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Challenges of validating cerebral protection for TAVI
While using cerebral embolic protection during transcatheter aortic valve implantation (TAVI) seems appealing to reduce the risk of stroke, which has been reported to be higher than in open aortic valve replacement, the challenge of developing practical CEP devices and then designing appropriate trials may be insurmountable, according to a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2017;154;880-3).
Dr. Messé and Dr. Furie reviewed completed trials of five different CEP devices in 630 patients, noting that the trials confirmed the difficulty of “designing a trial that can prove a clinical benefit.” They noted 30-day stroke rates ranged from 4% to 6.7%, although prospective, nonrandomized European registries reported rates of 3.4% to 4.1%, and a large U.S. registry reported a rate of 2.5%. These results suggest “that some neurologic complications are going undetected or underreported in routine clinical practice.”
That may be a function of the different methods the trials used to determine complications. “There are little data to define best practice, but direct comprehensive assessment by a neurologist is likely the most accurate and sensitive method for detecting clinical stroke,” they added.
Another important factor is the timing of the assessment. They pointed out that half of all 30-day stroke events in TAVI are detected within 2 days of the procedure, but mild or transient symptoms can be missed if the only evaluation occurs just before discharge. “Unfortunately, in most studies this is when the neurologic assessment is performed,” Dr. Messé and Dr. Furie wrote. They added that long-term effects of these strokes have not been well studied.
What’s more, many TAVI patients have subclinical ischemic injury that only neuroimaging can detect. “Studies of MRI performed early after TAVI have demonstrated acute infarcts in 68% to 97% of patients,” the stated. While small and multiple, these microinfarcts may not be totally silent. “Additional studies to assess the long-term implications of clinically silent infarcts are clearly needed,” the coauthors said.
They also noted that a trial of stenting vs. endarterectomy for carotid stenosis raises caution about CEP devices (Lancet Neurol. 2010;9:353-62), as patients who had angioplasty and stenting and were treated with a CEP device had higher rates of acute infarct detected on MRI than those who did not have the CEP. Placing the CEP device through a severely stenosed and symptomatic carotid artery may have led to additional cerebral emboli.
“Placing a cerebral protection device in the aorta for a TAVI procedure also could be problematic in the presence of severe aortic arch disease or variant anatomy,” Dr. Messé and Dr. Furie commented. With two large trials of embolic protection in TAVI currently underway, the coauthors said, “the field eagerly awaits these results.”
Dr. Messé has received research support from GlaxoSmithKline and Direct Flow Medical. Both Dr. Messé and Dr. Furie have participated in the National Institutes of Health/National Heart, Lung, and Blood Institute/National Institute of Neurologic Disorders and Stroke–sponsored Cardiothoracic Surgery Network.
Dr. Messé and Dr. Furie pointed out the difficulty of quantifying the incidence of stroke during TAVI. But the long-term impact of stroke is more important because TAVI, as opposed to surgical aortic valve replacement, is more likely to be performed in a younger, healthier population, John Bozinovski, MD, of the University of British Columbia in Victoria said in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:484-5).
While Dr. Messé and Dr. Furie make a valid point that clinically significant stroke, as opposed to diagnostically apparent stroke, is an important outcome of trials of embolic protection in TAVI, the long-term impact of silent strokes identified only with neuroimaging is unknown, “As such, ‘clinically significant’ stroke carries a nebulous definition,” Dr. Bozinovski said.
Nonetheless, CEP devices may become standard “even without good evidence” to support their use, Dr. Bozinovski said, “or perhaps they will be used infrequently or not at all.” Their uptake by cardiac surgeons will depend on the supporting evidence and their treatment effect. “Not only is it difficult to design an effective device, it is possible that we may not know whether a device is effective or what is the size of that effect,” he said. As Dr. Messé and Dr. Furie point out, “Designing and successfully conducting the trial to do so might never occur.”
Dr. Bozinovski disclosed he was a paid consultant with Edwards Life Sciences.
Dr. Messé and Dr. Furie pointed out the difficulty of quantifying the incidence of stroke during TAVI. But the long-term impact of stroke is more important because TAVI, as opposed to surgical aortic valve replacement, is more likely to be performed in a younger, healthier population, John Bozinovski, MD, of the University of British Columbia in Victoria said in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:484-5).
While Dr. Messé and Dr. Furie make a valid point that clinically significant stroke, as opposed to diagnostically apparent stroke, is an important outcome of trials of embolic protection in TAVI, the long-term impact of silent strokes identified only with neuroimaging is unknown, “As such, ‘clinically significant’ stroke carries a nebulous definition,” Dr. Bozinovski said.
Nonetheless, CEP devices may become standard “even without good evidence” to support their use, Dr. Bozinovski said, “or perhaps they will be used infrequently or not at all.” Their uptake by cardiac surgeons will depend on the supporting evidence and their treatment effect. “Not only is it difficult to design an effective device, it is possible that we may not know whether a device is effective or what is the size of that effect,” he said. As Dr. Messé and Dr. Furie point out, “Designing and successfully conducting the trial to do so might never occur.”
Dr. Bozinovski disclosed he was a paid consultant with Edwards Life Sciences.
Dr. Messé and Dr. Furie pointed out the difficulty of quantifying the incidence of stroke during TAVI. But the long-term impact of stroke is more important because TAVI, as opposed to surgical aortic valve replacement, is more likely to be performed in a younger, healthier population, John Bozinovski, MD, of the University of British Columbia in Victoria said in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:484-5).
While Dr. Messé and Dr. Furie make a valid point that clinically significant stroke, as opposed to diagnostically apparent stroke, is an important outcome of trials of embolic protection in TAVI, the long-term impact of silent strokes identified only with neuroimaging is unknown, “As such, ‘clinically significant’ stroke carries a nebulous definition,” Dr. Bozinovski said.
Nonetheless, CEP devices may become standard “even without good evidence” to support their use, Dr. Bozinovski said, “or perhaps they will be used infrequently or not at all.” Their uptake by cardiac surgeons will depend on the supporting evidence and their treatment effect. “Not only is it difficult to design an effective device, it is possible that we may not know whether a device is effective or what is the size of that effect,” he said. As Dr. Messé and Dr. Furie point out, “Designing and successfully conducting the trial to do so might never occur.”
Dr. Bozinovski disclosed he was a paid consultant with Edwards Life Sciences.
While using cerebral embolic protection during transcatheter aortic valve implantation (TAVI) seems appealing to reduce the risk of stroke, which has been reported to be higher than in open aortic valve replacement, the challenge of developing practical CEP devices and then designing appropriate trials may be insurmountable, according to a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2017;154;880-3).
Dr. Messé and Dr. Furie reviewed completed trials of five different CEP devices in 630 patients, noting that the trials confirmed the difficulty of “designing a trial that can prove a clinical benefit.” They noted 30-day stroke rates ranged from 4% to 6.7%, although prospective, nonrandomized European registries reported rates of 3.4% to 4.1%, and a large U.S. registry reported a rate of 2.5%. These results suggest “that some neurologic complications are going undetected or underreported in routine clinical practice.”
That may be a function of the different methods the trials used to determine complications. “There are little data to define best practice, but direct comprehensive assessment by a neurologist is likely the most accurate and sensitive method for detecting clinical stroke,” they added.
Another important factor is the timing of the assessment. They pointed out that half of all 30-day stroke events in TAVI are detected within 2 days of the procedure, but mild or transient symptoms can be missed if the only evaluation occurs just before discharge. “Unfortunately, in most studies this is when the neurologic assessment is performed,” Dr. Messé and Dr. Furie wrote. They added that long-term effects of these strokes have not been well studied.
What’s more, many TAVI patients have subclinical ischemic injury that only neuroimaging can detect. “Studies of MRI performed early after TAVI have demonstrated acute infarcts in 68% to 97% of patients,” the stated. While small and multiple, these microinfarcts may not be totally silent. “Additional studies to assess the long-term implications of clinically silent infarcts are clearly needed,” the coauthors said.
They also noted that a trial of stenting vs. endarterectomy for carotid stenosis raises caution about CEP devices (Lancet Neurol. 2010;9:353-62), as patients who had angioplasty and stenting and were treated with a CEP device had higher rates of acute infarct detected on MRI than those who did not have the CEP. Placing the CEP device through a severely stenosed and symptomatic carotid artery may have led to additional cerebral emboli.
“Placing a cerebral protection device in the aorta for a TAVI procedure also could be problematic in the presence of severe aortic arch disease or variant anatomy,” Dr. Messé and Dr. Furie commented. With two large trials of embolic protection in TAVI currently underway, the coauthors said, “the field eagerly awaits these results.”
Dr. Messé has received research support from GlaxoSmithKline and Direct Flow Medical. Both Dr. Messé and Dr. Furie have participated in the National Institutes of Health/National Heart, Lung, and Blood Institute/National Institute of Neurologic Disorders and Stroke–sponsored Cardiothoracic Surgery Network.
While using cerebral embolic protection during transcatheter aortic valve implantation (TAVI) seems appealing to reduce the risk of stroke, which has been reported to be higher than in open aortic valve replacement, the challenge of developing practical CEP devices and then designing appropriate trials may be insurmountable, according to a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2017;154;880-3).
Dr. Messé and Dr. Furie reviewed completed trials of five different CEP devices in 630 patients, noting that the trials confirmed the difficulty of “designing a trial that can prove a clinical benefit.” They noted 30-day stroke rates ranged from 4% to 6.7%, although prospective, nonrandomized European registries reported rates of 3.4% to 4.1%, and a large U.S. registry reported a rate of 2.5%. These results suggest “that some neurologic complications are going undetected or underreported in routine clinical practice.”
That may be a function of the different methods the trials used to determine complications. “There are little data to define best practice, but direct comprehensive assessment by a neurologist is likely the most accurate and sensitive method for detecting clinical stroke,” they added.
Another important factor is the timing of the assessment. They pointed out that half of all 30-day stroke events in TAVI are detected within 2 days of the procedure, but mild or transient symptoms can be missed if the only evaluation occurs just before discharge. “Unfortunately, in most studies this is when the neurologic assessment is performed,” Dr. Messé and Dr. Furie wrote. They added that long-term effects of these strokes have not been well studied.
What’s more, many TAVI patients have subclinical ischemic injury that only neuroimaging can detect. “Studies of MRI performed early after TAVI have demonstrated acute infarcts in 68% to 97% of patients,” the stated. While small and multiple, these microinfarcts may not be totally silent. “Additional studies to assess the long-term implications of clinically silent infarcts are clearly needed,” the coauthors said.
They also noted that a trial of stenting vs. endarterectomy for carotid stenosis raises caution about CEP devices (Lancet Neurol. 2010;9:353-62), as patients who had angioplasty and stenting and were treated with a CEP device had higher rates of acute infarct detected on MRI than those who did not have the CEP. Placing the CEP device through a severely stenosed and symptomatic carotid artery may have led to additional cerebral emboli.
“Placing a cerebral protection device in the aorta for a TAVI procedure also could be problematic in the presence of severe aortic arch disease or variant anatomy,” Dr. Messé and Dr. Furie commented. With two large trials of embolic protection in TAVI currently underway, the coauthors said, “the field eagerly awaits these results.”
Dr. Messé has received research support from GlaxoSmithKline and Direct Flow Medical. Both Dr. Messé and Dr. Furie have participated in the National Institutes of Health/National Heart, Lung, and Blood Institute/National Institute of Neurologic Disorders and Stroke–sponsored Cardiothoracic Surgery Network.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Cerebral embolic protection during TAVI is an appealing concept that faces challenges.
Major finding: Developing practical and safe devices and testing them in adequately powered trials are daunting tasks.
Data source: Review of five completed and two ongoing clinical trials of 603 and 613 patients, respectively.
Disclosures: Dr. Messé has received research support from GlaxoSmithKline and Direct Flow Medical. Both Dr. Messé and Dr. Furie have participated in the NIH/NHLBI/NINDS-sponsored Cardiothoracic Surgery Network.
TAVR wallops SAVR in cost-effectiveness for intermediate-risk patients
DENVER – A formal cost-effectiveness analysis indicates that transcatheter aortic valve replacement (TAVR) is substantially more cost effective than surgical valve replacement in patients at intermediate surgical risk similar to those enrolled in the landmark PARTNER 2 trial.
The analysis demonstrated that over a 1- and 2-year follow-up period, as well as with projected lifetime follow-up, TAVR entails both lower long-term costs and greater quality-adjusted life expectancy, David J. Cohen, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
His two-part, patient-level economic analysis examined data from nearly 2,000 participants in the PARTNER 2A randomized trial comparing TAVR, using the Sapien XT valve, with surgical aortic valve replacement (SAVR), as well as the experience with the current-generation Sapien 3 TAVR valve in 1,077 intermediate–surgical risk TAVR patients in the S3i registry. The analysis utilized Medicare claims data on the costs of the index hospitalization and follow-up care.
In PARTNER 2A, the average total cost of the index hospitalization for valve replacement was $61,433 with TAVR. That was just $2,888 more than the SAVR hospitalization, despite the far higher acquisition cost of the Sapien 3 valve, which was roughly $32,500, compared with $5,000 for the surgical valve. Most of this additional cost of the TAVR valve was counterbalanced by TAVR’s 2-hour shorter procedural duration, the 6.4-day average length of stay, compared with 10.9 days for SAVR, and the fact that TAVR patients spent only 2.4 days in intensive care while SAVR patients averaged 4.6 days, Dr. Cohen explained at the meeting sponsored by the Cardiovascular Research Foundation.
During 24 months of postdischarge follow-up in the PARTNER 2A trial, SAVR patients racked up an average of $9,303 more in costs than TAVR patients. This was mainly because of their much higher rates of rehospitalization and time spent in skilled nursing facilities and rehabilitation centers, mainly during months 2-6 post discharge. The result was that 2-year total costs including the index hospitalization averaged $107,716 per TAVR patient and $114,132 per SAVR patient.
“One of the really remarkable findings of this study was what happened during follow-up,” the cardiologist observed.
Extrapolating to projected remaining lifetime years, TAVR using the Sapien XT valve resulted in a cost savings of $7,949 per patient and a 0.15-year increase in quality-adjusted life expectancy compared with SAVR.
