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Cancer survivors with PCI die more often from cardiac causes
PARIS – Cancer survivors who subsequently undergo percutaneous coronary intervention are more likely to die of their cardiovascular disease than malignancy, Dr. Uri Landes reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
He presented a retrospective case-control study that included 969 patients who underwent PCI a mean of 3.6 years after being diagnosed with any form of cancer except nonmelanoma skin cancer and an equal number of PCI patients with no history of cancer. The two groups were matched for age, sex, left ventricular ejection fraction, estimated glomerular filtration rate, and diabetes and hypertension status.
In the patients with a history of cancer, 34% of in-hospital deaths were owing to cardiac causes, 25% to malignancy, and 24.5% to infection. In patients with no history of cancer, 42.5% of in-hospital deaths were cardiac, 5% were due to malignancy, and 33% were attributed to infection, according to Dr. Landes of Rabin Medical Center in Petah-Tikva, Israel.
During up to 10 years of follow-up, the all-cause mortality rate was 46% greater in patients with a prior cancer. Their risk of the composite endpoint of cardiac death or nonfatal MI was 40% greater than in controls without a history of cancer. Moreover, their risk of the composite outcome of cardiac death, MI, target vessel revascularization, and coronary artery bypass surgery was increased by 41% relative to that of PCI patients with no history of cancer.
The impetus for this study, Dr. Landes explained, is the dearth of information available on the long-term outcomes of PCI in patients with a history of cancer. The scarcity of information came about because cancer patients are typically excluded from participation in PCI clinical trials, and most PCI registries don’t include information as to whether or not a participant has a positive oncologic history.
Dr. Landes reported having no financial conflicts regarding this study, funded through Tel Aviv University.
PARIS – Cancer survivors who subsequently undergo percutaneous coronary intervention are more likely to die of their cardiovascular disease than malignancy, Dr. Uri Landes reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
He presented a retrospective case-control study that included 969 patients who underwent PCI a mean of 3.6 years after being diagnosed with any form of cancer except nonmelanoma skin cancer and an equal number of PCI patients with no history of cancer. The two groups were matched for age, sex, left ventricular ejection fraction, estimated glomerular filtration rate, and diabetes and hypertension status.
In the patients with a history of cancer, 34% of in-hospital deaths were owing to cardiac causes, 25% to malignancy, and 24.5% to infection. In patients with no history of cancer, 42.5% of in-hospital deaths were cardiac, 5% were due to malignancy, and 33% were attributed to infection, according to Dr. Landes of Rabin Medical Center in Petah-Tikva, Israel.
During up to 10 years of follow-up, the all-cause mortality rate was 46% greater in patients with a prior cancer. Their risk of the composite endpoint of cardiac death or nonfatal MI was 40% greater than in controls without a history of cancer. Moreover, their risk of the composite outcome of cardiac death, MI, target vessel revascularization, and coronary artery bypass surgery was increased by 41% relative to that of PCI patients with no history of cancer.
The impetus for this study, Dr. Landes explained, is the dearth of information available on the long-term outcomes of PCI in patients with a history of cancer. The scarcity of information came about because cancer patients are typically excluded from participation in PCI clinical trials, and most PCI registries don’t include information as to whether or not a participant has a positive oncologic history.
Dr. Landes reported having no financial conflicts regarding this study, funded through Tel Aviv University.
PARIS – Cancer survivors who subsequently undergo percutaneous coronary intervention are more likely to die of their cardiovascular disease than malignancy, Dr. Uri Landes reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
He presented a retrospective case-control study that included 969 patients who underwent PCI a mean of 3.6 years after being diagnosed with any form of cancer except nonmelanoma skin cancer and an equal number of PCI patients with no history of cancer. The two groups were matched for age, sex, left ventricular ejection fraction, estimated glomerular filtration rate, and diabetes and hypertension status.
In the patients with a history of cancer, 34% of in-hospital deaths were owing to cardiac causes, 25% to malignancy, and 24.5% to infection. In patients with no history of cancer, 42.5% of in-hospital deaths were cardiac, 5% were due to malignancy, and 33% were attributed to infection, according to Dr. Landes of Rabin Medical Center in Petah-Tikva, Israel.
During up to 10 years of follow-up, the all-cause mortality rate was 46% greater in patients with a prior cancer. Their risk of the composite endpoint of cardiac death or nonfatal MI was 40% greater than in controls without a history of cancer. Moreover, their risk of the composite outcome of cardiac death, MI, target vessel revascularization, and coronary artery bypass surgery was increased by 41% relative to that of PCI patients with no history of cancer.
The impetus for this study, Dr. Landes explained, is the dearth of information available on the long-term outcomes of PCI in patients with a history of cancer. The scarcity of information came about because cancer patients are typically excluded from participation in PCI clinical trials, and most PCI registries don’t include information as to whether or not a participant has a positive oncologic history.
Dr. Landes reported having no financial conflicts regarding this study, funded through Tel Aviv University.
AT EUROPCR 2016
Key clinical point: A malignancy background aggravates cardiovascular issues in percutaneous coronary intervention.
Major finding: Patients with a history of cancer who underwent PCI were 41% more likely to experience cardiac death, acute MI, target vessel revascularization, or CABG than were matched controls who had no history of cancer when they underwent PCI.
Data source: This was a matched-pairs retrospective study of 1,938 patients who underwent PCI, half of whom had prior cancer and were then followed for up to 10 years postprocedure.
Disclosures: The presenter reported having no financial conflicts regarding this study.
Insomnia Is Pervasive in Adult Neurodevelopmental Disorders
DENVER – Adults with ADHD or autism spectrum disorder experience a high burden of sleep disturbances, especially insomnia, Dr. Anastasios Galanopoulos reported at the annual meeting of the Associated Professional Sleep Societies.
This has previously been established to be the case in pediatric patients with these neurodevelopmental disorders. However, sleep pathology hasn’t previously been well studied in affected adults, according to Dr. Galanopoulos, a consulting psychiatrist at Maudsley Hospital and King’s College London.
He presented a cross-sectional study of insomnia in a clinically representative sample comprising 164 adult patients: 98 with a DSM-5 diagnosis of ADHD, 30 with autism spectrum disorder, and 34 carrying both diagnoses.
Fully 91% of participants fell into the “poor” sleep category on the Pittsburgh Sleep Quality Index. Moreover, 44% of subjects had either moderate or severe clinical insomnia as reflected in a score of 15 or more on the Insomnia Severity Index. The rate of high sleep disruption scores was similar, regardless of whether the diagnosis was ADHD, autism spectrum disorder, or both.
Anxiety but not depression ratings on the Hospital Anxiety and Depression Scale correlated with insomnia scores, regardless of neurodevelopmental diagnosis. Insomnia scores also increased in concert with higher levels of hyperactivity symptoms as scored on the Barkley Adult ADHD Rating Scale. In contrast, inattentiveness scores were unrelated to insomnia.
Hyperactivity scores on the Barkley scale were significantly higher in adults with ADHD than in those with autism spectrum disorder. On the other hand, anxiety scores were higher in adults with autism spectrum disorder.
While the burden of sleep disturbances is similarly high in adults with ADHD and autism spectrum disorder, the underlying mechanism may well be different. For this reason, Dr. Galanopoulos and coinvestigators have begun studies systematically looking at various possible interventions for sleep disorders in adults with neurodevelopmental disorders.
He reported having no financial conflicts regarding this study, which was conducted without commercial support.
DENVER – Adults with ADHD or autism spectrum disorder experience a high burden of sleep disturbances, especially insomnia, Dr. Anastasios Galanopoulos reported at the annual meeting of the Associated Professional Sleep Societies.
This has previously been established to be the case in pediatric patients with these neurodevelopmental disorders. However, sleep pathology hasn’t previously been well studied in affected adults, according to Dr. Galanopoulos, a consulting psychiatrist at Maudsley Hospital and King’s College London.
He presented a cross-sectional study of insomnia in a clinically representative sample comprising 164 adult patients: 98 with a DSM-5 diagnosis of ADHD, 30 with autism spectrum disorder, and 34 carrying both diagnoses.
Fully 91% of participants fell into the “poor” sleep category on the Pittsburgh Sleep Quality Index. Moreover, 44% of subjects had either moderate or severe clinical insomnia as reflected in a score of 15 or more on the Insomnia Severity Index. The rate of high sleep disruption scores was similar, regardless of whether the diagnosis was ADHD, autism spectrum disorder, or both.
Anxiety but not depression ratings on the Hospital Anxiety and Depression Scale correlated with insomnia scores, regardless of neurodevelopmental diagnosis. Insomnia scores also increased in concert with higher levels of hyperactivity symptoms as scored on the Barkley Adult ADHD Rating Scale. In contrast, inattentiveness scores were unrelated to insomnia.
Hyperactivity scores on the Barkley scale were significantly higher in adults with ADHD than in those with autism spectrum disorder. On the other hand, anxiety scores were higher in adults with autism spectrum disorder.
While the burden of sleep disturbances is similarly high in adults with ADHD and autism spectrum disorder, the underlying mechanism may well be different. For this reason, Dr. Galanopoulos and coinvestigators have begun studies systematically looking at various possible interventions for sleep disorders in adults with neurodevelopmental disorders.
He reported having no financial conflicts regarding this study, which was conducted without commercial support.
DENVER – Adults with ADHD or autism spectrum disorder experience a high burden of sleep disturbances, especially insomnia, Dr. Anastasios Galanopoulos reported at the annual meeting of the Associated Professional Sleep Societies.
This has previously been established to be the case in pediatric patients with these neurodevelopmental disorders. However, sleep pathology hasn’t previously been well studied in affected adults, according to Dr. Galanopoulos, a consulting psychiatrist at Maudsley Hospital and King’s College London.
He presented a cross-sectional study of insomnia in a clinically representative sample comprising 164 adult patients: 98 with a DSM-5 diagnosis of ADHD, 30 with autism spectrum disorder, and 34 carrying both diagnoses.
Fully 91% of participants fell into the “poor” sleep category on the Pittsburgh Sleep Quality Index. Moreover, 44% of subjects had either moderate or severe clinical insomnia as reflected in a score of 15 or more on the Insomnia Severity Index. The rate of high sleep disruption scores was similar, regardless of whether the diagnosis was ADHD, autism spectrum disorder, or both.
Anxiety but not depression ratings on the Hospital Anxiety and Depression Scale correlated with insomnia scores, regardless of neurodevelopmental diagnosis. Insomnia scores also increased in concert with higher levels of hyperactivity symptoms as scored on the Barkley Adult ADHD Rating Scale. In contrast, inattentiveness scores were unrelated to insomnia.
