Jennie E. Smith

HOUSTON – Findings from a cohort study of mothers and babies point to breastfeeding as influencing infants’ gut microbiome in a way that protects them from developing allergic disease.

In findings presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, epidemiologist Christine Cole Johnson, Ph.D., of the Henry Ford Health System in Detroit described a correlation between certain maternal and birth characteristics that had previously been shown to relate to allergic response, and measurable differences in the bacterial profiles of the study infants’ stools.

Using data from the WHEALS (Wayne County [Michigan] Health, Environment, Allergy, and Asthma Longitudinal Study) cohort, Dr. Johnson and her colleagues looked at stool samples from 298 children at 1 and 6 months of age. The investigators also collected dust samples from the infants’ homes, obtained medical records, and conducted interviews with the families (J. Allergy Clin. Immunol. 2015 [http://dx.doi.org/10.1016/j.jaci.2014.12.1443]).

The presence of household pets, the body mass index of mothers before delivery, the mode of delivery, household smoke exposure, marital status, income, race, and maternal education were all found to be significantly correlated to different gut bacterial profiles.

“Environmental and lifestyle variables that we’ve been working on related to childhood asthma and allergy seem to be associated – at least in our study – with the child’s gut microbiome,” Dr. Johnson said. “These factors vary a lot by whether those stool samples were collected at 1 or 6 months,” she said, noting that the infant gut microbiome is shaped rapidly in the first year.

But, at both 1 and 6 months of age, breastfeeding was seen as the dominant factor influencing gut bacterial composition.

At 6 months, breastfed infants had bacterial profiles showing overwhelming dominance of Bifidobacteriaceae, but vastly lower levels of other families of bacteria, notably Lachnospiraceae, which were prominent in the guts of non-breastfed babies.

In a related study that used the same cohort to explore whether the influence of breastfeeding on gut bacterial composition correlated to the development of allergic symptoms at 4 years old, Alexandra R. Sitarik, also of the Henry Ford Health System in Detroit, reported that babies being breastfed at 1 month of age had a significantly lower risk of developing allergiclike symptoms to pets by age 4 years (P = .028) (J. Allergy Clin. Immunol. 2015 [http://dx.doi.org/10.1016/j.jaci.2014.12.1444]).

Both breastfeeding and allergiclike response to pets were significantly related to compositional variation in gut microbiome (P < .001 and P = .023, respectively), Ms. Sitarik reported.

Of the 109 types of bacteria significantly associated with both breastfeeding and allergiclike response to pets, 71% were negatively associated with breastfeeding but positively associated with allergiclike response to pets.

This subset of risk-increasing bacteria suppressed by breastfeeding were predominantly members of the family Lachnospiraceae, the researchers found.

Lachnospiraceae are common adult gut colonizers, Ms. Sitarik said, and as people age the relative abundance of Lachnospiraceae increases. “What we think might be happening in terms of the gut microbiome is that maybe breastfeeding is preventing this premature shift into adulthood,” she said.

Dr. Johnson and Ms. Sitarik reported having no financial disclosures.

HOUSTON – Findings from a cohort study of mothers and babies point to breastfeeding as influencing infants’ gut microbiome in a way that protects them from developing allergic disease.

In findings presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, epidemiologist Christine Cole Johnson, Ph.D., of the Henry Ford Health System in Detroit described a correlation between certain maternal and birth characteristics that had previously been shown to relate to allergic response, and measurable differences in the bacterial profiles of the study infants’ stools.

Using data from the WHEALS (Wayne County [Michigan] Health, Environment, Allergy, and Asthma Longitudinal Study) cohort, Dr. Johnson and her colleagues looked at stool samples from 298 children at 1 and 6 months of age. The investigators also collected dust samples from the infants’ homes, obtained medical records, and conducted interviews with the families (J. Allergy Clin. Immunol. 2015 [http://dx.doi.org/10.1016/j.jaci.2014.12.1443]).

The presence of household pets, the body mass index of mothers before delivery, the mode of delivery, household smoke exposure, marital status, income, race, and maternal education were all found to be significantly correlated to different gut bacterial profiles.

