M. Alexander Otto

ST. LOUIS – A blood test that seems almost as good as amyloid PET scanning, the gold standard, for detecting asymptomatic amyloid plaques in the brain could be on the market in 2-3 years, according to a report at the annual meeting of the American Neurological Association. The research was also published in Neurology (2019 Oct 22;93[17]:e1647-59).

Investigators at Washington University, St. Louis, found that, among 158 mostly cognitively normal people in their 60s and 70s, the plasma ratio of amyloid-beta 42 peptide to amyloid-beta 40 peptide identified people who were PET positive and PET negative for amyloid with an area under the curve of 0.88 (95% confidence interval, 0.82-0.93) and climbed to 0.94 when combined with age and Apolipoprotein E epsilon 4 status (95% CI, 0.90-0.97), “which is really quite spectacular for a blood test,” said study lead Suzanne Schindler, MD, PhD, who is affiliated with the university.

People who had a positive blood test – a ratio below .1281 – but a negative PET scan were 15 times more likely to convert to a positive scan at an average of 4 years than subjects with a negative test. “The blood test [detected] brain changes of Alzheimer’s disease before the amyloid PET scan,” Dr. Schindler said.

Amyloid-beta 42 – the number refers to how many amino acids are in the peptide chain – is much stickier and more prone to aggregate in plaques than amyloid-beta 40. The ratio of the two falls as the 42 form is sequestered preferentially into amyloid plaques while the level of amyloid-beta 40 remains more constant, she explained at the meeting.

The team concluded that the test accurately “predicts current and future brain amyloidosis” and “could be used in prevention trials to screen for individuals likely to be amyloid PET-positive and at risk for Alzheimer disease dementia.”

“We are really excited about it. I think there’s been recognition for a long time that a blood test would really be a game changer. We still have a little bit more work to do, but I don’t think it’s that far away,” Dr. Schindler said in an interview after her presentation.

The goal of Alzheimer’s research is to slow, reverse, or even prevent brain pathology before symptoms set in, at which point damage is likely irreversible. For that to happen, plaques need to be detected early.

Currently there are two ways to do that, both with difficulties: PET scans, which are expensive, expose people to radiation, and of limited availability, and spinal fluid analysis, which involves a lumbar puncture that “not many people want to undergo.” The problems slow down enrollment for prevention trials, Dr. Schindler said.

The blood test, which the Food and Drug Administration granted breakthrough status in January 2019, could offer a much easier and less expensive way to identify subjects and monitor outcomes. It could “really speed up enrollment and help us get to effective drugs faster,” she said.

Beyond that, clinicians could use it to help figure out what’s going on in older people with cognitive issues. If a drug or some other way is ever found to prevent Alzheimer’s, there’s even the possibility of screening patients for amyloidosis during routine exams. Potentially, “I think the market is huge,” she said.

The test is being developed by a company, C2N diagnostics, founded by Dr. Schindler’s colleagues at the university, and could be available commercially in 2-3 years. It involves high precision immunoprecipitation and liquid chromatography/mass spectrometry, so “it isn’t something your general lab is going to do. It’s probably going to be a couple centers that have this test, and everybody mails their samples in, which we do for a lot of different tests,” she said.

Several companies are working on similar assays.

Dr. Schindler said she has no financial stake in the blood test.

[email protected]

SOURCE: Schindler S et al. Neurology. 2019 Oct 22;93(17):e1647-59.

ST. LOUIS – A blood test that seems almost as good as amyloid PET scanning, the gold standard, for detecting asymptomatic amyloid plaques in the brain could be on the market in 2-3 years, according to a report at the annual meeting of the American Neurological Association. The research was also published in Neurology (2019 Oct 22;93[17]:e1647-59).

Investigators at Washington University, St. Louis, found that, among 158 mostly cognitively normal people in their 60s and 70s, the plasma ratio of amyloid-beta 42 peptide to amyloid-beta 40 peptide identified people who were PET positive and PET negative for amyloid with an area under the curve of 0.88 (95% confidence interval, 0.82-0.93) and climbed to 0.94 when combined with age and Apolipoprotein E epsilon 4 status (95% CI, 0.90-0.97), “which is really quite spectacular for a blood test,” said study lead Suzanne Schindler, MD, PhD, who is affiliated with the university.

People who had a positive blood test – a ratio below .1281 – but a negative PET scan were 15 times more likely to convert to a positive scan at an average of 4 years than subjects with a negative test. “The blood test [detected] brain changes of Alzheimer’s disease before the amyloid PET scan,” Dr. Schindler said.

Amyloid-beta 42 – the number refers to how many amino acids are in the peptide chain – is much stickier and more prone to aggregate in plaques than amyloid-beta 40. The ratio of the two falls as the 42 form is sequestered preferentially into amyloid plaques while the level of amyloid-beta 40 remains more constant, she explained at the meeting.

The team concluded that the test accurately “predicts current and future brain amyloidosis” and “could be used in prevention trials to screen for individuals likely to be amyloid PET-positive and at risk for Alzheimer disease dementia.”

“We are really excited about it. I think there’s been recognition for a long time that a blood test would really be a game changer. We still have a little bit more work to do, but I don’t think it’s that far away,” Dr. Schindler said in an interview after her presentation.

The goal of Alzheimer’s research is to slow, reverse, or even prevent brain pathology before symptoms set in, at which point damage is likely irreversible. For that to happen, plaques need to be detected early.

Currently there are two ways to do that, both with difficulties: PET scans, which are expensive, expose people to radiation, and of limited availability, and spinal fluid analysis, which involves a lumbar puncture that “not many people want to undergo.” The problems slow down enrollment for prevention trials, Dr. Schindler said.

The blood test, which the Food and Drug Administration granted breakthrough status in January 2019, could offer a much easier and less expensive way to identify subjects and monitor outcomes. It could “really speed up enrollment and help us get to effective drugs faster,” she said.

Beyond that, clinicians could use it to help figure out what’s going on in older people with cognitive issues. If a drug or some other way is ever found to prevent Alzheimer’s, there’s even the possibility of screening patients for amyloidosis during routine exams. Potentially, “I think the market is huge,” she said.

The test is being developed by a company, C2N diagnostics, founded by Dr. Schindler’s colleagues at the university, and could be available commercially in 2-3 years. It involves high precision immunoprecipitation and liquid chromatography/mass spectrometry, so “it isn’t something your general lab is going to do. It’s probably going to be a couple centers that have this test, and everybody mails their samples in, which we do for a lot of different tests,” she said.

Several companies are working on similar assays.

Dr. Schindler said she has no financial stake in the blood test.

[email protected]

SOURCE: Schindler S et al. Neurology. 2019 Oct 22;93(17):e1647-59.

ST. LOUIS – A blood test that seems almost as good as amyloid PET scanning, the gold standard, for detecting asymptomatic amyloid plaques in the brain could be on the market in 2-3 years, according to a report at the annual meeting of the American Neurological Association. The research was also published in Neurology (2019 Oct 22;93[17]:e1647-59).

Investigators at Washington University, St. Louis, found that, among 158 mostly cognitively normal people in their 60s and 70s, the plasma ratio of amyloid-beta 42 peptide to amyloid-beta 40 peptide identified people who were PET positive and PET negative for amyloid with an area under the curve of 0.88 (95% confidence interval, 0.82-0.93) and climbed to 0.94 when combined with age and Apolipoprotein E epsilon 4 status (95% CI, 0.90-0.97), “which is really quite spectacular for a blood test,” said study lead Suzanne Schindler, MD, PhD, who is affiliated with the university.

People who had a positive blood test – a ratio below .1281 – but a negative PET scan were 15 times more likely to convert to a positive scan at an average of 4 years than subjects with a negative test. “The blood test [detected] brain changes of Alzheimer’s disease before the amyloid PET scan,” Dr. Schindler said.

Amyloid-beta 42 – the number refers to how many amino acids are in the peptide chain – is much stickier and more prone to aggregate in plaques than amyloid-beta 40. The ratio of the two falls as the 42 form is sequestered preferentially into amyloid plaques while the level of amyloid-beta 40 remains more constant, she explained at the meeting.

The team concluded that the test accurately “predicts current and future brain amyloidosis” and “could be used in prevention trials to screen for individuals likely to be amyloid PET-positive and at risk for Alzheimer disease dementia.”

“We are really excited about it. I think there’s been recognition for a long time that a blood test would really be a game changer. We still have a little bit more work to do, but I don’t think it’s that far away,” Dr. Schindler said in an interview after her presentation.

The goal of Alzheimer’s research is to slow, reverse, or even prevent brain pathology before symptoms set in, at which point damage is likely irreversible. For that to happen, plaques need to be detected early.

Currently there are two ways to do that, both with difficulties: PET scans, which are expensive, expose people to radiation, and of limited availability, and spinal fluid analysis, which involves a lumbar puncture that “not many people want to undergo.” The problems slow down enrollment for prevention trials, Dr. Schindler said.

The blood test, which the Food and Drug Administration granted breakthrough status in January 2019, could offer a much easier and less expensive way to identify subjects and monitor outcomes. It could “really speed up enrollment and help us get to effective drugs faster,” she said.

Beyond that, clinicians could use it to help figure out what’s going on in older people with cognitive issues. If a drug or some other way is ever found to prevent Alzheimer’s, there’s even the possibility of screening patients for amyloidosis during routine exams. Potentially, “I think the market is huge,” she said.

The test is being developed by a company, C2N diagnostics, founded by Dr. Schindler’s colleagues at the university, and could be available commercially in 2-3 years. It involves high precision immunoprecipitation and liquid chromatography/mass spectrometry, so “it isn’t something your general lab is going to do. It’s probably going to be a couple centers that have this test, and everybody mails their samples in, which we do for a lot of different tests,” she said.

Several companies are working on similar assays.

Dr. Schindler said she has no financial stake in the blood test.

[email protected]

SOURCE: Schindler S et al. Neurology. 2019 Oct 22;93(17):e1647-59.

ST. LOUIS – Children who have background EEG asymmetry while on extracorporeal membrane oxygenation (ECMO) have worse outcomes even after adjustment for recent cardiac arrest and EEG suppression, according to a review of 41 children treated at Washington University, St. Louis.

ECMO is a last-ditch heart/lung bypass for patients near death, be it from infection, trauma, cardiac abnormalities, or any other issue. Children can be on it for days or weeks while problems are addressed and the body attempts to recover. Sometimes ECMO works, and children make a remarkable recovery, but other times they die or are left with severe disabilities, and no one really knows why.

