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Debris left after TAVR varies by device
WASHINGTON – All transcatheter aortic valve replacement devices generate debris into the bloodstream, including debris larger than 1 mm, but the amount of the debris differs between devices, according to a study based on collections from a cerebral embolic protection system.
“The quantity of the debris measured by different methods and techniques revealed more debris in patients receiving the Evolut R or Lotus TAVR [transcatheter aortic valve replacement] devices than in patients receiving a Sapien 3 or Sapien XT prosthesis,” reported Tobias Schmidt, MD, a cardiologist at Asklepios Klinik St. Georg, Hamburg, Germany.
Of the 246 patients, 145 (59%) received a Sapien 3 device, 40 (16%) received an Evolut R, 36 (14%) received a Lotus, and 25 (10%) received a Sapien XT. Particle features based on histopathological and histomorphological analyses were compared. A multivariate analysis was conducted to test for interaction with the amount of debris according to patient demographics and procedural characteristics, which differed for the devices evaluated.
Debris was captured in essentially all patients (99%) and with every TAVR device. On automated histomorphometry, the Lotus device had significantly higher median particle counts relative to the Evolut R (P = .004), the Sapien S3 (P less than .001), and the Sapien XT (P = .02) devices. When stratified by particle size, the Evolut R generated significantly more particles greater than 500 mcm than either the Sapien S3 or the Sapien XT (both P less than .05).
For particle sizes greater than 1 mm, there were significantly higher counts for both the Lotus and Evolut R (both P less than .05) relative to the Sapien S3, but Dr. Schmidt emphasized all devices generated at least some debris this size and that particles greater than 1 mm were retrieved from 53% of all patients. Similarly, when median total particle area was calculated by histomorphometry, the Lotus (P = .0007) and Evolut R (P = .0009) devices were more likely to have particles greater than 1 mm than the Sapien devices, but again, debris with a large total particle area was retrieved from at least some patients in all device groups.
There were significant differences in patient demographics and procedural characteristics by device. For example, patients receiving an Evolut R were significantly more likely than those receiving the Lotus or Sapien S3 valves to have undergone dilation prior to TAVR. Patients receiving the Sapien XT were significantly older than patients receiving any of the other valve types.
In an effort to control for these differences, “multivariate analysis was performed to text for interaction with the amount of debris captured,” Dr. Schmidt explained. “This analysis showed that transcatheter valve type was the only significant predictor for the morphometric findings.”
In this study, most of the debris was found to come from the vascular bed, but foreign body debris and debris from myocardium was also identified. One hypothesis for the greater debris from the Lotus and Evolut R devices is that these are positionable, raising the possibility that manipulation of the devices was the source of the debris, according to Dr. Schmidt. However, this hypothesis needs verification.
One message from this study is that “capture of debris is universal across different transcatheter valve types,” Dr. Schmidt said, adding that this “supports the benefit of using a CPS device in all TAVR procedures.”
Several commentators, including Jeffrey Popma, MD, director of the Interventional Cardiology Clinical Service at Beth Israel Deaconess Hospital, Boston, observed that it would be inappropriate to conclude that the greater debris observed in this study would necessarily translate into a difference in risk of embolic events for the devices evaluated with or without a CPS device. He and others emphasized no relationship to clinical risk was demonstrated in this study.
Dr. Schmidt reports no potential conflicts of interest.
SOURCE: Schmidt T et al. CROI 2018.
WASHINGTON – All transcatheter aortic valve replacement devices generate debris into the bloodstream, including debris larger than 1 mm, but the amount of the debris differs between devices, according to a study based on collections from a cerebral embolic protection system.
“The quantity of the debris measured by different methods and techniques revealed more debris in patients receiving the Evolut R or Lotus TAVR [transcatheter aortic valve replacement] devices than in patients receiving a Sapien 3 or Sapien XT prosthesis,” reported Tobias Schmidt, MD, a cardiologist at Asklepios Klinik St. Georg, Hamburg, Germany.
Of the 246 patients, 145 (59%) received a Sapien 3 device, 40 (16%) received an Evolut R, 36 (14%) received a Lotus, and 25 (10%) received a Sapien XT. Particle features based on histopathological and histomorphological analyses were compared. A multivariate analysis was conducted to test for interaction with the amount of debris according to patient demographics and procedural characteristics, which differed for the devices evaluated.
Debris was captured in essentially all patients (99%) and with every TAVR device. On automated histomorphometry, the Lotus device had significantly higher median particle counts relative to the Evolut R (P = .004), the Sapien S3 (P less than .001), and the Sapien XT (P = .02) devices. When stratified by particle size, the Evolut R generated significantly more particles greater than 500 mcm than either the Sapien S3 or the Sapien XT (both P less than .05).
For particle sizes greater than 1 mm, there were significantly higher counts for both the Lotus and Evolut R (both P less than .05) relative to the Sapien S3, but Dr. Schmidt emphasized all devices generated at least some debris this size and that particles greater than 1 mm were retrieved from 53% of all patients. Similarly, when median total particle area was calculated by histomorphometry, the Lotus (P = .0007) and Evolut R (P = .0009) devices were more likely to have particles greater than 1 mm than the Sapien devices, but again, debris with a large total particle area was retrieved from at least some patients in all device groups.
There were significant differences in patient demographics and procedural characteristics by device. For example, patients receiving an Evolut R were significantly more likely than those receiving the Lotus or Sapien S3 valves to have undergone dilation prior to TAVR. Patients receiving the Sapien XT were significantly older than patients receiving any of the other valve types.
In an effort to control for these differences, “multivariate analysis was performed to text for interaction with the amount of debris captured,” Dr. Schmidt explained. “This analysis showed that transcatheter valve type was the only significant predictor for the morphometric findings.”
In this study, most of the debris was found to come from the vascular bed, but foreign body debris and debris from myocardium was also identified. One hypothesis for the greater debris from the Lotus and Evolut R devices is that these are positionable, raising the possibility that manipulation of the devices was the source of the debris, according to Dr. Schmidt. However, this hypothesis needs verification.