Hyperactivity scores on the Barkley scale were significantly higher in adults with ADHD than in those with autism spectrum disorder. On the other hand, anxiety scores were higher in adults with autism spectrum disorder.
While the burden of sleep disturbances is similarly high in adults with ADHD and autism spectrum disorder, the underlying mechanism may well be different. For this reason, Dr. Galanopoulos and coinvestigators have begun studies systematically looking at various possible interventions for sleep disorders in adults with neurodevelopmental disorders.
He reported having no financial conflicts regarding this study, which was conducted without commercial support.
AT SLEEP 2016
Insomnia is pervasive in adult neurodevelopmental disorders
DENVER – Adults with ADHD or autism spectrum disorder experience a high burden of sleep disturbances, especially insomnia, Dr. Anastasios Galanopoulos reported at the annual meeting of the Associated Professional Sleep Societies.
This has previously been established to be the case in pediatric patients with these neurodevelopmental disorders. However, sleep pathology hasn’t previously been well studied in affected adults, according to Dr. Galanopoulos, a consulting psychiatrist at Maudsley Hospital and King’s College London.
He presented a cross-sectional study of insomnia in a clinically representative sample comprising 164 adult patients: 98 with a DSM-5 diagnosis of ADHD, 30 with autism spectrum disorder, and 34 carrying both diagnoses.
Fully 91% of participants fell into the “poor” sleep category on the Pittsburgh Sleep Quality Index. Moreover, 44% of subjects had either moderate or severe clinical insomnia as reflected in a score of 15 or more on the Insomnia Severity Index. The rate of high sleep disruption scores was similar, regardless of whether the diagnosis was ADHD, autism spectrum disorder, or both.
Anxiety but not depression ratings on the Hospital Anxiety and Depression Scale correlated with insomnia scores, regardless of neurodevelopmental diagnosis. Insomnia scores also increased in concert with higher levels of hyperactivity symptoms as scored on the Barkley Adult ADHD Rating Scale. In contrast, inattentiveness scores were unrelated to insomnia.
Hyperactivity scores on the Barkley scale were significantly higher in adults with ADHD than in those with autism spectrum disorder. On the other hand, anxiety scores were higher in adults with autism spectrum disorder.
While the burden of sleep disturbances is similarly high in adults with ADHD and autism spectrum disorder, the underlying mechanism may well be different. For this reason, Dr. Galanopoulos and coinvestigators have begun studies systematically looking at various possible interventions for sleep disorders in adults with neurodevelopmental disorders.
He reported having no financial conflicts regarding this study, which was conducted without commercial support.
DENVER – Adults with ADHD or autism spectrum disorder experience a high burden of sleep disturbances, especially insomnia, Dr. Anastasios Galanopoulos reported at the annual meeting of the Associated Professional Sleep Societies.
This has previously been established to be the case in pediatric patients with these neurodevelopmental disorders. However, sleep pathology hasn’t previously been well studied in affected adults, according to Dr. Galanopoulos, a consulting psychiatrist at Maudsley Hospital and King’s College London.
He presented a cross-sectional study of insomnia in a clinically representative sample comprising 164 adult patients: 98 with a DSM-5 diagnosis of ADHD, 30 with autism spectrum disorder, and 34 carrying both diagnoses.
Fully 91% of participants fell into the “poor” sleep category on the Pittsburgh Sleep Quality Index. Moreover, 44% of subjects had either moderate or severe clinical insomnia as reflected in a score of 15 or more on the Insomnia Severity Index. The rate of high sleep disruption scores was similar, regardless of whether the diagnosis was ADHD, autism spectrum disorder, or both.
Anxiety but not depression ratings on the Hospital Anxiety and Depression Scale correlated with insomnia scores, regardless of neurodevelopmental diagnosis. Insomnia scores also increased in concert with higher levels of hyperactivity symptoms as scored on the Barkley Adult ADHD Rating Scale. In contrast, inattentiveness scores were unrelated to insomnia.
Hyperactivity scores on the Barkley scale were significantly higher in adults with ADHD than in those with autism spectrum disorder. On the other hand, anxiety scores were higher in adults with autism spectrum disorder.
While the burden of sleep disturbances is similarly high in adults with ADHD and autism spectrum disorder, the underlying mechanism may well be different. For this reason, Dr. Galanopoulos and coinvestigators have begun studies systematically looking at various possible interventions for sleep disorders in adults with neurodevelopmental disorders.
He reported having no financial conflicts regarding this study, which was conducted without commercial support.
DENVER – Adults with ADHD or autism spectrum disorder experience a high burden of sleep disturbances, especially insomnia, Dr. Anastasios Galanopoulos reported at the annual meeting of the Associated Professional Sleep Societies.
This has previously been established to be the case in pediatric patients with these neurodevelopmental disorders. However, sleep pathology hasn’t previously been well studied in affected adults, according to Dr. Galanopoulos, a consulting psychiatrist at Maudsley Hospital and King’s College London.
He presented a cross-sectional study of insomnia in a clinically representative sample comprising 164 adult patients: 98 with a DSM-5 diagnosis of ADHD, 30 with autism spectrum disorder, and 34 carrying both diagnoses.
Fully 91% of participants fell into the “poor” sleep category on the Pittsburgh Sleep Quality Index. Moreover, 44% of subjects had either moderate or severe clinical insomnia as reflected in a score of 15 or more on the Insomnia Severity Index. The rate of high sleep disruption scores was similar, regardless of whether the diagnosis was ADHD, autism spectrum disorder, or both.
Anxiety but not depression ratings on the Hospital Anxiety and Depression Scale correlated with insomnia scores, regardless of neurodevelopmental diagnosis. Insomnia scores also increased in concert with higher levels of hyperactivity symptoms as scored on the Barkley Adult ADHD Rating Scale. In contrast, inattentiveness scores were unrelated to insomnia.
Hyperactivity scores on the Barkley scale were significantly higher in adults with ADHD than in those with autism spectrum disorder. On the other hand, anxiety scores were higher in adults with autism spectrum disorder.
While the burden of sleep disturbances is similarly high in adults with ADHD and autism spectrum disorder, the underlying mechanism may well be different. For this reason, Dr. Galanopoulos and coinvestigators have begun studies systematically looking at various possible interventions for sleep disorders in adults with neurodevelopmental disorders.
He reported having no financial conflicts regarding this study, which was conducted without commercial support.
AT SLEEP 2016
Key clinical point: Clinically significant insomnia is extremely common in adults with ADHD or autism spectrum disorder.
Major finding: 44% of adults with ADHD, autism spectrum disorder, or both diagnoses had moderate or severe insomnia on the validated Insomnia Severity Index.
Data source: This was a cross-sectional study of insomnia in 164 adults with neurodevelopmental disorders.
Disclosures: The presenter reported having no financial conflicts regarding this study, which was conducted without commercial support.
Low paravalvular leak shown in real-world registry of Sapien 3 recipients
PARIS – The initial report from a large, prospective registry documenting outcomes in recipients of the Edwards Sapien 3 transcatheter aortic valve in real-world clinical practice confirm that the excellent results seen earlier in the rarified, randomized clinical trial setting are routinely reproducible in everyday practice, Dr. Olaf Wendler said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“The big thing with the Sapien 3 is the reduction in paravalvular leakage. Our rate of moderate or severe paravalvular leakage in the registry at 30 days is only 3.1%, with 73.6% of patients having no or only trace paravalvular leakage,” reported Dr. Wendler, professor of cardiothoracic surgery at King’s College Hospital, London.
The mean gradient improved from 43.8 mm Hg at baseline to 11.7 mm Hg at discharge, while the effective orifice area climbed from 0.72 to 1.67 cm2.
He presented 30-day outcomes from the SOURCE 3 registry for 1,947 recipients of the Edwards Sapien 3 valve during transcatheter aortic valve replacement at 80 European centers in 10 countries. Their average age was 81.6 years. Updates will continue during a planned 5 years of prospective follow-up.
“This will be a very rich dataset for subgroup analyses. We now have a number of procedural variables we can analyze over time. We will have good data to get to better outcomes in terms of how best to perform the procedure if you do it with a Sapien valve,” he explained.
Among the key findings: The lower profile of the Sapien 3 delivery system, compared with earlier iterations of the Sapien valve, enabled 87% of patients in the registry to undergo TAVR via transfemoral access. And, in these 1,695 patients, whose mean logistic EuroSCORE was 17.8, the 30-day rates of all-cause mortality and disabling stroke were just 1.9% and 0.5%, respectively.
“I think there are not many series that have shown better results than these,” Dr. Wendler commented.
The non–transfemoral-access group is a very different, higher surgical risk cohort with lots more comorbid conditions. Their mean logistic EuroSCORE was 21.8. Yet in this group, the 30-day all-cause mortality and disabling stroke rates were still only 4% and 0.8%.
The transfemoral access group had markedly lower rates of life-threatening bleeding (4%), new-onset atrial fibrillation (4.8%), extended ventilation (3.5%), stage 2-3 acute kidney injury (0.8%), plus a 2-day shorter mean hospital length of stay.
Sixty percent of transfemoral access patients had their TAVR done under conscious sedation. These 1,018 patients constitute the largest dataset ever treated using conscious sedation with one valve system. The conscious sedation group had significantly lower baseline rates of carotid artery disease, prior coronary artery bypass graft surgery, and heart failure than did patients who received general anesthesia. At 30 days post-TAVR, the conscious sedation group had significantly lower rates of extended ventilation and postdilatation, and they received less contrast volume than did the general anesthesia group. However, they had a significantly higher incidence of stroke: 1.7%, compared with 0.6% for the general anesthesia group.
“Why that is the case we don’t know at the moment. We need to look into this more in the future,” the surgeon said.
A particularly impressive finding was how well Sapien 3 valve recipients with a low left ventricular ejection fraction have done. For example, 30-day all-cause mortality in the 100 patients with a baseline LVEF below 30% was 3%, not significantly different from the 1.8% rate in the 1,198 subjects with an LVEF greater than 50% or the 2.6% in patients with an LVEF of 30%-50%.
“Three percent all-cause mortality with an ejection fraction below 30% is just remarkable from my point of view,” Dr. Wendler said.
The 778 who didn’t undergo balloon aortic valvuloplasty prior to Sapien 3 implantation did not fare any worse than did those who did in terms of 30-day all-cause mortality or all strokes, but they did have significantly higher rates of life-threatening bleeding and major vascular complications.
The SOURCE 3 registry is sponsored by Edwards Lifesciences. Dr. Wendler serves as a consultant to the company.