Because of this, the investigators in this review sought to identify predictors of poor outcomes with an eye toward identifying modifiable risk factors, said senior investigator Kristin Guilliams, MD, an assistant professor of pediatric critical care medicine.

“We are trying to figure out why some kids do fantastically, and others don’t. We were looking at whether EEG can give us any clues and new ways to think about modifiable risk factors so that every kid rescued by ECMO can go back to their normal life,” she said at the American Neurological Association annual meeting.

The 41 children had an EEG within a day or 2 of starting ECMO; 22 did well, but 19 had bad outcomes, defined in the study as either dying in the hospital or being discharged with a Functional Status Score above 12, meaning mild dysfunction across six domains or more severe disability in particular ones.

The finding that all four children with EEG suppression – overall low brain activity – did poorly was not surprising, but the fact that EEG background asymmetry – one side of the brain being much less active than the other or giving different signals – in five children predicted poor outcomes, even after adjustment for cardiac arrest and overall suppression, was “a big surprise,” Dr. Guilliams said (odds ratio, 29.3; 95% confidence interval, 2.2-398.3; P = .003).

“The asymmetry tells me that we need to look more closely into brain blood flow patterns on ECMO,” she said. There might be a way to change delivery that could help, but “it’s not obvious right now.” The issue warrants further investigation, Dr. Guilliams said.

Twelve children had ECMO during chest compressions for cardiac arrest, which as expected, also predicted poor outcomes (OR, 9.5; 95% CI 1.6-58.2; P = .008).

Neuroimaging was available for 34 children. Abnormalities (n = 13; P = .2), including ischemia (n = 8; P = .1), hemorrhage (n = 8; P = .06), and seizures (n = 4; P = .2) did not predict poor outcomes, nor did sex, age, and mode of ECMO delivery (veno-arterial versus veno-venous).

As of about a year ago, EEGs at the university are now standard for children on ECMO, with special software to pick out asymmetries. “We are paying more attention to” EEGs, Dr. Guilliams said.

Children were a median of about 10 years old, and subjects were at least 1 year old. There were about equal numbers of boys and girls; 25 children were alive at discharge.

There was no external funding, and Dr. Guilliams didn’t have any disclosures.
 

[email protected]

ST. LOUIS – Children who have background EEG asymmetry while on extracorporeal membrane oxygenation (ECMO) have worse outcomes even after adjustment for recent cardiac arrest and EEG suppression, according to a review of 41 children treated at Washington University, St. Louis.

ECMO is a last-ditch heart/lung bypass for patients near death, be it from infection, trauma, cardiac abnormalities, or any other issue. Children can be on it for days or weeks while problems are addressed and the body attempts to recover. Sometimes ECMO works, and children make a remarkable recovery, but other times they die or are left with severe disabilities, and no one really knows why.

Because of this, the investigators in this review sought to identify predictors of poor outcomes with an eye toward identifying modifiable risk factors, said senior investigator Kristin Guilliams, MD, an assistant professor of pediatric critical care medicine.

“We are trying to figure out why some kids do fantastically, and others don’t. We were looking at whether EEG can give us any clues and new ways to think about modifiable risk factors so that every kid rescued by ECMO can go back to their normal life,” she said at the American Neurological Association annual meeting.

The 41 children had an EEG within a day or 2 of starting ECMO; 22 did well, but 19 had bad outcomes, defined in the study as either dying in the hospital or being discharged with a Functional Status Score above 12, meaning mild dysfunction across six domains or more severe disability in particular ones.

The finding that all four children with EEG suppression – overall low brain activity – did poorly was not surprising, but the fact that EEG background asymmetry – one side of the brain being much less active than the other or giving different signals – in five children predicted poor outcomes, even after adjustment for cardiac arrest and overall suppression, was “a big surprise,” Dr. Guilliams said (odds ratio, 29.3; 95% confidence interval, 2.2-398.3; P = .003).

“The asymmetry tells me that we need to look more closely into brain blood flow patterns on ECMO,” she said. There might be a way to change delivery that could help, but “it’s not obvious right now.” The issue warrants further investigation, Dr. Guilliams said.

Twelve children had ECMO during chest compressions for cardiac arrest, which as expected, also predicted poor outcomes (OR, 9.5; 95% CI 1.6-58.2; P = .008).

Neuroimaging was available for 34 children. Abnormalities (n = 13; P = .2), including ischemia (n = 8; P = .1), hemorrhage (n = 8; P = .06), and seizures (n = 4; P = .2) did not predict poor outcomes, nor did sex, age, and mode of ECMO delivery (veno-arterial versus veno-venous).

As of about a year ago, EEGs at the university are now standard for children on ECMO, with special software to pick out asymmetries. “We are paying more attention to” EEGs, Dr. Guilliams said.

Children were a median of about 10 years old, and subjects were at least 1 year old. There were about equal numbers of boys and girls; 25 children were alive at discharge.

There was no external funding, and Dr. Guilliams didn’t have any disclosures.
 

[email protected]

ST. LOUIS – Children who have background EEG asymmetry while on extracorporeal membrane oxygenation (ECMO) have worse outcomes even after adjustment for recent cardiac arrest and EEG suppression, according to a review of 41 children treated at Washington University, St. Louis.

ECMO is a last-ditch heart/lung bypass for patients near death, be it from infection, trauma, cardiac abnormalities, or any other issue. Children can be on it for days or weeks while problems are addressed and the body attempts to recover. Sometimes ECMO works, and children make a remarkable recovery, but other times they die or are left with severe disabilities, and no one really knows why.

Because of this, the investigators in this review sought to identify predictors of poor outcomes with an eye toward identifying modifiable risk factors, said senior investigator Kristin Guilliams, MD, an assistant professor of pediatric critical care medicine.

“We are trying to figure out why some kids do fantastically, and others don’t. We were looking at whether EEG can give us any clues and new ways to think about modifiable risk factors so that every kid rescued by ECMO can go back to their normal life,” she said at the American Neurological Association annual meeting.

The 41 children had an EEG within a day or 2 of starting ECMO; 22 did well, but 19 had bad outcomes, defined in the study as either dying in the hospital or being discharged with a Functional Status Score above 12, meaning mild dysfunction across six domains or more severe disability in particular ones.

The finding that all four children with EEG suppression – overall low brain activity – did poorly was not surprising, but the fact that EEG background asymmetry – one side of the brain being much less active than the other or giving different signals – in five children predicted poor outcomes, even after adjustment for cardiac arrest and overall suppression, was “a big surprise,” Dr. Guilliams said (odds ratio, 29.3; 95% confidence interval, 2.2-398.3; P = .003).

“The asymmetry tells me that we need to look more closely into brain blood flow patterns on ECMO,” she said. There might be a way to change delivery that could help, but “it’s not obvious right now.” The issue warrants further investigation, Dr. Guilliams said.

Twelve children had ECMO during chest compressions for cardiac arrest, which as expected, also predicted poor outcomes (OR, 9.5; 95% CI 1.6-58.2; P = .008).

Neuroimaging was available for 34 children. Abnormalities (n = 13; P = .2), including ischemia (n = 8; P = .1), hemorrhage (n = 8; P = .06), and seizures (n = 4; P = .2) did not predict poor outcomes, nor did sex, age, and mode of ECMO delivery (veno-arterial versus veno-venous).

As of about a year ago, EEGs at the university are now standard for children on ECMO, with special software to pick out asymmetries. “We are paying more attention to” EEGs, Dr. Guilliams said.

Children were a median of about 10 years old, and subjects were at least 1 year old. There were about equal numbers of boys and girls; 25 children were alive at discharge.

There was no external funding, and Dr. Guilliams didn’t have any disclosures.
 

[email protected]

ST. LOUIS – The lower the blood pressure peaks and variability in the first 24 hours after ischemic stroke reperfusion, the better the outcomes, according to a review of 140 patients at the University of New Mexico, Albuquerque. Investigators found that every 10–mm Hg increase in peak systolic pressure boosted the risk of in-hospital death 24% (P = .01) and reduced the chance of being discharged home or to a inpatient rehabilitation facility 13% (P = .03). Results were even stronger for peak mean arterial pressure, at 76% (P = .01) and 29% (P = .04), respectively; trends in the same direction for peak diastolic pressure were not statistically significant.

Also, every 10–mm Hg increase in blood pressure variability again increased the risk of dying in the hospital, whether it was systolic (33%; P = .002), diastolic (33%; P = .03), or mean arterial pressure variability (58%; P = .02). Higher variability also reduced the chance of being discharged home or to a rehab 10%-20%, but the findings, although close, were not statistically significant.

Neurologists generally do what they can to control blood pressure after stroke, and the study confirms the need to do that. What’s new is that the work was limited to reperfusion patients – intravenous thrombolysis with alteplase in 83.5%, mechanical thrombectomy in 60%, with some having both – which has not been the specific focus of much research.

“Be much more aggressive in terms of making sure the variability is limited and limiting the peaks,” especially within 24 hours of reperfusion, said lead investigator and stroke neurologist Dinesh Jillella, MD, of Emory University, Atlanta, at the annual meeting of the American Neurological Association. “We want to be much more aggressive [with these patients]; it might limit our worse outcomes,” Dr. Jillella said. He conducted the review while in training at the University of New Mexico.

What led to the study is that Dr. Jillella and colleagues noticed that similar reperfusion patients can have very different outcomes, and he wanted to find modifiable risk factors that could account for the differences. The study did not address why high peaks and variability lead to worse outcomes, but he said hemorrhagic conversion might play a role.

It is also possible that higher pressures could be a marker of bad outcomes, as opposed to a direct cause, but the findings were adjusted for two significant confounders: age and the National Institutes of Health Stroke Scale score, which were both significantly higher in patients who did not do well. But after adjustment, “we [still] found an independent association with blood pressures and worse outcomes,” he said.

Higher peak systolic pressures and variability were also associated with about a 15% lower odds of leaving the hospital with a modified Rankin Scale score of 3 or less, which means the patient has some moderate disability but is still able to walk without assistance.

Patients were 69 years old on average, and about 60% were men. The majority were white. About a third had a modified Rankin Scale score at or below 3 at discharge, and about two-thirds were discharged home or to a rehabilitation facility; 17% of patients died in the hospital.

Differences in antihypertensive regimens were not associated with outcomes on univariate analysis. Dr. Jillella said that, ideally, he would like to run a multicenter, prospective trial of blood pressure reduction targets after reperfusion.

There was no external funding, and Dr. Jillella didn’t have any relevant disclosures.
 

