Interventional Cardiology & Surgery

According to the latest meta-analysis of sham-controlled randomized trials, catheter-based renal sympathetic denervation produces clinically meaningful reductions in blood pressure with acceptable safety, but the strategy is not yet regarded as ready for prime time, according to a summary of the results to be presented at the Transcatheter Cardiovascular Therapeutics annual meeting.

This meta-analysis was based on seven blinded trials, all of which associated denervation with a reduction in systolic ambulatory BP, according to Yousif Ahmad, BMBS, PhD, an interventional cardiologist at Yale University, New Haven, Conn.

Although the BP-lowering advantage in two of these studies did not reach statistical significance, the other five did, and all the data moved in the same direction.

For ambulatory diastolic pressure, the effect was more modest. One of the studies showed essentially a neutral effect. The reductions were statistically significant in only two, but, again, the data moved in the same direction in six of the studies, and a random-effects analysis suggested that the reductions, although modest, were potentially meaningful, according to Dr. Ahmad.

Overall, at a mean follow-up of 4.5 months, the reductions in ambulatory systolic and diastolic BPs were 3.61 and 1.85 mm Hg, respectively. The benefit was about the same whether renal denervation was or was not performed on the background of antihypertensive drugs, which was permitted in five of the seven trials. In the other two, all patients were off hypertensive medication.
 

Office-based systolic reduction: 6 mm Hg

When the same analysis was performed for office-based BP reductions, which were available for five of the seven trials, the overall reductions based on the meta-analysis were 5.86 and 3.63 mm Hg for the systolic and diastolic pressures, respectively. Again, background antihypertensive therapy was not a factor.

Of the seven trials, three randomized fewer than 100 patients. The largest, SYMPLICITY HTN-3, randomized 491 patients in 2:1 ratio to denervation or sham.

Three of the studies in the meta-analysis were trials of the Symplicity flex device. Another two evaluated the Symplicity Spyral catheter. Both deliver radiofrequency energy to for denervation. The Paradise device, the focus of the remaining two trials, employs energy in the form of ultrasound.

According to Dr. Ahmad, adverse events regardless of device were rare and not more common among those in the active treatment arm than in those treated with a sham procedure. Although one of these trials, RADIANCE-HTN SOLO associated denervation with efficacy and safety out to 12 months , Dr. Ahmad concluded that the mean follow-up of 4.5 months is not sufficient to consider long-term effects.

More than 20 meta-analyses published so far

By one count, there have been more than 20 meta-analyses of renal denervation published previously yet this intervention is still considered “controversial,” according to Dr. Ahmad. Relative to the previous meta-analyses, this included the RADIANCE-HTN TRIO trial, which is the latest such sham-controlled study and added 136 patients to the dataset of high-quality trials.

Basically, the results led Dr. Ahmad to conclude that, although the treatment effect is modest, it could be valuable in specific groups of patients, such as those reluctant or unable to take multiple medications or any medications at all. In addition to generating more data on efficacy and safety, he said longer follow-up is also needed for calculations of cost-effectiveness. Larger-scale observational studies might be one way of collecting these data, he reported.

The results of this study were published online in JACC Cardiovascular Interventions with an accompanying editorial by David E. Kandzari, MD, director of interventional cardiology, Piedmont Hart Institute, Atlanta.

Commenting on the large pile of meta-analyses, sometimes published months apart, Dr. Kandzari explained that their “short half-life” is a product of the continuous updating of data with new trials. For a procedure that remains controversial, he said these constant relooks are inevitable.

“My point is that, with more studies, we can expect to see more meta-analyses. It is just the way this is going to work,” Dr. Kandzari said in an interview.
 

Individual study data also relevant

Even as the authors of these analyses attempt to cull the best data from the most rigorously performed trials, “we are also going to have to look at the individual studies, because of the differences in the trial designs, particularly the devices used,” according to Dr. Kandzari, who was the principle investigator of the sham-controlled SPYRAL HTN-ON MED trial.

So far, the data, despite some inconsistencies, have supported “clinically meaningful” BP reductions and acceptable safety regardless of the device used, according to Dr. Kandzari. Although he also agrees with the basic premise that more long-term data are needed to better determine how renal denervation should be applied in management of hypertension, he does think it will eventually find a role that is “complimentary to, rather than a replacement for, drugs.”

“The effect is modest, but keep in mind that the effect size is similar to that of a single oral medication, and there are some features, such as an always-on 24-hour effect that could be useful,” he said.

“We have enough of a signal to start thinking of how this will be enveloped into routine care,” he said.

But it is not ready yet. This was the point made by Dr. Ahmad, and it was seconded by Dr. Kandzari. One of the senior authors of the meta-analysis, Deepak Bhatt, MD, executive director of interventional cardiovascular programs, Brigham and Women’s Health, Boston, was also asked to weigh on when it will be ready for prime time.