One message from this study is that “capture of debris is universal across different transcatheter valve types,” Dr. Schmidt said, adding that this “supports the benefit of using a CPS device in all TAVR procedures.”
Several commentators, including Jeffrey Popma, MD, director of the Interventional Cardiology Clinical Service at Beth Israel Deaconess Hospital, Boston, observed that it would be inappropriate to conclude that the greater debris observed in this study would necessarily translate into a difference in risk of embolic events for the devices evaluated with or without a CPS device. He and others emphasized no relationship to clinical risk was demonstrated in this study.
Dr. Schmidt reports no potential conflicts of interest.
SOURCE: Schmidt T et al. CROI 2018.
WASHINGTON – All transcatheter aortic valve replacement devices generate debris into the bloodstream, including debris larger than 1 mm, but the amount of the debris differs between devices, according to a study based on collections from a cerebral embolic protection system.
“The quantity of the debris measured by different methods and techniques revealed more debris in patients receiving the Evolut R or Lotus TAVR [transcatheter aortic valve replacement] devices than in patients receiving a Sapien 3 or Sapien XT prosthesis,” reported Tobias Schmidt, MD, a cardiologist at Asklepios Klinik St. Georg, Hamburg, Germany.
Of the 246 patients, 145 (59%) received a Sapien 3 device, 40 (16%) received an Evolut R, 36 (14%) received a Lotus, and 25 (10%) received a Sapien XT. Particle features based on histopathological and histomorphological analyses were compared. A multivariate analysis was conducted to test for interaction with the amount of debris according to patient demographics and procedural characteristics, which differed for the devices evaluated.
Debris was captured in essentially all patients (99%) and with every TAVR device. On automated histomorphometry, the Lotus device had significantly higher median particle counts relative to the Evolut R (P = .004), the Sapien S3 (P less than .001), and the Sapien XT (P = .02) devices. When stratified by particle size, the Evolut R generated significantly more particles greater than 500 mcm than either the Sapien S3 or the Sapien XT (both P less than .05).
For particle sizes greater than 1 mm, there were significantly higher counts for both the Lotus and Evolut R (both P less than .05) relative to the Sapien S3, but Dr. Schmidt emphasized all devices generated at least some debris this size and that particles greater than 1 mm were retrieved from 53% of all patients. Similarly, when median total particle area was calculated by histomorphometry, the Lotus (P = .0007) and Evolut R (P = .0009) devices were more likely to have particles greater than 1 mm than the Sapien devices, but again, debris with a large total particle area was retrieved from at least some patients in all device groups.
There were significant differences in patient demographics and procedural characteristics by device. For example, patients receiving an Evolut R were significantly more likely than those receiving the Lotus or Sapien S3 valves to have undergone dilation prior to TAVR. Patients receiving the Sapien XT were significantly older than patients receiving any of the other valve types.
In an effort to control for these differences, “multivariate analysis was performed to text for interaction with the amount of debris captured,” Dr. Schmidt explained. “This analysis showed that transcatheter valve type was the only significant predictor for the morphometric findings.”
In this study, most of the debris was found to come from the vascular bed, but foreign body debris and debris from myocardium was also identified. One hypothesis for the greater debris from the Lotus and Evolut R devices is that these are positionable, raising the possibility that manipulation of the devices was the source of the debris, according to Dr. Schmidt. However, this hypothesis needs verification.
One message from this study is that “capture of debris is universal across different transcatheter valve types,” Dr. Schmidt said, adding that this “supports the benefit of using a CPS device in all TAVR procedures.”
Several commentators, including Jeffrey Popma, MD, director of the Interventional Cardiology Clinical Service at Beth Israel Deaconess Hospital, Boston, observed that it would be inappropriate to conclude that the greater debris observed in this study would necessarily translate into a difference in risk of embolic events for the devices evaluated with or without a CPS device. He and others emphasized no relationship to clinical risk was demonstrated in this study.
Dr. Schmidt reports no potential conflicts of interest.
SOURCE: Schmidt T et al. CROI 2018.
AT CRT 2018
Key clinical point: Based on a study with a cerebral embolic collection system, transcatheter aortic valve replacement devices generate unequal debris.
Major finding: .
Data source: Data analysis from two randomized trials.
Disclosures: Dr. Schmidt reports no potential conflicts of interest.
Source: Schmidt T et al. CROI 2018.
Takotsubo cardiomyopathy incidence, mortality on the rise
WASHINGTON – Hospitalizations for Takotsubo cardiomyopathy (TCM), a condition that primarily affects postmenopausal women, have been rising steadily, along with rates of in-hospital mortality due to this condition, according to a study conducted with outcomes from the National Inpatient Sample (NIS) database.
The study was presented at CRT 2018, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Importantly, a multivariate analysis of predictors of in-hospital mortality based on this database revealed that there were “several potentially reversible causes,” reported Konstantinos V. Voudris, MD, PhD, who is completing a residency in internal medicine at the University of Illinois at Chicago.
TCM, which is characterized by left ventricular apical akinesis and chest pain that mimics the features of acute coronary syndromes (ACS), was first described in 1990 in Japan. The first U.S. case was reported in 1998, but the condition is now well recognized and an ICD code was created for Takotsubo cardiomyopathy in 2007.
There were 72,559 TCM admissions during the study period. When stratified by year, the annual rate of TCM cases rose significantly, from 11.1 to 43.8 per 100,000 hospitalizations from 2007 to 2013.
Although overall in-hospital mortality was 2.5%, it climbed from 1.4% in 2007 to 3.2% in 2013. When compared to patients who did not die during hospitalizations, those who did die were on average older (69.9 vs. 66.4 years; P less than .0001) and had more comorbidities. When a multivariate adjustment was made for baseline clinical risk, the presence of acute kidney injury (AKI), chronic obstructive pulmonary disease (COPD), peripheral artery disease (PAD), pulmonary hypertension, and arrhythmias remained significant predictors of mortality in patients with TCM.
“We found a number of modifiable and nonmodifiable factors that are associated with a significantly increased mortality, and we think clinicians should be aware of these factors when managing this condition,” Dr. Voudris reported.