But since the time of PARTNER 2A, the Sapien XT valve has been replaced by the updated Sapien 3 valve. The analysis of the S3i registry showed that the economic dominance of TAVR over SAVR was even greater owing to improved valve technology and contemporary care patterns. For this analysis, because there has been no randomized trial of TAVR with the Sapien 3 valve versus SAVR, patients in the SAVR of arm of PARTNER 2A served as the comparison group.
The cost of the index hospitalization was more than $4,000 less with TAVR in the S3i registry than with SAVR. The total cost of TAVR through 1 year of follow-up averaged $80,977, which was $15,511 less than the $96,489 for SAVR. The cost post discharge out to 1 year was more than $11,000 less per TAVR patient, driven by sharply lower rates of both cardiovascular and noncardiovascular hospitalizations as well as a greater than 50% reduction in days spent in rehab centers and skilled nursing facilities, compared with SAVR patients.
Projected over estimated remaining years of life, TAVR with the Sapien 3 valve yielded a cost savings of $9,692 per patient compared with SAVR, as well as a 0.27-year gain in quality-adjusted life-years.
Eighty-eight percent of patients in the S3i registry received their Sapien 3 valve via a transfemoral approach. When Dr. Cohen and his coinvestigators compared their costs and clinical outcomes to the subset of PARTNER 2A TAVR patients who got the Sapien XT valve transfemorally, the outcomes were “virtually identical,” he said.
“These findings are reassuring with regard to the S3i results and also suggest that the primary mechanism of benefit of the Sapien 3 valve over the XT valve is its lower profile, which allows roughly 90% of patients to be treated via a transfemoral approach,” according to Dr. Cohen.
He predicted the new cost-effectiveness findings will not substantially increase patient demand for TAVR, which is already high.
“By far what’s driving patients to TAVR today are the quality of life advantages. They love the idea of recovering quickly,” he said.
Michael Mack, MD, commented that this analysis probably underestimates the true cost advantage of TAVR by a fair amount, since the average hospital length of stay for TAVR patients in PARTNER 2A was 6.4 days.
“We now know that half of U.S. TAVR patients in many centers go home the day after the procedure, so you would expect that TAVR would look even more favorable based on current practice,” said Dr. Mack, medical director of cardiovascular surgery for the Baylor Health Care System and chairman of the Heart Hospital Baylor Plano (Tex.) Research Center.
Session moderator Patrick W. Serruys, MD, of Imperial College, London, observed that the cost differential between TAVR and SAVR will grow even larger once the sky-high cost of TAVR valves comes down. He predicted that’s likely to happen as a result of increased competition once a third valve receives marketing approval, just as occurred after a third drug-eluting stent hit the market.
Several physicians grumbled about the unfairness of current reimbursement for TAVR, which in effect penalizes hospitals. Dr. Cohen said that situation will change.
“I think the future of health care financing in the U.S. is bundled payment and accountable care organizations. In the setting of bundled payment for a 6-month period or even for 90 days, TAVR would look fantastic to a hospital or an health maintenance organization due to avoidance of rehospitalizations and rehabilitation and skilled nursing facility stays,” the cardiologist said.
The PARTNER 2A trial, the S3i registry, and the cost-effectiveness analysis were funded by Edwards Lifesciences. Dr. Cohen reported receiving research funding from and serving as a consultant to Edwards Lifesciences and other device companies.
DENVER – A formal cost-effectiveness analysis indicates that transcatheter aortic valve replacement (TAVR) is substantially more cost effective than surgical valve replacement in patients at intermediate surgical risk similar to those enrolled in the landmark PARTNER 2 trial.
The analysis demonstrated that over a 1- and 2-year follow-up period, as well as with projected lifetime follow-up, TAVR entails both lower long-term costs and greater quality-adjusted life expectancy, David J. Cohen, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
His two-part, patient-level economic analysis examined data from nearly 2,000 participants in the PARTNER 2A randomized trial comparing TAVR, using the Sapien XT valve, with surgical aortic valve replacement (SAVR), as well as the experience with the current-generation Sapien 3 TAVR valve in 1,077 intermediate–surgical risk TAVR patients in the S3i registry. The analysis utilized Medicare claims data on the costs of the index hospitalization and follow-up care.
In PARTNER 2A, the average total cost of the index hospitalization for valve replacement was $61,433 with TAVR. That was just $2,888 more than the SAVR hospitalization, despite the far higher acquisition cost of the Sapien 3 valve, which was roughly $32,500, compared with $5,000 for the surgical valve. Most of this additional cost of the TAVR valve was counterbalanced by TAVR’s 2-hour shorter procedural duration, the 6.4-day average length of stay, compared with 10.9 days for SAVR, and the fact that TAVR patients spent only 2.4 days in intensive care while SAVR patients averaged 4.6 days, Dr. Cohen explained at the meeting sponsored by the Cardiovascular Research Foundation.
During 24 months of postdischarge follow-up in the PARTNER 2A trial, SAVR patients racked up an average of $9,303 more in costs than TAVR patients. This was mainly because of their much higher rates of rehospitalization and time spent in skilled nursing facilities and rehabilitation centers, mainly during months 2-6 post discharge. The result was that 2-year total costs including the index hospitalization averaged $107,716 per TAVR patient and $114,132 per SAVR patient.
“One of the really remarkable findings of this study was what happened during follow-up,” the cardiologist observed.
Extrapolating to projected remaining lifetime years, TAVR using the Sapien XT valve resulted in a cost savings of $7,949 per patient and a 0.15-year increase in quality-adjusted life expectancy compared with SAVR.
But since the time of PARTNER 2A, the Sapien XT valve has been replaced by the updated Sapien 3 valve. The analysis of the S3i registry showed that the economic dominance of TAVR over SAVR was even greater owing to improved valve technology and contemporary care patterns. For this analysis, because there has been no randomized trial of TAVR with the Sapien 3 valve versus SAVR, patients in the SAVR of arm of PARTNER 2A served as the comparison group.
The cost of the index hospitalization was more than $4,000 less with TAVR in the S3i registry than with SAVR. The total cost of TAVR through 1 year of follow-up averaged $80,977, which was $15,511 less than the $96,489 for SAVR. The cost post discharge out to 1 year was more than $11,000 less per TAVR patient, driven by sharply lower rates of both cardiovascular and noncardiovascular hospitalizations as well as a greater than 50% reduction in days spent in rehab centers and skilled nursing facilities, compared with SAVR patients.
Projected over estimated remaining years of life, TAVR with the Sapien 3 valve yielded a cost savings of $9,692 per patient compared with SAVR, as well as a 0.27-year gain in quality-adjusted life-years.
Eighty-eight percent of patients in the S3i registry received their Sapien 3 valve via a transfemoral approach. When Dr. Cohen and his coinvestigators compared their costs and clinical outcomes to the subset of PARTNER 2A TAVR patients who got the Sapien XT valve transfemorally, the outcomes were “virtually identical,” he said.
“These findings are reassuring with regard to the S3i results and also suggest that the primary mechanism of benefit of the Sapien 3 valve over the XT valve is its lower profile, which allows roughly 90% of patients to be treated via a transfemoral approach,” according to Dr. Cohen.
He predicted the new cost-effectiveness findings will not substantially increase patient demand for TAVR, which is already high.
“By far what’s driving patients to TAVR today are the quality of life advantages. They love the idea of recovering quickly,” he said.
Michael Mack, MD, commented that this analysis probably underestimates the true cost advantage of TAVR by a fair amount, since the average hospital length of stay for TAVR patients in PARTNER 2A was 6.4 days.
“We now know that half of U.S. TAVR patients in many centers go home the day after the procedure, so you would expect that TAVR would look even more favorable based on current practice,” said Dr. Mack, medical director of cardiovascular surgery for the Baylor Health Care System and chairman of the Heart Hospital Baylor Plano (Tex.) Research Center.
Session moderator Patrick W. Serruys, MD, of Imperial College, London, observed that the cost differential between TAVR and SAVR will grow even larger once the sky-high cost of TAVR valves comes down. He predicted that’s likely to happen as a result of increased competition once a third valve receives marketing approval, just as occurred after a third drug-eluting stent hit the market.
Several physicians grumbled about the unfairness of current reimbursement for TAVR, which in effect penalizes hospitals. Dr. Cohen said that situation will change.
“I think the future of health care financing in the U.S. is bundled payment and accountable care organizations. In the setting of bundled payment for a 6-month period or even for 90 days, TAVR would look fantastic to a hospital or an health maintenance organization due to avoidance of rehospitalizations and rehabilitation and skilled nursing facility stays,” the cardiologist said.
The PARTNER 2A trial, the S3i registry, and the cost-effectiveness analysis were funded by Edwards Lifesciences. Dr. Cohen reported receiving research funding from and serving as a consultant to Edwards Lifesciences and other device companies.
DENVER – A formal cost-effectiveness analysis indicates that transcatheter aortic valve replacement (TAVR) is substantially more cost effective than surgical valve replacement in patients at intermediate surgical risk similar to those enrolled in the landmark PARTNER 2 trial.
The analysis demonstrated that over a 1- and 2-year follow-up period, as well as with projected lifetime follow-up, TAVR entails both lower long-term costs and greater quality-adjusted life expectancy, David J. Cohen, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
His two-part, patient-level economic analysis examined data from nearly 2,000 participants in the PARTNER 2A randomized trial comparing TAVR, using the Sapien XT valve, with surgical aortic valve replacement (SAVR), as well as the experience with the current-generation Sapien 3 TAVR valve in 1,077 intermediate–surgical risk TAVR patients in the S3i registry. The analysis utilized Medicare claims data on the costs of the index hospitalization and follow-up care.
In PARTNER 2A, the average total cost of the index hospitalization for valve replacement was $61,433 with TAVR. That was just $2,888 more than the SAVR hospitalization, despite the far higher acquisition cost of the Sapien 3 valve, which was roughly $32,500, compared with $5,000 for the surgical valve. Most of this additional cost of the TAVR valve was counterbalanced by TAVR’s 2-hour shorter procedural duration, the 6.4-day average length of stay, compared with 10.9 days for SAVR, and the fact that TAVR patients spent only 2.4 days in intensive care while SAVR patients averaged 4.6 days, Dr. Cohen explained at the meeting sponsored by the Cardiovascular Research Foundation.
During 24 months of postdischarge follow-up in the PARTNER 2A trial, SAVR patients racked up an average of $9,303 more in costs than TAVR patients. This was mainly because of their much higher rates of rehospitalization and time spent in skilled nursing facilities and rehabilitation centers, mainly during months 2-6 post discharge. The result was that 2-year total costs including the index hospitalization averaged $107,716 per TAVR patient and $114,132 per SAVR patient.
“One of the really remarkable findings of this study was what happened during follow-up,” the cardiologist observed.
Extrapolating to projected remaining lifetime years, TAVR using the Sapien XT valve resulted in a cost savings of $7,949 per patient and a 0.15-year increase in quality-adjusted life expectancy compared with SAVR.
But since the time of PARTNER 2A, the Sapien XT valve has been replaced by the updated Sapien 3 valve. The analysis of the S3i registry showed that the economic dominance of TAVR over SAVR was even greater owing to improved valve technology and contemporary care patterns. For this analysis, because there has been no randomized trial of TAVR with the Sapien 3 valve versus SAVR, patients in the SAVR of arm of PARTNER 2A served as the comparison group.
The cost of the index hospitalization was more than $4,000 less with TAVR in the S3i registry than with SAVR. The total cost of TAVR through 1 year of follow-up averaged $80,977, which was $15,511 less than the $96,489 for SAVR. The cost post discharge out to 1 year was more than $11,000 less per TAVR patient, driven by sharply lower rates of both cardiovascular and noncardiovascular hospitalizations as well as a greater than 50% reduction in days spent in rehab centers and skilled nursing facilities, compared with SAVR patients.
Projected over estimated remaining years of life, TAVR with the Sapien 3 valve yielded a cost savings of $9,692 per patient compared with SAVR, as well as a 0.27-year gain in quality-adjusted life-years.
Eighty-eight percent of patients in the S3i registry received their Sapien 3 valve via a transfemoral approach. When Dr. Cohen and his coinvestigators compared their costs and clinical outcomes to the subset of PARTNER 2A TAVR patients who got the Sapien XT valve transfemorally, the outcomes were “virtually identical,” he said.
“These findings are reassuring with regard to the S3i results and also suggest that the primary mechanism of benefit of the Sapien 3 valve over the XT valve is its lower profile, which allows roughly 90% of patients to be treated via a transfemoral approach,” according to Dr. Cohen.
He predicted the new cost-effectiveness findings will not substantially increase patient demand for TAVR, which is already high.
“By far what’s driving patients to TAVR today are the quality of life advantages. They love the idea of recovering quickly,” he said.
Michael Mack, MD, commented that this analysis probably underestimates the true cost advantage of TAVR by a fair amount, since the average hospital length of stay for TAVR patients in PARTNER 2A was 6.4 days.
“We now know that half of U.S. TAVR patients in many centers go home the day after the procedure, so you would expect that TAVR would look even more favorable based on current practice,” said Dr. Mack, medical director of cardiovascular surgery for the Baylor Health Care System and chairman of the Heart Hospital Baylor Plano (Tex.) Research Center.
Session moderator Patrick W. Serruys, MD, of Imperial College, London, observed that the cost differential between TAVR and SAVR will grow even larger once the sky-high cost of TAVR valves comes down. He predicted that’s likely to happen as a result of increased competition once a third valve receives marketing approval, just as occurred after a third drug-eluting stent hit the market.
Several physicians grumbled about the unfairness of current reimbursement for TAVR, which in effect penalizes hospitals. Dr. Cohen said that situation will change.
“I think the future of health care financing in the U.S. is bundled payment and accountable care organizations. In the setting of bundled payment for a 6-month period or even for 90 days, TAVR would look fantastic to a hospital or an health maintenance organization due to avoidance of rehospitalizations and rehabilitation and skilled nursing facility stays,” the cardiologist said.
The PARTNER 2A trial, the S3i registry, and the cost-effectiveness analysis were funded by Edwards Lifesciences. Dr. Cohen reported receiving research funding from and serving as a consultant to Edwards Lifesciences and other device companies.
AT TCT 2017
Key clinical point:
Major finding: The total cost of TAVR with the Sapien 3 valve in intermediate-risk patients, including the index hospitalization and costs incurred during the first year after, averaged $80,977, compared with $96,489 per SAVR patient.