“At a minimum, I would recommend completion of ongoing sham-controlled randomized trials before considering clinical use of renal denervation. Longer term safety and durability data, as well as data on cost-effectiveness, are all still needed – preferably from randomized trials as opposed to registries,” he said.

“Ideally, larger sham-controlled trials with longer follow-up and clinical endpoints, as opposed to only blood pressure measurements, would be performed, although I am not aware of any plans at present,” he added.

Dr. Ahmad reported no financial relationships relevant to this research. Dr. Bhatt has financial relationships with more than 30 pharmaceutical companies, including those developing products relevant to hypertension and renal denervation. Dr. Kandzari reported financial relationships with Ablative Solutions and Medtronic.

According to the latest meta-analysis of sham-controlled randomized trials, catheter-based renal sympathetic denervation produces clinically meaningful reductions in blood pressure with acceptable safety, but the strategy is not yet regarded as ready for prime time, according to a summary of the results to be presented at the Transcatheter Cardiovascular Therapeutics annual meeting.

This meta-analysis was based on seven blinded trials, all of which associated denervation with a reduction in systolic ambulatory BP, according to Yousif Ahmad, BMBS, PhD, an interventional cardiologist at Yale University, New Haven, Conn.

Although the BP-lowering advantage in two of these studies did not reach statistical significance, the other five did, and all the data moved in the same direction.

For ambulatory diastolic pressure, the effect was more modest. One of the studies showed essentially a neutral effect. The reductions were statistically significant in only two, but, again, the data moved in the same direction in six of the studies, and a random-effects analysis suggested that the reductions, although modest, were potentially meaningful, according to Dr. Ahmad.

Overall, at a mean follow-up of 4.5 months, the reductions in ambulatory systolic and diastolic BPs were 3.61 and 1.85 mm Hg, respectively. The benefit was about the same whether renal denervation was or was not performed on the background of antihypertensive drugs, which was permitted in five of the seven trials. In the other two, all patients were off hypertensive medication.
 

Office-based systolic reduction: 6 mm Hg

When the same analysis was performed for office-based BP reductions, which were available for five of the seven trials, the overall reductions based on the meta-analysis were 5.86 and 3.63 mm Hg for the systolic and diastolic pressures, respectively. Again, background antihypertensive therapy was not a factor.

Of the seven trials, three randomized fewer than 100 patients. The largest, SYMPLICITY HTN-3, randomized 491 patients in 2:1 ratio to denervation or sham.

Three of the studies in the meta-analysis were trials of the Symplicity flex device. Another two evaluated the Symplicity Spyral catheter. Both deliver radiofrequency energy to for denervation. The Paradise device, the focus of the remaining two trials, employs energy in the form of ultrasound.

According to Dr. Ahmad, adverse events regardless of device were rare and not more common among those in the active treatment arm than in those treated with a sham procedure. Although one of these trials, RADIANCE-HTN SOLO associated denervation with efficacy and safety out to 12 months , Dr. Ahmad concluded that the mean follow-up of 4.5 months is not sufficient to consider long-term effects.

More than 20 meta-analyses published so far

By one count, there have been more than 20 meta-analyses of renal denervation published previously yet this intervention is still considered “controversial,” according to Dr. Ahmad. Relative to the previous meta-analyses, this included the RADIANCE-HTN TRIO trial, which is the latest such sham-controlled study and added 136 patients to the dataset of high-quality trials.

Basically, the results led Dr. Ahmad to conclude that, although the treatment effect is modest, it could be valuable in specific groups of patients, such as those reluctant or unable to take multiple medications or any medications at all. In addition to generating more data on efficacy and safety, he said longer follow-up is also needed for calculations of cost-effectiveness. Larger-scale observational studies might be one way of collecting these data, he reported.

The results of this study were published online in JACC Cardiovascular Interventions with an accompanying editorial by David E. Kandzari, MD, director of interventional cardiology, Piedmont Hart Institute, Atlanta.

Commenting on the large pile of meta-analyses, sometimes published months apart, Dr. Kandzari explained that their “short half-life” is a product of the continuous updating of data with new trials. For a procedure that remains controversial, he said these constant relooks are inevitable.

“My point is that, with more studies, we can expect to see more meta-analyses. It is just the way this is going to work,” Dr. Kandzari said in an interview.
 

Individual study data also relevant

Even as the authors of these analyses attempt to cull the best data from the most rigorously performed trials, “we are also going to have to look at the individual studies, because of the differences in the trial designs, particularly the devices used,” according to Dr. Kandzari, who was the principle investigator of the sham-controlled SPYRAL HTN-ON MED trial.