“Environmental and lifestyle variables that we’ve been working on related to childhood asthma and allergy seem to be associated – at least in our study – with the child’s gut microbiome,” Dr. Johnson said. “These factors vary a lot by whether those stool samples were collected at 1 or 6 months,” she said, noting that the infant gut microbiome is shaped rapidly in the first year.

But, at both 1 and 6 months of age, breastfeeding was seen as the dominant factor influencing gut bacterial composition.

At 6 months, breastfed infants had bacterial profiles showing overwhelming dominance of Bifidobacteriaceae, but vastly lower levels of other families of bacteria, notably Lachnospiraceae, which were prominent in the guts of non-breastfed babies.

In a related study that used the same cohort to explore whether the influence of breastfeeding on gut bacterial composition correlated to the development of allergic symptoms at 4 years old, Alexandra R. Sitarik, also of the Henry Ford Health System in Detroit, reported that babies being breastfed at 1 month of age had a significantly lower risk of developing allergiclike symptoms to pets by age 4 years (P = .028) (J. Allergy Clin. Immunol. 2015 [http://dx.doi.org/10.1016/j.jaci.2014.12.1444]).

Both breastfeeding and allergiclike response to pets were significantly related to compositional variation in gut microbiome (P < .001 and P = .023, respectively), Ms. Sitarik reported.

Of the 109 types of bacteria significantly associated with both breastfeeding and allergiclike response to pets, 71% were negatively associated with breastfeeding but positively associated with allergiclike response to pets.

This subset of risk-increasing bacteria suppressed by breastfeeding were predominantly members of the family Lachnospiraceae, the researchers found.

Lachnospiraceae are common adult gut colonizers, Ms. Sitarik said, and as people age the relative abundance of Lachnospiraceae increases. “What we think might be happening in terms of the gut microbiome is that maybe breastfeeding is preventing this premature shift into adulthood,” she said.

Dr. Johnson and Ms. Sitarik reported having no financial disclosures.

HOUSTON – Findings from a cohort study of mothers and babies point to breastfeeding as influencing infants’ gut microbiome in a way that protects them from developing allergic disease.

In findings presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, epidemiologist Christine Cole Johnson, Ph.D., of the Henry Ford Health System in Detroit described a correlation between certain maternal and birth characteristics that had previously been shown to relate to allergic response, and measurable differences in the bacterial profiles of the study infants’ stools.

Using data from the WHEALS (Wayne County [Michigan] Health, Environment, Allergy, and Asthma Longitudinal Study) cohort, Dr. Johnson and her colleagues looked at stool samples from 298 children at 1 and 6 months of age. The investigators also collected dust samples from the infants’ homes, obtained medical records, and conducted interviews with the families (J. Allergy Clin. Immunol. 2015 [http://dx.doi.org/10.1016/j.jaci.2014.12.1443]).

The presence of household pets, the body mass index of mothers before delivery, the mode of delivery, household smoke exposure, marital status, income, race, and maternal education were all found to be significantly correlated to different gut bacterial profiles.

“Environmental and lifestyle variables that we’ve been working on related to childhood asthma and allergy seem to be associated – at least in our study – with the child’s gut microbiome,” Dr. Johnson said. “These factors vary a lot by whether those stool samples were collected at 1 or 6 months,” she said, noting that the infant gut microbiome is shaped rapidly in the first year.

But, at both 1 and 6 months of age, breastfeeding was seen as the dominant factor influencing gut bacterial composition.

At 6 months, breastfed infants had bacterial profiles showing overwhelming dominance of Bifidobacteriaceae, but vastly lower levels of other families of bacteria, notably Lachnospiraceae, which were prominent in the guts of non-breastfed babies.

In a related study that used the same cohort to explore whether the influence of breastfeeding on gut bacterial composition correlated to the development of allergic symptoms at 4 years old, Alexandra R. Sitarik, also of the Henry Ford Health System in Detroit, reported that babies being breastfed at 1 month of age had a significantly lower risk of developing allergiclike symptoms to pets by age 4 years (P = .028) (J. Allergy Clin. Immunol. 2015 [http://dx.doi.org/10.1016/j.jaci.2014.12.1444]).