Data source: This patient-level formal cost-effectiveness analysis included nearly 2,000 patients in the PARTNER 2A trial and more than 1,700 in a registry of recipients of the Sapien 3 TAVR valve.
Disclosures: The cost-effectiveness analysis was funded by Edwards Lifesciences. The presenter reported receiving research funding from and serving as a consultant to Edwards Lifesciences and other device companies.
U.S. judge orders Philips to cease AED manufacturing
A U.S. District Judge has ordered Philips North America, as well as two Philips officers, to cease manufacturing and distribution of automatic external defibrillators (AEDs) until they can comply with federal regulations in a consent decree, according to a statement from the Food and Drug Administration.
In a complaint filed with the decree, Philips North America in Andover, Mass., which operates as Philips Medical Systems and Philips Healthcare, sold compromised automatic external defibrillators and Q-CPR Meters in violation of current Federal Food, Drug and Cosmetic (FD&C) Act good manufacturing practice requirements. The injunction also applies to Carla Kriwet and Ojas Buch of the Patient Care and Monitoring Solutions business group, according to the statement.
“AEDs are life-saving tools and are designed to be used by the general public or professionals in an emergency. People rely on these devices to work when needed. By not adequately addressing corrective and preventative actions with their AEDs in a timely manner, Philips distributed adulterated products that put people at risk,” Melinda Plaisier, associate commissioner for regulatory affairs at the FDA said in the press release.
In an Oct. 11 statement, Carla Kriwet, head of Connected Care & Health Informatics at Royal Philips, said “We are committed to delivering high-quality, innovative products and solutions, and we take this matter very seriously. We are fully prepared to fulfill the terms of the decree, and we hope to resume the suspended defibrillator production in the course of 2018.”
Ms. Kriwet added that in the past several years Philips has made significant investments in its quality procedures and leadership.
The company recommends that Philips defibrillators currently in use by customers should remain in use, and should not be taken out of service as Philips has no reason to believe they pose a risk to patients.
A U.S. District Judge has ordered Philips North America, as well as two Philips officers, to cease manufacturing and distribution of automatic external defibrillators (AEDs) until they can comply with federal regulations in a consent decree, according to a statement from the Food and Drug Administration.
In a complaint filed with the decree, Philips North America in Andover, Mass., which operates as Philips Medical Systems and Philips Healthcare, sold compromised automatic external defibrillators and Q-CPR Meters in violation of current Federal Food, Drug and Cosmetic (FD&C) Act good manufacturing practice requirements. The injunction also applies to Carla Kriwet and Ojas Buch of the Patient Care and Monitoring Solutions business group, according to the statement.
“AEDs are life-saving tools and are designed to be used by the general public or professionals in an emergency. People rely on these devices to work when needed. By not adequately addressing corrective and preventative actions with their AEDs in a timely manner, Philips distributed adulterated products that put people at risk,” Melinda Plaisier, associate commissioner for regulatory affairs at the FDA said in the press release.
In an Oct. 11 statement, Carla Kriwet, head of Connected Care & Health Informatics at Royal Philips, said “We are committed to delivering high-quality, innovative products and solutions, and we take this matter very seriously. We are fully prepared to fulfill the terms of the decree, and we hope to resume the suspended defibrillator production in the course of 2018.”
Ms. Kriwet added that in the past several years Philips has made significant investments in its quality procedures and leadership.
The company recommends that Philips defibrillators currently in use by customers should remain in use, and should not be taken out of service as Philips has no reason to believe they pose a risk to patients.
A U.S. District Judge has ordered Philips North America, as well as two Philips officers, to cease manufacturing and distribution of automatic external defibrillators (AEDs) until they can comply with federal regulations in a consent decree, according to a statement from the Food and Drug Administration.
In a complaint filed with the decree, Philips North America in Andover, Mass., which operates as Philips Medical Systems and Philips Healthcare, sold compromised automatic external defibrillators and Q-CPR Meters in violation of current Federal Food, Drug and Cosmetic (FD&C) Act good manufacturing practice requirements. The injunction also applies to Carla Kriwet and Ojas Buch of the Patient Care and Monitoring Solutions business group, according to the statement.
“AEDs are life-saving tools and are designed to be used by the general public or professionals in an emergency. People rely on these devices to work when needed. By not adequately addressing corrective and preventative actions with their AEDs in a timely manner, Philips distributed adulterated products that put people at risk,” Melinda Plaisier, associate commissioner for regulatory affairs at the FDA said in the press release.
In an Oct. 11 statement, Carla Kriwet, head of Connected Care & Health Informatics at Royal Philips, said “We are committed to delivering high-quality, innovative products and solutions, and we take this matter very seriously. We are fully prepared to fulfill the terms of the decree, and we hope to resume the suspended defibrillator production in the course of 2018.”
Ms. Kriwet added that in the past several years Philips has made significant investments in its quality procedures and leadership.
The company recommends that Philips defibrillators currently in use by customers should remain in use, and should not be taken out of service as Philips has no reason to believe they pose a risk to patients.
Drug-eluting balloon is as good as drug-eluting stent for in-stent restenosis
DENVER – Treatment of coronary in-stent restenosis using a paclitaxel-eluting balloon proved noninferior to an everolimus-eluting stent in terms of minimal lumen diameter at 6 months in the DARE trial, Jose P.S. Henriques, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The two forms of device therapy also yielded similar rates of adverse clinical events, including target vessel revascularization, at 12 months, he said.
The DARE (Drug-Eluting Balloon for In-Stent Restenosis) trial included 278 patients with in-stent restenosis (ISR) randomized to the SeQuent Please paclitaxel-eluting balloon or Xience everolimus-eluting stent at high-volume Dutch percutaneous coronary intervention centers. The trial was unique in that it included a mix of patients with in-stent restenosis involving DES and bare-metal stents. Indeed, 44% of participants had ISR in a bare-metal stent. These older-model stents are still used in patients who require a shorter duration of dual-antiplatelet therapy, so the DARE population reflects real-world clinical practice better than do prior studies restricted to ISR in only one stent type or the other, according to the cardiologist.
The primary outcome in this noninferiority trial was the in-segment minimal lumen diameter at 6-month angiographic follow-up. The mean diameter was 1.71 mm in the drug-eluting balloon (DEB) group and closely similar at 1.74 mm in the DES group. There was greater acute gain with the drug-eluting stent, but it was canceled out by greater late loss by 6 months.
Moreover, the 12-month composite clinical event rate composed of death, target vessel MI, and target vessel revascularization was 10.9% in the DEB recipients and 9.2% with the DES, a nonsignificant difference. Of note, target vessel revascularization occurred in 8.8% of the DEB group and was similar at 7.1% in the DES recipients, although the DARE trial wasn’t powered to detect differences in clinical events.
These results confirm the European Society of Cardiology’s class 1A recommendation for DEB as well as DES for ISR, Dr. Henriques said at the meeting sponsored by the Cardiovascular Research Foundation.
U.S. guidelines don’t address DEB for the treatment of coronary ISR. That’s because the devices, which have long been available in Europe, aren’t approved for use in the coronary tree in the United States. They are available in the United States only for treatment of peripheral vascular disease. And no U.S. clinical trials of DEBs in the coronary tree are planned.
“I wish the U.S. Food and Drug Administration was listening to the DARE results because we really would like to see this technology in the U.S.,” said Roxana Mehran, MD, who moderated a press conference where the DARE findings were highlighted.
David J. Cohen, MD, director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City, Mo., commented, “This type of device, obviously with it being similar in performance to drug-eluting stents, would be a very welcome addition to our armamentarium, because one of the things I don’t like to do as a coronary interventionalist is to line up multiple stents inside each other.”
“Making club sandwiches out of patients’ arteries with stent after stent is not a good idea. We know that,” added Dr. Mehran, professor of medicine and director of interventional cardiovascular research and clinical trials at Mount Sinai School of Medicine in New York.
Cindy L. Grines, MD, chair of cardiology at the Hofstra Northwell School of Medicine in Hempstead, N.Y., said DEBs “would absolutely be welcome” if they were available to cardiologists in the United States.
“When you have repeated episodes of in-stent restenosis, you can start with a vessel that’s 3 mm in diameter; then when it restenoses and you place a second stent inside there, all of a sudden – even if you have a great stent result – you can be down to 2.25 mm. And then the next time you need to treat it for restenosis, you’re down to a very tiny lumen. That’s the big problem with trying to treat in-stent restenosis with more stents,” she explained.
The DEBs are expensive, and ISR has become so uncommon with the use of the current generation of drug-eluting stents that the device companies have little incentive to do the studies required to be able to market DEBs in the United States.
“I think the FDA should consider in-stent restenosis as an orphan disease. We really should be able to get a drug-eluting balloon approved in this country based on the data over in Europe,” Dr. Grines said.
Dr. Henriques reported receiving research grants from B. Braun, which markets the paclitaxel-eluting stent in Europe, as well as from Abbott Vascular.
DENVER – Treatment of coronary in-stent restenosis using a paclitaxel-eluting balloon proved noninferior to an everolimus-eluting stent in terms of minimal lumen diameter at 6 months in the DARE trial, Jose P.S. Henriques, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The two forms of device therapy also yielded similar rates of adverse clinical events, including target vessel revascularization, at 12 months, he said.
The DARE (Drug-Eluting Balloon for In-Stent Restenosis) trial included 278 patients with in-stent restenosis (ISR) randomized to the SeQuent Please paclitaxel-eluting balloon or Xience everolimus-eluting stent at high-volume Dutch percutaneous coronary intervention centers. The trial was unique in that it included a mix of patients with in-stent restenosis involving DES and bare-metal stents. Indeed, 44% of participants had ISR in a bare-metal stent. These older-model stents are still used in patients who require a shorter duration of dual-antiplatelet therapy, so the DARE population reflects real-world clinical practice better than do prior studies restricted to ISR in only one stent type or the other, according to the cardiologist.
The primary outcome in this noninferiority trial was the in-segment minimal lumen diameter at 6-month angiographic follow-up. The mean diameter was 1.71 mm in the drug-eluting balloon (DEB) group and closely similar at 1.74 mm in the DES group. There was greater acute gain with the drug-eluting stent, but it was canceled out by greater late loss by 6 months.
Moreover, the 12-month composite clinical event rate composed of death, target vessel MI, and target vessel revascularization was 10.9% in the DEB recipients and 9.2% with the DES, a nonsignificant difference. Of note, target vessel revascularization occurred in 8.8% of the DEB group and was similar at 7.1% in the DES recipients, although the DARE trial wasn’t powered to detect differences in clinical events.
These results confirm the European Society of Cardiology’s class 1A recommendation for DEB as well as DES for ISR, Dr. Henriques said at the meeting sponsored by the Cardiovascular Research Foundation.
U.S. guidelines don’t address DEB for the treatment of coronary ISR. That’s because the devices, which have long been available in Europe, aren’t approved for use in the coronary tree in the United States. They are available in the United States only for treatment of peripheral vascular disease. And no U.S. clinical trials of DEBs in the coronary tree are planned.
“I wish the U.S. Food and Drug Administration was listening to the DARE results because we really would like to see this technology in the U.S.,” said Roxana Mehran, MD, who moderated a press conference where the DARE findings were highlighted.
David J. Cohen, MD, director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City, Mo., commented, “This type of device, obviously with it being similar in performance to drug-eluting stents, would be a very welcome addition to our armamentarium, because one of the things I don’t like to do as a coronary interventionalist is to line up multiple stents inside each other.”
“Making club sandwiches out of patients’ arteries with stent after stent is not a good idea. We know that,” added Dr. Mehran, professor of medicine and director of interventional cardiovascular research and clinical trials at Mount Sinai School of Medicine in New York.
Cindy L. Grines, MD, chair of cardiology at the Hofstra Northwell School of Medicine in Hempstead, N.Y., said DEBs “would absolutely be welcome” if they were available to cardiologists in the United States.
“When you have repeated episodes of in-stent restenosis, you can start with a vessel that’s 3 mm in diameter; then when it restenoses and you place a second stent inside there, all of a sudden – even if you have a great stent result – you can be down to 2.25 mm. And then the next time you need to treat it for restenosis, you’re down to a very tiny lumen. That’s the big problem with trying to treat in-stent restenosis with more stents,” she explained.
The DEBs are expensive, and ISR has become so uncommon with the use of the current generation of drug-eluting stents that the device companies have little incentive to do the studies required to be able to market DEBs in the United States.
“I think the FDA should consider in-stent restenosis as an orphan disease. We really should be able to get a drug-eluting balloon approved in this country based on the data over in Europe,” Dr. Grines said.
Dr. Henriques reported receiving research grants from B. Braun, which markets the paclitaxel-eluting stent in Europe, as well as from Abbott Vascular.
DENVER – Treatment of coronary in-stent restenosis using a paclitaxel-eluting balloon proved noninferior to an everolimus-eluting stent in terms of minimal lumen diameter at 6 months in the DARE trial, Jose P.S. Henriques, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The two forms of device therapy also yielded similar rates of adverse clinical events, including target vessel revascularization, at 12 months, he said.
The DARE (Drug-Eluting Balloon for In-Stent Restenosis) trial included 278 patients with in-stent restenosis (ISR) randomized to the SeQuent Please paclitaxel-eluting balloon or Xience everolimus-eluting stent at high-volume Dutch percutaneous coronary intervention centers. The trial was unique in that it included a mix of patients with in-stent restenosis involving DES and bare-metal stents. Indeed, 44% of participants had ISR in a bare-metal stent. These older-model stents are still used in patients who require a shorter duration of dual-antiplatelet therapy, so the DARE population reflects real-world clinical practice better than do prior studies restricted to ISR in only one stent type or the other, according to the cardiologist.
The primary outcome in this noninferiority trial was the in-segment minimal lumen diameter at 6-month angiographic follow-up. The mean diameter was 1.71 mm in the drug-eluting balloon (DEB) group and closely similar at 1.74 mm in the DES group. There was greater acute gain with the drug-eluting stent, but it was canceled out by greater late loss by 6 months.
Moreover, the 12-month composite clinical event rate composed of death, target vessel MI, and target vessel revascularization was 10.9% in the DEB recipients and 9.2% with the DES, a nonsignificant difference. Of note, target vessel revascularization occurred in 8.8% of the DEB group and was similar at 7.1% in the DES recipients, although the DARE trial wasn’t powered to detect differences in clinical events.