So far, the data, despite some inconsistencies, have supported “clinically meaningful” BP reductions and acceptable safety regardless of the device used, according to Dr. Kandzari. Although he also agrees with the basic premise that more long-term data are needed to better determine how renal denervation should be applied in management of hypertension, he does think it will eventually find a role that is “complimentary to, rather than a replacement for, drugs.”

“The effect is modest, but keep in mind that the effect size is similar to that of a single oral medication, and there are some features, such as an always-on 24-hour effect that could be useful,” he said.

“We have enough of a signal to start thinking of how this will be enveloped into routine care,” he said.

But it is not ready yet. This was the point made by Dr. Ahmad, and it was seconded by Dr. Kandzari. One of the senior authors of the meta-analysis, Deepak Bhatt, MD, executive director of interventional cardiovascular programs, Brigham and Women’s Health, Boston, was also asked to weigh on when it will be ready for prime time.

“At a minimum, I would recommend completion of ongoing sham-controlled randomized trials before considering clinical use of renal denervation. Longer term safety and durability data, as well as data on cost-effectiveness, are all still needed – preferably from randomized trials as opposed to registries,” he said.

“Ideally, larger sham-controlled trials with longer follow-up and clinical endpoints, as opposed to only blood pressure measurements, would be performed, although I am not aware of any plans at present,” he added.

Dr. Ahmad reported no financial relationships relevant to this research. Dr. Bhatt has financial relationships with more than 30 pharmaceutical companies, including those developing products relevant to hypertension and renal denervation. Dr. Kandzari reported financial relationships with Ablative Solutions and Medtronic.

According to the latest meta-analysis of sham-controlled randomized trials, catheter-based renal sympathetic denervation produces clinically meaningful reductions in blood pressure with acceptable safety, but the strategy is not yet regarded as ready for prime time, according to a summary of the results to be presented at the Transcatheter Cardiovascular Therapeutics annual meeting.

This meta-analysis was based on seven blinded trials, all of which associated denervation with a reduction in systolic ambulatory BP, according to Yousif Ahmad, BMBS, PhD, an interventional cardiologist at Yale University, New Haven, Conn.

Although the BP-lowering advantage in two of these studies did not reach statistical significance, the other five did, and all the data moved in the same direction.

For ambulatory diastolic pressure, the effect was more modest. One of the studies showed essentially a neutral effect. The reductions were statistically significant in only two, but, again, the data moved in the same direction in six of the studies, and a random-effects analysis suggested that the reductions, although modest, were potentially meaningful, according to Dr. Ahmad.

Overall, at a mean follow-up of 4.5 months, the reductions in ambulatory systolic and diastolic BPs were 3.61 and 1.85 mm Hg, respectively. The benefit was about the same whether renal denervation was or was not performed on the background of antihypertensive drugs, which was permitted in five of the seven trials. In the other two, all patients were off hypertensive medication.
 

Office-based systolic reduction: 6 mm Hg

When the same analysis was performed for office-based BP reductions, which were available for five of the seven trials, the overall reductions based on the meta-analysis were 5.86 and 3.63 mm Hg for the systolic and diastolic pressures, respectively. Again, background antihypertensive therapy was not a factor.

Of the seven trials, three randomized fewer than 100 patients. The largest, SYMPLICITY HTN-3, randomized 491 patients in 2:1 ratio to denervation or sham.

Three of the studies in the meta-analysis were trials of the Symplicity flex device. Another two evaluated the Symplicity Spyral catheter. Both deliver radiofrequency energy to for denervation. The Paradise device, the focus of the remaining two trials, employs energy in the form of ultrasound.

According to Dr. Ahmad, adverse events regardless of device were rare and not more common among those in the active treatment arm than in those treated with a sham procedure. Although one of these trials, RADIANCE-HTN SOLO associated denervation with efficacy and safety out to 12 months , Dr. Ahmad concluded that the mean follow-up of 4.5 months is not sufficient to consider long-term effects.

More than 20 meta-analyses published so far

By one count, there have been more than 20 meta-analyses of renal denervation published previously yet this intervention is still considered “controversial,” according to Dr. Ahmad. Relative to the previous meta-analyses, this included the RADIANCE-HTN TRIO trial, which is the latest such sham-controlled study and added 136 patients to the dataset of high-quality trials.

Basically, the results led Dr. Ahmad to conclude that, although the treatment effect is modest, it could be valuable in specific groups of patients, such as those reluctant or unable to take multiple medications or any medications at all. In addition to generating more data on efficacy and safety, he said longer follow-up is also needed for calculations of cost-effectiveness. Larger-scale observational studies might be one way of collecting these data, he reported.