[email protected]

ST. LOUIS – The lower the blood pressure peaks and variability in the first 24 hours after ischemic stroke reperfusion, the better the outcomes, according to a review of 140 patients at the University of New Mexico, Albuquerque. Investigators found that every 10–mm Hg increase in peak systolic pressure boosted the risk of in-hospital death 24% (P = .01) and reduced the chance of being discharged home or to a inpatient rehabilitation facility 13% (P = .03). Results were even stronger for peak mean arterial pressure, at 76% (P = .01) and 29% (P = .04), respectively; trends in the same direction for peak diastolic pressure were not statistically significant.

Also, every 10–mm Hg increase in blood pressure variability again increased the risk of dying in the hospital, whether it was systolic (33%; P = .002), diastolic (33%; P = .03), or mean arterial pressure variability (58%; P = .02). Higher variability also reduced the chance of being discharged home or to a rehab 10%-20%, but the findings, although close, were not statistically significant.

Neurologists generally do what they can to control blood pressure after stroke, and the study confirms the need to do that. What’s new is that the work was limited to reperfusion patients – intravenous thrombolysis with alteplase in 83.5%, mechanical thrombectomy in 60%, with some having both – which has not been the specific focus of much research.

“Be much more aggressive in terms of making sure the variability is limited and limiting the peaks,” especially within 24 hours of reperfusion, said lead investigator and stroke neurologist Dinesh Jillella, MD, of Emory University, Atlanta, at the annual meeting of the American Neurological Association. “We want to be much more aggressive [with these patients]; it might limit our worse outcomes,” Dr. Jillella said. He conducted the review while in training at the University of New Mexico.

What led to the study is that Dr. Jillella and colleagues noticed that similar reperfusion patients can have very different outcomes, and he wanted to find modifiable risk factors that could account for the differences. The study did not address why high peaks and variability lead to worse outcomes, but he said hemorrhagic conversion might play a role.

It is also possible that higher pressures could be a marker of bad outcomes, as opposed to a direct cause, but the findings were adjusted for two significant confounders: age and the National Institutes of Health Stroke Scale score, which were both significantly higher in patients who did not do well. But after adjustment, “we [still] found an independent association with blood pressures and worse outcomes,” he said.

Higher peak systolic pressures and variability were also associated with about a 15% lower odds of leaving the hospital with a modified Rankin Scale score of 3 or less, which means the patient has some moderate disability but is still able to walk without assistance.

Patients were 69 years old on average, and about 60% were men. The majority were white. About a third had a modified Rankin Scale score at or below 3 at discharge, and about two-thirds were discharged home or to a rehabilitation facility; 17% of patients died in the hospital.

Differences in antihypertensive regimens were not associated with outcomes on univariate analysis. Dr. Jillella said that, ideally, he would like to run a multicenter, prospective trial of blood pressure reduction targets after reperfusion.

There was no external funding, and Dr. Jillella didn’t have any relevant disclosures.
 

[email protected]

ST. LOUIS – The lower the blood pressure peaks and variability in the first 24 hours after ischemic stroke reperfusion, the better the outcomes, according to a review of 140 patients at the University of New Mexico, Albuquerque. Investigators found that every 10–mm Hg increase in peak systolic pressure boosted the risk of in-hospital death 24% (P = .01) and reduced the chance of being discharged home or to a inpatient rehabilitation facility 13% (P = .03). Results were even stronger for peak mean arterial pressure, at 76% (P = .01) and 29% (P = .04), respectively; trends in the same direction for peak diastolic pressure were not statistically significant.

Also, every 10–mm Hg increase in blood pressure variability again increased the risk of dying in the hospital, whether it was systolic (33%; P = .002), diastolic (33%; P = .03), or mean arterial pressure variability (58%; P = .02). Higher variability also reduced the chance of being discharged home or to a rehab 10%-20%, but the findings, although close, were not statistically significant.

Neurologists generally do what they can to control blood pressure after stroke, and the study confirms the need to do that. What’s new is that the work was limited to reperfusion patients – intravenous thrombolysis with alteplase in 83.5%, mechanical thrombectomy in 60%, with some having both – which has not been the specific focus of much research.

“Be much more aggressive in terms of making sure the variability is limited and limiting the peaks,” especially within 24 hours of reperfusion, said lead investigator and stroke neurologist Dinesh Jillella, MD, of Emory University, Atlanta, at the annual meeting of the American Neurological Association. “We want to be much more aggressive [with these patients]; it might limit our worse outcomes,” Dr. Jillella said. He conducted the review while in training at the University of New Mexico.

What led to the study is that Dr. Jillella and colleagues noticed that similar reperfusion patients can have very different outcomes, and he wanted to find modifiable risk factors that could account for the differences. The study did not address why high peaks and variability lead to worse outcomes, but he said hemorrhagic conversion might play a role.

It is also possible that higher pressures could be a marker of bad outcomes, as opposed to a direct cause, but the findings were adjusted for two significant confounders: age and the National Institutes of Health Stroke Scale score, which were both significantly higher in patients who did not do well. But after adjustment, “we [still] found an independent association with blood pressures and worse outcomes,” he said.

Higher peak systolic pressures and variability were also associated with about a 15% lower odds of leaving the hospital with a modified Rankin Scale score of 3 or less, which means the patient has some moderate disability but is still able to walk without assistance.

Patients were 69 years old on average, and about 60% were men. The majority were white. About a third had a modified Rankin Scale score at or below 3 at discharge, and about two-thirds were discharged home or to a rehabilitation facility; 17% of patients died in the hospital.

Differences in antihypertensive regimens were not associated with outcomes on univariate analysis. Dr. Jillella said that, ideally, he would like to run a multicenter, prospective trial of blood pressure reduction targets after reperfusion.

There was no external funding, and Dr. Jillella didn’t have any relevant disclosures.
 

[email protected]

ST. LOUIS – Getting an MRI first for suspected stroke, instead of a CT, saves money by avoiding unnecessary admissions and might lead to better outcomes, according to a review from Johns Hopkins University, Baltimore.

MRI as the first scan leads to “a definitive diagnoses sooner and helps you manage the person more rapidly and appropriately, without negatively affecting outcomes even in stroke patients who receive endovascular therapy,” said neurologist and senior investigator Argye Hillis, MD, director of the Center of Excellence in Stroke Detection and Diagnosis at Hopkins. “Consider skipping the CT and getting an MRI, and get the MRI while they are still in the emergency room.”

Almost all emergency departments in the United States are set up to get a CT first, but MRI is known to be the better study, according to the researchers. MRI is much more sensitive to stroke, especially in the first 24 hours, and pinpoints the location and extent of the damage. It can detect causes of stroke invisible to CT, with no radiation, and rule out stroke entirely, whereas CT can rule out only intracranial bleeding. Increasingly in Europe, MRI is the first study in suspected stroke, and new EDs in the United States are being designed with an in-house MRI, or one nearby.

The ED at Hopkins’ main campus in downtown Baltimore already has an MRI, and uses it first whenever possible. The problem has been that MRI techs are available only during weekdays, so physicians have to default back to CT at night and on weekends. The impetus for the review, presented at the annual meeting of the American Neurological Association, was to see if savings from unnecessary admissions prevented by MRI would be enough to offset the cost of around-the-clock staffing for the MRI scanner.

Dr. Hillis and her team reviewed 320 patients with suspected ischemic stroke who were seen at the main campus in 2018 and had CT in the ED, and then definitive diagnosis by MRI, which is the usual approach in most U.S. hospitals.

A total of 134 patients had a final diagnosis on MRI that did not justify admission; techs were available to give 75 of them MRIs in the ED after the CT, and those patients were sent home. Techs were not available, however, for 59 patients and since the CT was not able to rule out stroke, those patients were admitted. The cost of those 59 admissions was $814,016.

The cost of the noncontrast CTs for the 75 patients who were sent home after definitive MRI imaging was $28,050, plus an additional $46,072 for those who had CT neck/head angiograms. Altogether, skipping the CT and going straight to the MRI would have saved Hopkins $888,138 in 2018, enough to cover round-the-clock MRI staffing in the ED, which is now the plan at the main campus.

Once the facility moves to 24-and-7 MRI coverage, the next step in the project is to compare stroke outcomes with Johns Hopkins Bayview Medical Center, also in Baltimore, which will continue to do CT first. “We know MRI first is cheaper. We want to see if we have better outcomes. If we find they’re much better, I think many hospitals will say it’s worth the 5 minutes longer it takes to get to the MRI scanner,” Dr. Hillis said.

Stroke mimics among the 134 patients included peripheral nerve palsy and migraine, but also people simply faking it for a hot meal and a warm bed. “Its pretty common, unfortunately,” she said.

The average age for stroke admissions at Hopkins is 55 years, with as many men as women.

There was no industry funding, and Dr. Hillis didn’t have any relevant disclosures.

[email protected]

ST. LOUIS – Getting an MRI first for suspected stroke, instead of a CT, saves money by avoiding unnecessary admissions and might lead to better outcomes, according to a review from Johns Hopkins University, Baltimore.

MRI as the first scan leads to “a definitive diagnoses sooner and helps you manage the person more rapidly and appropriately, without negatively affecting outcomes even in stroke patients who receive endovascular therapy,” said neurologist and senior investigator Argye Hillis, MD, director of the Center of Excellence in Stroke Detection and Diagnosis at Hopkins. “Consider skipping the CT and getting an MRI, and get the MRI while they are still in the emergency room.”

Almost all emergency departments in the United States are set up to get a CT first, but MRI is known to be the better study, according to the researchers. MRI is much more sensitive to stroke, especially in the first 24 hours, and pinpoints the location and extent of the damage. It can detect causes of stroke invisible to CT, with no radiation, and rule out stroke entirely, whereas CT can rule out only intracranial bleeding. Increasingly in Europe, MRI is the first study in suspected stroke, and new EDs in the United States are being designed with an in-house MRI, or one nearby.

The ED at Hopkins’ main campus in downtown Baltimore already has an MRI, and uses it first whenever possible. The problem has been that MRI techs are available only during weekdays, so physicians have to default back to CT at night and on weekends. The impetus for the review, presented at the annual meeting of the American Neurological Association, was to see if savings from unnecessary admissions prevented by MRI would be enough to offset the cost of around-the-clock staffing for the MRI scanner.

Dr. Hillis and her team reviewed 320 patients with suspected ischemic stroke who were seen at the main campus in 2018 and had CT in the ED, and then definitive diagnosis by MRI, which is the usual approach in most U.S. hospitals.