Both breastfeeding and allergiclike response to pets were significantly related to compositional variation in gut microbiome (P < .001 and P = .023, respectively), Ms. Sitarik reported.

Of the 109 types of bacteria significantly associated with both breastfeeding and allergiclike response to pets, 71% were negatively associated with breastfeeding but positively associated with allergiclike response to pets.

This subset of risk-increasing bacteria suppressed by breastfeeding were predominantly members of the family Lachnospiraceae, the researchers found.

Lachnospiraceae are common adult gut colonizers, Ms. Sitarik said, and as people age the relative abundance of Lachnospiraceae increases. “What we think might be happening in terms of the gut microbiome is that maybe breastfeeding is preventing this premature shift into adulthood,” she said.

Dr. Johnson and Ms. Sitarik reported having no financial disclosures.

HOUSTON – Findings from a cohort study of mothers and babies point to breastfeeding as influencing infants’ gut microbiome in a way that protects them from developing allergic disease.

In findings presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, epidemiologist Christine Cole Johnson, Ph.D., of the Henry Ford Health System in Detroit described a correlation between certain maternal and birth characteristics that had previously been shown to relate to allergic response, and measurable differences in the bacterial profiles of the study infants’ stools.

©Jupiterimages/Thinkstock

Using data from the WHEALS (Wayne County [Michigan] Health, Environment, Allergy, and Asthma Longitudinal Study) cohort, Dr. Johnson and her colleagues looked at stool samples from 298 children at 1 and 6 months of age. The investigators also collected dust samples from the infants’ homes, obtained medical records, and conducted interviews with the families (J. Allergy Clin. Immunol. 2015 [http://dx.doi.org/10.1016/j.jaci.2014.12.1443]).

The presence of household pets, the body mass index of mothers before delivery, the mode of delivery, household smoke exposure, marital status, income, race, and maternal education were all found to be significantly correlated to different gut bacterial profiles.

“Environmental and lifestyle variables that we’ve been working on related to childhood asthma and allergy seem to be associated – at least in our study – with the child’s gut microbiome,” Dr. Johnson said. “These factors vary a lot by whether those stool samples were collected at 1 or 6 months,” she said, noting that the infant gut microbiome is shaped rapidly in the first year.

But, at both 1 and 6 months of age, breastfeeding was seen as the dominant factor influencing gut bacterial composition.

At 6 months, breastfed infants had bacterial profiles showing overwhelming dominance of Bifidobacteriaceae, but vastly lower levels of other families of bacteria, notably Lachnospiraceae, which were prominent in the guts of non-breastfed babies.

In a related study that used the same cohort to explore whether the influence of breastfeeding on gut bacterial composition correlated to the development of allergic symptoms at 4 years old, Alexandra R. Sitarik, also of the Henry Ford Health System in Detroit, reported that babies being breastfed at 1 month of age had a significantly lower risk of developing allergiclike symptoms to pets by age 4 years (P = .028) (J. Allergy Clin. Immunol. 2015 [http://dx.doi.org/10.1016/j.jaci.2014.12.1444]).

Both breastfeeding and allergiclike response to pets were significantly related to compositional variation in gut microbiome (P < .001 and P = .023, respectively), Ms. Sitarik reported.

Of the 109 types of bacteria significantly associated with both breastfeeding and allergiclike response to pets, 71% were negatively associated with breastfeeding but positively associated with allergiclike response to pets.

This subset of risk-increasing bacteria suppressed by breastfeeding were predominantly members of the family Lachnospiraceae, the researchers found.

Lachnospiraceae are common adult gut colonizers, Ms. Sitarik said, and as people age the relative abundance of Lachnospiraceae increases. “What we think might be happening in terms of the gut microbiome is that maybe breastfeeding is preventing this premature shift into adulthood,” she said.

Dr. Johnson and Ms. Sitarik reported having no financial disclosures.

HOUSTON – Findings from a cohort study of mothers and babies point to breastfeeding as influencing infants’ gut microbiome in a way that protects them from developing allergic disease.

In findings presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, epidemiologist Christine Cole Johnson, Ph.D., of the Henry Ford Health System in Detroit described a correlation between certain maternal and birth characteristics that had previously been shown to relate to allergic response, and measurable differences in the bacterial profiles of the study infants’ stools.

