Higher stroke risk found for TAVR versus SAVR

 

SAN DIEGO – There was an 86% greater risk of ischemic stroke after transcatheter aortic valve replacement, compared with surgical aortic valve replacement, and a more than sixfold increased risk of hemorrhagic stroke, in a review of more than 44,000 patients in the Nationwide Readmissions Database who were followed out to a year after having one procedure or the other.

“Our data suggest an elevated risk of both ischemic and hemorrhagic stroke after TAVR [transcatheter aortic valve replacement]. I see a lot of people that have strokes after” TAVR, so “I wasn’t all that surprised that there is an increased risk, but could I have guessed it would have been so high? No.” Perhaps “we are offering it to people we shouldn’t be offering it to,” said lead investigator Laura Stein, MD, a vascular neurology fellow at Mount Sinai Hospital, New York.

Several previous studies have found no increased stroke risk with TAVR, but they were randomized trials with specific inclusion and exclusion criteria, good follow-up, good patient compliance, and often device company involvement. Dr. Stein and her colleagues wanted to look into the situation in a more real-world setting, under less optimal conditions.

The 2013 Nationwide Readmissions Database used in the study captured more than 14 million readmissions in the United States across all payers and the uninsured. “We used this database because its captures all comers” and reflects “more real-world practice,” Dr. Stein said.

There were 6,015 TAVR and 38,624 SAVR cases in 2013, and the team found consistently elevated cumulative risks of ischemic and hemorrhagic stroke after TAVR, compared with SAVR, according to a presentation at the annual meeting of the American Neurological Association.

Compared with SAVR, the hazard ratio for ischemic stroke with TAVR was 1.86 (95% confidence interval, 1.12-3.08; P = .016) and, for hemorrhagic stroke, 6.17 (95% CI, 1.97-19.33; P = .0018). Dr. Stein declined to release absolute numbers of strokes in the two groups, pending publication.

“A lot of attention is being paid to this topic because there has been a push, a lot of it by the device makers, to prove that [TAVR] outcomes are just as good as with traditional surgery, and that we should be offering [TAVR] to more people with higher risk factor profiles who might not have been offered repair otherwise. Our job is to help patients make the most informed decisions. Having another source of data like [ours]” adds to the conversation about risks and benefits, she said.

The investigators adjusted for a large number of potential confounders to make sure the comparison was as fair as possible given the limits of database reviews. Among other variables, they controlled for baseline cardiovascular risk factors, carotid artery disease, heart failure, obesity, smoking, surgical complications, mortality, and illness severity scores, as well as hospital size, teaching hospital status, and urban versus rural location.

“What we can’t know is what medications these patients were on that might have increased their bleeding or ischemia risk. Also, we were relying on coding done by other people,” Dr. Stein said.

The next step is to look at the impact of stenting and other concomitant procedures. “We were surprised by the number of people that had multiple procedures at the same time.” The ultimate goal is to develop a risk score to help patients and doctors decide between the two procedures, she said.

Meanwhile, the team found no difference in stroke risk between coronary artery bypass grafting and percutaneous coronary interventions in the 2013 database.

Three was no industry funding for the work, and Dr. Stein did not have any relevant disclosures.

[email protected]

 

SAN DIEGO – There was an 86% greater risk of ischemic stroke after transcatheter aortic valve replacement, compared with surgical aortic valve replacement, and a more than sixfold increased risk of hemorrhagic stroke, in a review of more than 44,000 patients in the Nationwide Readmissions Database who were followed out to a year after having one procedure or the other.

“Our data suggest an elevated risk of both ischemic and hemorrhagic stroke after TAVR [transcatheter aortic valve replacement]. I see a lot of people that have strokes after” TAVR, so “I wasn’t all that surprised that there is an increased risk, but could I have guessed it would have been so high? No.” Perhaps “we are offering it to people we shouldn’t be offering it to,” said lead investigator Laura Stein, MD, a vascular neurology fellow at Mount Sinai Hospital, New York.

Several previous studies have found no increased stroke risk with TAVR, but they were randomized trials with specific inclusion and exclusion criteria, good follow-up, good patient compliance, and often device company involvement. Dr. Stein and her colleagues wanted to look into the situation in a more real-world setting, under less optimal conditions.

The 2013 Nationwide Readmissions Database used in the study captured more than 14 million readmissions in the United States across all payers and the uninsured. “We used this database because its captures all comers” and reflects “more real-world practice,” Dr. Stein said.

There were 6,015 TAVR and 38,624 SAVR cases in 2013, and the team found consistently elevated cumulative risks of ischemic and hemorrhagic stroke after TAVR, compared with SAVR, according to a presentation at the annual meeting of the American Neurological Association.

