said. “I would not underplay the psychological burden.” Nevertheless, MRD should be measured in clinical trials, and it could be a valuable surrogate marker by which to compare drug efficacy.
One of the biggest hopes is that MRD status could eventually be useful in determining the need for allogeneic stem cell transplant in patients deemed intermediate risk, Dr. Altman said. “I think we are finally on the brink of this being actionable.”
Dr. Altman reports financial relationships with Astellas, Bristol-Myers Squibb, Celgene, Janssen, Novartis, and Syros. Dr. Stone reports financial relationships with AbbVie, Actinium, Agios, Amgen and many other companies.
SAN FRANCISCO – Routine testing for minimal residual disease is probably not of value in acute myeloid leukemia, as there is no evidence that changing treatment based on MRD status currently makes a difference in patient outcomes, experts said at the annual congress on Hematologic Malignancies held by the National Comprehensive Cancer Network.
“If we find minimal residual disease, we don’t always have a better therapy to offer our patients,” Jessica Altman, MD, associate professor of hematology and oncology at the Northwestern University Feinberg School of Medicine, said.
Beyond that therapeutic reality, there are no clear guidelines and standards for MRD testing. The optimal timing for MRD testing and a standard threshold for an MRD classification are not yet established, she said.
“Having MRD is bad, not having it is better,” Richard Stone, MD, PhD, clinical director of the adult leukemia program at the Dana-Farber Cancer Institute, said. The problem in AML, he said, is, “So?” There is no reliable “MRD eraser” in AML, he said. Until then, there is not much point in knowing whether a patient is MRD positive or not.
A recent survey conducted by researchers at Moffitt Cancer Center, Tampa, addressed MRD testing at 13 major cancer centers. While most centers reported that they test for MRD, many physicians said that they are unsure about what to do with the results.
A 2013 study by the HOVON group found that patients who were in complete remission but MRD positive after their first course of therapy, subsequently became MRD negative after their second course of therapy. But the second regimen would not have been different based on knowledge of MRD status, according to the HOVON/SAKK AML 42A study (J Clin Oncol. 2013; 31:3889-97).
The AML community is awaiting guidelines on MRD use from the NCCN and other groups, Dr. Altman said. An option for using NPM1 mutations to assess MRD should be available soon, and could be an improvement on existing options (N Engl J Med 2016; 374:422-33).
Given the treatment limitations, knowing about MRD status can have a negative mental toll on patients, Dr. Stone said. “I would not underplay the psychological burden.” Nevertheless, MRD should be measured in clinical trials, and it could be a valuable surrogate marker by which to compare drug efficacy.
One of the biggest hopes is that MRD status could eventually be useful in determining the need for allogeneic stem cell transplant in patients deemed intermediate risk, Dr. Altman said. “I think we are finally on the brink of this being actionable.”
Dr. Altman reports financial relationships with Astellas, Bristol-Myers Squibb, Celgene, Janssen, Novartis, and Syros. Dr. Stone reports financial relationships with AbbVie, Actinium, Agios, Amgen and many other companies.
EXPERT ANALYSIS AT NCCN HEMATOLOGIC MALIGNANCIES CONGRESS
Venography for stenting led to good results for patients with May-Thurner syndrome
Stenting of the left common iliac vein of patients with May-Thurner syndrome provided good short-term results as compared with nonstenting, according to the results of a retrospective, single-center registry study.
When to treat patients with May-Thurner syndrome (MTS) who have mild symptoms and what degree of compression should trigger intervention are in considerable question. Approximately 50% of the general population has some degree of left common iliac vein (LCIV) compression as detected using intravascular ultrasound (IVUS) and axial imaging, according to Johnathon C. Rollo, MD, of the University of Washington, Seattle, and his colleagues at the University of California, Los Angeles. They performed their study in order to address the debate over what were the optimal IVUS and venography criteria for stent implantation in these patients.
Of 102 patients in a registry, 63 had clear evidence of LCIV compression by the overlying right common iliac artery by IVUS assessment or venography. Nonthrombotic MTS patients who presented with chronic leg swelling or venous claudication underwent duplex ultrasound to rule out deep-vein thrombosis (DVT) were placed in compression therapy, and venography was performed to assess for iliac vein involvement
Iliac vein stenting was offered to those patients who met the following criteria:
• Sufficiently severe symptoms of swelling, venous claudication, or pain to affect their quality of life despite compression therapy.