©Jupiterimages/Thinkstock

Using data from the WHEALS (Wayne County [Michigan] Health, Environment, Allergy, and Asthma Longitudinal Study) cohort, Dr. Johnson and her colleagues looked at stool samples from 298 children at 1 and 6 months of age. The investigators also collected dust samples from the infants’ homes, obtained medical records, and conducted interviews with the families (J. Allergy Clin. Immunol. 2015 [http://dx.doi.org/10.1016/j.jaci.2014.12.1443]).

The presence of household pets, the body mass index of mothers before delivery, the mode of delivery, household smoke exposure, marital status, income, race, and maternal education were all found to be significantly correlated to different gut bacterial profiles.

“Environmental and lifestyle variables that we’ve been working on related to childhood asthma and allergy seem to be associated – at least in our study – with the child’s gut microbiome,” Dr. Johnson said. “These factors vary a lot by whether those stool samples were collected at 1 or 6 months,” she said, noting that the infant gut microbiome is shaped rapidly in the first year.

But, at both 1 and 6 months of age, breastfeeding was seen as the dominant factor influencing gut bacterial composition.

At 6 months, breastfed infants had bacterial profiles showing overwhelming dominance of Bifidobacteriaceae, but vastly lower levels of other families of bacteria, notably Lachnospiraceae, which were prominent in the guts of non-breastfed babies.

In a related study that used the same cohort to explore whether the influence of breastfeeding on gut bacterial composition correlated to the development of allergic symptoms at 4 years old, Alexandra R. Sitarik, also of the Henry Ford Health System in Detroit, reported that babies being breastfed at 1 month of age had a significantly lower risk of developing allergiclike symptoms to pets by age 4 years (P = .028) (J. Allergy Clin. Immunol. 2015 [http://dx.doi.org/10.1016/j.jaci.2014.12.1444]).

Both breastfeeding and allergiclike response to pets were significantly related to compositional variation in gut microbiome (P < .001 and P = .023, respectively), Ms. Sitarik reported.

Of the 109 types of bacteria significantly associated with both breastfeeding and allergiclike response to pets, 71% were negatively associated with breastfeeding but positively associated with allergiclike response to pets.

This subset of risk-increasing bacteria suppressed by breastfeeding were predominantly members of the family Lachnospiraceae, the researchers found.

Lachnospiraceae are common adult gut colonizers, Ms. Sitarik said, and as people age the relative abundance of Lachnospiraceae increases. “What we think might be happening in terms of the gut microbiome is that maybe breastfeeding is preventing this premature shift into adulthood,” she said.

Dr. Johnson and Ms. Sitarik reported having no financial disclosures.

HOUSTON – Findings from a cohort study of mothers and babies point to breastfeeding as influencing infants’ gut microbiome in a way that protects them from developing allergic disease.

In findings presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, epidemiologist Christine Cole Johnson, Ph.D., of the Henry Ford Health System in Detroit described a correlation between certain maternal and birth characteristics that had previously been shown to relate to allergic response, and measurable differences in the bacterial profiles of the study infants’ stools.

©Jupiterimages/Thinkstock

Using data from the WHEALS (Wayne County [Michigan] Health, Environment, Allergy, and Asthma Longitudinal Study) cohort, Dr. Johnson and her colleagues looked at stool samples from 298 children at 1 and 6 months of age. The investigators also collected dust samples from the infants’ homes, obtained medical records, and conducted interviews with the families (J. Allergy Clin. Immunol. 2015 [http://dx.doi.org/10.1016/j.jaci.2014.12.1443]).

The presence of household pets, the body mass index of mothers before delivery, the mode of delivery, household smoke exposure, marital status, income, race, and maternal education were all found to be significantly correlated to different gut bacterial profiles.

“Environmental and lifestyle variables that we’ve been working on related to childhood asthma and allergy seem to be associated – at least in our study – with the child’s gut microbiome,” Dr. Johnson said. “These factors vary a lot by whether those stool samples were collected at 1 or 6 months,” she said, noting that the infant gut microbiome is shaped rapidly in the first year.