A total of 134 patients had a final diagnosis on MRI that did not justify admission; techs were available to give 75 of them MRIs in the ED after the CT, and those patients were sent home. Techs were not available, however, for 59 patients and since the CT was not able to rule out stroke, those patients were admitted. The cost of those 59 admissions was $814,016.

The cost of the noncontrast CTs for the 75 patients who were sent home after definitive MRI imaging was $28,050, plus an additional $46,072 for those who had CT neck/head angiograms. Altogether, skipping the CT and going straight to the MRI would have saved Hopkins $888,138 in 2018, enough to cover round-the-clock MRI staffing in the ED, which is now the plan at the main campus.

Once the facility moves to 24-and-7 MRI coverage, the next step in the project is to compare stroke outcomes with Johns Hopkins Bayview Medical Center, also in Baltimore, which will continue to do CT first. “We know MRI first is cheaper. We want to see if we have better outcomes. If we find they’re much better, I think many hospitals will say it’s worth the 5 minutes longer it takes to get to the MRI scanner,” Dr. Hillis said.

Stroke mimics among the 134 patients included peripheral nerve palsy and migraine, but also people simply faking it for a hot meal and a warm bed. “Its pretty common, unfortunately,” she said.

The average age for stroke admissions at Hopkins is 55 years, with as many men as women.

There was no industry funding, and Dr. Hillis didn’t have any relevant disclosures.

[email protected]

ST. LOUIS – Getting an MRI first for suspected stroke, instead of a CT, saves money by avoiding unnecessary admissions and might lead to better outcomes, according to a review from Johns Hopkins University, Baltimore.

MRI as the first scan leads to “a definitive diagnoses sooner and helps you manage the person more rapidly and appropriately, without negatively affecting outcomes even in stroke patients who receive endovascular therapy,” said neurologist and senior investigator Argye Hillis, MD, director of the Center of Excellence in Stroke Detection and Diagnosis at Hopkins. “Consider skipping the CT and getting an MRI, and get the MRI while they are still in the emergency room.”

Almost all emergency departments in the United States are set up to get a CT first, but MRI is known to be the better study, according to the researchers. MRI is much more sensitive to stroke, especially in the first 24 hours, and pinpoints the location and extent of the damage. It can detect causes of stroke invisible to CT, with no radiation, and rule out stroke entirely, whereas CT can rule out only intracranial bleeding. Increasingly in Europe, MRI is the first study in suspected stroke, and new EDs in the United States are being designed with an in-house MRI, or one nearby.

The ED at Hopkins’ main campus in downtown Baltimore already has an MRI, and uses it first whenever possible. The problem has been that MRI techs are available only during weekdays, so physicians have to default back to CT at night and on weekends. The impetus for the review, presented at the annual meeting of the American Neurological Association, was to see if savings from unnecessary admissions prevented by MRI would be enough to offset the cost of around-the-clock staffing for the MRI scanner.

Dr. Hillis and her team reviewed 320 patients with suspected ischemic stroke who were seen at the main campus in 2018 and had CT in the ED, and then definitive diagnosis by MRI, which is the usual approach in most U.S. hospitals.

A total of 134 patients had a final diagnosis on MRI that did not justify admission; techs were available to give 75 of them MRIs in the ED after the CT, and those patients were sent home. Techs were not available, however, for 59 patients and since the CT was not able to rule out stroke, those patients were admitted. The cost of those 59 admissions was $814,016.

The cost of the noncontrast CTs for the 75 patients who were sent home after definitive MRI imaging was $28,050, plus an additional $46,072 for those who had CT neck/head angiograms. Altogether, skipping the CT and going straight to the MRI would have saved Hopkins $888,138 in 2018, enough to cover round-the-clock MRI staffing in the ED, which is now the plan at the main campus.

Once the facility moves to 24-and-7 MRI coverage, the next step in the project is to compare stroke outcomes with Johns Hopkins Bayview Medical Center, also in Baltimore, which will continue to do CT first. “We know MRI first is cheaper. We want to see if we have better outcomes. If we find they’re much better, I think many hospitals will say it’s worth the 5 minutes longer it takes to get to the MRI scanner,” Dr. Hillis said.

Stroke mimics among the 134 patients included peripheral nerve palsy and migraine, but also people simply faking it for a hot meal and a warm bed. “Its pretty common, unfortunately,” she said.

The average age for stroke admissions at Hopkins is 55 years, with as many men as women.

There was no industry funding, and Dr. Hillis didn’t have any relevant disclosures.

[email protected]

SAN DIEGO – A relatively new treatment approach called good psychiatric management (GPM) is available for patients with borderline personality disorder.

It’s a solid option for “environments where people may not have many resources and might not be able to deliver treatments that are more resource intensive, like dialectical behavioral therapy,” the standard intervention, said James Jenkins, MD, a psychiatrist affiliated with Massachusetts General Hospital, Boston, in a video interview at the annual Psych Congress.

“GPM is a treatment, not a psychotherapy, that’s maybe a little bit more easily adaptable to a variety of different contexts and situations,” he said.

It’s an atheoretical, pragmatic approach that focuses on helping people establish a life outside of therapy. Clinicians actively engage with patients, encouraging them to start working and building successful relationships with other people. The model emphasizes the value of educating people about the condition and giving them hope. Typically, patients participate in GPM once each week (Curr Opin Psychol. 2018 Jun;21:127-31).

Vidyard Video

For most people, it works just as well as dialectical behavioral therapy, and when it doesn’t, patients can transition to that or another more intensive approach. Training is less intensive and sometimes free. GPM is offered at McLean Hospital in Boston, where the intervention originated. McLean also is Dr. Jenkins’s former institution.

Dr. Jenkins reported that he had no disclosures.

[email protected]

SAN DIEGO – A relatively new treatment approach called good psychiatric management (GPM) is available for patients with borderline personality disorder.

It’s a solid option for “environments where people may not have many resources and might not be able to deliver treatments that are more resource intensive, like dialectical behavioral therapy,” the standard intervention, said James Jenkins, MD, a psychiatrist affiliated with Massachusetts General Hospital, Boston, in a video interview at the annual Psych Congress.

“GPM is a treatment, not a psychotherapy, that’s maybe a little bit more easily adaptable to a variety of different contexts and situations,” he said.

It’s an atheoretical, pragmatic approach that focuses on helping people establish a life outside of therapy. Clinicians actively engage with patients, encouraging them to start working and building successful relationships with other people. The model emphasizes the value of educating people about the condition and giving them hope. Typically, patients participate in GPM once each week (Curr Opin Psychol. 2018 Jun;21:127-31).

Vidyard Video

For most people, it works just as well as dialectical behavioral therapy, and when it doesn’t, patients can transition to that or another more intensive approach. Training is less intensive and sometimes free. GPM is offered at McLean Hospital in Boston, where the intervention originated. McLean also is Dr. Jenkins’s former institution.

Dr. Jenkins reported that he had no disclosures.

[email protected]

SAN DIEGO – A relatively new treatment approach called good psychiatric management (GPM) is available for patients with borderline personality disorder.

It’s a solid option for “environments where people may not have many resources and might not be able to deliver treatments that are more resource intensive, like dialectical behavioral therapy,” the standard intervention, said James Jenkins, MD, a psychiatrist affiliated with Massachusetts General Hospital, Boston, in a video interview at the annual Psych Congress.

“GPM is a treatment, not a psychotherapy, that’s maybe a little bit more easily adaptable to a variety of different contexts and situations,” he said.

It’s an atheoretical, pragmatic approach that focuses on helping people establish a life outside of therapy. Clinicians actively engage with patients, encouraging them to start working and building successful relationships with other people. The model emphasizes the value of educating people about the condition and giving them hope. Typically, patients participate in GPM once each week (Curr Opin Psychol. 2018 Jun;21:127-31).

Vidyard Video

For most people, it works just as well as dialectical behavioral therapy, and when it doesn’t, patients can transition to that or another more intensive approach. Training is less intensive and sometimes free. GPM is offered at McLean Hospital in Boston, where the intervention originated. McLean also is Dr. Jenkins’s former institution.

Dr. Jenkins reported that he had no disclosures.

[email protected]

SAN DIEGO – You don’t have to stop prescribing lithium when patients go on ACE inhibitors or angiotensin-receptor blockers (ARBs) for blood pressure treatment.

Some might opt to do that, but there’s no need to worry. In fact, the reason both classes are known to protect the kidneys is that they were tested with lithium; it was used to measure the drug’s effects on renal clearance, according to Stephen R. Saklad, PharmD, director of psychiatric pharmacy and clinical professor at the University of Texas at Austin.

There is interaction, but “lithium is not toxic in the presence of an ACE or an RB. You just have to adjust the dose,” he said at the annual Psych Congress.

Dr. Saklad shared lithium drug interaction pearls during a video interview at the meeting, including also using lithium with diuretics and NSAIDs. “The worst offender is probably my favorite of the NSAIDs, which is ibuprofen,” he said.

Most of the time with lithium, all that’s needed is a dose adjustment up or down of either it or the coadministered medication.

The overall guiding principle, he said, is that “lithium follows sodium. Anything that alters sodium in the body is going to alter sodium.”

[email protected]

SAN DIEGO – You don’t have to stop prescribing lithium when patients go on ACE inhibitors or angiotensin-receptor blockers (ARBs) for blood pressure treatment.

Some might opt to do that, but there’s no need to worry. In fact, the reason both classes are known to protect the kidneys is that they were tested with lithium; it was used to measure the drug’s effects on renal clearance, according to Stephen R. Saklad, PharmD, director of psychiatric pharmacy and clinical professor at the University of Texas at Austin.

There is interaction, but “lithium is not toxic in the presence of an ACE or an RB. You just have to adjust the dose,” he said at the annual Psych Congress.

Dr. Saklad shared lithium drug interaction pearls during a video interview at the meeting, including also using lithium with diuretics and NSAIDs. “The worst offender is probably my favorite of the NSAIDs, which is ibuprofen,” he said.

Most of the time with lithium, all that’s needed is a dose adjustment up or down of either it or the coadministered medication.

The overall guiding principle, he said, is that “lithium follows sodium. Anything that alters sodium in the body is going to alter sodium.”

[email protected]

SAN DIEGO – You don’t have to stop prescribing lithium when patients go on ACE inhibitors or angiotensin-receptor blockers (ARBs) for blood pressure treatment.

Some might opt to do that, but there’s no need to worry. In fact, the reason both classes are known to protect the kidneys is that they were tested with lithium; it was used to measure the drug’s effects on renal clearance, according to Stephen R. Saklad, PharmD, director of psychiatric pharmacy and clinical professor at the University of Texas at Austin.