PARIS – The initial report from a large, prospective registry documenting outcomes in recipients of the Edwards Sapien 3 transcatheter aortic valve in real-world clinical practice confirm that the excellent results seen earlier in the rarified, randomized clinical trial setting are routinely reproducible in everyday practice, Dr. Olaf Wendler said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“The big thing with the Sapien 3 is the reduction in paravalvular leakage. Our rate of moderate or severe paravalvular leakage in the registry at 30 days is only 3.1%, with 73.6% of patients having no or only trace paravalvular leakage,” reported Dr. Wendler, professor of cardiothoracic surgery at King’s College Hospital, London.
The mean gradient improved from 43.8 mm Hg at baseline to 11.7 mm Hg at discharge, while the effective orifice area climbed from 0.72 to 1.67 cm2.
He presented 30-day outcomes from the SOURCE 3 registry for 1,947 recipients of the Edwards Sapien 3 valve during transcatheter aortic valve replacement at 80 European centers in 10 countries. Their average age was 81.6 years. Updates will continue during a planned 5 years of prospective follow-up.
“This will be a very rich dataset for subgroup analyses. We now have a number of procedural variables we can analyze over time. We will have good data to get to better outcomes in terms of how best to perform the procedure if you do it with a Sapien valve,” he explained.
Among the key findings: The lower profile of the Sapien 3 delivery system, compared with earlier iterations of the Sapien valve, enabled 87% of patients in the registry to undergo TAVR via transfemoral access. And, in these 1,695 patients, whose mean logistic EuroSCORE was 17.8, the 30-day rates of all-cause mortality and disabling stroke were just 1.9% and 0.5%, respectively.
“I think there are not many series that have shown better results than these,” Dr. Wendler commented.
The non–transfemoral-access group is a very different, higher surgical risk cohort with lots more comorbid conditions. Their mean logistic EuroSCORE was 21.8. Yet in this group, the 30-day all-cause mortality and disabling stroke rates were still only 4% and 0.8%.
The transfemoral access group had markedly lower rates of life-threatening bleeding (4%), new-onset atrial fibrillation (4.8%), extended ventilation (3.5%), stage 2-3 acute kidney injury (0.8%), plus a 2-day shorter mean hospital length of stay.
Sixty percent of transfemoral access patients had their TAVR done under conscious sedation. These 1,018 patients constitute the largest dataset ever treated using conscious sedation with one valve system. The conscious sedation group had significantly lower baseline rates of carotid artery disease, prior coronary artery bypass graft surgery, and heart failure than did patients who received general anesthesia. At 30 days post-TAVR, the conscious sedation group had significantly lower rates of extended ventilation and postdilatation, and they received less contrast volume than did the general anesthesia group. However, they had a significantly higher incidence of stroke: 1.7%, compared with 0.6% for the general anesthesia group.
“Why that is the case we don’t know at the moment. We need to look into this more in the future,” the surgeon said.
A particularly impressive finding was how well Sapien 3 valve recipients with a low left ventricular ejection fraction have done. For example, 30-day all-cause mortality in the 100 patients with a baseline LVEF below 30% was 3%, not significantly different from the 1.8% rate in the 1,198 subjects with an LVEF greater than 50% or the 2.6% in patients with an LVEF of 30%-50%.
“Three percent all-cause mortality with an ejection fraction below 30% is just remarkable from my point of view,” Dr. Wendler said.
The 778 who didn’t undergo balloon aortic valvuloplasty prior to Sapien 3 implantation did not fare any worse than did those who did in terms of 30-day all-cause mortality or all strokes, but they did have significantly higher rates of life-threatening bleeding and major vascular complications.
The SOURCE 3 registry is sponsored by Edwards Lifesciences. Dr. Wendler serves as a consultant to the company.
PARIS – The initial report from a large, prospective registry documenting outcomes in recipients of the Edwards Sapien 3 transcatheter aortic valve in real-world clinical practice confirm that the excellent results seen earlier in the rarified, randomized clinical trial setting are routinely reproducible in everyday practice, Dr. Olaf Wendler said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“The big thing with the Sapien 3 is the reduction in paravalvular leakage. Our rate of moderate or severe paravalvular leakage in the registry at 30 days is only 3.1%, with 73.6% of patients having no or only trace paravalvular leakage,” reported Dr. Wendler, professor of cardiothoracic surgery at King’s College Hospital, London.
The mean gradient improved from 43.8 mm Hg at baseline to 11.7 mm Hg at discharge, while the effective orifice area climbed from 0.72 to 1.67 cm2.
He presented 30-day outcomes from the SOURCE 3 registry for 1,947 recipients of the Edwards Sapien 3 valve during transcatheter aortic valve replacement at 80 European centers in 10 countries. Their average age was 81.6 years. Updates will continue during a planned 5 years of prospective follow-up.
“This will be a very rich dataset for subgroup analyses. We now have a number of procedural variables we can analyze over time. We will have good data to get to better outcomes in terms of how best to perform the procedure if you do it with a Sapien valve,” he explained.
Among the key findings: The lower profile of the Sapien 3 delivery system, compared with earlier iterations of the Sapien valve, enabled 87% of patients in the registry to undergo TAVR via transfemoral access. And, in these 1,695 patients, whose mean logistic EuroSCORE was 17.8, the 30-day rates of all-cause mortality and disabling stroke were just 1.9% and 0.5%, respectively.
“I think there are not many series that have shown better results than these,” Dr. Wendler commented.
The non–transfemoral-access group is a very different, higher surgical risk cohort with lots more comorbid conditions. Their mean logistic EuroSCORE was 21.8. Yet in this group, the 30-day all-cause mortality and disabling stroke rates were still only 4% and 0.8%.
The transfemoral access group had markedly lower rates of life-threatening bleeding (4%), new-onset atrial fibrillation (4.8%), extended ventilation (3.5%), stage 2-3 acute kidney injury (0.8%), plus a 2-day shorter mean hospital length of stay.
Sixty percent of transfemoral access patients had their TAVR done under conscious sedation. These 1,018 patients constitute the largest dataset ever treated using conscious sedation with one valve system. The conscious sedation group had significantly lower baseline rates of carotid artery disease, prior coronary artery bypass graft surgery, and heart failure than did patients who received general anesthesia. At 30 days post-TAVR, the conscious sedation group had significantly lower rates of extended ventilation and postdilatation, and they received less contrast volume than did the general anesthesia group. However, they had a significantly higher incidence of stroke: 1.7%, compared with 0.6% for the general anesthesia group.
“Why that is the case we don’t know at the moment. We need to look into this more in the future,” the surgeon said.
A particularly impressive finding was how well Sapien 3 valve recipients with a low left ventricular ejection fraction have done. For example, 30-day all-cause mortality in the 100 patients with a baseline LVEF below 30% was 3%, not significantly different from the 1.8% rate in the 1,198 subjects with an LVEF greater than 50% or the 2.6% in patients with an LVEF of 30%-50%.
“Three percent all-cause mortality with an ejection fraction below 30% is just remarkable from my point of view,” Dr. Wendler said.
The 778 who didn’t undergo balloon aortic valvuloplasty prior to Sapien 3 implantation did not fare any worse than did those who did in terms of 30-day all-cause mortality or all strokes, but they did have significantly higher rates of life-threatening bleeding and major vascular complications.
The SOURCE 3 registry is sponsored by Edwards Lifesciences. Dr. Wendler serves as a consultant to the company.
AT EUROPCR 2016
Key clinical point: Only 3.1% of patients had moderate or severe paravalvular leak at 30 days after TAVR with the Sapien 3.
Major finding: The 30-day, all-cause mortality and disabling stroke rates were 1.9% and 0.5% in Sapien 3 valve recipients whose transcatheter aortic valve replacement was done by the transfemoral route.
Data source: A prospective multicenter European registry which includes 1,947 patients who underwent transcatheter aortic valve replacement with the Edwards Sapien 3 valve in real-world commercial settings.
Disclosures: The SOURCE 3 registry is sponsored by Edwards Lifesciences. Dr. Wendler serves as a consultant to the company.
Symptoms linger after ‘successful’ gyn. cancer therapy
SAN DIEGO – Fully half of gynecologic cancer survivors who are done with treatment and cancer free nonetheless report having moderate to severe symptoms 2 and even 5 years after diagnosis, Dr. Michelle Rowland reported at the annual meeting of the Society of Gynecologic Oncology.
The most common symptoms in her cross-sectional study of 237 women with a history of uterine, ovarian, cervical, or vulvar cancer who were cancer free and at least 2 years post diagnosis were fatigue, insomnia, pain, memory impairment, and neuropathy, according to Dr. Rowland, a gynecologic oncology fellow at the University of Oklahoma in Oklahoma City.
She found the high prevalence of fatigue in gynecologic cancer survivors so distant from treatment particularly unexpected.
“The fact that 60% of women report some degree of fatigue 2 and 5 years out from their gynecologic cancer diagnosis was surprising to me,” she said in an interview. “Fatigue is something we usually think of as being related either to the treatment that they’re getting or to the cancer itself. But these women don’t have cancer anymore and are not being treated.”
The cross-sectional study included 237 patients who completed a self-assessment symptom questionnaire during a university outpatient gynecologic oncology clinic for ongoing routine disease surveillance. All were believed to be cancer free and none were receiving treatment 2 or more years post diagnosis. Seventy-seven of the women were 5 or more years out from diagnosis. The prevalence and self-rated severity of symptoms on a 0-10 scale were similar in the 2- and 5-year survivor groups.
One-quarter of the 2-year survivors reported having three or more moderate to severe symptoms as defined by a rating of 4-10. So did 29% of the 5-year survivors.
Three-quarters of women reported having one or more symptom.
In an effort to identify predictors of high symptom burden, Dr. Rowland and coinvestigators conducted a multivariate logistic regression analysis controlling for tumor stage, disease, site, race, and all forms of cancer therapy received. Prior chemotherapy proved to be an independent risk factor for high symptom burden at 2 years, while prior radiation therapy predicted high symptom burden at 5 or more years. Of note, cancer type was not predictive.
Roughly 40% of subjects reported currently being on medications for chronic pain, 11% were taking antianxiety drugs, and a similar proportion were using sleep aids.
Dr. Rowland concluded that long-term follow-up of gynecologic cancer survivors should include a symptom assessment. Survivor clinics, which are becoming increasingly common, offer a way to specifically address ongoing symptoms.
She reported having no financial conflicts regarding her study.
SAN DIEGO – Fully half of gynecologic cancer survivors who are done with treatment and cancer free nonetheless report having moderate to severe symptoms 2 and even 5 years after diagnosis, Dr. Michelle Rowland reported at the annual meeting of the Society of Gynecologic Oncology.
The most common symptoms in her cross-sectional study of 237 women with a history of uterine, ovarian, cervical, or vulvar cancer who were cancer free and at least 2 years post diagnosis were fatigue, insomnia, pain, memory impairment, and neuropathy, according to Dr. Rowland, a gynecologic oncology fellow at the University of Oklahoma in Oklahoma City.