The results of this study were published online in JACC Cardiovascular Interventions with an accompanying editorial by David E. Kandzari, MD, director of interventional cardiology, Piedmont Hart Institute, Atlanta.

Commenting on the large pile of meta-analyses, sometimes published months apart, Dr. Kandzari explained that their “short half-life” is a product of the continuous updating of data with new trials. For a procedure that remains controversial, he said these constant relooks are inevitable.

“My point is that, with more studies, we can expect to see more meta-analyses. It is just the way this is going to work,” Dr. Kandzari said in an interview.
 

Individual study data also relevant

Even as the authors of these analyses attempt to cull the best data from the most rigorously performed trials, “we are also going to have to look at the individual studies, because of the differences in the trial designs, particularly the devices used,” according to Dr. Kandzari, who was the principle investigator of the sham-controlled SPYRAL HTN-ON MED trial.

So far, the data, despite some inconsistencies, have supported “clinically meaningful” BP reductions and acceptable safety regardless of the device used, according to Dr. Kandzari. Although he also agrees with the basic premise that more long-term data are needed to better determine how renal denervation should be applied in management of hypertension, he does think it will eventually find a role that is “complimentary to, rather than a replacement for, drugs.”

“The effect is modest, but keep in mind that the effect size is similar to that of a single oral medication, and there are some features, such as an always-on 24-hour effect that could be useful,” he said.

“We have enough of a signal to start thinking of how this will be enveloped into routine care,” he said.

But it is not ready yet. This was the point made by Dr. Ahmad, and it was seconded by Dr. Kandzari. One of the senior authors of the meta-analysis, Deepak Bhatt, MD, executive director of interventional cardiovascular programs, Brigham and Women’s Health, Boston, was also asked to weigh on when it will be ready for prime time.

“At a minimum, I would recommend completion of ongoing sham-controlled randomized trials before considering clinical use of renal denervation. Longer term safety and durability data, as well as data on cost-effectiveness, are all still needed – preferably from randomized trials as opposed to registries,” he said.

“Ideally, larger sham-controlled trials with longer follow-up and clinical endpoints, as opposed to only blood pressure measurements, would be performed, although I am not aware of any plans at present,” he added.

Dr. Ahmad reported no financial relationships relevant to this research. Dr. Bhatt has financial relationships with more than 30 pharmaceutical companies, including those developing products relevant to hypertension and renal denervation. Dr. Kandzari reported financial relationships with Ablative Solutions and Medtronic.

Datascope/Getinge/Maquet is recalling CardioSave Hybrid and Rescue intra-aortic balloon pumps (IABPs) because some battery packs may have a shortened run time and fail unexpectedly, according to a medical device recall notice posted on the U.S. Food and Drug Administration website.

The FDA has identified this as a class I recall, the most serious type of recall, because of the risk for serious injury or death.

The recalled IABPs have substandard batteries that do not meet performance specifications and were mistakenly released to a limited number of customers.

If a patient requires life-supporting therapy with an IABP and the device does not work or stops working during use because of battery failure, the patient will be at risk for serious injury, including death, the FDA cautions.

Both IABP monitors display battery life and have low battery alarms when alternative power sources are needed.

Datascope/Getting/Maquet has received six complaints but no reports of injury or death related to this issue.

“However, there is a potential for underreporting since the end user reporting a failed battery or short battery run time cannot be aware that they originally received a substandard battery,” the FDA said.

The recall involves 137 battery packs distributed in the United States between Sept. 23, 2017, and Aug. 17, 2021. Product codes and lot numbers are available in the recall notice.  

The company sent an urgent medical device removal letter to customers requesting that they check inventory to determine if there are any CardioSave LiIon battery packs with part number/reference number 0146-00-0097 and with serial numbers listed in the letter.

Customers are asked to replace any affected battery with an unaffected battery and remove the affected product from areas of use.

The company will issue credit or a replacement battery at no cost to the facility upon receipt of the response form attached to the letter.

Distributors who shipped any affected product to customers are asked to forward the device removal letter to customers.

All customers, regardless of whether or not they have defective batteries, are asked to complete and sign the response form to acknowledge that they received the notification and disposed of the affected batteries.

Completed forms can be scanned and emailed to Datascope/Getinge/Maquet at [email protected] or by FAX to 1-877-446-3360.

Customers who have questions about this recall should contact their Datascope/Getinge/Maquet sales representative or, for technical questions, customer service (1-888-943-8872, option 2), Monday through Friday, 8:00 a.m. to 6:00 p.m. ET.

Any adverse events or suspected adverse events related to the recalled CardioSave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.

A version of this article first appeared on Medscape.com.

Datascope/Getinge/Maquet is recalling CardioSave Hybrid and Rescue intra-aortic balloon pumps (IABPs) because some battery packs may have a shortened run time and fail unexpectedly, according to a medical device recall notice posted on the U.S. Food and Drug Administration website.