Of these risk factors, AKI was associated with the greatest increased odds ratio (OR) with a more than fourfold increased risk of death (OR, 4.18; P less than .001). The presence of PAD (OR, 1.87; P less than .0001) and arrhythmia (OR, 1.88; P less than .0001) almost doubled the risk of in-hospital mortality.
Although females represented 89% of the TCM cases collected during the study period, males with comorbid diseases were at particularly high risk of death, an observation that is consistent with previous reports, according to Dr. Voudris. Relative to women, men were more likely to present with unstable hemodynamics and to develop cardiogenic shock.
Although Dr. Voudris acknowledged that the rising number of hospitalizations for TCM is likely due largely to increasing recognition of this condition, he suggested that there may be other contributing factors to the growing incidence, such as the aging of the U.S. population. He noted that the rise in cases persisted throughout the study period when awareness of TCM might be expected to have improved.
“This is still an uncommon disease, but it is important to recognize,” agreed Sachin Kumar, MD, an interventional cardiologist at the University of Texas Health Science Center at Houston. Moderator of the session in which these data were presented, Dr. Kumar indicated that it is important to increase awareness of the condition to accelerate the time to diagnosis and treatment.
Dr. Voudris reported no financial relationships relevant to this study.
SOURCE: Voudris, KV. CRT 2018.
WASHINGTON – Hospitalizations for Takotsubo cardiomyopathy (TCM), a condition that primarily affects postmenopausal women, have been rising steadily, along with rates of in-hospital mortality due to this condition, according to a study conducted with outcomes from the National Inpatient Sample (NIS) database.
The study was presented at CRT 2018, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Importantly, a multivariate analysis of predictors of in-hospital mortality based on this database revealed that there were “several potentially reversible causes,” reported Konstantinos V. Voudris, MD, PhD, who is completing a residency in internal medicine at the University of Illinois at Chicago.
TCM, which is characterized by left ventricular apical akinesis and chest pain that mimics the features of acute coronary syndromes (ACS), was first described in 1990 in Japan. The first U.S. case was reported in 1998, but the condition is now well recognized and an ICD code was created for Takotsubo cardiomyopathy in 2007.
There were 72,559 TCM admissions during the study period. When stratified by year, the annual rate of TCM cases rose significantly, from 11.1 to 43.8 per 100,000 hospitalizations from 2007 to 2013.
Although overall in-hospital mortality was 2.5%, it climbed from 1.4% in 2007 to 3.2% in 2013. When compared to patients who did not die during hospitalizations, those who did die were on average older (69.9 vs. 66.4 years; P less than .0001) and had more comorbidities. When a multivariate adjustment was made for baseline clinical risk, the presence of acute kidney injury (AKI), chronic obstructive pulmonary disease (COPD), peripheral artery disease (PAD), pulmonary hypertension, and arrhythmias remained significant predictors of mortality in patients with TCM.
“We found a number of modifiable and nonmodifiable factors that are associated with a significantly increased mortality, and we think clinicians should be aware of these factors when managing this condition,” Dr. Voudris reported.
Of these risk factors, AKI was associated with the greatest increased odds ratio (OR) with a more than fourfold increased risk of death (OR, 4.18; P less than .001). The presence of PAD (OR, 1.87; P less than .0001) and arrhythmia (OR, 1.88; P less than .0001) almost doubled the risk of in-hospital mortality.
Although females represented 89% of the TCM cases collected during the study period, males with comorbid diseases were at particularly high risk of death, an observation that is consistent with previous reports, according to Dr. Voudris. Relative to women, men were more likely to present with unstable hemodynamics and to develop cardiogenic shock.
Although Dr. Voudris acknowledged that the rising number of hospitalizations for TCM is likely due largely to increasing recognition of this condition, he suggested that there may be other contributing factors to the growing incidence, such as the aging of the U.S. population. He noted that the rise in cases persisted throughout the study period when awareness of TCM might be expected to have improved.
“This is still an uncommon disease, but it is important to recognize,” agreed Sachin Kumar, MD, an interventional cardiologist at the University of Texas Health Science Center at Houston. Moderator of the session in which these data were presented, Dr. Kumar indicated that it is important to increase awareness of the condition to accelerate the time to diagnosis and treatment.
Dr. Voudris reported no financial relationships relevant to this study.
SOURCE: Voudris, KV. CRT 2018.
WASHINGTON – Hospitalizations for Takotsubo cardiomyopathy (TCM), a condition that primarily affects postmenopausal women, have been rising steadily, along with rates of in-hospital mortality due to this condition, according to a study conducted with outcomes from the National Inpatient Sample (NIS) database.
The study was presented at CRT 2018, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
Importantly, a multivariate analysis of predictors of in-hospital mortality based on this database revealed that there were “several potentially reversible causes,” reported Konstantinos V. Voudris, MD, PhD, who is completing a residency in internal medicine at the University of Illinois at Chicago.
TCM, which is characterized by left ventricular apical akinesis and chest pain that mimics the features of acute coronary syndromes (ACS), was first described in 1990 in Japan. The first U.S. case was reported in 1998, but the condition is now well recognized and an ICD code was created for Takotsubo cardiomyopathy in 2007.
There were 72,559 TCM admissions during the study period. When stratified by year, the annual rate of TCM cases rose significantly, from 11.1 to 43.8 per 100,000 hospitalizations from 2007 to 2013.
Although overall in-hospital mortality was 2.5%, it climbed from 1.4% in 2007 to 3.2% in 2013. When compared to patients who did not die during hospitalizations, those who did die were on average older (69.9 vs. 66.4 years; P less than .0001) and had more comorbidities. When a multivariate adjustment was made for baseline clinical risk, the presence of acute kidney injury (AKI), chronic obstructive pulmonary disease (COPD), peripheral artery disease (PAD), pulmonary hypertension, and arrhythmias remained significant predictors of mortality in patients with TCM.
“We found a number of modifiable and nonmodifiable factors that are associated with a significantly increased mortality, and we think clinicians should be aware of these factors when managing this condition,” Dr. Voudris reported.