She found the high prevalence of fatigue in gynecologic cancer survivors so distant from treatment particularly unexpected.
“The fact that 60% of women report some degree of fatigue 2 and 5 years out from their gynecologic cancer diagnosis was surprising to me,” she said in an interview. “Fatigue is something we usually think of as being related either to the treatment that they’re getting or to the cancer itself. But these women don’t have cancer anymore and are not being treated.”
The cross-sectional study included 237 patients who completed a self-assessment symptom questionnaire during a university outpatient gynecologic oncology clinic for ongoing routine disease surveillance. All were believed to be cancer free and none were receiving treatment 2 or more years post diagnosis. Seventy-seven of the women were 5 or more years out from diagnosis. The prevalence and self-rated severity of symptoms on a 0-10 scale were similar in the 2- and 5-year survivor groups.
One-quarter of the 2-year survivors reported having three or more moderate to severe symptoms as defined by a rating of 4-10. So did 29% of the 5-year survivors.
Three-quarters of women reported having one or more symptom.
In an effort to identify predictors of high symptom burden, Dr. Rowland and coinvestigators conducted a multivariate logistic regression analysis controlling for tumor stage, disease, site, race, and all forms of cancer therapy received. Prior chemotherapy proved to be an independent risk factor for high symptom burden at 2 years, while prior radiation therapy predicted high symptom burden at 5 or more years. Of note, cancer type was not predictive.
Roughly 40% of subjects reported currently being on medications for chronic pain, 11% were taking antianxiety drugs, and a similar proportion were using sleep aids.
Dr. Rowland concluded that long-term follow-up of gynecologic cancer survivors should include a symptom assessment. Survivor clinics, which are becoming increasingly common, offer a way to specifically address ongoing symptoms.
She reported having no financial conflicts regarding her study.
SAN DIEGO – Fully half of gynecologic cancer survivors who are done with treatment and cancer free nonetheless report having moderate to severe symptoms 2 and even 5 years after diagnosis, Dr. Michelle Rowland reported at the annual meeting of the Society of Gynecologic Oncology.
The most common symptoms in her cross-sectional study of 237 women with a history of uterine, ovarian, cervical, or vulvar cancer who were cancer free and at least 2 years post diagnosis were fatigue, insomnia, pain, memory impairment, and neuropathy, according to Dr. Rowland, a gynecologic oncology fellow at the University of Oklahoma in Oklahoma City.
She found the high prevalence of fatigue in gynecologic cancer survivors so distant from treatment particularly unexpected.
“The fact that 60% of women report some degree of fatigue 2 and 5 years out from their gynecologic cancer diagnosis was surprising to me,” she said in an interview. “Fatigue is something we usually think of as being related either to the treatment that they’re getting or to the cancer itself. But these women don’t have cancer anymore and are not being treated.”
The cross-sectional study included 237 patients who completed a self-assessment symptom questionnaire during a university outpatient gynecologic oncology clinic for ongoing routine disease surveillance. All were believed to be cancer free and none were receiving treatment 2 or more years post diagnosis. Seventy-seven of the women were 5 or more years out from diagnosis. The prevalence and self-rated severity of symptoms on a 0-10 scale were similar in the 2- and 5-year survivor groups.
One-quarter of the 2-year survivors reported having three or more moderate to severe symptoms as defined by a rating of 4-10. So did 29% of the 5-year survivors.
Three-quarters of women reported having one or more symptom.
In an effort to identify predictors of high symptom burden, Dr. Rowland and coinvestigators conducted a multivariate logistic regression analysis controlling for tumor stage, disease, site, race, and all forms of cancer therapy received. Prior chemotherapy proved to be an independent risk factor for high symptom burden at 2 years, while prior radiation therapy predicted high symptom burden at 5 or more years. Of note, cancer type was not predictive.
Roughly 40% of subjects reported currently being on medications for chronic pain, 11% were taking antianxiety drugs, and a similar proportion were using sleep aids.
Dr. Rowland concluded that long-term follow-up of gynecologic cancer survivors should include a symptom assessment. Survivor clinics, which are becoming increasingly common, offer a way to specifically address ongoing symptoms.
She reported having no financial conflicts regarding her study.
AT THE ANNUAL MEETING ON WOMEN’S CANCER
Key clinical point: Long-term follow-up of gynecologic cancer survivors should include assessment of cancer- or treatment-related symptoms.
Major finding: One-quarter of cancer-free patients reported three or more lingering symptoms of moderate to severe intensity 2 years after diagnosis.
Data source: This cross-sectional study utilized a structured questionnaire to evaluate the types and severity of symptoms present in 237 former gynecologic cancer patients who were off treatment and cancer free at least 2 years after diagnosis.
Disclosures: The study presenter reported having no financial conflicts of interest.
SLEEP TIGHT: CPAP may be vasculoprotective in stroke/TIA
DENVER – Long-term continuous positive airway pressure (CPAP) for treatment of sleep apnea in patients with a recent mild stroke or transient ischemic attack resulted in improved cardiovascular and metabolic risk factors, better neurologic function, and a reduction in the recurrent vascular event rate, compared with usual care in the SLEEP TIGHT study.
“Up to 25% of patients will have a stroke, cardiovascular event, or death within 90 days after a minor stroke or TIA [transient ischemic attack] despite current preventive strategies. And, importantly, patients with a TIA or stroke have a high prevalence of obstructive sleep apnea – on the order of 60%-80%,” explained Dr. H. Klar Yaggi at the annual meeting of the Associated Professional Sleep Societies.
SLEEP TIGHT’s findings support the hypothesis that diagnosis and treatment of sleep apnea in patients with a recent minor stroke or TIA will address a major unmet need for better methods of reducing the high vascular risk present in this population, said Dr. Yaggi of Yale University in New Haven, Conn.
SLEEP TIGHT was a National Heart, Lung, and Blood Institute–sponsored phase II, 12-month, multicenter, single-blind, randomized, proof-of-concept study. It included 252 patients, 80% of whom had a recent minor stroke, the rest a TIA. These were patients with high levels of cardiovascular risk factors: two-thirds had hypertension, half were hyperlipidemic, 40% had diabetes, 15% had a prior MI, 10% had atrial fibrillation, and the group’s mean body mass index was 30 kg/m2. Polysomnography revealed that 76% of subjects had sleep apnea as defined by an apnea-hypopnea index of at least 5 events per hour. In fact, they averaged about 23 events per hour, putting them in the moderate-severity range. As is common among stroke/TIA patients with sleep apnea, they experienced less daytime sleepiness than is typical in a sleep clinic population, with a mean baseline Epworth Sleepiness Scale score of 7.
Participants were randomized to one of three groups: a usual care control group, a CPAP arm, or an enhanced CPAP arm. The enhanced intervention protocol was designed to boost CPAP adherence; it included targeted education, a customized cognitive intervention, and additional CPAP support beyond the standard CPAP protocols used in sleep medicine clinics. Patients with sleep apnea in the two intervention arms were then placed on CPAP.
At 1 year of follow-up, the stroke rate was 8.7 per 100 patient-years in the usual care group, compared with 5.5 per 100 person-years in the combined intervention arms. The composite cardiovascular event rate, composed of all-cause mortality, acute MI, stroke, hospitalization for unstable angina, or urgent coronary revascularization, was 13.1 per 100 person-years with usual care and 11.0 in the CPAP intervention arms. While these results are encouraging, SLEEP TIGHT wasn’t powered to show significant differences in these hard events.
Outcomes across the board didn’t differ significantly between the CPAP and enhanced CPAP groups. And since the mean number of hours of CPAP use per night was also similar in the two groups – 3.9 hours with standard CPAP and 4.3 hours with enhanced CPAP – it’s likely that the phase III trial will rely upon the much simpler standard CPAP intervention, according to Dr. Yaggi.
He deemed CPAP adherence in this stroke/TIA population to be similar to the rates typically seen in routine sleep medicine practice. Roughly 40% of the stroke/TIA patients were rated as having good adherence, 30% made some use of the therapy, and 30% had no or poor adherence.
Nonetheless, patients in the two intervention arms did significantly better than the usual care group in terms of 1-year changes in insulin resistance and glycosylated hemoglobin. They also had lower 24-hour mean systolic blood pressure and were more likely to convert to a favorable pattern of nocturnal blood pressure dipping. However, no differences between the intervention and usual care groups were seen in levels of high-sensitivity C-reactive protein and interleukin-6, the two markers of systemic inflammation analyzed. Nor did the CPAP intervention provide any benefit in terms of heart rate variability and other measures of autonomic function.
Fifty-eight percent of patients in the intervention arms ended up with a desirable National Institutes of Health Stroke Scale score of 0-1, compared with 38% of the usual care group. In addition, daytime sleepiness as reflected in Epworth Sleepiness Scale scores was reduced at last follow-up to a significantly greater extent in the CPAP groups, Dr. Yaggi noted.
Greater CPAP use was associated with a favorable trend for improvement in the modified Rankin score, a measure of functional ability: a 0.3-point reduction with no or poor CPAP use, a 0.4-point decrease with some use, and a 0.9-point reduction with good use.
The encouraging results will be helpful in designing a planned much larger, event-driven, definitive phase III trial, Dr. Yaggi said.
Dr. Yaggi reported having no financial conflicts regarding this National Heart, Lung and Blood Institute-sponsored study.
DENVER – Long-term continuous positive airway pressure (CPAP) for treatment of sleep apnea in patients with a recent mild stroke or transient ischemic attack resulted in improved cardiovascular and metabolic risk factors, better neurologic function, and a reduction in the recurrent vascular event rate, compared with usual care in the SLEEP TIGHT study.
“Up to 25% of patients will have a stroke, cardiovascular event, or death within 90 days after a minor stroke or TIA [transient ischemic attack] despite current preventive strategies. And, importantly, patients with a TIA or stroke have a high prevalence of obstructive sleep apnea – on the order of 60%-80%,” explained Dr. H. Klar Yaggi at the annual meeting of the Associated Professional Sleep Societies.
SLEEP TIGHT’s findings support the hypothesis that diagnosis and treatment of sleep apnea in patients with a recent minor stroke or TIA will address a major unmet need for better methods of reducing the high vascular risk present in this population, said Dr. Yaggi of Yale University in New Haven, Conn.