These results confirm the European Society of Cardiology’s class 1A recommendation for DEB as well as DES for ISR, Dr. Henriques said at the meeting sponsored by the Cardiovascular Research Foundation.
U.S. guidelines don’t address DEB for the treatment of coronary ISR. That’s because the devices, which have long been available in Europe, aren’t approved for use in the coronary tree in the United States. They are available in the United States only for treatment of peripheral vascular disease. And no U.S. clinical trials of DEBs in the coronary tree are planned.
“I wish the U.S. Food and Drug Administration was listening to the DARE results because we really would like to see this technology in the U.S.,” said Roxana Mehran, MD, who moderated a press conference where the DARE findings were highlighted.
David J. Cohen, MD, director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City, Mo., commented, “This type of device, obviously with it being similar in performance to drug-eluting stents, would be a very welcome addition to our armamentarium, because one of the things I don’t like to do as a coronary interventionalist is to line up multiple stents inside each other.”
“Making club sandwiches out of patients’ arteries with stent after stent is not a good idea. We know that,” added Dr. Mehran, professor of medicine and director of interventional cardiovascular research and clinical trials at Mount Sinai School of Medicine in New York.
Cindy L. Grines, MD, chair of cardiology at the Hofstra Northwell School of Medicine in Hempstead, N.Y., said DEBs “would absolutely be welcome” if they were available to cardiologists in the United States.
“When you have repeated episodes of in-stent restenosis, you can start with a vessel that’s 3 mm in diameter; then when it restenoses and you place a second stent inside there, all of a sudden – even if you have a great stent result – you can be down to 2.25 mm. And then the next time you need to treat it for restenosis, you’re down to a very tiny lumen. That’s the big problem with trying to treat in-stent restenosis with more stents,” she explained.
The DEBs are expensive, and ISR has become so uncommon with the use of the current generation of drug-eluting stents that the device companies have little incentive to do the studies required to be able to market DEBs in the United States.
“I think the FDA should consider in-stent restenosis as an orphan disease. We really should be able to get a drug-eluting balloon approved in this country based on the data over in Europe,” Dr. Grines said.
Dr. Henriques reported receiving research grants from B. Braun, which markets the paclitaxel-eluting stent in Europe, as well as from Abbott Vascular.
AT TCT 2017
Key clinical point:
Major finding: The mean 6-month in-segment minimal lumen diameter following treatment of in-stent restenosis with a paclitaxel-eluting balloon was 1.71 mm and was similar at 1.74 mm in patients treated using an everolimus-eluting stent.
Data source: A prospective, multicenter Dutch randomized trial including 278 patients with in-stent restenosis.
Disclosures: The study was sponsored by the University of Amsterdam and financially supported by a research grant from B. Braun. The presenter reported receiving research grants from that company and Abbott Vascular.
In MI with cardiogenic shock, PCI of only culprit lesions is safer
In patients with acute myocardial infarction and multivessel coronary artery disease with cardiogenic shock, 30-day rates of death and renal-replacement therapy were lower when patients underwent percutaneous coronary intervention (PCI) of the culprit lesion as opposed to multivessel PCI.
The difference appeared to be driven by mortality, as the renal endpoint alone was not significant.
As many as 80% of patients with cardiogenic shock also present with multivessel coronary artery disease, and this is associated with worse mortality. It is unclear whether immediate PCI of clinically important stenoses of major nonculprit coronary arteries is of benefit, and previous randomized trials comparing the procedures did not look at patients with cardiogenic shock, Holger Thiele, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
European guidelines suggest that PCI of nonculprit lesions should be considered in patients with cardiogenic shock, while U.S. guidelines offer no opinion, but recent appropriate use criteria recommend revascularization of a nonculprit artery if cardiogenic shock continues after the culprit artery has been repaired. It is thought that immediate revascularization of all coronary arteries with clinically important stenoses might improve overall myocardial perfusion and function in patients with cardiogenic shock, but the procedure could also have drawbacks, including additional ischemia, volume overload, and renal impairment from higher doses of contrast material.
To better understand outcomes in these patients, the Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) trial randomized 706 patients to culprit-only PCI or multivessel PCI, in which PCI was performed on all major coronary arteries with more than 70% stenosis. Patients receiving culprit-only PCI could also undergo optional staged revascularization due to residual ischemic lesions, symptoms, or clinical or neurologic status.
At 30 days, death and/or renal-replacement therapy occurred in 45.9% of the culprit-only group, compared to 55.4% in the multivessel group (relative risk, 0.83; 95% confidence interval, 0.71-0.96; P = .01). A per-protocol analysis showed similar results (RR, 0.81; 95% CI, 0.69-0.96; P =.01), as did an analysis of the as-treated population (RR, 0.83; 95% CI, 0.72-0.97; P = .02).
All-cause mortality was lower in the culprit-only group (43.3% versus 51.6%; RR, 0.84; 95% CI, 0.72-0.98; P=.03). The rate of renal-replacement therapy was higher in the multivessel group (16.4% versus 11.6%), but this did not reach statistical significance (P = .07).
There were no statistically significant differences between the two groups with respect to recurrent myocardial infarction, rehospitalization for heart failure, bleeding, or stroke, Dr. Thiele reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Some limitations of the study included its unblinded nature, and the fact that 75 patients originally assigned to one treatment category crossed over to the other, including 14 in the culprit-lesion only category who underwent immediate multivessel PCI. This suggests that treatment strategy may need to be adopted to a patient’s clinical circumstances.
The CULPRIT-SHOCK results were published online at the time of Dr. Thiele’s presentation (N Engl J Med. 2017 Oct 30. doi:10/056/NEJMoa1710261).
Several of the study’s authors reported financial ties to the pharmaceutical industry.
This study’s findings reinforce those of previous trials that had suggested that multivessel percutaneous coronary intervention has higher early mortality than culprit-lesion-only PCI.
The study provides compelling evidence that culprit-lesion-only PCI should be the preferred treatment choice over multivessel PCI in patients with cardiogenic shock.
A previous meta-analysis of patients with uncomplicated ST-segment elevation myocardial infarction showed lower rates of mortality or MI with initial multivessel PCI. The disagreement between the two studies suggests that patients with cardiogenic shock may experience greater risk of these adverse outcomes during multivessel PCI procedures.
Future clinical trials should test individual multivessel revascularization strategies to reduce mortality in MI patients with cardiogenic shock, such as coronary artery bypass grafting (CABG) and venoarterial extracorporeal membrane oxygenation (ECMO).
Judith Hochman, MD, and Stuart Katz, MD, of New York University Langone Health, made these comments in an accompanying editorial (N Engl J Med. 2017 Oct 30. doi: 10.1056/nejme1713341). Dr. Hochman had no relevant disclosures. Dr. Katz has consulted for Novartis, Amgen, and Regeneron, and has received funding from Amgen, American Regent, and Janssen.
This study’s findings reinforce those of previous trials that had suggested that multivessel percutaneous coronary intervention has higher early mortality than culprit-lesion-only PCI.
The study provides compelling evidence that culprit-lesion-only PCI should be the preferred treatment choice over multivessel PCI in patients with cardiogenic shock.
A previous meta-analysis of patients with uncomplicated ST-segment elevation myocardial infarction showed lower rates of mortality or MI with initial multivessel PCI. The disagreement between the two studies suggests that patients with cardiogenic shock may experience greater risk of these adverse outcomes during multivessel PCI procedures.
Future clinical trials should test individual multivessel revascularization strategies to reduce mortality in MI patients with cardiogenic shock, such as coronary artery bypass grafting (CABG) and venoarterial extracorporeal membrane oxygenation (ECMO).
Judith Hochman, MD, and Stuart Katz, MD, of New York University Langone Health, made these comments in an accompanying editorial (N Engl J Med. 2017 Oct 30. doi: 10.1056/nejme1713341). Dr. Hochman had no relevant disclosures. Dr. Katz has consulted for Novartis, Amgen, and Regeneron, and has received funding from Amgen, American Regent, and Janssen.
This study’s findings reinforce those of previous trials that had suggested that multivessel percutaneous coronary intervention has higher early mortality than culprit-lesion-only PCI.
The study provides compelling evidence that culprit-lesion-only PCI should be the preferred treatment choice over multivessel PCI in patients with cardiogenic shock.
A previous meta-analysis of patients with uncomplicated ST-segment elevation myocardial infarction showed lower rates of mortality or MI with initial multivessel PCI. The disagreement between the two studies suggests that patients with cardiogenic shock may experience greater risk of these adverse outcomes during multivessel PCI procedures.
Future clinical trials should test individual multivessel revascularization strategies to reduce mortality in MI patients with cardiogenic shock, such as coronary artery bypass grafting (CABG) and venoarterial extracorporeal membrane oxygenation (ECMO).
Judith Hochman, MD, and Stuart Katz, MD, of New York University Langone Health, made these comments in an accompanying editorial (N Engl J Med. 2017 Oct 30. doi: 10.1056/nejme1713341). Dr. Hochman had no relevant disclosures. Dr. Katz has consulted for Novartis, Amgen, and Regeneron, and has received funding from Amgen, American Regent, and Janssen.
In patients with acute myocardial infarction and multivessel coronary artery disease with cardiogenic shock, 30-day rates of death and renal-replacement therapy were lower when patients underwent percutaneous coronary intervention (PCI) of the culprit lesion as opposed to multivessel PCI.
The difference appeared to be driven by mortality, as the renal endpoint alone was not significant.
As many as 80% of patients with cardiogenic shock also present with multivessel coronary artery disease, and this is associated with worse mortality. It is unclear whether immediate PCI of clinically important stenoses of major nonculprit coronary arteries is of benefit, and previous randomized trials comparing the procedures did not look at patients with cardiogenic shock, Holger Thiele, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
European guidelines suggest that PCI of nonculprit lesions should be considered in patients with cardiogenic shock, while U.S. guidelines offer no opinion, but recent appropriate use criteria recommend revascularization of a nonculprit artery if cardiogenic shock continues after the culprit artery has been repaired. It is thought that immediate revascularization of all coronary arteries with clinically important stenoses might improve overall myocardial perfusion and function in patients with cardiogenic shock, but the procedure could also have drawbacks, including additional ischemia, volume overload, and renal impairment from higher doses of contrast material.
To better understand outcomes in these patients, the Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) trial randomized 706 patients to culprit-only PCI or multivessel PCI, in which PCI was performed on all major coronary arteries with more than 70% stenosis. Patients receiving culprit-only PCI could also undergo optional staged revascularization due to residual ischemic lesions, symptoms, or clinical or neurologic status.
At 30 days, death and/or renal-replacement therapy occurred in 45.9% of the culprit-only group, compared to 55.4% in the multivessel group (relative risk, 0.83; 95% confidence interval, 0.71-0.96; P = .01). A per-protocol analysis showed similar results (RR, 0.81; 95% CI, 0.69-0.96; P =.01), as did an analysis of the as-treated population (RR, 0.83; 95% CI, 0.72-0.97; P = .02).
All-cause mortality was lower in the culprit-only group (43.3% versus 51.6%; RR, 0.84; 95% CI, 0.72-0.98; P=.03). The rate of renal-replacement therapy was higher in the multivessel group (16.4% versus 11.6%), but this did not reach statistical significance (P = .07).
There were no statistically significant differences between the two groups with respect to recurrent myocardial infarction, rehospitalization for heart failure, bleeding, or stroke, Dr. Thiele reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Some limitations of the study included its unblinded nature, and the fact that 75 patients originally assigned to one treatment category crossed over to the other, including 14 in the culprit-lesion only category who underwent immediate multivessel PCI. This suggests that treatment strategy may need to be adopted to a patient’s clinical circumstances.
The CULPRIT-SHOCK results were published online at the time of Dr. Thiele’s presentation (N Engl J Med. 2017 Oct 30. doi:10/056/NEJMoa1710261).
Several of the study’s authors reported financial ties to the pharmaceutical industry.
In patients with acute myocardial infarction and multivessel coronary artery disease with cardiogenic shock, 30-day rates of death and renal-replacement therapy were lower when patients underwent percutaneous coronary intervention (PCI) of the culprit lesion as opposed to multivessel PCI.
The difference appeared to be driven by mortality, as the renal endpoint alone was not significant.
As many as 80% of patients with cardiogenic shock also present with multivessel coronary artery disease, and this is associated with worse mortality. It is unclear whether immediate PCI of clinically important stenoses of major nonculprit coronary arteries is of benefit, and previous randomized trials comparing the procedures did not look at patients with cardiogenic shock, Holger Thiele, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
European guidelines suggest that PCI of nonculprit lesions should be considered in patients with cardiogenic shock, while U.S. guidelines offer no opinion, but recent appropriate use criteria recommend revascularization of a nonculprit artery if cardiogenic shock continues after the culprit artery has been repaired. It is thought that immediate revascularization of all coronary arteries with clinically important stenoses might improve overall myocardial perfusion and function in patients with cardiogenic shock, but the procedure could also have drawbacks, including additional ischemia, volume overload, and renal impairment from higher doses of contrast material.
To better understand outcomes in these patients, the Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) trial randomized 706 patients to culprit-only PCI or multivessel PCI, in which PCI was performed on all major coronary arteries with more than 70% stenosis. Patients receiving culprit-only PCI could also undergo optional staged revascularization due to residual ischemic lesions, symptoms, or clinical or neurologic status.
At 30 days, death and/or renal-replacement therapy occurred in 45.9% of the culprit-only group, compared to 55.4% in the multivessel group (relative risk, 0.83; 95% confidence interval, 0.71-0.96; P = .01). A per-protocol analysis showed similar results (RR, 0.81; 95% CI, 0.69-0.96; P =.01), as did an analysis of the as-treated population (RR, 0.83; 95% CI, 0.72-0.97; P = .02).
All-cause mortality was lower in the culprit-only group (43.3% versus 51.6%; RR, 0.84; 95% CI, 0.72-0.98; P=.03). The rate of renal-replacement therapy was higher in the multivessel group (16.4% versus 11.6%), but this did not reach statistical significance (P = .07).