Of these risk factors, AKI was associated with the greatest increased odds ratio (OR) with a more than fourfold increased risk of death (OR, 4.18; P less than .001). The presence of PAD (OR, 1.87; P less than .0001) and arrhythmia (OR, 1.88; P less than .0001) almost doubled the risk of in-hospital mortality.
Although females represented 89% of the TCM cases collected during the study period, males with comorbid diseases were at particularly high risk of death, an observation that is consistent with previous reports, according to Dr. Voudris. Relative to women, men were more likely to present with unstable hemodynamics and to develop cardiogenic shock.
Although Dr. Voudris acknowledged that the rising number of hospitalizations for TCM is likely due largely to increasing recognition of this condition, he suggested that there may be other contributing factors to the growing incidence, such as the aging of the U.S. population. He noted that the rise in cases persisted throughout the study period when awareness of TCM might be expected to have improved.
“This is still an uncommon disease, but it is important to recognize,” agreed Sachin Kumar, MD, an interventional cardiologist at the University of Texas Health Science Center at Houston. Moderator of the session in which these data were presented, Dr. Kumar indicated that it is important to increase awareness of the condition to accelerate the time to diagnosis and treatment.
Dr. Voudris reported no financial relationships relevant to this study.
SOURCE: Voudris, KV. CRT 2018.
REPORTING FROM CRT 2018
Key clinical point: The Takotsubo cardiomyopathy hospitalization and mortality rates have increased in the United States, according to national data.
Major finding: From 2007 to 2013, Takotsubo cases rose from 11.1 to 43.8 cases per 100,000 hospitalizations and in-hospital mortality more than doubled.
Data source: Retrospective national database analysis.
Disclosures: Dr. Voudris reports no financial relationships relevant to this study.
Source: Voudris, KV. CRT 2018.
CT angiography boosts success in chronic total occlusion revascularization
WASHINGTON – When performed prior to revascularization, CT angiography almost doubles the likelihood of successful revascularization of chronic total occlusion relative to no CT angiography, according to a meta-analysis.
Because the meta-analysis relied primarily on retrospective data, the conclusion was characterized as hypothesis-generating. But the author, Wael Abuzeid, MD, an interventional cardiologist and assistant professor at Queen’s University, Kingston, Ont., suggested that there are several arguments to be made for pursuing a randomized trial.
This is not a new idea, according to results of a systematic review of the literature. Although only four articles met prespecified criteria for entry into the meta-analysis that was eventually conducted, Dr. Abuzeid and his coauthors found 424 articles on this subject in a search of three literature databases.
Only one of the four studies entered into the meta-analysis involved prospective data collection, but three of the four found a significant advantage for preprocedural CTA when compared with no CTA for procedural success, meaning restoration of blood flow in the target CTO. The fourth study also associated preprocedural CTA with improved procedural success, but the advantage did not reach statistical significance.
When the data were combined for a meta-analysis, the odds ratio for procedural success for conducting a preprocedural CTA relative to no preprocedural CTA was 1.89 with a significant 95% confidence interval (1.18-3.04; P less than .05).
The four studies were published during 2012-2015. Two of them used CTA with only a 64-slice capacity, raising the possibility that an even greater improvement in results would have been achieved with CTA using the greater resolutions now available.
There were several important limitations of the study, particularly the potential for selection bias from the nonrandomized designs in the studies evaluated, Dr. Abuzeid acknowledged. However, the most likely selection bias would be funneling of more challenging cases to preprocedural CTA, a potential disadvantage for CTA if this resulted in a patient population likely to have a poor outcome.
Currently, few centers employ preprocedural CTA in routine management of CTO, according to Dr. Abuzeid.
“CTA prior to revascularization in CTO is not a standard approach even in complex patients,” Dr. Abuzeid said. However, he believes an argument can already be made for preprocedural CTA in some types of challenging patients, such as those with particularly long target lesions. In such cases, CTA could provide advance information about negative distal remodeling and the likelihood that a retrograde approach might be needed.
“For the junior operator, I think the information provided by preprocedural CTA could be very useful in planning,” Dr. Abuzeid said.
The arguments against preprocedural CTA include higher radiation exposure and a delay in the time to procedure by adding the extra step of first conducting the imaging study. In addition to verifying that procedural success is achieved with preprocedural CTA, these issues are among those that deserve evaluation in a prospective study.
“The appropriate randomized trial would be conducted at high-volume centers with all comers, not just complex patients, randomized to undergo a preprocedural CTA or no preprocedural imaging,” Dr. Abuzeid suggested. He said the appropriate primary outcome is relative success at restoring Thrombolysis in Myocardial Infarction grade 2 flow, but suggested that other endpoints, such as procedure time and rate of complications, would be useful for determining the value of this approach.
Dr. Abuzeid reports having no financial relationships.
SOURCE: Abuzeid W. CRT 18.
WASHINGTON – When performed prior to revascularization, CT angiography almost doubles the likelihood of successful revascularization of chronic total occlusion relative to no CT angiography, according to a meta-analysis.
Because the meta-analysis relied primarily on retrospective data, the conclusion was characterized as hypothesis-generating. But the author, Wael Abuzeid, MD, an interventional cardiologist and assistant professor at Queen’s University, Kingston, Ont., suggested that there are several arguments to be made for pursuing a randomized trial.
This is not a new idea, according to results of a systematic review of the literature. Although only four articles met prespecified criteria for entry into the meta-analysis that was eventually conducted, Dr. Abuzeid and his coauthors found 424 articles on this subject in a search of three literature databases.
Only one of the four studies entered into the meta-analysis involved prospective data collection, but three of the four found a significant advantage for preprocedural CTA when compared with no CTA for procedural success, meaning restoration of blood flow in the target CTO. The fourth study also associated preprocedural CTA with improved procedural success, but the advantage did not reach statistical significance.
When the data were combined for a meta-analysis, the odds ratio for procedural success for conducting a preprocedural CTA relative to no preprocedural CTA was 1.89 with a significant 95% confidence interval (1.18-3.04; P less than .05).