SLEEP TIGHT was a National Heart, Lung, and Blood Institute–sponsored phase II, 12-month, multicenter, single-blind, randomized, proof-of-concept study. It included 252 patients, 80% of whom had a recent minor stroke, the rest a TIA. These were patients with high levels of cardiovascular risk factors: two-thirds had hypertension, half were hyperlipidemic, 40% had diabetes, 15% had a prior MI, 10% had atrial fibrillation, and the group’s mean body mass index was 30 kg/m2. Polysomnography revealed that 76% of subjects had sleep apnea as defined by an apnea-hypopnea index of at least 5 events per hour. In fact, they averaged about 23 events per hour, putting them in the moderate-severity range. As is common among stroke/TIA patients with sleep apnea, they experienced less daytime sleepiness than is typical in a sleep clinic population, with a mean baseline Epworth Sleepiness Scale score of 7.
Participants were randomized to one of three groups: a usual care control group, a CPAP arm, or an enhanced CPAP arm. The enhanced intervention protocol was designed to boost CPAP adherence; it included targeted education, a customized cognitive intervention, and additional CPAP support beyond the standard CPAP protocols used in sleep medicine clinics. Patients with sleep apnea in the two intervention arms were then placed on CPAP.
At 1 year of follow-up, the stroke rate was 8.7 per 100 patient-years in the usual care group, compared with 5.5 per 100 person-years in the combined intervention arms. The composite cardiovascular event rate, composed of all-cause mortality, acute MI, stroke, hospitalization for unstable angina, or urgent coronary revascularization, was 13.1 per 100 person-years with usual care and 11.0 in the CPAP intervention arms. While these results are encouraging, SLEEP TIGHT wasn’t powered to show significant differences in these hard events.
Outcomes across the board didn’t differ significantly between the CPAP and enhanced CPAP groups. And since the mean number of hours of CPAP use per night was also similar in the two groups – 3.9 hours with standard CPAP and 4.3 hours with enhanced CPAP – it’s likely that the phase III trial will rely upon the much simpler standard CPAP intervention, according to Dr. Yaggi.
He deemed CPAP adherence in this stroke/TIA population to be similar to the rates typically seen in routine sleep medicine practice. Roughly 40% of the stroke/TIA patients were rated as having good adherence, 30% made some use of the therapy, and 30% had no or poor adherence.
Nonetheless, patients in the two intervention arms did significantly better than the usual care group in terms of 1-year changes in insulin resistance and glycosylated hemoglobin. They also had lower 24-hour mean systolic blood pressure and were more likely to convert to a favorable pattern of nocturnal blood pressure dipping. However, no differences between the intervention and usual care groups were seen in levels of high-sensitivity C-reactive protein and interleukin-6, the two markers of systemic inflammation analyzed. Nor did the CPAP intervention provide any benefit in terms of heart rate variability and other measures of autonomic function.
Fifty-eight percent of patients in the intervention arms ended up with a desirable National Institutes of Health Stroke Scale score of 0-1, compared with 38% of the usual care group. In addition, daytime sleepiness as reflected in Epworth Sleepiness Scale scores was reduced at last follow-up to a significantly greater extent in the CPAP groups, Dr. Yaggi noted.
Greater CPAP use was associated with a favorable trend for improvement in the modified Rankin score, a measure of functional ability: a 0.3-point reduction with no or poor CPAP use, a 0.4-point decrease with some use, and a 0.9-point reduction with good use.
The encouraging results will be helpful in designing a planned much larger, event-driven, definitive phase III trial, Dr. Yaggi said.
Dr. Yaggi reported having no financial conflicts regarding this National Heart, Lung and Blood Institute-sponsored study.
DENVER – Long-term continuous positive airway pressure (CPAP) for treatment of sleep apnea in patients with a recent mild stroke or transient ischemic attack resulted in improved cardiovascular and metabolic risk factors, better neurologic function, and a reduction in the recurrent vascular event rate, compared with usual care in the SLEEP TIGHT study.
“Up to 25% of patients will have a stroke, cardiovascular event, or death within 90 days after a minor stroke or TIA [transient ischemic attack] despite current preventive strategies. And, importantly, patients with a TIA or stroke have a high prevalence of obstructive sleep apnea – on the order of 60%-80%,” explained Dr. H. Klar Yaggi at the annual meeting of the Associated Professional Sleep Societies.
SLEEP TIGHT’s findings support the hypothesis that diagnosis and treatment of sleep apnea in patients with a recent minor stroke or TIA will address a major unmet need for better methods of reducing the high vascular risk present in this population, said Dr. Yaggi of Yale University in New Haven, Conn.
SLEEP TIGHT was a National Heart, Lung, and Blood Institute–sponsored phase II, 12-month, multicenter, single-blind, randomized, proof-of-concept study. It included 252 patients, 80% of whom had a recent minor stroke, the rest a TIA. These were patients with high levels of cardiovascular risk factors: two-thirds had hypertension, half were hyperlipidemic, 40% had diabetes, 15% had a prior MI, 10% had atrial fibrillation, and the group’s mean body mass index was 30 kg/m2. Polysomnography revealed that 76% of subjects had sleep apnea as defined by an apnea-hypopnea index of at least 5 events per hour. In fact, they averaged about 23 events per hour, putting them in the moderate-severity range. As is common among stroke/TIA patients with sleep apnea, they experienced less daytime sleepiness than is typical in a sleep clinic population, with a mean baseline Epworth Sleepiness Scale score of 7.
Participants were randomized to one of three groups: a usual care control group, a CPAP arm, or an enhanced CPAP arm. The enhanced intervention protocol was designed to boost CPAP adherence; it included targeted education, a customized cognitive intervention, and additional CPAP support beyond the standard CPAP protocols used in sleep medicine clinics. Patients with sleep apnea in the two intervention arms were then placed on CPAP.
At 1 year of follow-up, the stroke rate was 8.7 per 100 patient-years in the usual care group, compared with 5.5 per 100 person-years in the combined intervention arms. The composite cardiovascular event rate, composed of all-cause mortality, acute MI, stroke, hospitalization for unstable angina, or urgent coronary revascularization, was 13.1 per 100 person-years with usual care and 11.0 in the CPAP intervention arms. While these results are encouraging, SLEEP TIGHT wasn’t powered to show significant differences in these hard events.
Outcomes across the board didn’t differ significantly between the CPAP and enhanced CPAP groups. And since the mean number of hours of CPAP use per night was also similar in the two groups – 3.9 hours with standard CPAP and 4.3 hours with enhanced CPAP – it’s likely that the phase III trial will rely upon the much simpler standard CPAP intervention, according to Dr. Yaggi.
He deemed CPAP adherence in this stroke/TIA population to be similar to the rates typically seen in routine sleep medicine practice. Roughly 40% of the stroke/TIA patients were rated as having good adherence, 30% made some use of the therapy, and 30% had no or poor adherence.
Nonetheless, patients in the two intervention arms did significantly better than the usual care group in terms of 1-year changes in insulin resistance and glycosylated hemoglobin. They also had lower 24-hour mean systolic blood pressure and were more likely to convert to a favorable pattern of nocturnal blood pressure dipping. However, no differences between the intervention and usual care groups were seen in levels of high-sensitivity C-reactive protein and interleukin-6, the two markers of systemic inflammation analyzed. Nor did the CPAP intervention provide any benefit in terms of heart rate variability and other measures of autonomic function.
Fifty-eight percent of patients in the intervention arms ended up with a desirable National Institutes of Health Stroke Scale score of 0-1, compared with 38% of the usual care group. In addition, daytime sleepiness as reflected in Epworth Sleepiness Scale scores was reduced at last follow-up to a significantly greater extent in the CPAP groups, Dr. Yaggi noted.
Greater CPAP use was associated with a favorable trend for improvement in the modified Rankin score, a measure of functional ability: a 0.3-point reduction with no or poor CPAP use, a 0.4-point decrease with some use, and a 0.9-point reduction with good use.
The encouraging results will be helpful in designing a planned much larger, event-driven, definitive phase III trial, Dr. Yaggi said.
Dr. Yaggi reported having no financial conflicts regarding this National Heart, Lung and Blood Institute-sponsored study.
AT SLEEP 2016
Key clinical point: CPAP treatment of obstructive sleep apnea in patients with a recent TIA or mild stroke appears to reduce their risk of further vascular events.
Major finding: At 1 year of follow-up, the stroke rate in patients randomized to CPAP, including the large subgroup with poor or no adherence, was 5.5 events per 100 person-years, compared with 8.7 in usual care controls.
Data source: SLEEP TIGHT was a 12-month, multicenter, prospective, randomized, single-blind, phase II trial including 252 patients.
Disclosures: The study presenter reported having no financial conflicts regarding this National Heart, Lung, and Blood Institute–sponsored trial.
Statins improve ovarian cancer survival
SAN DIEGO – Statin therapy was independently associated with a substantial survival benefit in women with ovarian cancer in an analysis of the linked Surveillance, Epidemiology and End Results and Medicare databases.
“This is the largest series ever reported supporting the anticancer effect of statin therapy on epithelial ovarian cancer with a concomitant improvement in overall survival. A prospective study in ovarian cancer patients is warranted. Identification of biomarkers that may predict response to statins would help further select patient populations and guide therapy,” Dr. Tilley Jenkins Vogel said in presenting the study results at the annual meeting of the Society of Gynecologic Oncology.
She and her coinvestigators at Cedars-Sinai Medical Center in Los Angeles identified 1,510 women in the SEER registry who were diagnosed with epithelial ovarian cancer during 2007-2009, underwent primary surgical resection, and survived for at least 60 days post surgery. Forty-nine percent were stage III, 25% stage IV. Forty-two percent of the women were on a statin.
Mean overall survival in the statin users was 32.2 months compared to 28.7 months in nonusers. In the stage III cohort, mean overall survival in statin users versus nonusers was 31.7 and 25.9 months.
In a multivariate analysis adjusted for potential confounders of age, race, heart disease and other comorbid conditions prior to cancer diagnosis, and the use of platinum-based chemotherapy, statin therapy was independently associated with a 34% reduction in the risk of mortality. In women whose ovarian cancer histology was serous, statin use was associated with a 31% reduction in death; in those with a nonserous histology, it was a 48% reduction, Dr. Vogel continued.
Diving deeper into the dataset, she found that the overall survival benefit was present only in the 89% of statin users who were on lipophilic statins, such as atorvastatin or simvastatin. This is consistent with other investigators’ reports that the noncardiovascular benefits of statin therapy are largely restricted to the lipophilic class of the LDL-lowering agents.
An anti–ovarian cancer benefit for statin therapy appears to have biologic plausibility, according to Dr. Vogel. She and her coworkers have previously shown synergistic cytotoxicity in vitro when statins are administered concurrently with platinum chemotherapy.
“This effect is believed to be mediated by greater inhibition of cell proliferation, increased apoptosis, and modification of proteins in the RAS pathway,” she said.