There is interaction, but “lithium is not toxic in the presence of an ACE or an RB. You just have to adjust the dose,” he said at the annual Psych Congress.

Dr. Saklad shared lithium drug interaction pearls during a video interview at the meeting, including also using lithium with diuretics and NSAIDs. “The worst offender is probably my favorite of the NSAIDs, which is ibuprofen,” he said.

Most of the time with lithium, all that’s needed is a dose adjustment up or down of either it or the coadministered medication.

The overall guiding principle, he said, is that “lithium follows sodium. Anything that alters sodium in the body is going to alter sodium.”

[email protected]

SAN DIEGO – Lofexidine (Lucemyra), the new kid on the block in the United States for opioid withdrawal, can help patients get through the process in a few days, instead of a week or more, according to Thomas Kosten, MD, a psychiatry professor and director of the division of addictions at Baylor College of Medicine, Houston.

Lofexidine relieves symptom withdrawal and has significant advantages over clonidine, a similar drug, including easier dosing and no orthostatic hypertension.

In a video interview at the annual Psych Congress, Dr. Kosten went into the nuts and bolts of how to use lofexidine with buprenorphine and naltrexone – plus benzodiazepines when needed – to help people safely go through withdrawal and in just a few days.

Once chronic pain patients are off opioids, the next question is what to do for their pain. In a presentation before the interview, Dr. Kosten said he favors tricyclic antidepressants, especially desipramine because it has the fewest side effects. The effect size with tricyclic antidepressants is larger than with gabapentin and other options. They take a few weeks to kick in, however, so he’s thinking about a unique approach: using ketamine – either infusions or the new nasal spray esketamine (Spravato) – to tide people over in the meantime. It’s becoming well known that ketamine works amazingly fast for depression and suicidality, and there is emerging support that it might do the same for chronic pain. Dr. Kosten is a consultant for US Worldmeds, maker of lofexidine.

[email protected]

SAN DIEGO – Lofexidine (Lucemyra), the new kid on the block in the United States for opioid withdrawal, can help patients get through the process in a few days, instead of a week or more, according to Thomas Kosten, MD, a psychiatry professor and director of the division of addictions at Baylor College of Medicine, Houston.

Lofexidine relieves symptom withdrawal and has significant advantages over clonidine, a similar drug, including easier dosing and no orthostatic hypertension.

In a video interview at the annual Psych Congress, Dr. Kosten went into the nuts and bolts of how to use lofexidine with buprenorphine and naltrexone – plus benzodiazepines when needed – to help people safely go through withdrawal and in just a few days.

Once chronic pain patients are off opioids, the next question is what to do for their pain. In a presentation before the interview, Dr. Kosten said he favors tricyclic antidepressants, especially desipramine because it has the fewest side effects. The effect size with tricyclic antidepressants is larger than with gabapentin and other options. They take a few weeks to kick in, however, so he’s thinking about a unique approach: using ketamine – either infusions or the new nasal spray esketamine (Spravato) – to tide people over in the meantime. It’s becoming well known that ketamine works amazingly fast for depression and suicidality, and there is emerging support that it might do the same for chronic pain. Dr. Kosten is a consultant for US Worldmeds, maker of lofexidine.

[email protected]

SAN DIEGO – Lofexidine (Lucemyra), the new kid on the block in the United States for opioid withdrawal, can help patients get through the process in a few days, instead of a week or more, according to Thomas Kosten, MD, a psychiatry professor and director of the division of addictions at Baylor College of Medicine, Houston.

Lofexidine relieves symptom withdrawal and has significant advantages over clonidine, a similar drug, including easier dosing and no orthostatic hypertension.

In a video interview at the annual Psych Congress, Dr. Kosten went into the nuts and bolts of how to use lofexidine with buprenorphine and naltrexone – plus benzodiazepines when needed – to help people safely go through withdrawal and in just a few days.

Once chronic pain patients are off opioids, the next question is what to do for their pain. In a presentation before the interview, Dr. Kosten said he favors tricyclic antidepressants, especially desipramine because it has the fewest side effects. The effect size with tricyclic antidepressants is larger than with gabapentin and other options. They take a few weeks to kick in, however, so he’s thinking about a unique approach: using ketamine – either infusions or the new nasal spray esketamine (Spravato) – to tide people over in the meantime. It’s becoming well known that ketamine works amazingly fast for depression and suicidality, and there is emerging support that it might do the same for chronic pain. Dr. Kosten is a consultant for US Worldmeds, maker of lofexidine.

[email protected]

SAN FRANCISCO – It took about 50 MitraClip cases for operator outcomes to start improving, and outcomes were still improving at 200 cases, in a study reviewing 14,923 MitraClip procedures in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from November 2013 to March 2018.

“These findings demonstrate the key role of operator experience in optimizing outcomes” of transcatheter mitral valve repair (TMVr) with MitraClip (Abbott Structural), said investigators, led by Adnan Chhatriwalla, MD, an interventional cardiologist at Saint Luke’s Mid America Heart Institute in Kansas City, Mo.

“New operators may experience a ‘learning curve’ irrespective of the overall site experience or experience of other members of the Heart Team,” they wrote in the study (JACC Cardiovasc Interv. 2019 Sep 27. doi: 10.1016/j.jacc.2019.09.014).

“As TMVr becomes more prevalent in the U.S., it may be prudent for less experienced operators to be cognizant of where they sit on the ‘learning curve’ and to pay particular attention to case selection in their early experience, considering that more complex patients may be referred to more experienced centers for treatment when prudent,” they noted.

“The overall duration of the learning curve may exceed 200 cases,” Dr. Chhatriwalla said at the Transcatheter Cardiovascular Therapeutics annual meeting in a presentation that coincided with the study’s publication.

“This is a more complex procedure than [transcatheter aortic valve replacement], and the volume/outcome relationship is stronger. We are seeing issues that are related to early experience in low-volume programs. Public reporting so consumers can determine how many cases a center does is going to be critical,” said cardiothoracic surgeon Michael Mack, MD, director of the cardiovascular service line at a health system in Dallas, after the talk. He was one of the authors of the study.

The investigators compared outcomes among 549 operators who had done 1-25 MitraClip cases, 230 who had performed 26-50 cases, and 116 who had performed 50 or more.

Optimal procedural success – defined as less than or equal to 1+ residual mitral regurgitation (MR) without death or cardiac surgery – was 63.9%, 68.4%, and 75.1%, respectively, across the three groups (P less than .001). The “acceptable” procedural success rate – less than or equal to 2+ residual MR without death or cardiac surgery – was 91.4%, 92.4%, and 93.8% (P less than .001). No interaction was observed between the mechanism of mitral valve regurgitation and procedural outcomes.

Procedure time decreased as operators gained experience (145, 118, and 99 minutes), and atrial septal defect closure rates increased (0.9%, 1.4%, and 2.2%, respectively).

Composite complications rates also fell (9.7%, 8.1%, and 7.3%), driven mostly by less frequent cardiac perforation (1.0%, 1.1%, and 0.4%) and less frequent blood transfusion (9.6%, 8.6%, and 6.5%). The results were statistically significant.

“Adjusted learning curves for procedural success were visually evident after approximately 50 cases, and continued improvement in clinical outcomes was observed for the entire case sequence up to 200 cases,” the investigators wrote. The improvements could not be attributed to patient selection alone, they said.

More experienced operators were more likely to use more than one clip per case, and more frequently treated central and medial, as opposed to lateral, pathology. Operators with more than 50 cases were less likely to treat patients who had preexisting mitral stenosis or required home oxygen, and experienced operators were more likely to perform the procedure in unstable patients, when appropriate. The proportion of patients with functional MR – as opposed to degenerative disease – increased with increasing experience.

There were no statistically significant differences across the groups in stroke rates (P = .26), single-leaflet device attachments (P = .11), trans-septal complications (P = .25), urgent cardiac surgery (P = .42), or in-hospital mortality (P = .55).

Patients were a median of 81 years old, and most were white; 93% had 3+ or 4+ MR at baseline, and 86.3% had degenerative mitral disease. Two-thirds had atrial fibrillation/flutter.

The work was supported by the ACC/STS TVT Registry. Dr. Chhatriwalla is a proctor for Edwards Lifesciences and Medtronic, and is a speaker for Abbott, Edwards Lifesciences, and Medtronic. Dr. Mack has served as an investigator for Edwards Lifesciences and Abbott, and as a study chair for Medtronic. Other investigators reported similar industry disclosures.

The meeting is sponsored by the Cardiovascular Research Foundation.

[email protected]

SOURCE: Chhatriwalla A et. al. JACC Cardiovasc Interv. 2019 Sep 27. doi: 10.1016/j.jacc.2019.09.014.

SAN FRANCISCO – It took about 50 MitraClip cases for operator outcomes to start improving, and outcomes were still improving at 200 cases, in a study reviewing 14,923 MitraClip procedures in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from November 2013 to March 2018.

“These findings demonstrate the key role of operator experience in optimizing outcomes” of transcatheter mitral valve repair (TMVr) with MitraClip (Abbott Structural), said investigators, led by Adnan Chhatriwalla, MD, an interventional cardiologist at Saint Luke’s Mid America Heart Institute in Kansas City, Mo.

“New operators may experience a ‘learning curve’ irrespective of the overall site experience or experience of other members of the Heart Team,” they wrote in the study (JACC Cardiovasc Interv. 2019 Sep 27. doi: 10.1016/j.jacc.2019.09.014).

“As TMVr becomes more prevalent in the U.S., it may be prudent for less experienced operators to be cognizant of where they sit on the ‘learning curve’ and to pay particular attention to case selection in their early experience, considering that more complex patients may be referred to more experienced centers for treatment when prudent,” they noted.

“The overall duration of the learning curve may exceed 200 cases,” Dr. Chhatriwalla said at the Transcatheter Cardiovascular Therapeutics annual meeting in a presentation that coincided with the study’s publication.

“This is a more complex procedure than [transcatheter aortic valve replacement], and the volume/outcome relationship is stronger. We are seeing issues that are related to early experience in low-volume programs. Public reporting so consumers can determine how many cases a center does is going to be critical,” said cardiothoracic surgeon Michael Mack, MD, director of the cardiovascular service line at a health system in Dallas, after the talk. He was one of the authors of the study.

The investigators compared outcomes among 549 operators who had done 1-25 MitraClip cases, 230 who had performed 26-50 cases, and 116 who had performed 50 or more.