The four studies were published during 2012-2015. Two of them used CTA with only a 64-slice capacity, raising the possibility that an even greater improvement in results would have been achieved with CTA using the greater resolutions now available.
There were several important limitations of the study, particularly the potential for selection bias from the nonrandomized designs in the studies evaluated, Dr. Abuzeid acknowledged. However, the most likely selection bias would be funneling of more challenging cases to preprocedural CTA, a potential disadvantage for CTA if this resulted in a patient population likely to have a poor outcome.
Currently, few centers employ preprocedural CTA in routine management of CTO, according to Dr. Abuzeid.
“CTA prior to revascularization in CTO is not a standard approach even in complex patients,” Dr. Abuzeid said. However, he believes an argument can already be made for preprocedural CTA in some types of challenging patients, such as those with particularly long target lesions. In such cases, CTA could provide advance information about negative distal remodeling and the likelihood that a retrograde approach might be needed.
“For the junior operator, I think the information provided by preprocedural CTA could be very useful in planning,” Dr. Abuzeid said.
The arguments against preprocedural CTA include higher radiation exposure and a delay in the time to procedure by adding the extra step of first conducting the imaging study. In addition to verifying that procedural success is achieved with preprocedural CTA, these issues are among those that deserve evaluation in a prospective study.
“The appropriate randomized trial would be conducted at high-volume centers with all comers, not just complex patients, randomized to undergo a preprocedural CTA or no preprocedural imaging,” Dr. Abuzeid suggested. He said the appropriate primary outcome is relative success at restoring Thrombolysis in Myocardial Infarction grade 2 flow, but suggested that other endpoints, such as procedure time and rate of complications, would be useful for determining the value of this approach.
Dr. Abuzeid reports having no financial relationships.
SOURCE: Abuzeid W. CRT 18.
WASHINGTON – When performed prior to revascularization, CT angiography almost doubles the likelihood of successful revascularization of chronic total occlusion relative to no CT angiography, according to a meta-analysis.
Because the meta-analysis relied primarily on retrospective data, the conclusion was characterized as hypothesis-generating. But the author, Wael Abuzeid, MD, an interventional cardiologist and assistant professor at Queen’s University, Kingston, Ont., suggested that there are several arguments to be made for pursuing a randomized trial.
This is not a new idea, according to results of a systematic review of the literature. Although only four articles met prespecified criteria for entry into the meta-analysis that was eventually conducted, Dr. Abuzeid and his coauthors found 424 articles on this subject in a search of three literature databases.
Only one of the four studies entered into the meta-analysis involved prospective data collection, but three of the four found a significant advantage for preprocedural CTA when compared with no CTA for procedural success, meaning restoration of blood flow in the target CTO. The fourth study also associated preprocedural CTA with improved procedural success, but the advantage did not reach statistical significance.
When the data were combined for a meta-analysis, the odds ratio for procedural success for conducting a preprocedural CTA relative to no preprocedural CTA was 1.89 with a significant 95% confidence interval (1.18-3.04; P less than .05).
The four studies were published during 2012-2015. Two of them used CTA with only a 64-slice capacity, raising the possibility that an even greater improvement in results would have been achieved with CTA using the greater resolutions now available.
There were several important limitations of the study, particularly the potential for selection bias from the nonrandomized designs in the studies evaluated, Dr. Abuzeid acknowledged. However, the most likely selection bias would be funneling of more challenging cases to preprocedural CTA, a potential disadvantage for CTA if this resulted in a patient population likely to have a poor outcome.
Currently, few centers employ preprocedural CTA in routine management of CTO, according to Dr. Abuzeid.
“CTA prior to revascularization in CTO is not a standard approach even in complex patients,” Dr. Abuzeid said. However, he believes an argument can already be made for preprocedural CTA in some types of challenging patients, such as those with particularly long target lesions. In such cases, CTA could provide advance information about negative distal remodeling and the likelihood that a retrograde approach might be needed.
“For the junior operator, I think the information provided by preprocedural CTA could be very useful in planning,” Dr. Abuzeid said.
The arguments against preprocedural CTA include higher radiation exposure and a delay in the time to procedure by adding the extra step of first conducting the imaging study. In addition to verifying that procedural success is achieved with preprocedural CTA, these issues are among those that deserve evaluation in a prospective study.
“The appropriate randomized trial would be conducted at high-volume centers with all comers, not just complex patients, randomized to undergo a preprocedural CTA or no preprocedural imaging,” Dr. Abuzeid suggested. He said the appropriate primary outcome is relative success at restoring Thrombolysis in Myocardial Infarction grade 2 flow, but suggested that other endpoints, such as procedure time and rate of complications, would be useful for determining the value of this approach.
Dr. Abuzeid reports having no financial relationships.
SOURCE: Abuzeid W. CRT 18.
REPORTING FROM CRT 2018
Key clinical point:
Major finding: In a meta-analysis of data from four studies, CT angiography almost doubled the likelihood of procedural success (OR 1.89; P less than .05).
Study details: A systematic review and meta-analysis of four studies.
Disclosures: Dr. Abuzeid reports having no financial relationships.
Source: Abuzaid W. CRT 18.
Radial access PCI best for acute coronary syndrome patients
WASHINGTON – Radial access should be the preferred approach to percutaneous interventions in acute coronary syndromes in the United States as it is now in Europe, according to an investigator whose data from a randomized trial substudy was the topic of a late-breaker presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center..
It was not just these data, but “the totality of the evidence supports radial access as the first choice in PCI [percutaneous intervention] for acute coronary events,” asserted Elmir Omerovic, MD, professor of cardiology at Sahlgrenska University Hospital, Gothenburg, Sweden.
The data for the prespecified substudy was drawn from the VALIDATE-SWEDEHEART trial, published 6 months ago (N Engl J Med 2017;377:1132-42). In that trial, which randomized patients with ACS undergoing PCI to heparin or bivalirudin, there was no difference between anticoagulation strategies for the primary composite endpoint of death from any cause, myocardial infarction or bleeding from any cause.