Rapidly growing cells, such as cancer cells, require cholesterol to synthesize cell membrane. It’s hypothesized that one mechanism for statins’ anticancer effect is that by reducing intracellular cholesterol levels the drugs interfere with this process, Dr. Vogel noted.
She reported having no financial conflicts regarding this study, conducted without commercial support.
SAN DIEGO – Statin therapy was independently associated with a substantial survival benefit in women with ovarian cancer in an analysis of the linked Surveillance, Epidemiology and End Results and Medicare databases.
“This is the largest series ever reported supporting the anticancer effect of statin therapy on epithelial ovarian cancer with a concomitant improvement in overall survival. A prospective study in ovarian cancer patients is warranted. Identification of biomarkers that may predict response to statins would help further select patient populations and guide therapy,” Dr. Tilley Jenkins Vogel said in presenting the study results at the annual meeting of the Society of Gynecologic Oncology.
She and her coinvestigators at Cedars-Sinai Medical Center in Los Angeles identified 1,510 women in the SEER registry who were diagnosed with epithelial ovarian cancer during 2007-2009, underwent primary surgical resection, and survived for at least 60 days post surgery. Forty-nine percent were stage III, 25% stage IV. Forty-two percent of the women were on a statin.
Mean overall survival in the statin users was 32.2 months compared to 28.7 months in nonusers. In the stage III cohort, mean overall survival in statin users versus nonusers was 31.7 and 25.9 months.
In a multivariate analysis adjusted for potential confounders of age, race, heart disease and other comorbid conditions prior to cancer diagnosis, and the use of platinum-based chemotherapy, statin therapy was independently associated with a 34% reduction in the risk of mortality. In women whose ovarian cancer histology was serous, statin use was associated with a 31% reduction in death; in those with a nonserous histology, it was a 48% reduction, Dr. Vogel continued.
Diving deeper into the dataset, she found that the overall survival benefit was present only in the 89% of statin users who were on lipophilic statins, such as atorvastatin or simvastatin. This is consistent with other investigators’ reports that the noncardiovascular benefits of statin therapy are largely restricted to the lipophilic class of the LDL-lowering agents.
An anti–ovarian cancer benefit for statin therapy appears to have biologic plausibility, according to Dr. Vogel. She and her coworkers have previously shown synergistic cytotoxicity in vitro when statins are administered concurrently with platinum chemotherapy.
“This effect is believed to be mediated by greater inhibition of cell proliferation, increased apoptosis, and modification of proteins in the RAS pathway,” she said.
Rapidly growing cells, such as cancer cells, require cholesterol to synthesize cell membrane. It’s hypothesized that one mechanism for statins’ anticancer effect is that by reducing intracellular cholesterol levels the drugs interfere with this process, Dr. Vogel noted.
She reported having no financial conflicts regarding this study, conducted without commercial support.
SAN DIEGO – Statin therapy was independently associated with a substantial survival benefit in women with ovarian cancer in an analysis of the linked Surveillance, Epidemiology and End Results and Medicare databases.
“This is the largest series ever reported supporting the anticancer effect of statin therapy on epithelial ovarian cancer with a concomitant improvement in overall survival. A prospective study in ovarian cancer patients is warranted. Identification of biomarkers that may predict response to statins would help further select patient populations and guide therapy,” Dr. Tilley Jenkins Vogel said in presenting the study results at the annual meeting of the Society of Gynecologic Oncology.
She and her coinvestigators at Cedars-Sinai Medical Center in Los Angeles identified 1,510 women in the SEER registry who were diagnosed with epithelial ovarian cancer during 2007-2009, underwent primary surgical resection, and survived for at least 60 days post surgery. Forty-nine percent were stage III, 25% stage IV. Forty-two percent of the women were on a statin.
Mean overall survival in the statin users was 32.2 months compared to 28.7 months in nonusers. In the stage III cohort, mean overall survival in statin users versus nonusers was 31.7 and 25.9 months.
In a multivariate analysis adjusted for potential confounders of age, race, heart disease and other comorbid conditions prior to cancer diagnosis, and the use of platinum-based chemotherapy, statin therapy was independently associated with a 34% reduction in the risk of mortality. In women whose ovarian cancer histology was serous, statin use was associated with a 31% reduction in death; in those with a nonserous histology, it was a 48% reduction, Dr. Vogel continued.
Diving deeper into the dataset, she found that the overall survival benefit was present only in the 89% of statin users who were on lipophilic statins, such as atorvastatin or simvastatin. This is consistent with other investigators’ reports that the noncardiovascular benefits of statin therapy are largely restricted to the lipophilic class of the LDL-lowering agents.
An anti–ovarian cancer benefit for statin therapy appears to have biologic plausibility, according to Dr. Vogel. She and her coworkers have previously shown synergistic cytotoxicity in vitro when statins are administered concurrently with platinum chemotherapy.
“This effect is believed to be mediated by greater inhibition of cell proliferation, increased apoptosis, and modification of proteins in the RAS pathway,” she said.
Rapidly growing cells, such as cancer cells, require cholesterol to synthesize cell membrane. It’s hypothesized that one mechanism for statins’ anticancer effect is that by reducing intracellular cholesterol levels the drugs interfere with this process, Dr. Vogel noted.
She reported having no financial conflicts regarding this study, conducted without commercial support.
AT THE ANNUAL MEETING ON WOMEN’S CANCER
Key clinical point: The risk of all-cause mortality in ovarian cancer patients on statin therapy was reduced by one-third.
Major finding: Mean survival in a large cohort of women with stage III ovarian cancer was 5.8 months longer among those on statin therapy.
Data source: A retrospective study of 1,510 women diagnosed with epithelial ovarian cancer during 2007-2009.
Disclosures: Dr. Vogel reported having no financial conflicts regarding this study, conducted without commercial support.
Insomnia linked to increased risk of pregnancy loss
DENVER – Women who experience difficulty staying asleep are at increased risk of having one or more pregnancies that don’t result in a live birth, a large epidemiologic study suggests.
In contrast, other expressions of insomnia – difficulty in falling asleep, early morning awakening, or nonrestorative sleep – were not significantly associated with pregnancy loss in this analysis of a nationally representative sample comprised of 5,554 women aged 18-45 years, Sara Nowakowski, Ph.D., reported at the annual meeting of the Associated Professional Sleep Societies.
The women were participants in the National Health and Nutrition Examination Survey for 2005-2008, which collected data on reproductive history as well as sleep patterns. Roughly 20% of the women self-reported experiencing insomnia. Eighty-three percent of the 18- to 45-year-old women had been pregnant at least once, and 1,870 (40%) of them had one or more prior pregnancies that didn’t result in a live birth.
In a multivariate logistic regression analysis adjusted for age, race, education level, and frequency of sleep apnea symptoms, such as snoring or snorting/gasping, frequent difficulty in maintaining sleep was independently associated with an 85% increased risk of having experienced a pregnancy that didn’t result in a live birth, according to Dr. Nowakowski, a clinical psychologist in the department of ob.gyn. at the University of Texas, Galveston.
In an interview, she was quick to note that these are correlational, hypothesis-generating data, and that an epidemiologic study such as this can’t establish causality.
Dr. Nowakowski and her coinvestigators hope to conduct a prospective randomized trial of cognitive behavioral therapy for insomnia – a well-established treatment – in a group of women with prior spontaneous abortion, miscarriage, or other infertility issues, to determine whether insomnia is a modifiable risk factor for adverse pregnancy outcomes.
One physician at the meeting remarked that if women with fertility problems and insomnia knew of Dr. Nowakowski’s work showing an association between insomnia and unsuccessful pregnancies, they would be pounding down the doors of sleep specialists. Dr. Nowakowski agreed.
“I surf the online networks set up for infertile women. They’re very distraught over their trouble conceiving. They’re doing yoga, de-stress programs, taking all sorts of supplements – including melatonin – to try to improve their chances of fertility,” she said. “If insomnia turns out to partially account for the risk of having pregnancies that don’t result in live birth, and treating the insomnia reduces that risk, there would be a huge amount of patient interest.”
The study was supported by the National Institutes of Health. Dr. Nowakowski reported having no financial conflicts.
DENVER – Women who experience difficulty staying asleep are at increased risk of having one or more pregnancies that don’t result in a live birth, a large epidemiologic study suggests.
In contrast, other expressions of insomnia – difficulty in falling asleep, early morning awakening, or nonrestorative sleep – were not significantly associated with pregnancy loss in this analysis of a nationally representative sample comprised of 5,554 women aged 18-45 years, Sara Nowakowski, Ph.D., reported at the annual meeting of the Associated Professional Sleep Societies.
The women were participants in the National Health and Nutrition Examination Survey for 2005-2008, which collected data on reproductive history as well as sleep patterns. Roughly 20% of the women self-reported experiencing insomnia. Eighty-three percent of the 18- to 45-year-old women had been pregnant at least once, and 1,870 (40%) of them had one or more prior pregnancies that didn’t result in a live birth.
In a multivariate logistic regression analysis adjusted for age, race, education level, and frequency of sleep apnea symptoms, such as snoring or snorting/gasping, frequent difficulty in maintaining sleep was independently associated with an 85% increased risk of having experienced a pregnancy that didn’t result in a live birth, according to Dr. Nowakowski, a clinical psychologist in the department of ob.gyn. at the University of Texas, Galveston.
In an interview, she was quick to note that these are correlational, hypothesis-generating data, and that an epidemiologic study such as this can’t establish causality.
Dr. Nowakowski and her coinvestigators hope to conduct a prospective randomized trial of cognitive behavioral therapy for insomnia – a well-established treatment – in a group of women with prior spontaneous abortion, miscarriage, or other infertility issues, to determine whether insomnia is a modifiable risk factor for adverse pregnancy outcomes.
One physician at the meeting remarked that if women with fertility problems and insomnia knew of Dr. Nowakowski’s work showing an association between insomnia and unsuccessful pregnancies, they would be pounding down the doors of sleep specialists. Dr. Nowakowski agreed.
“I surf the online networks set up for infertile women. They’re very distraught over their trouble conceiving. They’re doing yoga, de-stress programs, taking all sorts of supplements – including melatonin – to try to improve their chances of fertility,” she said. “If insomnia turns out to partially account for the risk of having pregnancies that don’t result in live birth, and treating the insomnia reduces that risk, there would be a huge amount of patient interest.”
The study was supported by the National Institutes of Health. Dr. Nowakowski reported having no financial conflicts.
DENVER – Women who experience difficulty staying asleep are at increased risk of having one or more pregnancies that don’t result in a live birth, a large epidemiologic study suggests.