Optimal procedural success – defined as less than or equal to 1+ residual mitral regurgitation (MR) without death or cardiac surgery – was 63.9%, 68.4%, and 75.1%, respectively, across the three groups (P less than .001). The “acceptable” procedural success rate – less than or equal to 2+ residual MR without death or cardiac surgery – was 91.4%, 92.4%, and 93.8% (P less than .001). No interaction was observed between the mechanism of mitral valve regurgitation and procedural outcomes.

Procedure time decreased as operators gained experience (145, 118, and 99 minutes), and atrial septal defect closure rates increased (0.9%, 1.4%, and 2.2%, respectively).

Composite complications rates also fell (9.7%, 8.1%, and 7.3%), driven mostly by less frequent cardiac perforation (1.0%, 1.1%, and 0.4%) and less frequent blood transfusion (9.6%, 8.6%, and 6.5%). The results were statistically significant.

“Adjusted learning curves for procedural success were visually evident after approximately 50 cases, and continued improvement in clinical outcomes was observed for the entire case sequence up to 200 cases,” the investigators wrote. The improvements could not be attributed to patient selection alone, they said.

More experienced operators were more likely to use more than one clip per case, and more frequently treated central and medial, as opposed to lateral, pathology. Operators with more than 50 cases were less likely to treat patients who had preexisting mitral stenosis or required home oxygen, and experienced operators were more likely to perform the procedure in unstable patients, when appropriate. The proportion of patients with functional MR – as opposed to degenerative disease – increased with increasing experience.

There were no statistically significant differences across the groups in stroke rates (P = .26), single-leaflet device attachments (P = .11), trans-septal complications (P = .25), urgent cardiac surgery (P = .42), or in-hospital mortality (P = .55).

Patients were a median of 81 years old, and most were white; 93% had 3+ or 4+ MR at baseline, and 86.3% had degenerative mitral disease. Two-thirds had atrial fibrillation/flutter.

The work was supported by the ACC/STS TVT Registry. Dr. Chhatriwalla is a proctor for Edwards Lifesciences and Medtronic, and is a speaker for Abbott, Edwards Lifesciences, and Medtronic. Dr. Mack has served as an investigator for Edwards Lifesciences and Abbott, and as a study chair for Medtronic. Other investigators reported similar industry disclosures.

The meeting is sponsored by the Cardiovascular Research Foundation.

[email protected]

SOURCE: Chhatriwalla A et. al. JACC Cardiovasc Interv. 2019 Sep 27. doi: 10.1016/j.jacc.2019.09.014.

SAN FRANCISCO – It took about 50 MitraClip cases for operator outcomes to start improving, and outcomes were still improving at 200 cases, in a study reviewing 14,923 MitraClip procedures in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from November 2013 to March 2018.

“These findings demonstrate the key role of operator experience in optimizing outcomes” of transcatheter mitral valve repair (TMVr) with MitraClip (Abbott Structural), said investigators, led by Adnan Chhatriwalla, MD, an interventional cardiologist at Saint Luke’s Mid America Heart Institute in Kansas City, Mo.

“New operators may experience a ‘learning curve’ irrespective of the overall site experience or experience of other members of the Heart Team,” they wrote in the study (JACC Cardiovasc Interv. 2019 Sep 27. doi: 10.1016/j.jacc.2019.09.014).

“As TMVr becomes more prevalent in the U.S., it may be prudent for less experienced operators to be cognizant of where they sit on the ‘learning curve’ and to pay particular attention to case selection in their early experience, considering that more complex patients may be referred to more experienced centers for treatment when prudent,” they noted.

“The overall duration of the learning curve may exceed 200 cases,” Dr. Chhatriwalla said at the Transcatheter Cardiovascular Therapeutics annual meeting in a presentation that coincided with the study’s publication.

“This is a more complex procedure than [transcatheter aortic valve replacement], and the volume/outcome relationship is stronger. We are seeing issues that are related to early experience in low-volume programs. Public reporting so consumers can determine how many cases a center does is going to be critical,” said cardiothoracic surgeon Michael Mack, MD, director of the cardiovascular service line at a health system in Dallas, after the talk. He was one of the authors of the study.

The investigators compared outcomes among 549 operators who had done 1-25 MitraClip cases, 230 who had performed 26-50 cases, and 116 who had performed 50 or more.

Optimal procedural success – defined as less than or equal to 1+ residual mitral regurgitation (MR) without death or cardiac surgery – was 63.9%, 68.4%, and 75.1%, respectively, across the three groups (P less than .001). The “acceptable” procedural success rate – less than or equal to 2+ residual MR without death or cardiac surgery – was 91.4%, 92.4%, and 93.8% (P less than .001). No interaction was observed between the mechanism of mitral valve regurgitation and procedural outcomes.

Procedure time decreased as operators gained experience (145, 118, and 99 minutes), and atrial septal defect closure rates increased (0.9%, 1.4%, and 2.2%, respectively).

Composite complications rates also fell (9.7%, 8.1%, and 7.3%), driven mostly by less frequent cardiac perforation (1.0%, 1.1%, and 0.4%) and less frequent blood transfusion (9.6%, 8.6%, and 6.5%). The results were statistically significant.

“Adjusted learning curves for procedural success were visually evident after approximately 50 cases, and continued improvement in clinical outcomes was observed for the entire case sequence up to 200 cases,” the investigators wrote. The improvements could not be attributed to patient selection alone, they said.

More experienced operators were more likely to use more than one clip per case, and more frequently treated central and medial, as opposed to lateral, pathology. Operators with more than 50 cases were less likely to treat patients who had preexisting mitral stenosis or required home oxygen, and experienced operators were more likely to perform the procedure in unstable patients, when appropriate. The proportion of patients with functional MR – as opposed to degenerative disease – increased with increasing experience.

There were no statistically significant differences across the groups in stroke rates (P = .26), single-leaflet device attachments (P = .11), trans-septal complications (P = .25), urgent cardiac surgery (P = .42), or in-hospital mortality (P = .55).

Patients were a median of 81 years old, and most were white; 93% had 3+ or 4+ MR at baseline, and 86.3% had degenerative mitral disease. Two-thirds had atrial fibrillation/flutter.

The work was supported by the ACC/STS TVT Registry. Dr. Chhatriwalla is a proctor for Edwards Lifesciences and Medtronic, and is a speaker for Abbott, Edwards Lifesciences, and Medtronic. Dr. Mack has served as an investigator for Edwards Lifesciences and Abbott, and as a study chair for Medtronic. Other investigators reported similar industry disclosures.

The meeting is sponsored by the Cardiovascular Research Foundation.

[email protected]

SOURCE: Chhatriwalla A et. al. JACC Cardiovasc Interv. 2019 Sep 27. doi: 10.1016/j.jacc.2019.09.014.

SAN FRANCISCO – After 3 months of ticagrelor (Brilinta) plus aspirin following cardiac stenting, stopping the aspirin but continuing the ticagrelor resulted in less bleeding with no increase in ischemic events in a randomized trial with more than 7,000 drug-eluting stent patients at high risk for both.

“This was a superior therapy” to staying on both drugs, the more usual approach, said lead investigator Roxana Mehran, MD, director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai, New York.

“We can’t say this is for all comers, but for patients whose physician felt comfortable putting them on aspirin and ticagrelor,” who tolerated it well for the first 3 months, and who had clinical and angiographic indications of risk, “I think these patients can be peeled away” from aspirin, she said in a presentation at the Transcatheter Cardiovascular Therapeutics annual meeting that coincided with publication of the trial, dubbed TWILIGHT (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention).

Interventional cardiologists have long sought the sweet spot for dual-antiplatelet therapy (DAPT) after stenting; the idea is to maximize thrombosis prevention while minimizing bleeding risk. The trial supports the trend in recent years towards shorter DAPT. Often, however, it’s the P2Y12 inhibitor – ticagrelor, clopidogrel (Plavix), or prasugrel (Effient) – that goes first, not the aspirin.

Responding to an audience question about why the trial didn’t include an aspirin monotherapy arm, Dr. Mehran said that aspirin alone wouldn’t have been sufficient in high-risk patients “in whom you have almost 70% acute coronary syndrome.” She added that her team has data showing that aspirin itself doesn’t have much effect on blood thrombogenicity.

The 7,119 patients in TWILIGHT were on ticagrelor 90 mg twice daily and aspirin 81-100 mg daily for 3 months, then evenly randomized to continued treatment or ticagrelor plus an aspirin placebo for a year.

Subjects had to have at least one clinical and angiographic finding that put them at high risk for bleeding or an ischemic event, such as chronic kidney disease, acute coronary syndrome, diabetes, or a bifurcated target lesion treated with two stents.

One year after randomization, 4% in the ticagrelor monotherapy group versus 7.1% in the ticagrelor plus aspirin arm reached the primary end point, actionable (type 2), severe (type 3), or fatal (type 5) bleeding on the Bleeding Academic Research Consortium scale (hazard ratio, 0.56; 95% confidence interval, 0.45 - 0.68, P less than .001).

The incidence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke was 3.9% in both groups (HR, 0.99; 95% CI, 0.78-1.25; P less than .001 for noninferiority).

There were more ischemic strokes in the ticagrelor monotherapy arm (0.5% versus 0.2%). All-cause mortality (1.3% versus 1%) and stent thrombosis (0.6% versus 0.4%) were more frequent in the ticagrelor/aspirin group, but the differences were not statistically significant.

The two groups were well balanced. The mean age was 65 years, 23.8% of the patients were female, 37% had diabetes, and 65% had percutaneous coronary intervention for an acute coronary syndrome. Almost two-thirds had multivessel disease. Mean stent length was about 40 mm. The trial excluded patients with prior strokes.

Almost 2,000 patients originally enrolled in the trial never made it to randomization because they had a major bleeding or ischemic event in the 3-month run up, or dyspnea or some other reaction to ticagrelor.

The recent STOPDAPT-2 trial had a similar outcome – less bleeding with no increase in ischemic events – with clopidogrel monotherapy after a month-long run in of dual therapy with aspirin, versus continued treatment with both, in patients at low risk for ischemic events after stenting (JAMA. 2019 Jun 25;321[24]:2414-27).

Another recent study, GLOBAL LEADERS, concluded that 1 month of DAPT followed by ticagrelor monotherapy for 23 months was not superior to 12 months of DAPT followed by a year of aspirin. There was a numerical advantage for solo ticagrelor on death, myocardial infarction, and bleeding, but it did not reach statistical significance (Lancet. 2018 Sep 15;392[10151]:940-9).

The work was funded by ticagrelor’s maker, AstraZeneca. Dr. Mehran reported consulting and other relationships with Abbott, Janssen, and other companies.