• Diagnostic venogram imaging showing evidence of physiologically significant MTS compression, including contrast stagnation within the proximal left common and external iliac vein, contralateral cross-filling to the right iliac venous • circulation via hypogastric collateral networks, and/or significant retroperitoneal collateralization.
• IVUS assessment demonstrating greater than 50% luminal narrowing of the LCIV or extensive intravascular webs.
Patients who did not meet one of these criteria (generally the venogram findings) were treated with continued conservative management, which consisted of compression therapy, weight loss and exercise programs, and other conservative measures (J Vasc Surg: Venous Lymphatic Disorders. 2017;5:667-76).
Of the 63 patients in the final study group, a total of 44 were treated with iliofemoral stents, with or without thrombolysis, and 19 conservatively managed patients who were not treated with stents served as controls. The mean age of the patients was 46 years, and 76% of them were women. With regard to comorbidities, 63% had a patient-reported history of DVT, and 22% had a patient-reported history of pulmonary embolism. Of the 63 patients, 32 had nonthrombotic MTS.
Stent diameter was based on IVUS measurement, with the goal of achieving normal vein diameter, and undersizing was avoided. Stenting was performed under local anesthesia.
A total of 44 patients (70%) underwent primary stenting (70%) or thrombolysis and stenting (30%), whereas 19 patients were not stented. Of these latter, 14 were nonthrombotic and were treated conservatively with compression therapy alone; the remaining 5 patients with thrombotic MTS were treated with lysis or angioplasty alone. Technical success was achieved in 100% of patients who had an intervention.
Primary and secondary patency rates in the stented thrombotic population were 87% and 93% at 24 months, respectively, by Kaplan-Meier analysis and were not significantly different from the results of the nonthrombotic stented patients.
Clinical improvement was significantly more likely in stented patients, compared with those managed without stenting (95% vs. 58%, respectively; P less than .001), Complete clinical resolution, defined as an absence of swelling or any other venous symptoms, was three times more likely in stented patients than in nonstented patients (64% vs. 21%, respectively; P less than .001), according to the researchers.
“MTS patients are typically young and relatively healthy. Whereas several series have demonstrated good intermediate-term results out to 7-10 years, the durability of these stents 20-30 years or more after implantation is unknown. For this reason, our group has been conservative in offering stent implantation to nonthrombotic patients,” Dr. Rollo and his colleagues stated.
“Regardless of the differential in clinical outcomes between stented and nonstented patients, this selective approach to stenting is reasonable in that those believed to be best managed with conservative therapy can be re-evaluated at regular intervals for clinical deterioration,” they concluded.
The authors reported that they had no disclosures.
Most vascular specialists, including our group in New York, have relied heavily on intravascular ultrasound demonstrating greater than 50% stenosis to decide whether or not stenting is indicated. Dr. Rollo and his associates emphasized the importance of using venography-guided findings (contrast stagnation within the external iliac vein, contralateral cross-filling to the right iliac system, and/or significant retroperitoneal collateralization) to decide on stent indication. They did, however, use IVUS to guide in stent sizing and placement.
Todd Berland, MD , is the director, outpatient vascular interventions, NYU Langone Health, New York, N.Y. He had no relevant financial disclosures.
Most vascular specialists, including our group in New York, have relied heavily on intravascular ultrasound demonstrating greater than 50% stenosis to decide whether or not stenting is indicated. Dr. Rollo and his associates emphasized the importance of using venography-guided findings (contrast stagnation within the external iliac vein, contralateral cross-filling to the right iliac system, and/or significant retroperitoneal collateralization) to decide on stent indication. They did, however, use IVUS to guide in stent sizing and placement.
Todd Berland, MD , is the director, outpatient vascular interventions, NYU Langone Health, New York, N.Y. He had no relevant financial disclosures.