In contrast, other expressions of insomnia – difficulty in falling asleep, early morning awakening, or nonrestorative sleep – were not significantly associated with pregnancy loss in this analysis of a nationally representative sample comprised of 5,554 women aged 18-45 years, Sara Nowakowski, Ph.D., reported at the annual meeting of the Associated Professional Sleep Societies.
The women were participants in the National Health and Nutrition Examination Survey for 2005-2008, which collected data on reproductive history as well as sleep patterns. Roughly 20% of the women self-reported experiencing insomnia. Eighty-three percent of the 18- to 45-year-old women had been pregnant at least once, and 1,870 (40%) of them had one or more prior pregnancies that didn’t result in a live birth.
In a multivariate logistic regression analysis adjusted for age, race, education level, and frequency of sleep apnea symptoms, such as snoring or snorting/gasping, frequent difficulty in maintaining sleep was independently associated with an 85% increased risk of having experienced a pregnancy that didn’t result in a live birth, according to Dr. Nowakowski, a clinical psychologist in the department of ob.gyn. at the University of Texas, Galveston.
In an interview, she was quick to note that these are correlational, hypothesis-generating data, and that an epidemiologic study such as this can’t establish causality.
Dr. Nowakowski and her coinvestigators hope to conduct a prospective randomized trial of cognitive behavioral therapy for insomnia – a well-established treatment – in a group of women with prior spontaneous abortion, miscarriage, or other infertility issues, to determine whether insomnia is a modifiable risk factor for adverse pregnancy outcomes.
One physician at the meeting remarked that if women with fertility problems and insomnia knew of Dr. Nowakowski’s work showing an association between insomnia and unsuccessful pregnancies, they would be pounding down the doors of sleep specialists. Dr. Nowakowski agreed.
“I surf the online networks set up for infertile women. They’re very distraught over their trouble conceiving. They’re doing yoga, de-stress programs, taking all sorts of supplements – including melatonin – to try to improve their chances of fertility,” she said. “If insomnia turns out to partially account for the risk of having pregnancies that don’t result in live birth, and treating the insomnia reduces that risk, there would be a huge amount of patient interest.”
The study was supported by the National Institutes of Health. Dr. Nowakowski reported having no financial conflicts.
AT SLEEP 2016
Key clinical point: Insomnia may be a factor in some cases of poor pregnancy outcomes.
Major finding: Reproductive-age women who experienced difficulty staying asleep had an 85% greater likelihood of having a pregnancy that didn’t result in a live birth.
Data source: This epidemiologic study included 5,554 women aged 18-45 who provided details of their reproductive history and sleep status in the National Health and Nutrition Examination Survey.
Disclosures: This study was supported by the National Institutes of Health. Dr. Nowakowski reported having no financial conflicts.
How to defeat radial artery spasm in transradial PCI
PARIS – The threat of radial artery spasm is the chief impediment to broader use of transradial access cardiac catheterization and percutaneous coronary intervention, but Dr. Julien Adjedj has a series of tips and tricks to defeat it.
At Cochin University Hospital in Paris, where he is chief of the interventional cardiology clinic, 95% of all PCIs are done transradially.
“With the tips and tricks we use, we have a transradial approach failure rate of only 1.5% at our center,” Dr. Adjedj said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
He and his colleagues have conducted a series of prospective, randomized studies of various prophylactic vasodilator regimens in 1,950 patients undergoing transradial PCI.
The winning strategy? Place 2.5-5.0 mg of the calcium channel blocker verapamil in the arterial sheath as first-line preventive therapy.
In a multivariate analysis adjusted for potential confounders – for example, the investigators found that the incidence of radial artery spasm (RAS) is higher in women and younger patients – the use of prophylactic verapamil placed in the arterial sheath reduced the likelihood of RAS by 75% and 72%, respectively, compared with placebo.
Intra-arterial diltiazem at 5 mg, isosorbide dinitrate at 1 mg, and molsidomine at 1 mg were also more effective than placebo. However, diltiazem and isosorbide dinitrate were associated with an unacceptable increased risk of severe hypotension compared to placebo, and molsidomine is not widely available outside France.
In contrast, verapamil was not linked to severe hypotension.
Overall, RAS occurred in 22.2 % of patients on placebo, 7.1% of those on verapamil at 2.5 mg, 7.9% with verapamil at 5 mg, 6.5% with isosorbide dinitrate at 1 mg, 9.1% of those on diltiazem at 5 mg, 13.3% with molsidomine at 1 mg, and 4.8% with verapamil 2.5 mg plus molsidomine 1 mg.
When it proves difficult to advance the catheter during a transradial PCI despite prophylactic verapamil, the first thing to do is check whether the problem really is RAS or is instead a matter of having entered a remnant artery. This is accomplished by supplementing the verapamil with 1 mg of intra-arterial isosorbide dinitrate; if the catheter still won’t pass, seriously consider the possibility of a remnant artery.
Among Dr. Adjedj’s tips on how to successfully pass the catheter through a drug-refractory RAS: Use a hydrophilic 0.035-inch guide wire, switch from a 6 Fr to a smaller 5 or 4 Fr catheter, or use a long multipurpose 5 Fr catheter inside the 6 Fr guiding catheter.
“It’s like nested Russian dolls. It can pass through the spasm without any pain,” said Dr. Adjedj.
He reported having no financial conflicts regarding his presentation.
PARIS – The threat of radial artery spasm is the chief impediment to broader use of transradial access cardiac catheterization and percutaneous coronary intervention, but Dr. Julien Adjedj has a series of tips and tricks to defeat it.
At Cochin University Hospital in Paris, where he is chief of the interventional cardiology clinic, 95% of all PCIs are done transradially.
“With the tips and tricks we use, we have a transradial approach failure rate of only 1.5% at our center,” Dr. Adjedj said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
He and his colleagues have conducted a series of prospective, randomized studies of various prophylactic vasodilator regimens in 1,950 patients undergoing transradial PCI.
The winning strategy? Place 2.5-5.0 mg of the calcium channel blocker verapamil in the arterial sheath as first-line preventive therapy.
In a multivariate analysis adjusted for potential confounders – for example, the investigators found that the incidence of radial artery spasm (RAS) is higher in women and younger patients – the use of prophylactic verapamil placed in the arterial sheath reduced the likelihood of RAS by 75% and 72%, respectively, compared with placebo.
Intra-arterial diltiazem at 5 mg, isosorbide dinitrate at 1 mg, and molsidomine at 1 mg were also more effective than placebo. However, diltiazem and isosorbide dinitrate were associated with an unacceptable increased risk of severe hypotension compared to placebo, and molsidomine is not widely available outside France.
In contrast, verapamil was not linked to severe hypotension.
Overall, RAS occurred in 22.2 % of patients on placebo, 7.1% of those on verapamil at 2.5 mg, 7.9% with verapamil at 5 mg, 6.5% with isosorbide dinitrate at 1 mg, 9.1% of those on diltiazem at 5 mg, 13.3% with molsidomine at 1 mg, and 4.8% with verapamil 2.5 mg plus molsidomine 1 mg.
When it proves difficult to advance the catheter during a transradial PCI despite prophylactic verapamil, the first thing to do is check whether the problem really is RAS or is instead a matter of having entered a remnant artery. This is accomplished by supplementing the verapamil with 1 mg of intra-arterial isosorbide dinitrate; if the catheter still won’t pass, seriously consider the possibility of a remnant artery.
Among Dr. Adjedj’s tips on how to successfully pass the catheter through a drug-refractory RAS: Use a hydrophilic 0.035-inch guide wire, switch from a 6 Fr to a smaller 5 or 4 Fr catheter, or use a long multipurpose 5 Fr catheter inside the 6 Fr guiding catheter.
“It’s like nested Russian dolls. It can pass through the spasm without any pain,” said Dr. Adjedj.
He reported having no financial conflicts regarding his presentation.
PARIS – The threat of radial artery spasm is the chief impediment to broader use of transradial access cardiac catheterization and percutaneous coronary intervention, but Dr. Julien Adjedj has a series of tips and tricks to defeat it.
At Cochin University Hospital in Paris, where he is chief of the interventional cardiology clinic, 95% of all PCIs are done transradially.
“With the tips and tricks we use, we have a transradial approach failure rate of only 1.5% at our center,” Dr. Adjedj said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
He and his colleagues have conducted a series of prospective, randomized studies of various prophylactic vasodilator regimens in 1,950 patients undergoing transradial PCI.
The winning strategy? Place 2.5-5.0 mg of the calcium channel blocker verapamil in the arterial sheath as first-line preventive therapy.
In a multivariate analysis adjusted for potential confounders – for example, the investigators found that the incidence of radial artery spasm (RAS) is higher in women and younger patients – the use of prophylactic verapamil placed in the arterial sheath reduced the likelihood of RAS by 75% and 72%, respectively, compared with placebo.
Intra-arterial diltiazem at 5 mg, isosorbide dinitrate at 1 mg, and molsidomine at 1 mg were also more effective than placebo. However, diltiazem and isosorbide dinitrate were associated with an unacceptable increased risk of severe hypotension compared to placebo, and molsidomine is not widely available outside France.
In contrast, verapamil was not linked to severe hypotension.
Overall, RAS occurred in 22.2 % of patients on placebo, 7.1% of those on verapamil at 2.5 mg, 7.9% with verapamil at 5 mg, 6.5% with isosorbide dinitrate at 1 mg, 9.1% of those on diltiazem at 5 mg, 13.3% with molsidomine at 1 mg, and 4.8% with verapamil 2.5 mg plus molsidomine 1 mg.
When it proves difficult to advance the catheter during a transradial PCI despite prophylactic verapamil, the first thing to do is check whether the problem really is RAS or is instead a matter of having entered a remnant artery. This is accomplished by supplementing the verapamil with 1 mg of intra-arterial isosorbide dinitrate; if the catheter still won’t pass, seriously consider the possibility of a remnant artery.
Among Dr. Adjedj’s tips on how to successfully pass the catheter through a drug-refractory RAS: Use a hydrophilic 0.035-inch guide wire, switch from a 6 Fr to a smaller 5 or 4 Fr catheter, or use a long multipurpose 5 Fr catheter inside the 6 Fr guiding catheter.
“It’s like nested Russian dolls. It can pass through the spasm without any pain,” said Dr. Adjedj.
He reported having no financial conflicts regarding his presentation.
AT EUROPCR 2016
Key clinical point: Placing 2.5-5.0 mg of verapamil in the arterial sheath when performing transradial access PCI reduces the risk of radial artery spasm by three-quarters compared with placebo.
Major finding: The incidence of radial artery spasm during transradial access PCI was 7.1% when 2.5 mg of verapamil was introduced through the arterial sheath, compared with 22.2% with placebo.
Data source: This series of prospective randomized studies comprised 1,950 patients undergoing transradial access PCI by way of various intra-arterial vasodilators or placebo.