Of the 6,006 randomized patients in that study, of which about half had an ST-elevation MI and half had a non–ST-elevation MI event, 5,424 (90%) underwent PCI by the radial route and the remainder by the femoral route. The goal of the prespecified subgroup analysis presented by Dr. Omerovic was to evaluate whether choice of access site had an impact on the primary endpoint or its components.
There was a 34% relative risk reduction (P less than .001) in the primary composite endpoint at the end of 180 days of follow-up “after adjusting basically for all of the important differences that might affect risk,” Dr. Omerovic reported. The long list included type of acute coronary syndrome, age, hypertension, diabetes, and history of vascular events or prior procedures.
Radial access was also linked with a 59% lower risk of mortality and a 43% lower risk of major bleeding (both P less than .001) when compared with femoral access, according to Dr. Omerovic. He attributed most of the difference in bleeding to bleeding events at the access site.
Baseline differences between the two groups indicated that patients undergoing PCI with femoral access were a higher-risk group. Femoral patients had higher rates of diabetes, hyperlipidemia, and hypertension (all P less than .001). They were also older, more likely to be in Killip class II or above, and more likely to have history of prior MI, prior stroke, and prior coronary artery bypass grafting (also all P less than .001).
Dr. Omerovic maintained that proper adjustment was made for these confounders. He also defended his conclusion that radial access should be preferred over femoral access by stressing that the data regarding this question, including those from other studies and from registries, are uniformly consistent. “They all go in the same direction,” he said.
Dr. Omerovic claimed that the key message is that “there should be more radial access performed in the United States.” The 90% radial access in this study is reflective of current practice in Sweden and most other European countries, according to Dr. Omerovic. In contrast, the U.S. rate is closer to 60% by some estimates.
“I would always be concerned that if you are performing radial access 90% of the time, you are going to lose your femoral skills,” Dr. Grines said. Like other U.S. interventionalists who commented during an animated discussion, she insisted that a prospective randomized trial, not a subgroup analysis, is needed before declaring radial access preferred.
Dr. Omerovic reports financial relationships with AstraZeneca, Bayer, and Boston Scientific.
SOURCE: Omerovic E. CRT 2018.
WASHINGTON – Radial access should be the preferred approach to percutaneous interventions in acute coronary syndromes in the United States as it is now in Europe, according to an investigator whose data from a randomized trial substudy was the topic of a late-breaker presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center..
It was not just these data, but “the totality of the evidence supports radial access as the first choice in PCI [percutaneous intervention] for acute coronary events,” asserted Elmir Omerovic, MD, professor of cardiology at Sahlgrenska University Hospital, Gothenburg, Sweden.
The data for the prespecified substudy was drawn from the VALIDATE-SWEDEHEART trial, published 6 months ago (N Engl J Med 2017;377:1132-42). In that trial, which randomized patients with ACS undergoing PCI to heparin or bivalirudin, there was no difference between anticoagulation strategies for the primary composite endpoint of death from any cause, myocardial infarction or bleeding from any cause.
Of the 6,006 randomized patients in that study, of which about half had an ST-elevation MI and half had a non–ST-elevation MI event, 5,424 (90%) underwent PCI by the radial route and the remainder by the femoral route. The goal of the prespecified subgroup analysis presented by Dr. Omerovic was to evaluate whether choice of access site had an impact on the primary endpoint or its components.
There was a 34% relative risk reduction (P less than .001) in the primary composite endpoint at the end of 180 days of follow-up “after adjusting basically for all of the important differences that might affect risk,” Dr. Omerovic reported. The long list included type of acute coronary syndrome, age, hypertension, diabetes, and history of vascular events or prior procedures.
Radial access was also linked with a 59% lower risk of mortality and a 43% lower risk of major bleeding (both P less than .001) when compared with femoral access, according to Dr. Omerovic. He attributed most of the difference in bleeding to bleeding events at the access site.
Baseline differences between the two groups indicated that patients undergoing PCI with femoral access were a higher-risk group. Femoral patients had higher rates of diabetes, hyperlipidemia, and hypertension (all P less than .001). They were also older, more likely to be in Killip class II or above, and more likely to have history of prior MI, prior stroke, and prior coronary artery bypass grafting (also all P less than .001).
Dr. Omerovic maintained that proper adjustment was made for these confounders. He also defended his conclusion that radial access should be preferred over femoral access by stressing that the data regarding this question, including those from other studies and from registries, are uniformly consistent. “They all go in the same direction,” he said.
Dr. Omerovic claimed that the key message is that “there should be more radial access performed in the United States.” The 90% radial access in this study is reflective of current practice in Sweden and most other European countries, according to Dr. Omerovic. In contrast, the U.S. rate is closer to 60% by some estimates.
“I would always be concerned that if you are performing radial access 90% of the time, you are going to lose your femoral skills,” Dr. Grines said. Like other U.S. interventionalists who commented during an animated discussion, she insisted that a prospective randomized trial, not a subgroup analysis, is needed before declaring radial access preferred.
Dr. Omerovic reports financial relationships with AstraZeneca, Bayer, and Boston Scientific.
SOURCE: Omerovic E. CRT 2018.
WASHINGTON – Radial access should be the preferred approach to percutaneous interventions in acute coronary syndromes in the United States as it is now in Europe, according to an investigator whose data from a randomized trial substudy was the topic of a late-breaker presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center..
It was not just these data, but “the totality of the evidence supports radial access as the first choice in PCI [percutaneous intervention] for acute coronary events,” asserted Elmir Omerovic, MD, professor of cardiology at Sahlgrenska University Hospital, Gothenburg, Sweden.
The data for the prespecified substudy was drawn from the VALIDATE-SWEDEHEART trial, published 6 months ago (N Engl J Med 2017;377:1132-42). In that trial, which randomized patients with ACS undergoing PCI to heparin or bivalirudin, there was no difference between anticoagulation strategies for the primary composite endpoint of death from any cause, myocardial infarction or bleeding from any cause.