Most vascular specialists, including our group in New York, have relied heavily on intravascular ultrasound demonstrating greater than 50% stenosis to decide whether or not stenting is indicated. Dr. Rollo and his associates emphasized the importance of using venography-guided findings (contrast stagnation within the external iliac vein, contralateral cross-filling to the right iliac system, and/or significant retroperitoneal collateralization) to decide on stent indication. They did, however, use IVUS to guide in stent sizing and placement.
Todd Berland, MD , is the director, outpatient vascular interventions, NYU Langone Health, New York, N.Y. He had no relevant financial disclosures.
Stenting of the left common iliac vein of patients with May-Thurner syndrome provided good short-term results as compared with nonstenting, according to the results of a retrospective, single-center registry study.
When to treat patients with May-Thurner syndrome (MTS) who have mild symptoms and what degree of compression should trigger intervention are in considerable question. Approximately 50% of the general population has some degree of left common iliac vein (LCIV) compression as detected using intravascular ultrasound (IVUS) and axial imaging, according to Johnathon C. Rollo, MD, of the University of Washington, Seattle, and his colleagues at the University of California, Los Angeles. They performed their study in order to address the debate over what were the optimal IVUS and venography criteria for stent implantation in these patients.
Of 102 patients in a registry, 63 had clear evidence of LCIV compression by the overlying right common iliac artery by IVUS assessment or venography. Nonthrombotic MTS patients who presented with chronic leg swelling or venous claudication underwent duplex ultrasound to rule out deep-vein thrombosis (DVT) were placed in compression therapy, and venography was performed to assess for iliac vein involvement
Iliac vein stenting was offered to those patients who met the following criteria:
• Sufficiently severe symptoms of swelling, venous claudication, or pain to affect their quality of life despite compression therapy.
• Diagnostic venogram imaging showing evidence of physiologically significant MTS compression, including contrast stagnation within the proximal left common and external iliac vein, contralateral cross-filling to the right iliac venous • circulation via hypogastric collateral networks, and/or significant retroperitoneal collateralization.
• IVUS assessment demonstrating greater than 50% luminal narrowing of the LCIV or extensive intravascular webs.
Patients who did not meet one of these criteria (generally the venogram findings) were treated with continued conservative management, which consisted of compression therapy, weight loss and exercise programs, and other conservative measures (J Vasc Surg: Venous Lymphatic Disorders. 2017;5:667-76).
Of the 63 patients in the final study group, a total of 44 were treated with iliofemoral stents, with or without thrombolysis, and 19 conservatively managed patients who were not treated with stents served as controls. The mean age of the patients was 46 years, and 76% of them were women. With regard to comorbidities, 63% had a patient-reported history of DVT, and 22% had a patient-reported history of pulmonary embolism. Of the 63 patients, 32 had nonthrombotic MTS.
Stent diameter was based on IVUS measurement, with the goal of achieving normal vein diameter, and undersizing was avoided. Stenting was performed under local anesthesia.
A total of 44 patients (70%) underwent primary stenting (70%) or thrombolysis and stenting (30%), whereas 19 patients were not stented. Of these latter, 14 were nonthrombotic and were treated conservatively with compression therapy alone; the remaining 5 patients with thrombotic MTS were treated with lysis or angioplasty alone. Technical success was achieved in 100% of patients who had an intervention.
Primary and secondary patency rates in the stented thrombotic population were 87% and 93% at 24 months, respectively, by Kaplan-Meier analysis and were not significantly different from the results of the nonthrombotic stented patients.
Clinical improvement was significantly more likely in stented patients, compared with those managed without stenting (95% vs. 58%, respectively; P less than .001), Complete clinical resolution, defined as an absence of swelling or any other venous symptoms, was three times more likely in stented patients than in nonstented patients (64% vs. 21%, respectively; P less than .001), according to the researchers.
“MTS patients are typically young and relatively healthy. Whereas several series have demonstrated good intermediate-term results out to 7-10 years, the durability of these stents 20-30 years or more after implantation is unknown. For this reason, our group has been conservative in offering stent implantation to nonthrombotic patients,” Dr. Rollo and his colleagues stated.
“Regardless of the differential in clinical outcomes between stented and nonstented patients, this selective approach to stenting is reasonable in that those believed to be best managed with conservative therapy can be re-evaluated at regular intervals for clinical deterioration,” they concluded.