Disclosures: The presenter reported having no financial conflicts regarding the study, conducted free of commercial support.
LAA occlusion studied for stroke prevention in atrial fib with prior intracerebral hemorrhage
PARIS – Transcatheter left atrial appendage occlusion shows promise in providing a far better stroke prevention strategy than does standard medical management in patients with atrial fibrillation who have had a prior intracerebral hemorrhage, Dr. Jens E. Nielsen-Kudsk reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“This is a difficult group of patients because there is no consensus on how to treat patients with atrial fibrillation after an intracerebral hemorrhage. They are very often left without any antithrombotic therapy because physicians and the patients themselves fear to resume anticoagulant therapy. Left atrial appendage occlusion is a nice nonpharmacologic way to obtain stroke prevention,” said Dr. Nielsen-Kudsk of Aarhus (Denmark) University.
He presented a propensity-matched follow-up study of 147 pairs of such patients at seven Nordic heart centers. Half received the percutaneously delivered St. Jude Medical Amplatzer Amulet device, which is approved in Europe for stroke prevention in patients with atrial fibrillation (AF). These 147 device recipients were matched for stroke risk by CHA2DS2-VASc score and for bleeding risk by HASBLED score with 147 patients with AF and a prior intracerebral hemorrhage who received standard medical therapy, ranging from warfarin or a novel oral anticoagulant in nearly half of patients to no antithrombotic therapy in 44%. The Amplatzer recipients were most often placed on aspirin for 6 months afterward unless they had an indication for continued aspirin, such as known coronary artery disease.
During a mean of 166 days of follow-up, the primary study endpoint – a composite of ischemic stroke, major bleeding, or death – occurred in the standard medical therapy group at a rate of 278.9 events per 1,000 patient-years, compared with 47.9 per 1,000 patient-years in patients with left atrial appendage occlusion (LAAO). This translates to an 81% relative risk reduction.
Moreover, the risk of ischemic stroke in the LAAO group was reduced by 65%, major bleeding was reduced by 61%, the rate of intracerebral hemorrhage was reduced by 71%, and mortality was decreased by 92%, the cardiologist continued.
On the basis of these encouraging results, a randomized, prospective clinical trial of LAAO using the Amplatzer device versus standard medical therapy in patients with AF and a prior intracerebral hemorrhage will get underway in the Nordic countries within the next several months. It will be called STROKECLOSE, he added.
Asked if the Watchman, the only LAAO device approved in the United States, might be similarly amenable for stroke prevention in this high-stroke-and-bleeding-risk population, Dr. Nielsen-Kudsk said in theory, yes, but the device’s labeling calls for an initial 45 days of anticoagulation therapy. That’s a daunting prospect in patients who’ve already had an intracerebral bleed, he observed.
Dr. Nicolo Piazza, who chaired a press conference where the Nordic study was highlighted, said the Watchman labeling needn’t be a deal breaker.
“Although the Watchman recommendations suggest an anticoagulant for the first 45 days afterward, real-world practice is not necessarily that. Many of those patients are put on dual-antiplatelet therapy or a single antiplatelet agent for a period of 45 days, 3 months, 6 months – it’s very heterogeneous out there,” said Dr. Piazza of McGill University in Montreal.
He added that STROKEBLED will be a very important trial in terms of providing guidance for daily clinical practice. A propensity matched-pairs analysis can’t be considered the final word because of the possibility of unrecognized and unmatched variables that could affect outcomes.
Dr. Nielsen-Kudsk reported receiving research grants from and serving as a consultant to St. Jude Medical.
PARIS – Transcatheter left atrial appendage occlusion shows promise in providing a far better stroke prevention strategy than does standard medical management in patients with atrial fibrillation who have had a prior intracerebral hemorrhage, Dr. Jens E. Nielsen-Kudsk reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“This is a difficult group of patients because there is no consensus on how to treat patients with atrial fibrillation after an intracerebral hemorrhage. They are very often left without any antithrombotic therapy because physicians and the patients themselves fear to resume anticoagulant therapy. Left atrial appendage occlusion is a nice nonpharmacologic way to obtain stroke prevention,” said Dr. Nielsen-Kudsk of Aarhus (Denmark) University.
He presented a propensity-matched follow-up study of 147 pairs of such patients at seven Nordic heart centers. Half received the percutaneously delivered St. Jude Medical Amplatzer Amulet device, which is approved in Europe for stroke prevention in patients with atrial fibrillation (AF). These 147 device recipients were matched for stroke risk by CHA2DS2-VASc score and for bleeding risk by HASBLED score with 147 patients with AF and a prior intracerebral hemorrhage who received standard medical therapy, ranging from warfarin or a novel oral anticoagulant in nearly half of patients to no antithrombotic therapy in 44%. The Amplatzer recipients were most often placed on aspirin for 6 months afterward unless they had an indication for continued aspirin, such as known coronary artery disease.
During a mean of 166 days of follow-up, the primary study endpoint – a composite of ischemic stroke, major bleeding, or death – occurred in the standard medical therapy group at a rate of 278.9 events per 1,000 patient-years, compared with 47.9 per 1,000 patient-years in patients with left atrial appendage occlusion (LAAO). This translates to an 81% relative risk reduction.
Moreover, the risk of ischemic stroke in the LAAO group was reduced by 65%, major bleeding was reduced by 61%, the rate of intracerebral hemorrhage was reduced by 71%, and mortality was decreased by 92%, the cardiologist continued.
On the basis of these encouraging results, a randomized, prospective clinical trial of LAAO using the Amplatzer device versus standard medical therapy in patients with AF and a prior intracerebral hemorrhage will get underway in the Nordic countries within the next several months. It will be called STROKECLOSE, he added.
Asked if the Watchman, the only LAAO device approved in the United States, might be similarly amenable for stroke prevention in this high-stroke-and-bleeding-risk population, Dr. Nielsen-Kudsk said in theory, yes, but the device’s labeling calls for an initial 45 days of anticoagulation therapy. That’s a daunting prospect in patients who’ve already had an intracerebral bleed, he observed.
Dr. Nicolo Piazza, who chaired a press conference where the Nordic study was highlighted, said the Watchman labeling needn’t be a deal breaker.
“Although the Watchman recommendations suggest an anticoagulant for the first 45 days afterward, real-world practice is not necessarily that. Many of those patients are put on dual-antiplatelet therapy or a single antiplatelet agent for a period of 45 days, 3 months, 6 months – it’s very heterogeneous out there,” said Dr. Piazza of McGill University in Montreal.
He added that STROKEBLED will be a very important trial in terms of providing guidance for daily clinical practice. A propensity matched-pairs analysis can’t be considered the final word because of the possibility of unrecognized and unmatched variables that could affect outcomes.
Dr. Nielsen-Kudsk reported receiving research grants from and serving as a consultant to St. Jude Medical.
PARIS – Transcatheter left atrial appendage occlusion shows promise in providing a far better stroke prevention strategy than does standard medical management in patients with atrial fibrillation who have had a prior intracerebral hemorrhage, Dr. Jens E. Nielsen-Kudsk reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“This is a difficult group of patients because there is no consensus on how to treat patients with atrial fibrillation after an intracerebral hemorrhage. They are very often left without any antithrombotic therapy because physicians and the patients themselves fear to resume anticoagulant therapy. Left atrial appendage occlusion is a nice nonpharmacologic way to obtain stroke prevention,” said Dr. Nielsen-Kudsk of Aarhus (Denmark) University.
He presented a propensity-matched follow-up study of 147 pairs of such patients at seven Nordic heart centers. Half received the percutaneously delivered St. Jude Medical Amplatzer Amulet device, which is approved in Europe for stroke prevention in patients with atrial fibrillation (AF). These 147 device recipients were matched for stroke risk by CHA2DS2-VASc score and for bleeding risk by HASBLED score with 147 patients with AF and a prior intracerebral hemorrhage who received standard medical therapy, ranging from warfarin or a novel oral anticoagulant in nearly half of patients to no antithrombotic therapy in 44%. The Amplatzer recipients were most often placed on aspirin for 6 months afterward unless they had an indication for continued aspirin, such as known coronary artery disease.
During a mean of 166 days of follow-up, the primary study endpoint – a composite of ischemic stroke, major bleeding, or death – occurred in the standard medical therapy group at a rate of 278.9 events per 1,000 patient-years, compared with 47.9 per 1,000 patient-years in patients with left atrial appendage occlusion (LAAO). This translates to an 81% relative risk reduction.
Moreover, the risk of ischemic stroke in the LAAO group was reduced by 65%, major bleeding was reduced by 61%, the rate of intracerebral hemorrhage was reduced by 71%, and mortality was decreased by 92%, the cardiologist continued.
On the basis of these encouraging results, a randomized, prospective clinical trial of LAAO using the Amplatzer device versus standard medical therapy in patients with AF and a prior intracerebral hemorrhage will get underway in the Nordic countries within the next several months. It will be called STROKECLOSE, he added.
Asked if the Watchman, the only LAAO device approved in the United States, might be similarly amenable for stroke prevention in this high-stroke-and-bleeding-risk population, Dr. Nielsen-Kudsk said in theory, yes, but the device’s labeling calls for an initial 45 days of anticoagulation therapy. That’s a daunting prospect in patients who’ve already had an intracerebral bleed, he observed.
Dr. Nicolo Piazza, who chaired a press conference where the Nordic study was highlighted, said the Watchman labeling needn’t be a deal breaker.
“Although the Watchman recommendations suggest an anticoagulant for the first 45 days afterward, real-world practice is not necessarily that. Many of those patients are put on dual-antiplatelet therapy or a single antiplatelet agent for a period of 45 days, 3 months, 6 months – it’s very heterogeneous out there,” said Dr. Piazza of McGill University in Montreal.
He added that STROKEBLED will be a very important trial in terms of providing guidance for daily clinical practice. A propensity matched-pairs analysis can’t be considered the final word because of the possibility of unrecognized and unmatched variables that could affect outcomes.
Dr. Nielsen-Kudsk reported receiving research grants from and serving as a consultant to St. Jude Medical.
AT EUROPCR 2016
Key clinical point: Left atrial appendage occlusion appears to be better than medical management for stroke prevention in patients with AF and prior intracerebral hemorrhage.
Major finding: The risk of a combined endpoint of ischemic stroke, major bleeding, or death during follow-up was 81% lower in patients with atrial fibrillation and a prior intracerebral hemorrhage treated with a transcatheter left atrial appendage occlusion device than in controls on standard medical therapy.
Data source: This study included 147 patient pairs propensity-matched for stroke and bleeding risk.
Disclosures: The study presenter reported receiving research grants from and serving as a consultant to St. Jude Medical.