There were no statistically significant differences between the two groups with respect to recurrent myocardial infarction, rehospitalization for heart failure, bleeding, or stroke, Dr. Thiele reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Some limitations of the study included its unblinded nature, and the fact that 75 patients originally assigned to one treatment category crossed over to the other, including 14 in the culprit-lesion only category who underwent immediate multivessel PCI. This suggests that treatment strategy may need to be adopted to a patient’s clinical circumstances.
The CULPRIT-SHOCK results were published online at the time of Dr. Thiele’s presentation (N Engl J Med. 2017 Oct 30. doi:10/056/NEJMoa1710261).
Several of the study’s authors reported financial ties to the pharmaceutical industry.
FROM TCT 2017
Key clinical point: The combined rate of 30-day mortality and renal-replacement therapy was lower when the culprit lesion alone was treated.
Major finding: The culprit-only PCI group had a relative risk of death or renal-replacement therapy of 0.83.
Data source: CULPRIT-SHOCK, a randomized, controlled trial of 706 patients.
Disclosures: Some of the study’s authors reported financial ties to the pharmaceutical industry. Dr. Katz has consulted for Novartis, Amgen, and Regeneron, and has received funding from Amgen, American Regent, and Janssen.
Left main distal bifurcation? Double kiss and crush it
DENVER – A planned two-stent, double-kissing crush PCI technique proved superior to the widely utilized provisional stenting strategy for treatment of unprotected distal left main bifurcation lesions in the randomized DKCRUSH-V trial, Shao-Liang Chen, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
The study randomized 482 patients with unprotected true distal left main bifurcation lesions to one of the two PCI strategies at 26 centers in five countries, including the United States. Roughly 80% of the left main lesions were categorized as Medina 1,1,1.
The primary outcome was the 1-year composite rate of target lesion failure (TLF), defined as cardiac death, target vessel MI, or clinically driven target lesion revascularization. The rate was 10.7% in patients assigned to provisional stenting and 5.0% with double kissing (DK) crush. This clinically and statistically significant difference was driven by a sharp reduction in target vessel MI in the DK crush group: 0.4%, compared with 2.9% in the provisional stenting group.
Moreover, the DK crush group’s 3.8% rate of clinically driven target lesion revascularization and 7.1% rate of angiographic restenosis within the left main complex were both less than half the rates in the provisional stenting group, he added at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The absolute benefit for the DK crush strategy was greatest in the roughly 30% of patients with complex bifurcations, defined as those with an ostial side branch lesion length of at least 10 mm and 70% diameter stenosis while meeting at least two of six minor criteria. The 1-year TLF rate in such patients was 18.2% with provisional stenting versus 7% with DK crush. For simple bifurcations, the TLF rates were 8% versus 1.9%.
The results favored DK crush in all examined subgroups, including those based upon age, gender, SYNTAX score, distal angle, and diabetes status.
Forty-seven percent of patients in the provisional stenting arm received a second stent, typically needed as a bailout for the side branch. Most of the excess target vessel MIs and other TLF events in the provisional stenting group occurred in patients who got a second stent.
The DK crush is an advanced technique with numerous steps involving multiple vessel wirings, rewirings, and stent crushing. It can be challenging to perform. It took an average of 82 minutes, 16 minutes longer than provisional stenting – a difference in procedural time that interventional cardiologists don’t take lightly. It also entailed an average of 36 mL more contrast media than the 191 mL for provisional stenting.
In an earlier multicenter, randomized, prospective trial – DKCRUSH-III – Dr. Chen and his coinvestigators showed that the DK crush technique provides superior outcomes compared with culotte stenting, another widely used treatment strategy for distal left main bifurcation lesions (J Am Coll Cardiol. 2013 Apr 9;61[14]:1482-8).
“The take home message on the surface of the data would be that we should consider this particular two-stent bifurcation technique as perhaps the treatment of choice for true distal bifurcation lesions,” said Gregg W. Stone, MD, who was a coinvestigator in DKCRUSH-V and chaired the late-breaking clinical trial session where Dr. Chen presented the results.
“This technique theoretically gives you the largest amount of laminar flow both in the main vessel and the side branch,” added Dr. Stone, professor of medicine and director of cardiovascular research and education at Columbia University Medical Center in New York.
Simultaneously with Dr. Chen’s presentation at TCT 2017, the DKCRUSH-V results were published online (J Am Coll Cardiol. 2017 Oct 30. doi: 10.1016/j.jacc.2017.09.1066). In an accompanying editorial, Emmanouil S. Brilakis, MD, declared that DK crush should become the preferred strategy for treating unprotected left main bifurcation lesions.
It’s not a technique for the average interventionalist, though. It should be performed in high-volume centers of excellence accustomed to performing complex PCIs. Indeed, the DKCRUSH-V trial required the primary operators to have performed at least 300 PCIs per year for 5 years, including 20 left main PCIs per year or more. To put that in perspective, the median annual PCI volume in the United States is 59 cases, noted Dr. Brilakis of the Minneapolis Heart Institute (J Am Coll Cardiol. 2017 Oct. 30. doi: 10.1016/j.jacc.2017.09.1083).
At TCT 2017 in Denver, not everyone found the DKCRUSH-V findings persuasive.
“I’m quite surprised by the results,” said panel discussant David Hildick-Smith, MD.
“There’s something we have yet to understand about the divergence between the results that are coming out of China and the results coming out of Europe. Almost everything coming out of Europe tends to suggest that provisional stenting is better, while in Chinese hands the DK crush technique has proved to be an extremely successful strategy,” said Dr. Hildick-Smith, professor of interventional cardiology and director of the cardiac research unit at the Brighton and Sussex (England) Medical School.
He added that he intends to reserve judgment as to the preferred strategy until the results of the ongoing European Bifurcation Club Left Main Study (EBC MAIN) become available late in 2018. EBC MAIN is comparing the DK crush, culotte, and other strategies, with the choice of technique left to the operator’s discretion.
The DKCRUSH-V trial was supported by the National Science Foundation of China, the Nanjing Municipal Medical Development Project, Microport, Abbott Vascular, and Medtronic. Dr. Chen and Dr. Stone reported having no financial conflicts of interest regarding the study.
DENVER – A planned two-stent, double-kissing crush PCI technique proved superior to the widely utilized provisional stenting strategy for treatment of unprotected distal left main bifurcation lesions in the randomized DKCRUSH-V trial, Shao-Liang Chen, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
The study randomized 482 patients with unprotected true distal left main bifurcation lesions to one of the two PCI strategies at 26 centers in five countries, including the United States. Roughly 80% of the left main lesions were categorized as Medina 1,1,1.
The primary outcome was the 1-year composite rate of target lesion failure (TLF), defined as cardiac death, target vessel MI, or clinically driven target lesion revascularization. The rate was 10.7% in patients assigned to provisional stenting and 5.0% with double kissing (DK) crush. This clinically and statistically significant difference was driven by a sharp reduction in target vessel MI in the DK crush group: 0.4%, compared with 2.9% in the provisional stenting group.
Moreover, the DK crush group’s 3.8% rate of clinically driven target lesion revascularization and 7.1% rate of angiographic restenosis within the left main complex were both less than half the rates in the provisional stenting group, he added at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The absolute benefit for the DK crush strategy was greatest in the roughly 30% of patients with complex bifurcations, defined as those with an ostial side branch lesion length of at least 10 mm and 70% diameter stenosis while meeting at least two of six minor criteria. The 1-year TLF rate in such patients was 18.2% with provisional stenting versus 7% with DK crush. For simple bifurcations, the TLF rates were 8% versus 1.9%.
The results favored DK crush in all examined subgroups, including those based upon age, gender, SYNTAX score, distal angle, and diabetes status.
Forty-seven percent of patients in the provisional stenting arm received a second stent, typically needed as a bailout for the side branch. Most of the excess target vessel MIs and other TLF events in the provisional stenting group occurred in patients who got a second stent.
The DK crush is an advanced technique with numerous steps involving multiple vessel wirings, rewirings, and stent crushing. It can be challenging to perform. It took an average of 82 minutes, 16 minutes longer than provisional stenting – a difference in procedural time that interventional cardiologists don’t take lightly. It also entailed an average of 36 mL more contrast media than the 191 mL for provisional stenting.
In an earlier multicenter, randomized, prospective trial – DKCRUSH-III – Dr. Chen and his coinvestigators showed that the DK crush technique provides superior outcomes compared with culotte stenting, another widely used treatment strategy for distal left main bifurcation lesions (J Am Coll Cardiol. 2013 Apr 9;61[14]:1482-8).
“The take home message on the surface of the data would be that we should consider this particular two-stent bifurcation technique as perhaps the treatment of choice for true distal bifurcation lesions,” said Gregg W. Stone, MD, who was a coinvestigator in DKCRUSH-V and chaired the late-breaking clinical trial session where Dr. Chen presented the results.
“This technique theoretically gives you the largest amount of laminar flow both in the main vessel and the side branch,” added Dr. Stone, professor of medicine and director of cardiovascular research and education at Columbia University Medical Center in New York.
Simultaneously with Dr. Chen’s presentation at TCT 2017, the DKCRUSH-V results were published online (J Am Coll Cardiol. 2017 Oct 30. doi: 10.1016/j.jacc.2017.09.1066). In an accompanying editorial, Emmanouil S. Brilakis, MD, declared that DK crush should become the preferred strategy for treating unprotected left main bifurcation lesions.
It’s not a technique for the average interventionalist, though. It should be performed in high-volume centers of excellence accustomed to performing complex PCIs. Indeed, the DKCRUSH-V trial required the primary operators to have performed at least 300 PCIs per year for 5 years, including 20 left main PCIs per year or more. To put that in perspective, the median annual PCI volume in the United States is 59 cases, noted Dr. Brilakis of the Minneapolis Heart Institute (J Am Coll Cardiol. 2017 Oct. 30. doi: 10.1016/j.jacc.2017.09.1083).
At TCT 2017 in Denver, not everyone found the DKCRUSH-V findings persuasive.
“I’m quite surprised by the results,” said panel discussant David Hildick-Smith, MD.
“There’s something we have yet to understand about the divergence between the results that are coming out of China and the results coming out of Europe. Almost everything coming out of Europe tends to suggest that provisional stenting is better, while in Chinese hands the DK crush technique has proved to be an extremely successful strategy,” said Dr. Hildick-Smith, professor of interventional cardiology and director of the cardiac research unit at the Brighton and Sussex (England) Medical School.
He added that he intends to reserve judgment as to the preferred strategy until the results of the ongoing European Bifurcation Club Left Main Study (EBC MAIN) become available late in 2018. EBC MAIN is comparing the DK crush, culotte, and other strategies, with the choice of technique left to the operator’s discretion.
The DKCRUSH-V trial was supported by the National Science Foundation of China, the Nanjing Municipal Medical Development Project, Microport, Abbott Vascular, and Medtronic. Dr. Chen and Dr. Stone reported having no financial conflicts of interest regarding the study.
DENVER – A planned two-stent, double-kissing crush PCI technique proved superior to the widely utilized provisional stenting strategy for treatment of unprotected distal left main bifurcation lesions in the randomized DKCRUSH-V trial, Shao-Liang Chen, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
The study randomized 482 patients with unprotected true distal left main bifurcation lesions to one of the two PCI strategies at 26 centers in five countries, including the United States. Roughly 80% of the left main lesions were categorized as Medina 1,1,1.
The primary outcome was the 1-year composite rate of target lesion failure (TLF), defined as cardiac death, target vessel MI, or clinically driven target lesion revascularization. The rate was 10.7% in patients assigned to provisional stenting and 5.0% with double kissing (DK) crush. This clinically and statistically significant difference was driven by a sharp reduction in target vessel MI in the DK crush group: 0.4%, compared with 2.9% in the provisional stenting group.
Moreover, the DK crush group’s 3.8% rate of clinically driven target lesion revascularization and 7.1% rate of angiographic restenosis within the left main complex were both less than half the rates in the provisional stenting group, he added at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The absolute benefit for the DK crush strategy was greatest in the roughly 30% of patients with complex bifurcations, defined as those with an ostial side branch lesion length of at least 10 mm and 70% diameter stenosis while meeting at least two of six minor criteria. The 1-year TLF rate in such patients was 18.2% with provisional stenting versus 7% with DK crush. For simple bifurcations, the TLF rates were 8% versus 1.9%.
The results favored DK crush in all examined subgroups, including those based upon age, gender, SYNTAX score, distal angle, and diabetes status.
Forty-seven percent of patients in the provisional stenting arm received a second stent, typically needed as a bailout for the side branch. Most of the excess target vessel MIs and other TLF events in the provisional stenting group occurred in patients who got a second stent.
The DK crush is an advanced technique with numerous steps involving multiple vessel wirings, rewirings, and stent crushing. It can be challenging to perform. It took an average of 82 minutes, 16 minutes longer than provisional stenting – a difference in procedural time that interventional cardiologists don’t take lightly. It also entailed an average of 36 mL more contrast media than the 191 mL for provisional stenting.
In an earlier multicenter, randomized, prospective trial – DKCRUSH-III – Dr. Chen and his coinvestigators showed that the DK crush technique provides superior outcomes compared with culotte stenting, another widely used treatment strategy for distal left main bifurcation lesions (J Am Coll Cardiol. 2013 Apr 9;61[14]:1482-8).
“The take home message on the surface of the data would be that we should consider this particular two-stent bifurcation technique as perhaps the treatment of choice for true distal bifurcation lesions,” said Gregg W. Stone, MD, who was a coinvestigator in DKCRUSH-V and chaired the late-breaking clinical trial session where Dr. Chen presented the results.
“This technique theoretically gives you the largest amount of laminar flow both in the main vessel and the side branch,” added Dr. Stone, professor of medicine and director of cardiovascular research and education at Columbia University Medical Center in New York.
Simultaneously with Dr. Chen’s presentation at TCT 2017, the DKCRUSH-V results were published online (J Am Coll Cardiol. 2017 Oct 30. doi: 10.1016/j.jacc.2017.09.1066). In an accompanying editorial, Emmanouil S. Brilakis, MD, declared that DK crush should become the preferred strategy for treating unprotected left main bifurcation lesions.
It’s not a technique for the average interventionalist, though. It should be performed in high-volume centers of excellence accustomed to performing complex PCIs. Indeed, the DKCRUSH-V trial required the primary operators to have performed at least 300 PCIs per year for 5 years, including 20 left main PCIs per year or more. To put that in perspective, the median annual PCI volume in the United States is 59 cases, noted Dr. Brilakis of the Minneapolis Heart Institute (J Am Coll Cardiol. 2017 Oct. 30. doi: 10.1016/j.jacc.2017.09.1083).