The authors reported that they had no disclosures.
Stenting of the left common iliac vein of patients with May-Thurner syndrome provided good short-term results as compared with nonstenting, according to the results of a retrospective, single-center registry study.
When to treat patients with May-Thurner syndrome (MTS) who have mild symptoms and what degree of compression should trigger intervention are in considerable question. Approximately 50% of the general population has some degree of left common iliac vein (LCIV) compression as detected using intravascular ultrasound (IVUS) and axial imaging, according to Johnathon C. Rollo, MD, of the University of Washington, Seattle, and his colleagues at the University of California, Los Angeles. They performed their study in order to address the debate over what were the optimal IVUS and venography criteria for stent implantation in these patients.
Of 102 patients in a registry, 63 had clear evidence of LCIV compression by the overlying right common iliac artery by IVUS assessment or venography. Nonthrombotic MTS patients who presented with chronic leg swelling or venous claudication underwent duplex ultrasound to rule out deep-vein thrombosis (DVT) were placed in compression therapy, and venography was performed to assess for iliac vein involvement
Iliac vein stenting was offered to those patients who met the following criteria:
• Sufficiently severe symptoms of swelling, venous claudication, or pain to affect their quality of life despite compression therapy.
• Diagnostic venogram imaging showing evidence of physiologically significant MTS compression, including contrast stagnation within the proximal left common and external iliac vein, contralateral cross-filling to the right iliac venous • circulation via hypogastric collateral networks, and/or significant retroperitoneal collateralization.
• IVUS assessment demonstrating greater than 50% luminal narrowing of the LCIV or extensive intravascular webs.
Patients who did not meet one of these criteria (generally the venogram findings) were treated with continued conservative management, which consisted of compression therapy, weight loss and exercise programs, and other conservative measures (J Vasc Surg: Venous Lymphatic Disorders. 2017;5:667-76).
Of the 63 patients in the final study group, a total of 44 were treated with iliofemoral stents, with or without thrombolysis, and 19 conservatively managed patients who were not treated with stents served as controls. The mean age of the patients was 46 years, and 76% of them were women. With regard to comorbidities, 63% had a patient-reported history of DVT, and 22% had a patient-reported history of pulmonary embolism. Of the 63 patients, 32 had nonthrombotic MTS.
Stent diameter was based on IVUS measurement, with the goal of achieving normal vein diameter, and undersizing was avoided. Stenting was performed under local anesthesia.
A total of 44 patients (70%) underwent primary stenting (70%) or thrombolysis and stenting (30%), whereas 19 patients were not stented. Of these latter, 14 were nonthrombotic and were treated conservatively with compression therapy alone; the remaining 5 patients with thrombotic MTS were treated with lysis or angioplasty alone. Technical success was achieved in 100% of patients who had an intervention.
Primary and secondary patency rates in the stented thrombotic population were 87% and 93% at 24 months, respectively, by Kaplan-Meier analysis and were not significantly different from the results of the nonthrombotic stented patients.
Clinical improvement was significantly more likely in stented patients, compared with those managed without stenting (95% vs. 58%, respectively; P less than .001), Complete clinical resolution, defined as an absence of swelling or any other venous symptoms, was three times more likely in stented patients than in nonstented patients (64% vs. 21%, respectively; P less than .001), according to the researchers.
“MTS patients are typically young and relatively healthy. Whereas several series have demonstrated good intermediate-term results out to 7-10 years, the durability of these stents 20-30 years or more after implantation is unknown. For this reason, our group has been conservative in offering stent implantation to nonthrombotic patients,” Dr. Rollo and his colleagues stated.
“Regardless of the differential in clinical outcomes between stented and nonstented patients, this selective approach to stenting is reasonable in that those believed to be best managed with conservative therapy can be re-evaluated at regular intervals for clinical deterioration,” they concluded.
The authors reported that they had no disclosures.
FROM THE JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS
Key clinical point:
Major finding: May-Thurner patients treated with iliofemoral stents had significantly better (95%) clinical improvement than 21 patients not treated with stents (58%).
Data source: Retrospective analysis of a single-center registry of 65 patients with May-Thurner syndrome.
Disclosures: The authors reported that they had no disclosures.