[email protected]

SOURCE: Mehran A et al. N Engl J Med. 2019 Sep 26. doi: 10.1056/NEJMoa1908419.

SAN FRANCISCO – After 3 months of ticagrelor (Brilinta) plus aspirin following cardiac stenting, stopping the aspirin but continuing the ticagrelor resulted in less bleeding with no increase in ischemic events in a randomized trial with more than 7,000 drug-eluting stent patients at high risk for both.

“This was a superior therapy” to staying on both drugs, the more usual approach, said lead investigator Roxana Mehran, MD, director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai, New York.

“We can’t say this is for all comers, but for patients whose physician felt comfortable putting them on aspirin and ticagrelor,” who tolerated it well for the first 3 months, and who had clinical and angiographic indications of risk, “I think these patients can be peeled away” from aspirin, she said in a presentation at the Transcatheter Cardiovascular Therapeutics annual meeting that coincided with publication of the trial, dubbed TWILIGHT (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention).

Interventional cardiologists have long sought the sweet spot for dual-antiplatelet therapy (DAPT) after stenting; the idea is to maximize thrombosis prevention while minimizing bleeding risk. The trial supports the trend in recent years towards shorter DAPT. Often, however, it’s the P2Y12 inhibitor – ticagrelor, clopidogrel (Plavix), or prasugrel (Effient) – that goes first, not the aspirin.

Responding to an audience question about why the trial didn’t include an aspirin monotherapy arm, Dr. Mehran said that aspirin alone wouldn’t have been sufficient in high-risk patients “in whom you have almost 70% acute coronary syndrome.” She added that her team has data showing that aspirin itself doesn’t have much effect on blood thrombogenicity.

The 7,119 patients in TWILIGHT were on ticagrelor 90 mg twice daily and aspirin 81-100 mg daily for 3 months, then evenly randomized to continued treatment or ticagrelor plus an aspirin placebo for a year.

Subjects had to have at least one clinical and angiographic finding that put them at high risk for bleeding or an ischemic event, such as chronic kidney disease, acute coronary syndrome, diabetes, or a bifurcated target lesion treated with two stents.

One year after randomization, 4% in the ticagrelor monotherapy group versus 7.1% in the ticagrelor plus aspirin arm reached the primary end point, actionable (type 2), severe (type 3), or fatal (type 5) bleeding on the Bleeding Academic Research Consortium scale (hazard ratio, 0.56; 95% confidence interval, 0.45 - 0.68, P less than .001).

The incidence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke was 3.9% in both groups (HR, 0.99; 95% CI, 0.78-1.25; P less than .001 for noninferiority).

There were more ischemic strokes in the ticagrelor monotherapy arm (0.5% versus 0.2%). All-cause mortality (1.3% versus 1%) and stent thrombosis (0.6% versus 0.4%) were more frequent in the ticagrelor/aspirin group, but the differences were not statistically significant.

The two groups were well balanced. The mean age was 65 years, 23.8% of the patients were female, 37% had diabetes, and 65% had percutaneous coronary intervention for an acute coronary syndrome. Almost two-thirds had multivessel disease. Mean stent length was about 40 mm. The trial excluded patients with prior strokes.

Almost 2,000 patients originally enrolled in the trial never made it to randomization because they had a major bleeding or ischemic event in the 3-month run up, or dyspnea or some other reaction to ticagrelor.

The recent STOPDAPT-2 trial had a similar outcome – less bleeding with no increase in ischemic events – with clopidogrel monotherapy after a month-long run in of dual therapy with aspirin, versus continued treatment with both, in patients at low risk for ischemic events after stenting (JAMA. 2019 Jun 25;321[24]:2414-27).

Another recent study, GLOBAL LEADERS, concluded that 1 month of DAPT followed by ticagrelor monotherapy for 23 months was not superior to 12 months of DAPT followed by a year of aspirin. There was a numerical advantage for solo ticagrelor on death, myocardial infarction, and bleeding, but it did not reach statistical significance (Lancet. 2018 Sep 15;392[10151]:940-9).

The work was funded by ticagrelor’s maker, AstraZeneca. Dr. Mehran reported consulting and other relationships with Abbott, Janssen, and other companies.

[email protected]

SOURCE: Mehran A et al. N Engl J Med. 2019 Sep 26. doi: 10.1056/NEJMoa1908419.

SAN FRANCISCO – After 3 months of ticagrelor (Brilinta) plus aspirin following cardiac stenting, stopping the aspirin but continuing the ticagrelor resulted in less bleeding with no increase in ischemic events in a randomized trial with more than 7,000 drug-eluting stent patients at high risk for both.

“This was a superior therapy” to staying on both drugs, the more usual approach, said lead investigator Roxana Mehran, MD, director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai, New York.

“We can’t say this is for all comers, but for patients whose physician felt comfortable putting them on aspirin and ticagrelor,” who tolerated it well for the first 3 months, and who had clinical and angiographic indications of risk, “I think these patients can be peeled away” from aspirin, she said in a presentation at the Transcatheter Cardiovascular Therapeutics annual meeting that coincided with publication of the trial, dubbed TWILIGHT (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention).

Interventional cardiologists have long sought the sweet spot for dual-antiplatelet therapy (DAPT) after stenting; the idea is to maximize thrombosis prevention while minimizing bleeding risk. The trial supports the trend in recent years towards shorter DAPT. Often, however, it’s the P2Y12 inhibitor – ticagrelor, clopidogrel (Plavix), or prasugrel (Effient) – that goes first, not the aspirin.

Responding to an audience question about why the trial didn’t include an aspirin monotherapy arm, Dr. Mehran said that aspirin alone wouldn’t have been sufficient in high-risk patients “in whom you have almost 70% acute coronary syndrome.” She added that her team has data showing that aspirin itself doesn’t have much effect on blood thrombogenicity.

The 7,119 patients in TWILIGHT were on ticagrelor 90 mg twice daily and aspirin 81-100 mg daily for 3 months, then evenly randomized to continued treatment or ticagrelor plus an aspirin placebo for a year.

Subjects had to have at least one clinical and angiographic finding that put them at high risk for bleeding or an ischemic event, such as chronic kidney disease, acute coronary syndrome, diabetes, or a bifurcated target lesion treated with two stents.

One year after randomization, 4% in the ticagrelor monotherapy group versus 7.1% in the ticagrelor plus aspirin arm reached the primary end point, actionable (type 2), severe (type 3), or fatal (type 5) bleeding on the Bleeding Academic Research Consortium scale (hazard ratio, 0.56; 95% confidence interval, 0.45 - 0.68, P less than .001).

The incidence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke was 3.9% in both groups (HR, 0.99; 95% CI, 0.78-1.25; P less than .001 for noninferiority).

There were more ischemic strokes in the ticagrelor monotherapy arm (0.5% versus 0.2%). All-cause mortality (1.3% versus 1%) and stent thrombosis (0.6% versus 0.4%) were more frequent in the ticagrelor/aspirin group, but the differences were not statistically significant.

The two groups were well balanced. The mean age was 65 years, 23.8% of the patients were female, 37% had diabetes, and 65% had percutaneous coronary intervention for an acute coronary syndrome. Almost two-thirds had multivessel disease. Mean stent length was about 40 mm. The trial excluded patients with prior strokes.

Almost 2,000 patients originally enrolled in the trial never made it to randomization because they had a major bleeding or ischemic event in the 3-month run up, or dyspnea or some other reaction to ticagrelor.

The recent STOPDAPT-2 trial had a similar outcome – less bleeding with no increase in ischemic events – with clopidogrel monotherapy after a month-long run in of dual therapy with aspirin, versus continued treatment with both, in patients at low risk for ischemic events after stenting (JAMA. 2019 Jun 25;321[24]:2414-27).

Another recent study, GLOBAL LEADERS, concluded that 1 month of DAPT followed by ticagrelor monotherapy for 23 months was not superior to 12 months of DAPT followed by a year of aspirin. There was a numerical advantage for solo ticagrelor on death, myocardial infarction, and bleeding, but it did not reach statistical significance (Lancet. 2018 Sep 15;392[10151]:940-9).

The work was funded by ticagrelor’s maker, AstraZeneca. Dr. Mehran reported consulting and other relationships with Abbott, Janssen, and other companies.

[email protected]

SOURCE: Mehran A et al. N Engl J Med. 2019 Sep 26. doi: 10.1056/NEJMoa1908419.

SAN FRANCISCO – Using the guidewire for rapid pacing of the left ventricle during transcatheter aortic valve implantation (TAVI) instead of the usual approach – right ventricular pacing through a lead snaked up the femoral vein – significantly reduced procedure duration, fluoroscopy time, and cost, without affecting efficacy or safety, in a 10-center randomized controlled trial in France.

Pacing using the 0.035-inch guidewire in the left ventricle eliminates “the need for a transvenous temporary pacing lead or additional venous access in most cases,”said investigators led by Benjamin Faurie, MD, an interventional cardiologist at the Cardiovascular Institute, Groupe Hospitalier Mutualiste, Grenoble, France. It simplifies TAVI “and should be considered as the default strategy for rapid ventricular pacing.”

“If risk factors for development of high-grade conduction disturbances are present, upfront RV [right ventricular] stimulation with a temporary pacing lead should be considered; otherwise LV [left ventricular] stimulation might be used.” LV stimulation in TAVI “is particularly attractive in patients with an indwelling permanent pacemaker to avoid the risk of pacemaker lead dislodgement with a temporary pacing lead,” they said.

“This technique may also be useful in transcatheter heart valve implantation in the mitral position and in transcatheter tricuspid valve interventions, where having a standard temporary pacing lead across the tricuspid valve may interfere with the procedure,” the investigators said.

Rapid ventricular pacing ensures cardiac standstill during TAVI, but the RV approach carries the risk of vascular complications and RV perforation. LV guidewire pacing, a technique borrowed from pediatric balloon aortic valvuloplasty, avoids the risks. The French study – dubbed Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI (EASY-TAVI) – is the first randomized trial to compare the technique with conventional RV stimulation, and it was published to coincide with a presentation at Transcatheter Cardiovascular Therapeutics annual meeting (JACC Cardiovasc Interv. 2019 Sep 14. doi: 10.1016/j.jcin.2019.09.029).

The patients were undergoing transfemoral TAVI with a Sapien 3 valve (Edwards Lifesciences); 151 were randomized to LV stimulation through the guidewire, and 152 to RV stimulation through a temporary pacing lead.