At TCT 2017 in Denver, not everyone found the DKCRUSH-V findings persuasive.
“I’m quite surprised by the results,” said panel discussant David Hildick-Smith, MD.
“There’s something we have yet to understand about the divergence between the results that are coming out of China and the results coming out of Europe. Almost everything coming out of Europe tends to suggest that provisional stenting is better, while in Chinese hands the DK crush technique has proved to be an extremely successful strategy,” said Dr. Hildick-Smith, professor of interventional cardiology and director of the cardiac research unit at the Brighton and Sussex (England) Medical School.
He added that he intends to reserve judgment as to the preferred strategy until the results of the ongoing European Bifurcation Club Left Main Study (EBC MAIN) become available late in 2018. EBC MAIN is comparing the DK crush, culotte, and other strategies, with the choice of technique left to the operator’s discretion.
The DKCRUSH-V trial was supported by the National Science Foundation of China, the Nanjing Municipal Medical Development Project, Microport, Abbott Vascular, and Medtronic. Dr. Chen and Dr. Stone reported having no financial conflicts of interest regarding the study.
AT TCT 2017
Key clinical point:
Major finding: The 1-year composite rate of target lesion failure in patients treated with the planned two-stent double-kissing crush strategy was 5%, significantly less than the 10.7% rate with provisional stenting.
Data source: The DKCRUSH-V study randomized 482 patients with unprotected true distal left main bifurcation lesions to one of the two PCI strategies at 26 centers in five countries.
Disclosures: The study was supported by the National Science Foundation of China, the Nanjing Municipal Medical Development Project, Microport, Abbott Vascular, and Medtronic. The presenter reported having no financial conflicts of interest.
AF patients without oral anticoagulation face higher dementia risk
BARCELONA – The risk of developing dementia was reduced by 48% in patients with atrial fibrillation who were adherent to oral anticoagulation compared with those who were not, according to a Swedish propensity-matched registry study involving nearly 162,000 patients with the arrhythmia.
The study also addressed whether patients with atrial fibrillation (AF) are better off in terms of reducing their dementia risk if they’re on warfarin versus one of the novel oral anticoagulants. The answer is that it makes absolutely no difference, Leif Friberg, MD, reported at the annual congress of the European Society of Cardiology.
“We found no difference whatsoever in any of the subgroups. It appears that it is more important that you have some kind of oral treatment than exactly what kind to have,” said Dr. Friberg, a cardiologist at the Karolinska Institute in Stockholm.
It’s well established that AF is associated with increased risk of dementia, presumably because the arrhythmia kicks out microemboli that get distributed throughout the brain. But it has been unclear whether oral anticoagulation (OAC) prescribed for stroke prevention has the side benefit of reducing the elevated dementia risk.
“A randomized, controlled trial would be ideal to look at this, but it would be impractical and unethical. Second best [would be] a registry study with propensity matching,” according to Dr. Friberg.
And that’s just what he and his coinvestigators carried out. The study included 80,948 AF patients with no baseline diagnosis of dementia who were prescribed an OAC and an equal number of propensity-matched, dementia-free AF patients not on OAC therapy. During up to 8 years of follow-up, the unadjusted risk of a new diagnosis of dementia was 29% lower in the group on an OAC at baseline.
But the Swedish registries also enabled investigators to zero in on the impact of OAC in patients who were actually medication adherent over time. Dr. Friberg and his coworkers identified a subgroup of 50,406 AF patients who regularly filled their OAC prescriptions and took the medication at least 80% of the time, as well as 48,947 propensity-matched controls who never used OACs. In this on-treatment analysis, the OAC users had a robust 48% relative risk reduction in new diagnosis of dementia. The dementia curves diverged almost immediately and the gap between the two curves continued to widen throughout follow-up. All examined subgroups benefited, regardless of age, gender, AF duration, CHA2DS2-VASc score, or the presence or absence of diabetes, renal failure, or frequent falling.
“This is an important issue,” Dr. Friberg declared. “You may say, ‘What do we care about these findings? These patients are all supposed to be on an oral anticoagulant anyway.’ But you know, patients stop taking their oral anticoagulant. We’re pretty good at initiating treatment when we meet patients for the first time, if they have stroke risk factors, but annually, 10%-15% of patients drop out of treatment. And if patients aren’t concerned enough about their risk of stroke, they might be more concerned about the risk of becoming demented. So these data provide an additional argument for the need to persevere with oral anticoagulation therapy.”
Session cochair Gabriel Tatu-Chitoiu, MD, was skeptical.
“I’ve been working in the atrial fibrillation field for 40 years, and I have to say I haven’t seen a strong dementia possibility in my patients,” said Dr. Tatu-Chitoiu, a cardiologist in Bucharest, Romania, and immediate past president of the Romanian Cardiology Society.
Dr. Friberg replied that AF patients are elderly, and many of them may stop going to their cardiologist when they develop dementia.
“I don’t think you can make extensions from personal experience on this. You have to trust in statistical evidence,” he observed.
Dr. Friberg reported receiving research funding from Bayer, Bristol-Myers Squibb, Pfizer, and Sanofi. However, the registry study was carried out without commercial support.
BARCELONA – The risk of developing dementia was reduced by 48% in patients with atrial fibrillation who were adherent to oral anticoagulation compared with those who were not, according to a Swedish propensity-matched registry study involving nearly 162,000 patients with the arrhythmia.
The study also addressed whether patients with atrial fibrillation (AF) are better off in terms of reducing their dementia risk if they’re on warfarin versus one of the novel oral anticoagulants. The answer is that it makes absolutely no difference, Leif Friberg, MD, reported at the annual congress of the European Society of Cardiology.
“We found no difference whatsoever in any of the subgroups. It appears that it is more important that you have some kind of oral treatment than exactly what kind to have,” said Dr. Friberg, a cardiologist at the Karolinska Institute in Stockholm.
It’s well established that AF is associated with increased risk of dementia, presumably because the arrhythmia kicks out microemboli that get distributed throughout the brain. But it has been unclear whether oral anticoagulation (OAC) prescribed for stroke prevention has the side benefit of reducing the elevated dementia risk.
“A randomized, controlled trial would be ideal to look at this, but it would be impractical and unethical. Second best [would be] a registry study with propensity matching,” according to Dr. Friberg.
And that’s just what he and his coinvestigators carried out. The study included 80,948 AF patients with no baseline diagnosis of dementia who were prescribed an OAC and an equal number of propensity-matched, dementia-free AF patients not on OAC therapy. During up to 8 years of follow-up, the unadjusted risk of a new diagnosis of dementia was 29% lower in the group on an OAC at baseline.
But the Swedish registries also enabled investigators to zero in on the impact of OAC in patients who were actually medication adherent over time. Dr. Friberg and his coworkers identified a subgroup of 50,406 AF patients who regularly filled their OAC prescriptions and took the medication at least 80% of the time, as well as 48,947 propensity-matched controls who never used OACs. In this on-treatment analysis, the OAC users had a robust 48% relative risk reduction in new diagnosis of dementia. The dementia curves diverged almost immediately and the gap between the two curves continued to widen throughout follow-up. All examined subgroups benefited, regardless of age, gender, AF duration, CHA2DS2-VASc score, or the presence or absence of diabetes, renal failure, or frequent falling.
“This is an important issue,” Dr. Friberg declared. “You may say, ‘What do we care about these findings? These patients are all supposed to be on an oral anticoagulant anyway.’ But you know, patients stop taking their oral anticoagulant. We’re pretty good at initiating treatment when we meet patients for the first time, if they have stroke risk factors, but annually, 10%-15% of patients drop out of treatment. And if patients aren’t concerned enough about their risk of stroke, they might be more concerned about the risk of becoming demented. So these data provide an additional argument for the need to persevere with oral anticoagulation therapy.”
Session cochair Gabriel Tatu-Chitoiu, MD, was skeptical.
“I’ve been working in the atrial fibrillation field for 40 years, and I have to say I haven’t seen a strong dementia possibility in my patients,” said Dr. Tatu-Chitoiu, a cardiologist in Bucharest, Romania, and immediate past president of the Romanian Cardiology Society.
Dr. Friberg replied that AF patients are elderly, and many of them may stop going to their cardiologist when they develop dementia.
“I don’t think you can make extensions from personal experience on this. You have to trust in statistical evidence,” he observed.
Dr. Friberg reported receiving research funding from Bayer, Bristol-Myers Squibb, Pfizer, and Sanofi. However, the registry study was carried out without commercial support.
BARCELONA – The risk of developing dementia was reduced by 48% in patients with atrial fibrillation who were adherent to oral anticoagulation compared with those who were not, according to a Swedish propensity-matched registry study involving nearly 162,000 patients with the arrhythmia.
The study also addressed whether patients with atrial fibrillation (AF) are better off in terms of reducing their dementia risk if they’re on warfarin versus one of the novel oral anticoagulants. The answer is that it makes absolutely no difference, Leif Friberg, MD, reported at the annual congress of the European Society of Cardiology.
“We found no difference whatsoever in any of the subgroups. It appears that it is more important that you have some kind of oral treatment than exactly what kind to have,” said Dr. Friberg, a cardiologist at the Karolinska Institute in Stockholm.
It’s well established that AF is associated with increased risk of dementia, presumably because the arrhythmia kicks out microemboli that get distributed throughout the brain. But it has been unclear whether oral anticoagulation (OAC) prescribed for stroke prevention has the side benefit of reducing the elevated dementia risk.
“A randomized, controlled trial would be ideal to look at this, but it would be impractical and unethical. Second best [would be] a registry study with propensity matching,” according to Dr. Friberg.
And that’s just what he and his coinvestigators carried out. The study included 80,948 AF patients with no baseline diagnosis of dementia who were prescribed an OAC and an equal number of propensity-matched, dementia-free AF patients not on OAC therapy. During up to 8 years of follow-up, the unadjusted risk of a new diagnosis of dementia was 29% lower in the group on an OAC at baseline.
But the Swedish registries also enabled investigators to zero in on the impact of OAC in patients who were actually medication adherent over time. Dr. Friberg and his coworkers identified a subgroup of 50,406 AF patients who regularly filled their OAC prescriptions and took the medication at least 80% of the time, as well as 48,947 propensity-matched controls who never used OACs. In this on-treatment analysis, the OAC users had a robust 48% relative risk reduction in new diagnosis of dementia. The dementia curves diverged almost immediately and the gap between the two curves continued to widen throughout follow-up. All examined subgroups benefited, regardless of age, gender, AF duration, CHA2DS2-VASc score, or the presence or absence of diabetes, renal failure, or frequent falling.
“This is an important issue,” Dr. Friberg declared. “You may say, ‘What do we care about these findings? These patients are all supposed to be on an oral anticoagulant anyway.’ But you know, patients stop taking their oral anticoagulant. We’re pretty good at initiating treatment when we meet patients for the first time, if they have stroke risk factors, but annually, 10%-15% of patients drop out of treatment. And if patients aren’t concerned enough about their risk of stroke, they might be more concerned about the risk of becoming demented. So these data provide an additional argument for the need to persevere with oral anticoagulation therapy.”
Session cochair Gabriel Tatu-Chitoiu, MD, was skeptical.
“I’ve been working in the atrial fibrillation field for 40 years, and I have to say I haven’t seen a strong dementia possibility in my patients,” said Dr. Tatu-Chitoiu, a cardiologist in Bucharest, Romania, and immediate past president of the Romanian Cardiology Society.
Dr. Friberg replied that AF patients are elderly, and many of them may stop going to their cardiologist when they develop dementia.
“I don’t think you can make extensions from personal experience on this. You have to trust in statistical evidence,” he observed.
Dr. Friberg reported receiving research funding from Bayer, Bristol-Myers Squibb, Pfizer, and Sanofi. However, the registry study was carried out without commercial support.
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: The risk of new diagnosis of dementia during up to 8 years of follow-up was 48% lower in AF patients on an oral anticoagulant at least 80% of the time, compared with those not on the medication.
Data source: This was a Swedish registry study including nearly 162,000 propensity-matched patients with atrial fibrillation free of baseline dementia.
Disclosures: The study was conducted without commercial support.
PCI advances produce CABG-like 1-year outcomes
BARCELONA – Improvements in percutaneous coronary intervention over the past decade have made a difference. Coronary stenting to treat triple-vessel disease produced roughly the same 1-year results as coronary artery bypass surgery, based on results from 454 patients in an uncontrolled, prospective trial.
With state-of-the-art percutaneous coronary intervention (PCI), the 1-year incidence of major cardiac and cerebrovascular events was 11% in the Synergy Between PCI with Taxus and Cardiac Surgery (SYNTAX) II trial, a PCI outcome substantially better than the 18% rate with PCI seen in the original SYNTAX trial, run during 2005-2007. That incidence was similar to the 11% 1-year major adverse event rate seen in patients who underwent coronary artery bypass grafting (CABG) in the first SYNTAX trial (N Engl J Med. 2009 Mar 5;360[10]:961-72), said Javier Escaned, MD, who reported the results at the annual congress of the European Society of Cardiology.
- Initial assessment of patients using both clinical and anatomic criteria with the SYNTAX score II (Lancet. 2013 Feb 23;381[9867]:639-50), an improvement over the original SYNTAX score that only used anatomic data.
- Assessment of each coronary stenosis for its physiologic impact using a pressure wire to measure the instantaneous wave-free ratio and fractional flow reserve of each suspicious lesion.
- Performing PCI with a second-generation everolimus-eluting stent with a bioabsorbable polymer stent (Synergy) instead of the paclitaxel-eluting first-generation stent (Taxus) used in the first SYNTAX trial.
- Optimization of stent placement with intravascular ultrasound.
- Application of contemporary methods for treating total chronic occlusions that produce higher success rates than a decade ago.
- Prescription of current guideline-directed medical therapy to each patient following PCI.
“To get the best results you need to do all of this; none of these steps takes full credit by itself,” said Dr. Escaned, an interventional cardiologist at the Hospital Clinic San Carlos in Madrid. “The message from SYNTAX II is that if you put all of these steps together, this is the result,” he said in an interview.