But, at both 1 and 6 months of age, breastfeeding was seen as the dominant factor influencing gut bacterial composition.

At 6 months, breastfed infants had bacterial profiles showing overwhelming dominance of Bifidobacteriaceae, but vastly lower levels of other families of bacteria, notably Lachnospiraceae, which were prominent in the guts of non-breastfed babies.

In a related study that used the same cohort to explore whether the influence of breastfeeding on gut bacterial composition correlated to the development of allergic symptoms at 4 years old, Alexandra R. Sitarik, also of the Henry Ford Health System in Detroit, reported that babies being breastfed at 1 month of age had a significantly lower risk of developing allergiclike symptoms to pets by age 4 years (P = .028) (J. Allergy Clin. Immunol. 2015 [http://dx.doi.org/10.1016/j.jaci.2014.12.1444]).

Both breastfeeding and allergiclike response to pets were significantly related to compositional variation in gut microbiome (P < .001 and P = .023, respectively), Ms. Sitarik reported.

Of the 109 types of bacteria significantly associated with both breastfeeding and allergiclike response to pets, 71% were negatively associated with breastfeeding but positively associated with allergiclike response to pets.

This subset of risk-increasing bacteria suppressed by breastfeeding were predominantly members of the family Lachnospiraceae, the researchers found.

Lachnospiraceae are common adult gut colonizers, Ms. Sitarik said, and as people age the relative abundance of Lachnospiraceae increases. “What we think might be happening in terms of the gut microbiome is that maybe breastfeeding is preventing this premature shift into adulthood,” she said.

Dr. Johnson and Ms. Sitarik reported having no financial disclosures.

Patients with high-risk aortic stenosis undergoing transfemoral transcatheter aortic valve replacement saw better results with balloon-expandable valve prostheses, compared with self-expanding valve prostheses, according to results from the first multicenter, randomized trial comparing the two types of devices directly.

For their research, presented at the annual meeting of the American College of Cardiology, Dr. Mohamed Abdel-Wahab of the Segeberger Kliniken in Bad Segeberg, Germany, and his associates randomized 241 patients with severe aortic stenosis to either a balloon-expandable valve (n = 121; 43% men) or a self-expanding valve (n = 120; 28.3% men). Patients were recruited from five centers in Germany between March 2012 and December 2013, and followed up for 30 days post procedure.

The trial’s main endpoint was device success – a 4-point composite, incorporating correct device positioning, performance of the valve without more than mild regurgitation, successful vascular access and deployment of the device and retrieval of the delivery system, and only one valve implanted.

Secondary endpoints included cardiovascular mortality, need for new pacemaker placement post procedure, major stroke and other vascular events, and a combined safety endpoint of all-cause mortality, major stroke, bleeding, kidney injury, myocardial infarction, major vascular complications, and repeat procedure for valve-related dysfunction, they said in a report on their research that was simultaneously published in JAMA (2014 March 30 [doi:10.1001/jama.2014.3316]).

Device success was seen as markedly higher among patients receiving the balloon-expandable valves (95.9% of patients, compared with 77.5%; relative risk 1.24; 95% confidence interval, 1.12-1.37; P less than .001), thanks mainly to less incidence of moderate to severe aortic regurgitation after valve placement (4.1% vs. 18.3%; RR, 0.23; 95% CI, 0.09-0.58; P less than .001).

Observational studies have found widely differing outcomes in aortic regurgitation associated with the different devices, due in part to "challenges in identification and quantification of aortic regurgitation after TAVR [transcatheter aortic valve replacement], but also to the observational and nonrandomized nature of all reported comparisons," Dr. Abdel-Wahab and his colleagues wrote. This study used angiographic, echocardiographic, and hemodynamic assessments of aortic regurgitation following TAVR.

At 30 days post procedure, new pacemakers had been placed half as frequently in the balloon-expandable valve group (17.3% vs. 37.6%, P = .001). Altogether five patients were rehospitalized for heart failure in the self-expanding valve group, compared with none in the balloon-expandable group.