Both procedure duration (48.4 minutes vs. 55.6 minutes) and fluoroscopy time (13.48 minutes vs. 14.6 minutes) were significantly shorter in the LV group than in the RV group. The procedure was also less costly (€18,807 vs. €19,437) because of shorter catheterization lab time and materials savings.

There were no significant difference between LV and RV groups in rates of effective stimulation (84.9% vs. 87.1%, respectively), procedural success (100% vs. 99.3%), 30-day TAVI-related major adverse cardiovascular events (13.9% vs. 17.1%), or permanent pacemaker implantation within 30 days (17.9% vs. 11.8%). There were two cases of cardiac tamponade in the RV group from the temporary lead; there were no guidewire related tamponades in the LV group.

Fourteen LV patients (9%) needed bailout with an RV lead because of new-onset left bundle branch block or atrioventricular block. The temporary pacing lead, meanwhile, was left in place in 38 RV patients (25%), which suggests “a lower threshold for an indwelling temporary pacing lead post procedure when there is already one in place,” the investigators said.

To deliver LV stimulation, the cathode of an external pacemaker was attached to the distal external end of the guidewire using a crocodile clip. A second crocodile clip – the anode – was attached to the incised skin at the sheath insertion site in the groin. The valve delivery system provided the required insulation.

The investigators noted that “the benefit of LV-stimulation may be less with self-expanding valves due to the significantly higher incidence of conduction disturbances requiring permanent pacemaker implantation post procedure.”

Patients were a mean age of 83 years, with about equal numbers of men and women. They had an intermediate risk of dying during the procedure. “However, we feel that the results are generalizable to the classical patient at high predicted risk of surgical mortality undergoing TAVI. Such patients tend to have higher rates of comorbidities, including peripheral vascular disease, placing them at higher risk of vascular complications and tend to have thinner RV walls, placing them at higher risk of RV-perforation,” the investigators said.

The work was funded by Edwards Lifesciences and others. Dr. Faurie had no disclosures. The senior author is a proctor for Edwards Lifesciences

[email protected]

SOURCE: Faurie B et al. TCT 2019. JACC Cardiovasc Interv. 2019 Sep 14. doi: 10.1016/j.jcin.2019.09.029.

SAN FRANCISCO – Using the guidewire for rapid pacing of the left ventricle during transcatheter aortic valve implantation (TAVI) instead of the usual approach – right ventricular pacing through a lead snaked up the femoral vein – significantly reduced procedure duration, fluoroscopy time, and cost, without affecting efficacy or safety, in a 10-center randomized controlled trial in France.

Pacing using the 0.035-inch guidewire in the left ventricle eliminates “the need for a transvenous temporary pacing lead or additional venous access in most cases,”said investigators led by Benjamin Faurie, MD, an interventional cardiologist at the Cardiovascular Institute, Groupe Hospitalier Mutualiste, Grenoble, France. It simplifies TAVI “and should be considered as the default strategy for rapid ventricular pacing.”

“If risk factors for development of high-grade conduction disturbances are present, upfront RV [right ventricular] stimulation with a temporary pacing lead should be considered; otherwise LV [left ventricular] stimulation might be used.” LV stimulation in TAVI “is particularly attractive in patients with an indwelling permanent pacemaker to avoid the risk of pacemaker lead dislodgement with a temporary pacing lead,” they said.

“This technique may also be useful in transcatheter heart valve implantation in the mitral position and in transcatheter tricuspid valve interventions, where having a standard temporary pacing lead across the tricuspid valve may interfere with the procedure,” the investigators said.

Rapid ventricular pacing ensures cardiac standstill during TAVI, but the RV approach carries the risk of vascular complications and RV perforation. LV guidewire pacing, a technique borrowed from pediatric balloon aortic valvuloplasty, avoids the risks. The French study – dubbed Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI (EASY-TAVI) – is the first randomized trial to compare the technique with conventional RV stimulation, and it was published to coincide with a presentation at Transcatheter Cardiovascular Therapeutics annual meeting (JACC Cardiovasc Interv. 2019 Sep 14. doi: 10.1016/j.jcin.2019.09.029).

The patients were undergoing transfemoral TAVI with a Sapien 3 valve (Edwards Lifesciences); 151 were randomized to LV stimulation through the guidewire, and 152 to RV stimulation through a temporary pacing lead.

Both procedure duration (48.4 minutes vs. 55.6 minutes) and fluoroscopy time (13.48 minutes vs. 14.6 minutes) were significantly shorter in the LV group than in the RV group. The procedure was also less costly (€18,807 vs. €19,437) because of shorter catheterization lab time and materials savings.

There were no significant difference between LV and RV groups in rates of effective stimulation (84.9% vs. 87.1%, respectively), procedural success (100% vs. 99.3%), 30-day TAVI-related major adverse cardiovascular events (13.9% vs. 17.1%), or permanent pacemaker implantation within 30 days (17.9% vs. 11.8%). There were two cases of cardiac tamponade in the RV group from the temporary lead; there were no guidewire related tamponades in the LV group.

Fourteen LV patients (9%) needed bailout with an RV lead because of new-onset left bundle branch block or atrioventricular block. The temporary pacing lead, meanwhile, was left in place in 38 RV patients (25%), which suggests “a lower threshold for an indwelling temporary pacing lead post procedure when there is already one in place,” the investigators said.

To deliver LV stimulation, the cathode of an external pacemaker was attached to the distal external end of the guidewire using a crocodile clip. A second crocodile clip – the anode – was attached to the incised skin at the sheath insertion site in the groin. The valve delivery system provided the required insulation.

The investigators noted that “the benefit of LV-stimulation may be less with self-expanding valves due to the significantly higher incidence of conduction disturbances requiring permanent pacemaker implantation post procedure.”

Patients were a mean age of 83 years, with about equal numbers of men and women. They had an intermediate risk of dying during the procedure. “However, we feel that the results are generalizable to the classical patient at high predicted risk of surgical mortality undergoing TAVI. Such patients tend to have higher rates of comorbidities, including peripheral vascular disease, placing them at higher risk of vascular complications and tend to have thinner RV walls, placing them at higher risk of RV-perforation,” the investigators said.

The work was funded by Edwards Lifesciences and others. Dr. Faurie had no disclosures. The senior author is a proctor for Edwards Lifesciences

[email protected]

SOURCE: Faurie B et al. TCT 2019. JACC Cardiovasc Interv. 2019 Sep 14. doi: 10.1016/j.jcin.2019.09.029.

SAN FRANCISCO – Using the guidewire for rapid pacing of the left ventricle during transcatheter aortic valve implantation (TAVI) instead of the usual approach – right ventricular pacing through a lead snaked up the femoral vein – significantly reduced procedure duration, fluoroscopy time, and cost, without affecting efficacy or safety, in a 10-center randomized controlled trial in France.

Pacing using the 0.035-inch guidewire in the left ventricle eliminates “the need for a transvenous temporary pacing lead or additional venous access in most cases,”said investigators led by Benjamin Faurie, MD, an interventional cardiologist at the Cardiovascular Institute, Groupe Hospitalier Mutualiste, Grenoble, France. It simplifies TAVI “and should be considered as the default strategy for rapid ventricular pacing.”

“If risk factors for development of high-grade conduction disturbances are present, upfront RV [right ventricular] stimulation with a temporary pacing lead should be considered; otherwise LV [left ventricular] stimulation might be used.” LV stimulation in TAVI “is particularly attractive in patients with an indwelling permanent pacemaker to avoid the risk of pacemaker lead dislodgement with a temporary pacing lead,” they said.

“This technique may also be useful in transcatheter heart valve implantation in the mitral position and in transcatheter tricuspid valve interventions, where having a standard temporary pacing lead across the tricuspid valve may interfere with the procedure,” the investigators said.

Rapid ventricular pacing ensures cardiac standstill during TAVI, but the RV approach carries the risk of vascular complications and RV perforation. LV guidewire pacing, a technique borrowed from pediatric balloon aortic valvuloplasty, avoids the risks. The French study – dubbed Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI (EASY-TAVI) – is the first randomized trial to compare the technique with conventional RV stimulation, and it was published to coincide with a presentation at Transcatheter Cardiovascular Therapeutics annual meeting (JACC Cardiovasc Interv. 2019 Sep 14. doi: 10.1016/j.jcin.2019.09.029).

The patients were undergoing transfemoral TAVI with a Sapien 3 valve (Edwards Lifesciences); 151 were randomized to LV stimulation through the guidewire, and 152 to RV stimulation through a temporary pacing lead.

Both procedure duration (48.4 minutes vs. 55.6 minutes) and fluoroscopy time (13.48 minutes vs. 14.6 minutes) were significantly shorter in the LV group than in the RV group. The procedure was also less costly (€18,807 vs. €19,437) because of shorter catheterization lab time and materials savings.

There were no significant difference between LV and RV groups in rates of effective stimulation (84.9% vs. 87.1%, respectively), procedural success (100% vs. 99.3%), 30-day TAVI-related major adverse cardiovascular events (13.9% vs. 17.1%), or permanent pacemaker implantation within 30 days (17.9% vs. 11.8%). There were two cases of cardiac tamponade in the RV group from the temporary lead; there were no guidewire related tamponades in the LV group.

Fourteen LV patients (9%) needed bailout with an RV lead because of new-onset left bundle branch block or atrioventricular block. The temporary pacing lead, meanwhile, was left in place in 38 RV patients (25%), which suggests “a lower threshold for an indwelling temporary pacing lead post procedure when there is already one in place,” the investigators said.

To deliver LV stimulation, the cathode of an external pacemaker was attached to the distal external end of the guidewire using a crocodile clip. A second crocodile clip – the anode – was attached to the incised skin at the sheath insertion site in the groin. The valve delivery system provided the required insulation.

The investigators noted that “the benefit of LV-stimulation may be less with self-expanding valves due to the significantly higher incidence of conduction disturbances requiring permanent pacemaker implantation post procedure.”

Patients were a mean age of 83 years, with about equal numbers of men and women. They had an intermediate risk of dying during the procedure. “However, we feel that the results are generalizable to the classical patient at high predicted risk of surgical mortality undergoing TAVI. Such patients tend to have higher rates of comorbidities, including peripheral vascular disease, placing them at higher risk of vascular complications and tend to have thinner RV walls, placing them at higher risk of RV-perforation,” the investigators said.

The work was funded by Edwards Lifesciences and others. Dr. Faurie had no disclosures. The senior author is a proctor for Edwards Lifesciences

[email protected]

SOURCE: Faurie B et al. TCT 2019. JACC Cardiovasc Interv. 2019 Sep 14. doi: 10.1016/j.jcin.2019.09.029.