An underlying assumption of the single-arm design of SYNTAX II and its “exploratory” comparison to a 334-patient subset of the 897 patients who underwent CABG in the original SYNTAX trial who retrospectively met the SYNTAX score II enrollment criteria used in the current trial was that “CABG has not changed much” since the first SYNTAX trial, Dr. Escaned said. Although he acknowledged that some progress also occurred with CABG in the subsequent 10 years, “it has not been as big a change” as going to second-generation drug-eluting stents, using a pressure wire assessment to target physiologically important stenoses, and improved techniques for treating chronic total occlusions that have nearly doubled success rates in patients with these lesions.
The SYNTAX II trial enrolled 454 patients with de novo triple-vessel coronary disease without left main stem involvement at 22 centers in four European countries during 2014 and 2015. The improvement in the primary 1-year endpoint in the current patients compared with PCI patients from the first SYNTAX trial was driven primarily by reductions in MI and in repeat revascularizations. The SYNTAX II patients also had a 0.7% rate of definite stent thrombosis events, compared with a 2.4% rate in the original SYNTAX PCI patients, a statistically significant difference. Concurrently with Dr. Escaned’s report at the meeting an article with the results appeared online (Eur Heart J. 2017 Aug 26;doi: 10.1093/eurheartj/ehx512).
Dr. Escaned cautioned that longer-term follow-up is needed to more fully compare the PCI results with CABG.
SYNTAX II received unrestricted grant support from Philips/Volcano and Boston Scientific, the companies that market the pressure wires and stents used in the study. Dr. Escaned reported ties to Abbott, AstraZeneca, Biosensors, Boston Scientific, Medtronic, OrbusNeich, Philips/Volcano, and Boston Scientific.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
BARCELONA – Improvements in percutaneous coronary intervention over the past decade have made a difference. Coronary stenting to treat triple-vessel disease produced roughly the same 1-year results as coronary artery bypass surgery, based on results from 454 patients in an uncontrolled, prospective trial.
With state-of-the-art percutaneous coronary intervention (PCI), the 1-year incidence of major cardiac and cerebrovascular events was 11% in the Synergy Between PCI with Taxus and Cardiac Surgery (SYNTAX) II trial, a PCI outcome substantially better than the 18% rate with PCI seen in the original SYNTAX trial, run during 2005-2007. That incidence was similar to the 11% 1-year major adverse event rate seen in patients who underwent coronary artery bypass grafting (CABG) in the first SYNTAX trial (N Engl J Med. 2009 Mar 5;360[10]:961-72), said Javier Escaned, MD, who reported the results at the annual congress of the European Society of Cardiology.
- Initial assessment of patients using both clinical and anatomic criteria with the SYNTAX score II (Lancet. 2013 Feb 23;381[9867]:639-50), an improvement over the original SYNTAX score that only used anatomic data.
- Assessment of each coronary stenosis for its physiologic impact using a pressure wire to measure the instantaneous wave-free ratio and fractional flow reserve of each suspicious lesion.
- Performing PCI with a second-generation everolimus-eluting stent with a bioabsorbable polymer stent (Synergy) instead of the paclitaxel-eluting first-generation stent (Taxus) used in the first SYNTAX trial.
- Optimization of stent placement with intravascular ultrasound.
- Application of contemporary methods for treating total chronic occlusions that produce higher success rates than a decade ago.
- Prescription of current guideline-directed medical therapy to each patient following PCI.
“To get the best results you need to do all of this; none of these steps takes full credit by itself,” said Dr. Escaned, an interventional cardiologist at the Hospital Clinic San Carlos in Madrid. “The message from SYNTAX II is that if you put all of these steps together, this is the result,” he said in an interview.
An underlying assumption of the single-arm design of SYNTAX II and its “exploratory” comparison to a 334-patient subset of the 897 patients who underwent CABG in the original SYNTAX trial who retrospectively met the SYNTAX score II enrollment criteria used in the current trial was that “CABG has not changed much” since the first SYNTAX trial, Dr. Escaned said. Although he acknowledged that some progress also occurred with CABG in the subsequent 10 years, “it has not been as big a change” as going to second-generation drug-eluting stents, using a pressure wire assessment to target physiologically important stenoses, and improved techniques for treating chronic total occlusions that have nearly doubled success rates in patients with these lesions.
The SYNTAX II trial enrolled 454 patients with de novo triple-vessel coronary disease without left main stem involvement at 22 centers in four European countries during 2014 and 2015. The improvement in the primary 1-year endpoint in the current patients compared with PCI patients from the first SYNTAX trial was driven primarily by reductions in MI and in repeat revascularizations. The SYNTAX II patients also had a 0.7% rate of definite stent thrombosis events, compared with a 2.4% rate in the original SYNTAX PCI patients, a statistically significant difference. Concurrently with Dr. Escaned’s report at the meeting an article with the results appeared online (Eur Heart J. 2017 Aug 26;doi: 10.1093/eurheartj/ehx512).
Dr. Escaned cautioned that longer-term follow-up is needed to more fully compare the PCI results with CABG.
SYNTAX II received unrestricted grant support from Philips/Volcano and Boston Scientific, the companies that market the pressure wires and stents used in the study. Dr. Escaned reported ties to Abbott, AstraZeneca, Biosensors, Boston Scientific, Medtronic, OrbusNeich, Philips/Volcano, and Boston Scientific.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
BARCELONA – Improvements in percutaneous coronary intervention over the past decade have made a difference. Coronary stenting to treat triple-vessel disease produced roughly the same 1-year results as coronary artery bypass surgery, based on results from 454 patients in an uncontrolled, prospective trial.
With state-of-the-art percutaneous coronary intervention (PCI), the 1-year incidence of major cardiac and cerebrovascular events was 11% in the Synergy Between PCI with Taxus and Cardiac Surgery (SYNTAX) II trial, a PCI outcome substantially better than the 18% rate with PCI seen in the original SYNTAX trial, run during 2005-2007. That incidence was similar to the 11% 1-year major adverse event rate seen in patients who underwent coronary artery bypass grafting (CABG) in the first SYNTAX trial (N Engl J Med. 2009 Mar 5;360[10]:961-72), said Javier Escaned, MD, who reported the results at the annual congress of the European Society of Cardiology.
- Initial assessment of patients using both clinical and anatomic criteria with the SYNTAX score II (Lancet. 2013 Feb 23;381[9867]:639-50), an improvement over the original SYNTAX score that only used anatomic data.
- Assessment of each coronary stenosis for its physiologic impact using a pressure wire to measure the instantaneous wave-free ratio and fractional flow reserve of each suspicious lesion.
- Performing PCI with a second-generation everolimus-eluting stent with a bioabsorbable polymer stent (Synergy) instead of the paclitaxel-eluting first-generation stent (Taxus) used in the first SYNTAX trial.
- Optimization of stent placement with intravascular ultrasound.
- Application of contemporary methods for treating total chronic occlusions that produce higher success rates than a decade ago.
- Prescription of current guideline-directed medical therapy to each patient following PCI.
“To get the best results you need to do all of this; none of these steps takes full credit by itself,” said Dr. Escaned, an interventional cardiologist at the Hospital Clinic San Carlos in Madrid. “The message from SYNTAX II is that if you put all of these steps together, this is the result,” he said in an interview.
An underlying assumption of the single-arm design of SYNTAX II and its “exploratory” comparison to a 334-patient subset of the 897 patients who underwent CABG in the original SYNTAX trial who retrospectively met the SYNTAX score II enrollment criteria used in the current trial was that “CABG has not changed much” since the first SYNTAX trial, Dr. Escaned said. Although he acknowledged that some progress also occurred with CABG in the subsequent 10 years, “it has not been as big a change” as going to second-generation drug-eluting stents, using a pressure wire assessment to target physiologically important stenoses, and improved techniques for treating chronic total occlusions that have nearly doubled success rates in patients with these lesions.
The SYNTAX II trial enrolled 454 patients with de novo triple-vessel coronary disease without left main stem involvement at 22 centers in four European countries during 2014 and 2015. The improvement in the primary 1-year endpoint in the current patients compared with PCI patients from the first SYNTAX trial was driven primarily by reductions in MI and in repeat revascularizations. The SYNTAX II patients also had a 0.7% rate of definite stent thrombosis events, compared with a 2.4% rate in the original SYNTAX PCI patients, a statistically significant difference. Concurrently with Dr. Escaned’s report at the meeting an article with the results appeared online (Eur Heart J. 2017 Aug 26;doi: 10.1093/eurheartj/ehx512).
Dr. Escaned cautioned that longer-term follow-up is needed to more fully compare the PCI results with CABG.
SYNTAX II received unrestricted grant support from Philips/Volcano and Boston Scientific, the companies that market the pressure wires and stents used in the study. Dr. Escaned reported ties to Abbott, AstraZeneca, Biosensors, Boston Scientific, Medtronic, OrbusNeich, Philips/Volcano, and Boston Scientific.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: At 1 year, the combined major adverse event rate was 11%, similar to the CABG rate in the original SYNTAX trial.
Data source: SYNTAX II, a prospective, multicenter, single-arm study with 454 patients.
Disclosures: SYNTAX II received unrestricted grant support from Philips/Volcano and Boston Scientific, the companies that market the pressure wires and stents used in the study. Dr. Escaned reported ties to Abbott, AstraZeneca, Biosensors, Boston Scientific, Medtronic, OrbusNeich, Philips/Volcano, and Boston Scientific.
Abnormal potassium plus suspected ACS spell trouble
BARCELONA – A serum potassium level of at least 5.0 mmol/L or 3.5 mmol/L or less at admission for suspected acute coronary syndrome is a red flag for increased risk of in-hospital mortality and cardiac arrest, according to a Swedish study of nearly 33,000 consecutive patients.
That’s true even if, as so often ultimately proves to be the case, the patient turns out not to have ACS, Jonas Faxén, MD, of the Karolinska Institute, Stockholm, reported at the annual congress of the European Society of Cardiology.
“This study highlights that, if you have a patient in the emergency department with a possible ACS and potassium imbalance, you should really be cautious,” Dr. Faxén said.
He reported on 32,955 consecutive patients admitted to Stockholm County hospitals for suspected ACS during 2006-2011 and thereby enrolled in the SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry.
Overall in-hospital mortality was 2.7%. In-hospital cardiac arrest occurred in 1.5% of patients. New-onset atrial fibrillation occurred in 2.4% of patients. These key outcomes were compared between the reference group – defined as patients with an admission serum potassium of 3.5 to less than 4.0 mmol/L – and patients with an admission serum potassium above or below those cutoffs.
In a multivariate logistic regression analysis adjusted for 24 potential confounders, including demographics, presentation characteristics, main diagnosis, comorbid conditions, medications on admission, and estimated glomerular filtration rate, patients with a serum potassium of 5.0 to less than 5.5 mmol/L were at 1.8-fold increased risk of in-hospital mortality. Those with a potassium of 5.5 mmol/L or greater were at 2.3-fold increased risk.
In contrast, a low rather than a high serum potassium was an independent risk factor cardiac arrest. An admission potassium of 3.0 to less than 3.5 mmol/L carried a 1.8-fold increased risk of in-hospital cardiac arrest, while a potassium of less than 3.0 was associated with a 2.7-fold increased risk.
A serum potassium below 3.0 mmol/L at admission also was associated with a 1.7-fold increased risk of new-onset atrial fibrillation.
These elevated risks of bad outcomes didn’t differ significantly between patients with ST-elevation MI, non-STEMI ACS, and those whose final diagnosis was not ACS, Dr. Faxén noted.
Session cochair David W. Walker, MD, medical director of the East Sussex (England) Healthcare NHS Trust, observed, “When I was a junior doctor I was always taught that when patients came onto coronary care we had to get their potassium to 4.5-5.0 mmol/L. I think you might want to change that advice now.”
“The implication would be that, if you intervene quickly in a patient with an abnormal potassium level, you might make a difference. Clearly, a potassium that’s too high is much worse than too low, since patients with in-hospital cardiac arrest can often be resuscitated,” Dr. Walker commented.
Dr. Faxén reported having no financial conflicts regarding his study, which was funded by the Swedish Heart and Lung Foundation and the Stockholm County Council.
BARCELONA – A serum potassium level of at least 5.0 mmol/L or 3.5 mmol/L or less at admission for suspected acute coronary syndrome is a red flag for increased risk of in-hospital mortality and cardiac arrest, according to a Swedish study of nearly 33,000 consecutive patients.
That’s true even if, as so often ultimately proves to be the case, the patient turns out not to have ACS, Jonas Faxén, MD, of the Karolinska Institute, Stockholm, reported at the annual congress of the European Society of Cardiology.
“This study highlights that, if you have a patient in the emergency department with a possible ACS and potassium imbalance, you should really be cautious,” Dr. Faxén said.
He reported on 32,955 consecutive patients admitted to Stockholm County hospitals for suspected ACS during 2006-2011 and thereby enrolled in the SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry.
Overall in-hospital mortality was 2.7%. In-hospital cardiac arrest occurred in 1.5% of patients. New-onset atrial fibrillation occurred in 2.4% of patients. These key outcomes were compared between the reference group – defined as patients with an admission serum potassium of 3.5 to less than 4.0 mmol/L – and patients with an admission serum potassium above or below those cutoffs.
In a multivariate logistic regression analysis adjusted for 24 potential confounders, including demographics, presentation characteristics, main diagnosis, comorbid conditions, medications on admission, and estimated glomerular filtration rate, patients with a serum potassium of 5.0 to less than 5.5 mmol/L were at 1.8-fold increased risk of in-hospital mortality. Those with a potassium of 5.5 mmol/L or greater were at 2.3-fold increased risk.
In contrast, a low rather than a high serum potassium was an independent risk factor cardiac arrest. An admission potassium of 3.0 to less than 3.5 mmol/L carried a 1.8-fold increased risk of in-hospital cardiac arrest, while a potassium of less than 3.0 was associated with a 2.7-fold increased risk.
A serum potassium below 3.0 mmol/L at admission also was associated with a 1.7-fold increased risk of new-onset atrial fibrillation.
These elevated risks of bad outcomes didn’t differ significantly between patients with ST-elevation MI, non-STEMI ACS, and those whose final diagnosis was not ACS, Dr. Faxén noted.