Of the 6,006 randomized patients in that study, of which about half had an ST-elevation MI and half had a non–ST-elevation MI event, 5,424 (90%) underwent PCI by the radial route and the remainder by the femoral route. The goal of the prespecified subgroup analysis presented by Dr. Omerovic was to evaluate whether choice of access site had an impact on the primary endpoint or its components.
There was a 34% relative risk reduction (P less than .001) in the primary composite endpoint at the end of 180 days of follow-up “after adjusting basically for all of the important differences that might affect risk,” Dr. Omerovic reported. The long list included type of acute coronary syndrome, age, hypertension, diabetes, and history of vascular events or prior procedures.
Radial access was also linked with a 59% lower risk of mortality and a 43% lower risk of major bleeding (both P less than .001) when compared with femoral access, according to Dr. Omerovic. He attributed most of the difference in bleeding to bleeding events at the access site.
Baseline differences between the two groups indicated that patients undergoing PCI with femoral access were a higher-risk group. Femoral patients had higher rates of diabetes, hyperlipidemia, and hypertension (all P less than .001). They were also older, more likely to be in Killip class II or above, and more likely to have history of prior MI, prior stroke, and prior coronary artery bypass grafting (also all P less than .001).
Dr. Omerovic maintained that proper adjustment was made for these confounders. He also defended his conclusion that radial access should be preferred over femoral access by stressing that the data regarding this question, including those from other studies and from registries, are uniformly consistent. “They all go in the same direction,” he said.
Dr. Omerovic claimed that the key message is that “there should be more radial access performed in the United States.” The 90% radial access in this study is reflective of current practice in Sweden and most other European countries, according to Dr. Omerovic. In contrast, the U.S. rate is closer to 60% by some estimates.
“I would always be concerned that if you are performing radial access 90% of the time, you are going to lose your femoral skills,” Dr. Grines said. Like other U.S. interventionalists who commented during an animated discussion, she insisted that a prospective randomized trial, not a subgroup analysis, is needed before declaring radial access preferred.
Dr. Omerovic reports financial relationships with AstraZeneca, Bayer, and Boston Scientific.
SOURCE: Omerovic E. CRT 2018.
REPORTING FROM THE 2018 CRT MEETING
Key clinical point:
Major finding: At 180 days, the risk of major cardiac events was 34% lower for PCI performed with radial than with femoral access after risk adjustment.
Data source: Prespecified subgroup analysis of a randomized trial.
Disclosures: Dr. Omerovic reports financial relationships with AstraZeneca, Bayer, and Boston Scientific.
Source: Omerovic E. CRT 2018.
Revascularization in paraplegics best performed with PCI
WASHINGTON – When paraplegics and quadriplegics have an acute MI and are candidates for revascularization, they should be treated preferentially with a percutaneous coronary intervention, according to data presented at the 2018 Cardiovascular Research Technologies meeting.
When compared 30 days after revascularization, the rates of major adverse cardiovascular events (MACE) following coronary artery bypass grafting (CABG) were 22% in the group with paraplegia or quadriplegia versus only 3.5% in those without loss of limb function. For percutaneous coronary intervention (PCI), the rates were 6% versus 2%, respectively, reported Xuming Dai, MD, PhD, an interventional cardiologist and assistant professor at the University of North Carolina at Chapel Hill.
“There are no guidelines, no studies. I could not even find a case report,” Dr. Dai recounted.
As a result, he initiated his own study, looking for such cases in the New York State Inpatient Database, in which there were 1,400 patients with paraplegia or quadriplegia and more than 400,000 without these limb impairments who had presented with acute MI over the period of study. After comparing outcomes in these two groups, a subsequent analysis was performed in which each patient with paraplegia/quadriplegia was matched by propensity scoring to five patients from the database without paraplegia/quadriplegia.
Notably, patients with paraplegia/quadriplegia were found to represent a small but steady proportion of acute MI cases. With only modest variation, the rate hovered around 0.2%-0.3% of cases per year.
“The patients with paraplegia or quadriplegia tended to be somewhat younger [67 vs. 70 years of age; P less than .001], have more comorbidities, and were more likely to be enrolled in Medicare,” Dr. Dai reported.
Of patients in the database without paraplegia/quadriplegia, 56% received medical therapy alone and 14% underwent catheterization but were not revascularized. Of the 31% who were revascularized, 82% underwent PCI, and the remainder underwent CABG.
Among those with paraplegia/quadriplegia, 83.7% were managed medically and 7.2% underwent catheterization but no revascularization. Of the 9.1% who were revascularized, 7.2% underwent PCI and 1.9% underwent CABG.
When evaluated with propensity scoring, the differences in outcomes between those with or without paraplegia/quadriplegia were more modest, but MACE rates after CABG remained significantly higher (8.4% vs. 3.5%; P = .02). In contrast, the difference in MACE rates after propensity matching was no longer significantly higher in the paraplegia/quadriplegia group treated with PCI (4.4% vs. 2.0%; P = .46).
When CABG was compared to PCI among those with paraplegia/quadriplegia, the rate of in-hospital mortality was almost four times higher (9.5% vs. 2.5; P less than.01). Paraplegic/quadriplegic patients treated with CABG also had longer lengths of hospital stay and incurred higher treatment costs, according to Dr. Dai.
The moderator of the session at which these data were presented, Scott Schurmer, MD, chief of cardiology at Texas Tech Health Sciences Center, Lubbock, cautioned about the limitations of propensity scoring. He also suggested that PCI, based on concern for potential comorbidities in patients with paraplegia and quadriplegia, would likely be the choice of many physicians even without these data.
Dr. Dai reported no financial relationships to disclose.
SOURCE: Dai X. CRT 2018.
WASHINGTON – When paraplegics and quadriplegics have an acute MI and are candidates for revascularization, they should be treated preferentially with a percutaneous coronary intervention, according to data presented at the 2018 Cardiovascular Research Technologies meeting.