The FDA has identified this as a class I recall, the most serious type of recall, because of the risk for serious injury or death.

The recalled IABPs have substandard batteries that do not meet performance specifications and were mistakenly released to a limited number of customers.

If a patient requires life-supporting therapy with an IABP and the device does not work or stops working during use because of battery failure, the patient will be at risk for serious injury, including death, the FDA cautions.

Both IABP monitors display battery life and have low battery alarms when alternative power sources are needed.

Datascope/Getting/Maquet has received six complaints but no reports of injury or death related to this issue.

“However, there is a potential for underreporting since the end user reporting a failed battery or short battery run time cannot be aware that they originally received a substandard battery,” the FDA said.

The recall involves 137 battery packs distributed in the United States between Sept. 23, 2017, and Aug. 17, 2021. Product codes and lot numbers are available in the recall notice.  

The company sent an urgent medical device removal letter to customers requesting that they check inventory to determine if there are any CardioSave LiIon battery packs with part number/reference number 0146-00-0097 and with serial numbers listed in the letter.

Customers are asked to replace any affected battery with an unaffected battery and remove the affected product from areas of use.

The company will issue credit or a replacement battery at no cost to the facility upon receipt of the response form attached to the letter.

Distributors who shipped any affected product to customers are asked to forward the device removal letter to customers.

All customers, regardless of whether or not they have defective batteries, are asked to complete and sign the response form to acknowledge that they received the notification and disposed of the affected batteries.

Completed forms can be scanned and emailed to Datascope/Getinge/Maquet at [email protected] or by FAX to 1-877-446-3360.

Customers who have questions about this recall should contact their Datascope/Getinge/Maquet sales representative or, for technical questions, customer service (1-888-943-8872, option 2), Monday through Friday, 8:00 a.m. to 6:00 p.m. ET.

Any adverse events or suspected adverse events related to the recalled CardioSave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.

A version of this article first appeared on Medscape.com.

Datascope/Getinge/Maquet is recalling CardioSave Hybrid and Rescue intra-aortic balloon pumps (IABPs) because some battery packs may have a shortened run time and fail unexpectedly, according to a medical device recall notice posted on the U.S. Food and Drug Administration website.

The FDA has identified this as a class I recall, the most serious type of recall, because of the risk for serious injury or death.

The recalled IABPs have substandard batteries that do not meet performance specifications and were mistakenly released to a limited number of customers.

If a patient requires life-supporting therapy with an IABP and the device does not work or stops working during use because of battery failure, the patient will be at risk for serious injury, including death, the FDA cautions.

Both IABP monitors display battery life and have low battery alarms when alternative power sources are needed.

Datascope/Getting/Maquet has received six complaints but no reports of injury or death related to this issue.

“However, there is a potential for underreporting since the end user reporting a failed battery or short battery run time cannot be aware that they originally received a substandard battery,” the FDA said.

The recall involves 137 battery packs distributed in the United States between Sept. 23, 2017, and Aug. 17, 2021. Product codes and lot numbers are available in the recall notice.  

The company sent an urgent medical device removal letter to customers requesting that they check inventory to determine if there are any CardioSave LiIon battery packs with part number/reference number 0146-00-0097 and with serial numbers listed in the letter.

Customers are asked to replace any affected battery with an unaffected battery and remove the affected product from areas of use.

The company will issue credit or a replacement battery at no cost to the facility upon receipt of the response form attached to the letter.

Distributors who shipped any affected product to customers are asked to forward the device removal letter to customers.

All customers, regardless of whether or not they have defective batteries, are asked to complete and sign the response form to acknowledge that they received the notification and disposed of the affected batteries.

Completed forms can be scanned and emailed to Datascope/Getinge/Maquet at [email protected] or by FAX to 1-877-446-3360.

Customers who have questions about this recall should contact their Datascope/Getinge/Maquet sales representative or, for technical questions, customer service (1-888-943-8872, option 2), Monday through Friday, 8:00 a.m. to 6:00 p.m. ET.

Any adverse events or suspected adverse events related to the recalled CardioSave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.

A version of this article first appeared on Medscape.com.

Most patients with advanced chronic kidney disease (CKD) and non–ST-elevation myocardial infarction (NSTEMI) fare better with coronary angiography with and without revascularization than with medical therapy, a large nationwide study suggests.

Bruce Jancin/MDedge News

“Invasive management was associated with lower mortality, major adverse cardiovascular events (MACE), and need for revascularization, with a minimal increased risk of in-hospital, postprocedural acute kidney injury (AKI) requiring dialysis and major bleeding,” said lead researcher Ankur Kalra, MD, Cleveland Clinic.