Neither 30-day cardiovascular mortality nor vascular nor bleeding complications were significantly different between the two groups. In the balloon-expandable group, 30-day mortality was 4.1%, compared with 4.3% for the self-expanding group. The combined safety end point occurred in 18.2% of those in the balloon-expandable valve group and 23.1% of the self-expanding group (RR, 0.79; 95% CI, 0.48-1.30; P = .42).

However, patients in the balloon-expandable arm saw higher numerical incidence of stroke. Stroke was seen in seven patients (three major and four minor strokes), compared with three (all major strokes) in the self-expanding valve group.

The investigators described the use of core laboratory–adjudicated angiography and the lack of an echocardiographic core laboratory as potential limitations of their study. Long-term follow-up was needed, they said, to "determine whether differences in device success will translate into a clinically relevant overall benefit for the balloon-expandable valve."

The study was sponsored by Dr. Abdel-Wahab’s institution. Dr. Abdel-Wahab disclosed support from Medtronic, Edwards Lifesciences, and Boston Scientific. Four of his 11 coauthors disclosed support from Abbott Vascular, Terumo Lilly/Daiichi Sankyo, Biotronik, Edwards Lifesciences, Medtronic, and/or Boston Scientific.

Patients with high-risk aortic stenosis undergoing transfemoral transcatheter aortic valve replacement saw better results with balloon-expandable valve prostheses, compared with self-expanding valve prostheses, according to results from the first multicenter, randomized trial comparing the two types of devices directly.

For their research, presented at the annual meeting of the American College of Cardiology, Dr. Mohamed Abdel-Wahab of the Segeberger Kliniken in Bad Segeberg, Germany, and his associates randomized 241 patients with severe aortic stenosis to either a balloon-expandable valve (n = 121; 43% men) or a self-expanding valve (n = 120; 28.3% men). Patients were recruited from five centers in Germany between March 2012 and December 2013, and followed up for 30 days post procedure.

The trial’s main endpoint was device success – a 4-point composite, incorporating correct device positioning, performance of the valve without more than mild regurgitation, successful vascular access and deployment of the device and retrieval of the delivery system, and only one valve implanted.

Secondary endpoints included cardiovascular mortality, need for new pacemaker placement post procedure, major stroke and other vascular events, and a combined safety endpoint of all-cause mortality, major stroke, bleeding, kidney injury, myocardial infarction, major vascular complications, and repeat procedure for valve-related dysfunction, they said in a report on their research that was simultaneously published in JAMA (2014 March 30 [doi:10.1001/jama.2014.3316]).

Device success was seen as markedly higher among patients receiving the balloon-expandable valves (95.9% of patients, compared with 77.5%; relative risk 1.24; 95% confidence interval, 1.12-1.37; P less than .001), thanks mainly to less incidence of moderate to severe aortic regurgitation after valve placement (4.1% vs. 18.3%; RR, 0.23; 95% CI, 0.09-0.58; P less than .001).

Observational studies have found widely differing outcomes in aortic regurgitation associated with the different devices, due in part to "challenges in identification and quantification of aortic regurgitation after TAVR [transcatheter aortic valve replacement], but also to the observational and nonrandomized nature of all reported comparisons," Dr. Abdel-Wahab and his colleagues wrote. This study used angiographic, echocardiographic, and hemodynamic assessments of aortic regurgitation following TAVR.

At 30 days post procedure, new pacemakers had been placed half as frequently in the balloon-expandable valve group (17.3% vs. 37.6%, P = .001). Altogether five patients were rehospitalized for heart failure in the self-expanding valve group, compared with none in the balloon-expandable group.

Neither 30-day cardiovascular mortality nor vascular nor bleeding complications were significantly different between the two groups. In the balloon-expandable group, 30-day mortality was 4.1%, compared with 4.3% for the self-expanding group. The combined safety end point occurred in 18.2% of those in the balloon-expandable valve group and 23.1% of the self-expanding group (RR, 0.79; 95% CI, 0.48-1.30; P = .42).

However, patients in the balloon-expandable arm saw higher numerical incidence of stroke. Stroke was seen in seven patients (three major and four minor strokes), compared with three (all major strokes) in the self-expanding valve group.