Session cochair David W. Walker, MD, medical director of the East Sussex (England) Healthcare NHS Trust, observed, “When I was a junior doctor I was always taught that when patients came onto coronary care we had to get their potassium to 4.5-5.0 mmol/L. I think you might want to change that advice now.”
“The implication would be that, if you intervene quickly in a patient with an abnormal potassium level, you might make a difference. Clearly, a potassium that’s too high is much worse than too low, since patients with in-hospital cardiac arrest can often be resuscitated,” Dr. Walker commented.
Dr. Faxén reported having no financial conflicts regarding his study, which was funded by the Swedish Heart and Lung Foundation and the Stockholm County Council.
BARCELONA – A serum potassium level of at least 5.0 mmol/L or 3.5 mmol/L or less at admission for suspected acute coronary syndrome is a red flag for increased risk of in-hospital mortality and cardiac arrest, according to a Swedish study of nearly 33,000 consecutive patients.
That’s true even if, as so often ultimately proves to be the case, the patient turns out not to have ACS, Jonas Faxén, MD, of the Karolinska Institute, Stockholm, reported at the annual congress of the European Society of Cardiology.
“This study highlights that, if you have a patient in the emergency department with a possible ACS and potassium imbalance, you should really be cautious,” Dr. Faxén said.
He reported on 32,955 consecutive patients admitted to Stockholm County hospitals for suspected ACS during 2006-2011 and thereby enrolled in the SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry.
Overall in-hospital mortality was 2.7%. In-hospital cardiac arrest occurred in 1.5% of patients. New-onset atrial fibrillation occurred in 2.4% of patients. These key outcomes were compared between the reference group – defined as patients with an admission serum potassium of 3.5 to less than 4.0 mmol/L – and patients with an admission serum potassium above or below those cutoffs.
In a multivariate logistic regression analysis adjusted for 24 potential confounders, including demographics, presentation characteristics, main diagnosis, comorbid conditions, medications on admission, and estimated glomerular filtration rate, patients with a serum potassium of 5.0 to less than 5.5 mmol/L were at 1.8-fold increased risk of in-hospital mortality. Those with a potassium of 5.5 mmol/L or greater were at 2.3-fold increased risk.
In contrast, a low rather than a high serum potassium was an independent risk factor cardiac arrest. An admission potassium of 3.0 to less than 3.5 mmol/L carried a 1.8-fold increased risk of in-hospital cardiac arrest, while a potassium of less than 3.0 was associated with a 2.7-fold increased risk.
A serum potassium below 3.0 mmol/L at admission also was associated with a 1.7-fold increased risk of new-onset atrial fibrillation.
These elevated risks of bad outcomes didn’t differ significantly between patients with ST-elevation MI, non-STEMI ACS, and those whose final diagnosis was not ACS, Dr. Faxén noted.
Session cochair David W. Walker, MD, medical director of the East Sussex (England) Healthcare NHS Trust, observed, “When I was a junior doctor I was always taught that when patients came onto coronary care we had to get their potassium to 4.5-5.0 mmol/L. I think you might want to change that advice now.”
“The implication would be that, if you intervene quickly in a patient with an abnormal potassium level, you might make a difference. Clearly, a potassium that’s too high is much worse than too low, since patients with in-hospital cardiac arrest can often be resuscitated,” Dr. Walker commented.
Dr. Faxén reported having no financial conflicts regarding his study, which was funded by the Swedish Heart and Lung Foundation and the Stockholm County Council.
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: Hyperkalemia of 5.0 to less than 5.5 mmol/L at admission for suspected ACS was associated with close to a twofold increased risk of in-hospital mortality.
Data source: The SWEDEHEART study is an ongoing prospective registry of patients with cardiovascular disease admitted to Stockholm County hospitals.
Disclosures: The presenter reported having no financial conflicts regarding his study, which was funded by the Swedish Heart and Lung Foundation and the Stockholm County Council.
New appropriate use criteria reframe severe aortic stenosis
New appropriate use criteria (AUC) for severe aortic stenosis (AS) run the full gamut of clinical scenarios and treatment options.
“Cardiology is seeing a radical change in the management of aortic stenosis. This new document incorporates all therapies currently available in the world,” said Vinod H. Thourani, MD, who served on the AUC’s writing group on behalf of the American College of Cardiology. “The AUC highlights state-of-the-art therapy for aortic stenosis and, even more importantly, helps clarify the right indications for surgical and transcatheter valve replacement.”
Surgical risk is assessed based on the Society of Thoracic Surgeons Predicted Risk of Mortality score plus additional anatomic and functional considerations that should be assessed by a multidisciplinary heart team. The AUC repeatedly emphasizes this team’s importance. “Multiple comorbidities can change the pathway of treating AS, and this determination is best made by a heart team that at least includes a noninvasive cardiologist, an interventional cardiologist, and a cardiac surgeon,” Dr. Thourani said. “That’s how patients get the best care.”
Historically, aortic stenosis typically was managed medically or with balloon aortic valvuloplasty (BAV) or open aortic valve replacement, Dr. Thourani said. However, BAV is less common now, and indications for surgical or transcatheter aortic valve replacement (SAVR or TAVR) are expanding. Balloon aortic valvuloplasty sometimes does provide palliative treatment or serve as a bridge to a decision, the AUC states. For example, for a high-risk patient with severe aortic stenosis and severe secondary mitral regurgitation, BAV can help the heart team decide whether TAVR alone will improve mitral regurgitation or whether a double valve procedure is preferable.
Regardless of risk score, the AUC considers a wait-and-see approach as potentially appropriate for patients with asymptomatic high-grade AS whose left ventricular ejection fraction is at least 50%, peak aortic valve velocity is 4.0-4.9 m/sec, and exercise stress test is normal and with no predictors of symptom onset or rapid progression. Asymptomatic patients who are likely to become symptomatic but who have a low risk of sudden death are candidates for intervention (rated “appropriate”) or medical management (“may be appropriate”). In contrast, a positive stress test in an otherwise asymptomatic patient merits consideration of SAVR or TAVR regardless of surgical risk. The recommendations for asymptomatic patients reflect a lack of head-to-head trials in this population, Dr. Thourani said. “We don’t have good randomized data to show one therapy is better than another.”
Symptomatic, high-gradient, severe AS with associated coronary artery disease merits consideration of SAVR with coronary artery bypass graft or, in some cases, TAVR with percutaneous coronary intervention, according to the AUC. Less evidence supports SAVR with PCI. “Optimal management of coronary artery disease in patients with AS is a complex decision process requiring clinical, anatomical, and technical considerations that is best achieved with close collaboration between heart team members,” the authors stress.
The document covers other valvular and structural heart conditions that commonly accompany severe AS, such as symptomatic AS with bicuspid aortic valve and ascending aortic dilation. “Although there remains an increasing prevalence of transcatheter valve usage in bicuspid aortic valve, the standard of care remains surgical therapy, especially in patients who have a dilated aorta,” Dr. Thourani said.
For the first time, the AUC also addresses failing aortic valve prostheses, presenting six relevant clinical scenarios. The AUC consistently recommends SAVR, although the use of TAVR has “dramatically increased” in these patients, Dr. Thourani said. “Long-term data are still pending, but TAVR appears to be a less morbid procedure, when done appropriately.”
The societies involved in creating the AUC statement were the American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Valve Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons.
Dr. Thourani disclosed ties to Edwards Lifesciences, St. Jude Medical, Abbott, Boston Scientific, and Medtronic.
New appropriate use criteria (AUC) for severe aortic stenosis (AS) run the full gamut of clinical scenarios and treatment options.
“Cardiology is seeing a radical change in the management of aortic stenosis. This new document incorporates all therapies currently available in the world,” said Vinod H. Thourani, MD, who served on the AUC’s writing group on behalf of the American College of Cardiology. “The AUC highlights state-of-the-art therapy for aortic stenosis and, even more importantly, helps clarify the right indications for surgical and transcatheter valve replacement.”
Surgical risk is assessed based on the Society of Thoracic Surgeons Predicted Risk of Mortality score plus additional anatomic and functional considerations that should be assessed by a multidisciplinary heart team. The AUC repeatedly emphasizes this team’s importance. “Multiple comorbidities can change the pathway of treating AS, and this determination is best made by a heart team that at least includes a noninvasive cardiologist, an interventional cardiologist, and a cardiac surgeon,” Dr. Thourani said. “That’s how patients get the best care.”
Historically, aortic stenosis typically was managed medically or with balloon aortic valvuloplasty (BAV) or open aortic valve replacement, Dr. Thourani said. However, BAV is less common now, and indications for surgical or transcatheter aortic valve replacement (SAVR or TAVR) are expanding. Balloon aortic valvuloplasty sometimes does provide palliative treatment or serve as a bridge to a decision, the AUC states. For example, for a high-risk patient with severe aortic stenosis and severe secondary mitral regurgitation, BAV can help the heart team decide whether TAVR alone will improve mitral regurgitation or whether a double valve procedure is preferable.
Regardless of risk score, the AUC considers a wait-and-see approach as potentially appropriate for patients with asymptomatic high-grade AS whose left ventricular ejection fraction is at least 50%, peak aortic valve velocity is 4.0-4.9 m/sec, and exercise stress test is normal and with no predictors of symptom onset or rapid progression. Asymptomatic patients who are likely to become symptomatic but who have a low risk of sudden death are candidates for intervention (rated “appropriate”) or medical management (“may be appropriate”). In contrast, a positive stress test in an otherwise asymptomatic patient merits consideration of SAVR or TAVR regardless of surgical risk. The recommendations for asymptomatic patients reflect a lack of head-to-head trials in this population, Dr. Thourani said. “We don’t have good randomized data to show one therapy is better than another.”
Symptomatic, high-gradient, severe AS with associated coronary artery disease merits consideration of SAVR with coronary artery bypass graft or, in some cases, TAVR with percutaneous coronary intervention, according to the AUC. Less evidence supports SAVR with PCI. “Optimal management of coronary artery disease in patients with AS is a complex decision process requiring clinical, anatomical, and technical considerations that is best achieved with close collaboration between heart team members,” the authors stress.
The document covers other valvular and structural heart conditions that commonly accompany severe AS, such as symptomatic AS with bicuspid aortic valve and ascending aortic dilation. “Although there remains an increasing prevalence of transcatheter valve usage in bicuspid aortic valve, the standard of care remains surgical therapy, especially in patients who have a dilated aorta,” Dr. Thourani said.
For the first time, the AUC also addresses failing aortic valve prostheses, presenting six relevant clinical scenarios. The AUC consistently recommends SAVR, although the use of TAVR has “dramatically increased” in these patients, Dr. Thourani said. “Long-term data are still pending, but TAVR appears to be a less morbid procedure, when done appropriately.”
The societies involved in creating the AUC statement were the American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Valve Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons.
Dr. Thourani disclosed ties to Edwards Lifesciences, St. Jude Medical, Abbott, Boston Scientific, and Medtronic.
New appropriate use criteria (AUC) for severe aortic stenosis (AS) run the full gamut of clinical scenarios and treatment options.
“Cardiology is seeing a radical change in the management of aortic stenosis. This new document incorporates all therapies currently available in the world,” said Vinod H. Thourani, MD, who served on the AUC’s writing group on behalf of the American College of Cardiology. “The AUC highlights state-of-the-art therapy for aortic stenosis and, even more importantly, helps clarify the right indications for surgical and transcatheter valve replacement.”
Surgical risk is assessed based on the Society of Thoracic Surgeons Predicted Risk of Mortality score plus additional anatomic and functional considerations that should be assessed by a multidisciplinary heart team. The AUC repeatedly emphasizes this team’s importance. “Multiple comorbidities can change the pathway of treating AS, and this determination is best made by a heart team that at least includes a noninvasive cardiologist, an interventional cardiologist, and a cardiac surgeon,” Dr. Thourani said. “That’s how patients get the best care.”
Historically, aortic stenosis typically was managed medically or with balloon aortic valvuloplasty (BAV) or open aortic valve replacement, Dr. Thourani said. However, BAV is less common now, and indications for surgical or transcatheter aortic valve replacement (SAVR or TAVR) are expanding. Balloon aortic valvuloplasty sometimes does provide palliative treatment or serve as a bridge to a decision, the AUC states. For example, for a high-risk patient with severe aortic stenosis and severe secondary mitral regurgitation, BAV can help the heart team decide whether TAVR alone will improve mitral regurgitation or whether a double valve procedure is preferable.
Regardless of risk score, the AUC considers a wait-and-see approach as potentially appropriate for patients with asymptomatic high-grade AS whose left ventricular ejection fraction is at least 50%, peak aortic valve velocity is 4.0-4.9 m/sec, and exercise stress test is normal and with no predictors of symptom onset or rapid progression. Asymptomatic patients who are likely to become symptomatic but who have a low risk of sudden death are candidates for intervention (rated “appropriate”) or medical management (“may be appropriate”). In contrast, a positive stress test in an otherwise asymptomatic patient merits consideration of SAVR or TAVR regardless of surgical risk. The recommendations for asymptomatic patients reflect a lack of head-to-head trials in this population, Dr. Thourani said. “We don’t have good randomized data to show one therapy is better than another.”
Symptomatic, high-gradient, severe AS with associated coronary artery disease merits consideration of SAVR with coronary artery bypass graft or, in some cases, TAVR with percutaneous coronary intervention, according to the AUC. Less evidence supports SAVR with PCI. “Optimal management of coronary artery disease in patients with AS is a complex decision process requiring clinical, anatomical, and technical considerations that is best achieved with close collaboration between heart team members,” the authors stress.
The document covers other valvular and structural heart conditions that commonly accompany severe AS, such as symptomatic AS with bicuspid aortic valve and ascending aortic dilation. “Although there remains an increasing prevalence of transcatheter valve usage in bicuspid aortic valve, the standard of care remains surgical therapy, especially in patients who have a dilated aorta,” Dr. Thourani said.
For the first time, the AUC also addresses failing aortic valve prostheses, presenting six relevant clinical scenarios. The AUC consistently recommends SAVR, although the use of TAVR has “dramatically increased” in these patients, Dr. Thourani said. “Long-term data are still pending, but TAVR appears to be a less morbid procedure, when done appropriately.”
The societies involved in creating the AUC statement were the American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Valve Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons.
Dr. Thourani disclosed ties to Edwards Lifesciences, St. Jude Medical, Abbott, Boston Scientific, and Medtronic.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