Also, similar post-discharge safety outcomes were seen at 6 months, he said in an online presentation of “key abstracts” released in advance of next month’s Transcatheter Cardiovascular Therapeutics (TCT) 2021 hybrid meeting.

Advanced CKD is an independent predictor of mortality and morbidity in patients with NSTEMI. In CKD, however, current guidelines lack evidence on the efficacy and safety of invasive versus medical management, he noted.

A rare randomized clinical trial in this high-risk population, ISCHEMIA-CKD, recently found no benefit and an increase in stroke with initial invasive management compared with optimal medical therapy.

Session co-moderator Ziad A. Ali, MD, DPhil, St. Francis Hospital & Heart Center, New York, said the current study is “incredibly clinically impactful and answers a question that’s very difficult to answer because these patients aren’t randomized in randomized controlled trials, and there’s a general avoidance, which we’ve now coined ‘renalism,’ like racism, where people don’t really want to touch these patients.”

He questioned, however, how the authors reconcile the results of ISCHEMIA-CKD, a “small but meaningful randomized controlled trial,” with their findings from a large dataset. “Perhaps this is all selection bias, even though the numbers are very large.”

Dr. Kalra replied that ISCHEMIA-CKD examined stable ischemic heart disease, whereas they looked at NSTEMI. “Even though it may fall under the same rubric, I truly believe it is a different set of patients – they are at a heightened risk for future cardiovascular events and have had an acute coronary event.”

For the study, ICD-10 coding data from 2016-2018 in the Nationwide Readmission Database was used to identify NSTEMI patients with CKD stages 3, 4, 5, and end-stage renal disease (ESRD). A total of 141,052 patients were available for in-hospital outcomes and 133,642 patients for post-discharge outcomes.

In-hospital and 6-month mortality – the study’s primary outcome – favored invasive management across all CKD stages and ESRD but did not achieve statistical significance for CKD stage 5. The number needed to treat (NNT) for CKD stages 3, 4, 5, and ESRD were 26, 56, 48, and 18, respectively.

Six-month MACE, including mortality, MI, stroke, and heart failure readmission, was significantly better in all groups with invasive management.

Kaplan-Meier curves for mortality showed similar benefits with an invasive strategy across CKD stages, again barring stage 5 disease. 

With regard to in-hospital safety, stroke rates were not significantly different between the two treatment strategies across all groups.

Rates of AKI requiring dialysis, however, were lower with medical versus invasive management for CKD stage 3 (0.43% vs. 0.6%; hazard ratio, 1.39; P = .016), stage 4 (1.2% vs. 2.0%; HR 1.87; P < .001), and stage 5 (3.7% vs. 4.3%; HR 1.17; P = .527). The number needed to harm (NNH) was 588 for CKD 3 and 125 for CKD 4.

Major bleeding, defined as requiring transfusion, was lower with medical management for all CKD stages but not for ESRD. The rates are as follows:

• CKD stage 3: 2.5% vs. 2.8% (HR, 1.11; P = .078; NNH = 333)
• CKD stage 4: 2.9% vs. 4.0% (HR, 1.42; P < .001; NNH = 91)
• CKD stage 5: 2.2% vs. 4.7% (HR, 2.17; P = .008; NNH = 40)
• ESRD: 3.4% vs. 3.3% (HR, 0.97; P = .709)

“The risk of AKI requiring dialysis and bleeding, as has been shown previously in other studies, was high, but the number needed to harm was also high,” observed Dr. Kalra.

A separate analysis showed no difference in rates of AKI requiring dialysis among patients with CKD stages 3 and 4 who underwent angiography without revascularization and their peers who were medically managed.

Rates of the composite safety outcome of vascular complications, major bleeding, AKI, or stroke readmission at 6 months were not significantly different for invasive versus medical management for CKD stage 3 (both 3.3%), stage 4 (4.5% and 4.2%), stage 5 (3.9% vs. 4.3%), and ESRD (2.3% vs. 2.1%).

Besides the inherent limitations of observational studies and potential for selection bias, Dr. Kalra pointed out that the analysis relied on coding data for exact glomerular filtration rates and lacked information on contrast use, crystalloids before the procedure, and nephrotoxic medication use before or during admission. Out-of-hospital mortality was also not available in the database.

Co-moderator Allen Jeremias, MD, also with St. Francis Hospital & Heart Center, said one of the study’s strengths was that it included all comers, unlike randomized trials that typically exclude the highest risk patients.

“So, when we do these trials it’s very difficult to find the right balance, whereas this is a real-world analysis including everybody, and I think the benefits are clearly demonstrated,” he said. “So I think I’m bullish on doing complex [percutaneous coronary intervention] PCI in this patient population.”