When compared 30 days after revascularization, the rates of major adverse cardiovascular events (MACE) following coronary artery bypass grafting (CABG) were 22% in the group with paraplegia or quadriplegia versus only 3.5% in those without loss of limb function. For percutaneous coronary intervention (PCI), the rates were 6% versus 2%, respectively, reported Xuming Dai, MD, PhD, an interventional cardiologist and assistant professor at the University of North Carolina at Chapel Hill.
“There are no guidelines, no studies. I could not even find a case report,” Dr. Dai recounted.
As a result, he initiated his own study, looking for such cases in the New York State Inpatient Database, in which there were 1,400 patients with paraplegia or quadriplegia and more than 400,000 without these limb impairments who had presented with acute MI over the period of study. After comparing outcomes in these two groups, a subsequent analysis was performed in which each patient with paraplegia/quadriplegia was matched by propensity scoring to five patients from the database without paraplegia/quadriplegia.
Notably, patients with paraplegia/quadriplegia were found to represent a small but steady proportion of acute MI cases. With only modest variation, the rate hovered around 0.2%-0.3% of cases per year.
“The patients with paraplegia or quadriplegia tended to be somewhat younger [67 vs. 70 years of age; P less than .001], have more comorbidities, and were more likely to be enrolled in Medicare,” Dr. Dai reported.
Of patients in the database without paraplegia/quadriplegia, 56% received medical therapy alone and 14% underwent catheterization but were not revascularized. Of the 31% who were revascularized, 82% underwent PCI, and the remainder underwent CABG.
Among those with paraplegia/quadriplegia, 83.7% were managed medically and 7.2% underwent catheterization but no revascularization. Of the 9.1% who were revascularized, 7.2% underwent PCI and 1.9% underwent CABG.
When evaluated with propensity scoring, the differences in outcomes between those with or without paraplegia/quadriplegia were more modest, but MACE rates after CABG remained significantly higher (8.4% vs. 3.5%; P = .02). In contrast, the difference in MACE rates after propensity matching was no longer significantly higher in the paraplegia/quadriplegia group treated with PCI (4.4% vs. 2.0%; P = .46).
When CABG was compared to PCI among those with paraplegia/quadriplegia, the rate of in-hospital mortality was almost four times higher (9.5% vs. 2.5; P less than.01). Paraplegic/quadriplegic patients treated with CABG also had longer lengths of hospital stay and incurred higher treatment costs, according to Dr. Dai.
The moderator of the session at which these data were presented, Scott Schurmer, MD, chief of cardiology at Texas Tech Health Sciences Center, Lubbock, cautioned about the limitations of propensity scoring. He also suggested that PCI, based on concern for potential comorbidities in patients with paraplegia and quadriplegia, would likely be the choice of many physicians even without these data.
Dr. Dai reported no financial relationships to disclose.
SOURCE: Dai X. CRT 2018.
WASHINGTON – When paraplegics and quadriplegics have an acute MI and are candidates for revascularization, they should be treated preferentially with a percutaneous coronary intervention, according to data presented at the 2018 Cardiovascular Research Technologies meeting.
When compared 30 days after revascularization, the rates of major adverse cardiovascular events (MACE) following coronary artery bypass grafting (CABG) were 22% in the group with paraplegia or quadriplegia versus only 3.5% in those without loss of limb function. For percutaneous coronary intervention (PCI), the rates were 6% versus 2%, respectively, reported Xuming Dai, MD, PhD, an interventional cardiologist and assistant professor at the University of North Carolina at Chapel Hill.
“There are no guidelines, no studies. I could not even find a case report,” Dr. Dai recounted.
As a result, he initiated his own study, looking for such cases in the New York State Inpatient Database, in which there were 1,400 patients with paraplegia or quadriplegia and more than 400,000 without these limb impairments who had presented with acute MI over the period of study. After comparing outcomes in these two groups, a subsequent analysis was performed in which each patient with paraplegia/quadriplegia was matched by propensity scoring to five patients from the database without paraplegia/quadriplegia.
Notably, patients with paraplegia/quadriplegia were found to represent a small but steady proportion of acute MI cases. With only modest variation, the rate hovered around 0.2%-0.3% of cases per year.
“The patients with paraplegia or quadriplegia tended to be somewhat younger [67 vs. 70 years of age; P less than .001], have more comorbidities, and were more likely to be enrolled in Medicare,” Dr. Dai reported.
Of patients in the database without paraplegia/quadriplegia, 56% received medical therapy alone and 14% underwent catheterization but were not revascularized. Of the 31% who were revascularized, 82% underwent PCI, and the remainder underwent CABG.
Among those with paraplegia/quadriplegia, 83.7% were managed medically and 7.2% underwent catheterization but no revascularization. Of the 9.1% who were revascularized, 7.2% underwent PCI and 1.9% underwent CABG.
When evaluated with propensity scoring, the differences in outcomes between those with or without paraplegia/quadriplegia were more modest, but MACE rates after CABG remained significantly higher (8.4% vs. 3.5%; P = .02). In contrast, the difference in MACE rates after propensity matching was no longer significantly higher in the paraplegia/quadriplegia group treated with PCI (4.4% vs. 2.0%; P = .46).
When CABG was compared to PCI among those with paraplegia/quadriplegia, the rate of in-hospital mortality was almost four times higher (9.5% vs. 2.5; P less than.01). Paraplegic/quadriplegic patients treated with CABG also had longer lengths of hospital stay and incurred higher treatment costs, according to Dr. Dai.
The moderator of the session at which these data were presented, Scott Schurmer, MD, chief of cardiology at Texas Tech Health Sciences Center, Lubbock, cautioned about the limitations of propensity scoring. He also suggested that PCI, based on concern for potential comorbidities in patients with paraplegia and quadriplegia, would likely be the choice of many physicians even without these data.
Dr. Dai reported no financial relationships to disclose.
SOURCE: Dai X. CRT 2018.
AT THE 2018 CRT MEETING
Key clinical point:
Major finding: Major adverse cardiovascular events at 30 days were lower after PCI than coronary artery bypass grafting (6% vs. 22%).
Data source: A nonrandomized retrospective analysis.
Disclosures: Dr. Dai reported no financial relationships to disclose. Source: Dai X. CRT 2018.