The investigators described the use of core laboratory–adjudicated angiography and the lack of an echocardiographic core laboratory as potential limitations of their study. Long-term follow-up was needed, they said, to "determine whether differences in device success will translate into a clinically relevant overall benefit for the balloon-expandable valve."

The study was sponsored by Dr. Abdel-Wahab’s institution. Dr. Abdel-Wahab disclosed support from Medtronic, Edwards Lifesciences, and Boston Scientific. Four of his 11 coauthors disclosed support from Abbott Vascular, Terumo Lilly/Daiichi Sankyo, Biotronik, Edwards Lifesciences, Medtronic, and/or Boston Scientific.

Patients with high-risk aortic stenosis undergoing transfemoral transcatheter aortic valve replacement saw better results with balloon-expandable valve prostheses, compared with self-expanding valve prostheses, according to results from the first multicenter, randomized trial comparing the two types of devices directly.

For their research, presented at the annual meeting of the American College of Cardiology, Dr. Mohamed Abdel-Wahab of the Segeberger Kliniken in Bad Segeberg, Germany, and his associates randomized 241 patients with severe aortic stenosis to either a balloon-expandable valve (n = 121; 43% men) or a self-expanding valve (n = 120; 28.3% men). Patients were recruited from five centers in Germany between March 2012 and December 2013, and followed up for 30 days post procedure.

The trial’s main endpoint was device success – a 4-point composite, incorporating correct device positioning, performance of the valve without more than mild regurgitation, successful vascular access and deployment of the device and retrieval of the delivery system, and only one valve implanted.

Secondary endpoints included cardiovascular mortality, need for new pacemaker placement post procedure, major stroke and other vascular events, and a combined safety endpoint of all-cause mortality, major stroke, bleeding, kidney injury, myocardial infarction, major vascular complications, and repeat procedure for valve-related dysfunction, they said in a report on their research that was simultaneously published in JAMA (2014 March 30 [doi:10.1001/jama.2014.3316]).

Device success was seen as markedly higher among patients receiving the balloon-expandable valves (95.9% of patients, compared with 77.5%; relative risk 1.24; 95% confidence interval, 1.12-1.37; P less than .001), thanks mainly to less incidence of moderate to severe aortic regurgitation after valve placement (4.1% vs. 18.3%; RR, 0.23; 95% CI, 0.09-0.58; P less than .001).

Observational studies have found widely differing outcomes in aortic regurgitation associated with the different devices, due in part to "challenges in identification and quantification of aortic regurgitation after TAVR [transcatheter aortic valve replacement], but also to the observational and nonrandomized nature of all reported comparisons," Dr. Abdel-Wahab and his colleagues wrote. This study used angiographic, echocardiographic, and hemodynamic assessments of aortic regurgitation following TAVR.

At 30 days post procedure, new pacemakers had been placed half as frequently in the balloon-expandable valve group (17.3% vs. 37.6%, P = .001). Altogether five patients were rehospitalized for heart failure in the self-expanding valve group, compared with none in the balloon-expandable group.

Neither 30-day cardiovascular mortality nor vascular nor bleeding complications were significantly different between the two groups. In the balloon-expandable group, 30-day mortality was 4.1%, compared with 4.3% for the self-expanding group. The combined safety end point occurred in 18.2% of those in the balloon-expandable valve group and 23.1% of the self-expanding group (RR, 0.79; 95% CI, 0.48-1.30; P = .42).

However, patients in the balloon-expandable arm saw higher numerical incidence of stroke. Stroke was seen in seven patients (three major and four minor strokes), compared with three (all major strokes) in the self-expanding valve group.

The investigators described the use of core laboratory–adjudicated angiography and the lack of an echocardiographic core laboratory as potential limitations of their study. Long-term follow-up was needed, they said, to "determine whether differences in device success will translate into a clinically relevant overall benefit for the balloon-expandable valve."

The study was sponsored by Dr. Abdel-Wahab’s institution. Dr. Abdel-Wahab disclosed support from Medtronic, Edwards Lifesciences, and Boston Scientific. Four of his 11 coauthors disclosed support from Abbott Vascular, Terumo Lilly/Daiichi Sankyo, Biotronik, Edwards Lifesciences, Medtronic, and/or Boston Scientific.