Dr. Kalra reports having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Most patients with advanced chronic kidney disease (CKD) and non–ST-elevation myocardial infarction (NSTEMI) fare better with coronary angiography with and without revascularization than with medical therapy, a large nationwide study suggests.

Bruce Jancin/MDedge News

“Invasive management was associated with lower mortality, major adverse cardiovascular events (MACE), and need for revascularization, with a minimal increased risk of in-hospital, postprocedural acute kidney injury (AKI) requiring dialysis and major bleeding,” said lead researcher Ankur Kalra, MD, Cleveland Clinic.

Also, similar post-discharge safety outcomes were seen at 6 months, he said in an online presentation of “key abstracts” released in advance of next month’s Transcatheter Cardiovascular Therapeutics (TCT) 2021 hybrid meeting.

Advanced CKD is an independent predictor of mortality and morbidity in patients with NSTEMI. In CKD, however, current guidelines lack evidence on the efficacy and safety of invasive versus medical management, he noted.

A rare randomized clinical trial in this high-risk population, ISCHEMIA-CKD, recently found no benefit and an increase in stroke with initial invasive management compared with optimal medical therapy.

Session co-moderator Ziad A. Ali, MD, DPhil, St. Francis Hospital & Heart Center, New York, said the current study is “incredibly clinically impactful and answers a question that’s very difficult to answer because these patients aren’t randomized in randomized controlled trials, and there’s a general avoidance, which we’ve now coined ‘renalism,’ like racism, where people don’t really want to touch these patients.”

He questioned, however, how the authors reconcile the results of ISCHEMIA-CKD, a “small but meaningful randomized controlled trial,” with their findings from a large dataset. “Perhaps this is all selection bias, even though the numbers are very large.”

Dr. Kalra replied that ISCHEMIA-CKD examined stable ischemic heart disease, whereas they looked at NSTEMI. “Even though it may fall under the same rubric, I truly believe it is a different set of patients – they are at a heightened risk for future cardiovascular events and have had an acute coronary event.”

For the study, ICD-10 coding data from 2016-2018 in the Nationwide Readmission Database was used to identify NSTEMI patients with CKD stages 3, 4, 5, and end-stage renal disease (ESRD). A total of 141,052 patients were available for in-hospital outcomes and 133,642 patients for post-discharge outcomes.

In-hospital and 6-month mortality – the study’s primary outcome – favored invasive management across all CKD stages and ESRD but did not achieve statistical significance for CKD stage 5. The number needed to treat (NNT) for CKD stages 3, 4, 5, and ESRD were 26, 56, 48, and 18, respectively.

Six-month MACE, including mortality, MI, stroke, and heart failure readmission, was significantly better in all groups with invasive management.

Kaplan-Meier curves for mortality showed similar benefits with an invasive strategy across CKD stages, again barring stage 5 disease. 

With regard to in-hospital safety, stroke rates were not significantly different between the two treatment strategies across all groups.

Rates of AKI requiring dialysis, however, were lower with medical versus invasive management for CKD stage 3 (0.43% vs. 0.6%; hazard ratio, 1.39; P = .016), stage 4 (1.2% vs. 2.0%; HR 1.87; P < .001), and stage 5 (3.7% vs. 4.3%; HR 1.17; P = .527). The number needed to harm (NNH) was 588 for CKD 3 and 125 for CKD 4.

Major bleeding, defined as requiring transfusion, was lower with medical management for all CKD stages but not for ESRD. The rates are as follows:

• CKD stage 3: 2.5% vs. 2.8% (HR, 1.11; P = .078; NNH = 333)
• CKD stage 4: 2.9% vs. 4.0% (HR, 1.42; P < .001; NNH = 91)
• CKD stage 5: 2.2% vs. 4.7% (HR, 2.17; P = .008; NNH = 40)
• ESRD: 3.4% vs. 3.3% (HR, 0.97; P = .709)

“The risk of AKI requiring dialysis and bleeding, as has been shown previously in other studies, was high, but the number needed to harm was also high,” observed Dr. Kalra.

A separate analysis showed no difference in rates of AKI requiring dialysis among patients with CKD stages 3 and 4 who underwent angiography without revascularization and their peers who were medically managed.

Rates of the composite safety outcome of vascular complications, major bleeding, AKI, or stroke readmission at 6 months were not significantly different for invasive versus medical management for CKD stage 3 (both 3.3%), stage 4 (4.5% and 4.2%), stage 5 (3.9% vs. 4.3%), and ESRD (2.3% vs. 2.1%).

Besides the inherent limitations of observational studies and potential for selection bias, Dr. Kalra pointed out that the analysis relied on coding data for exact glomerular filtration rates and lacked information on contrast use, crystalloids before the procedure, and nephrotoxic medication use before or during admission. Out-of-hospital mortality was also not available in the database.