Compared with SAVR, the hazard ratio for ischemic stroke with TAVR was 1.86 (95% confidence interval, 1.12-3.08; P = .016) and, for hemorrhagic stroke, 6.17 (95% CI, 1.97-19.33; P = .0018). Dr. Stein declined to release absolute numbers of strokes in the two groups, pending publication.

“A lot of attention is being paid to this topic because there has been a push, a lot of it by the device makers, to prove that [TAVR] outcomes are just as good as with traditional surgery, and that we should be offering [TAVR] to more people with higher risk factor profiles who might not have been offered repair otherwise. Our job is to help patients make the most informed decisions. Having another source of data like [ours]” adds to the conversation about risks and benefits, she said.

The investigators adjusted for a large number of potential confounders to make sure the comparison was as fair as possible given the limits of database reviews. Among other variables, they controlled for baseline cardiovascular risk factors, carotid artery disease, heart failure, obesity, smoking, surgical complications, mortality, and illness severity scores, as well as hospital size, teaching hospital status, and urban versus rural location.

“What we can’t know is what medications these patients were on that might have increased their bleeding or ischemia risk. Also, we were relying on coding done by other people,” Dr. Stein said.

The next step is to look at the impact of stenting and other concomitant procedures. “We were surprised by the number of people that had multiple procedures at the same time.” The ultimate goal is to develop a risk score to help patients and doctors decide between the two procedures, she said.

Meanwhile, the team found no difference in stroke risk between coronary artery bypass grafting and percutaneous coronary interventions in the 2013 database.

Three was no industry funding for the work, and Dr. Stein did not have any relevant disclosures.

[email protected]

 

SAN DIEGO – There was an 86% greater risk of ischemic stroke after transcatheter aortic valve replacement, compared with surgical aortic valve replacement, and a more than sixfold increased risk of hemorrhagic stroke, in a review of more than 44,000 patients in the Nationwide Readmissions Database who were followed out to a year after having one procedure or the other.

“Our data suggest an elevated risk of both ischemic and hemorrhagic stroke after TAVR [transcatheter aortic valve replacement]. I see a lot of people that have strokes after” TAVR, so “I wasn’t all that surprised that there is an increased risk, but could I have guessed it would have been so high? No.” Perhaps “we are offering it to people we shouldn’t be offering it to,” said lead investigator Laura Stein, MD, a vascular neurology fellow at Mount Sinai Hospital, New York.

Several previous studies have found no increased stroke risk with TAVR, but they were randomized trials with specific inclusion and exclusion criteria, good follow-up, good patient compliance, and often device company involvement. Dr. Stein and her colleagues wanted to look into the situation in a more real-world setting, under less optimal conditions.

The 2013 Nationwide Readmissions Database used in the study captured more than 14 million readmissions in the United States across all payers and the uninsured. “We used this database because its captures all comers” and reflects “more real-world practice,” Dr. Stein said.

There were 6,015 TAVR and 38,624 SAVR cases in 2013, and the team found consistently elevated cumulative risks of ischemic and hemorrhagic stroke after TAVR, compared with SAVR, according to a presentation at the annual meeting of the American Neurological Association.

Compared with SAVR, the hazard ratio for ischemic stroke with TAVR was 1.86 (95% confidence interval, 1.12-3.08; P = .016) and, for hemorrhagic stroke, 6.17 (95% CI, 1.97-19.33; P = .0018). Dr. Stein declined to release absolute numbers of strokes in the two groups, pending publication.

“A lot of attention is being paid to this topic because there has been a push, a lot of it by the device makers, to prove that [TAVR] outcomes are just as good as with traditional surgery, and that we should be offering [TAVR] to more people with higher risk factor profiles who might not have been offered repair otherwise. Our job is to help patients make the most informed decisions. Having another source of data like [ours]” adds to the conversation about risks and benefits, she said.

The investigators adjusted for a large number of potential confounders to make sure the comparison was as fair as possible given the limits of database reviews. Among other variables, they controlled for baseline cardiovascular risk factors, carotid artery disease, heart failure, obesity, smoking, surgical complications, mortality, and illness severity scores, as well as hospital size, teaching hospital status, and urban versus rural location.

“What we can’t know is what medications these patients were on that might have increased their bleeding or ischemia risk. Also, we were relying on coding done by other people,” Dr. Stein said.

The next step is to look at the impact of stenting and other concomitant procedures. “We were surprised by the number of people that had multiple procedures at the same time.” The ultimate goal is to develop a risk score to help patients and doctors decide between the two procedures, she said.

Meanwhile, the team found no difference in stroke risk between coronary artery bypass grafting and percutaneous coronary interventions in the 2013 database.

Three was no industry funding for the work, and Dr. Stein did not have any relevant disclosures.

[email protected]