Co-moderator Allen Jeremias, MD, also with St. Francis Hospital & Heart Center, said one of the study’s strengths was that it included all comers, unlike randomized trials that typically exclude the highest risk patients.

“So, when we do these trials it’s very difficult to find the right balance, whereas this is a real-world analysis including everybody, and I think the benefits are clearly demonstrated,” he said. “So I think I’m bullish on doing complex [percutaneous coronary intervention] PCI in this patient population.”

Dr. Kalra reports having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Most patients with advanced chronic kidney disease (CKD) and non–ST-elevation myocardial infarction (NSTEMI) fare better with coronary angiography with and without revascularization than with medical therapy, a large nationwide study suggests.

Bruce Jancin/MDedge News

“Invasive management was associated with lower mortality, major adverse cardiovascular events (MACE), and need for revascularization, with a minimal increased risk of in-hospital, postprocedural acute kidney injury (AKI) requiring dialysis and major bleeding,” said lead researcher Ankur Kalra, MD, Cleveland Clinic.

Also, similar post-discharge safety outcomes were seen at 6 months, he said in an online presentation of “key abstracts” released in advance of next month’s Transcatheter Cardiovascular Therapeutics (TCT) 2021 hybrid meeting.

Advanced CKD is an independent predictor of mortality and morbidity in patients with NSTEMI. In CKD, however, current guidelines lack evidence on the efficacy and safety of invasive versus medical management, he noted.

A rare randomized clinical trial in this high-risk population, ISCHEMIA-CKD, recently found no benefit and an increase in stroke with initial invasive management compared with optimal medical therapy.

Session co-moderator Ziad A. Ali, MD, DPhil, St. Francis Hospital & Heart Center, New York, said the current study is “incredibly clinically impactful and answers a question that’s very difficult to answer because these patients aren’t randomized in randomized controlled trials, and there’s a general avoidance, which we’ve now coined ‘renalism,’ like racism, where people don’t really want to touch these patients.”

He questioned, however, how the authors reconcile the results of ISCHEMIA-CKD, a “small but meaningful randomized controlled trial,” with their findings from a large dataset. “Perhaps this is all selection bias, even though the numbers are very large.”

Dr. Kalra replied that ISCHEMIA-CKD examined stable ischemic heart disease, whereas they looked at NSTEMI. “Even though it may fall under the same rubric, I truly believe it is a different set of patients – they are at a heightened risk for future cardiovascular events and have had an acute coronary event.”

For the study, ICD-10 coding data from 2016-2018 in the Nationwide Readmission Database was used to identify NSTEMI patients with CKD stages 3, 4, 5, and end-stage renal disease (ESRD). A total of 141,052 patients were available for in-hospital outcomes and 133,642 patients for post-discharge outcomes.

In-hospital and 6-month mortality – the study’s primary outcome – favored invasive management across all CKD stages and ESRD but did not achieve statistical significance for CKD stage 5. The number needed to treat (NNT) for CKD stages 3, 4, 5, and ESRD were 26, 56, 48, and 18, respectively.

Six-month MACE, including mortality, MI, stroke, and heart failure readmission, was significantly better in all groups with invasive management.

Kaplan-Meier curves for mortality showed similar benefits with an invasive strategy across CKD stages, again barring stage 5 disease. 

With regard to in-hospital safety, stroke rates were not significantly different between the two treatment strategies across all groups.

Rates of AKI requiring dialysis, however, were lower with medical versus invasive management for CKD stage 3 (0.43% vs. 0.6%; hazard ratio, 1.39; P = .016), stage 4 (1.2% vs. 2.0%; HR 1.87; P < .001), and stage 5 (3.7% vs. 4.3%; HR 1.17; P = .527). The number needed to harm (NNH) was 588 for CKD 3 and 125 for CKD 4.

Major bleeding, defined as requiring transfusion, was lower with medical management for all CKD stages but not for ESRD. The rates are as follows:

• CKD stage 3: 2.5% vs. 2.8% (HR, 1.11; P = .078; NNH = 333)
• CKD stage 4: 2.9% vs. 4.0% (HR, 1.42; P < .001; NNH = 91)
• CKD stage 5: 2.2% vs. 4.7% (HR, 2.17; P = .008; NNH = 40)
• ESRD: 3.4% vs. 3.3% (HR, 0.97; P = .709)

“The risk of AKI requiring dialysis and bleeding, as has been shown previously in other studies, was high, but the number needed to harm was also high,” observed Dr. Kalra.

A separate analysis showed no difference in rates of AKI requiring dialysis among patients with CKD stages 3 and 4 who underwent angiography without revascularization and their peers who were medically managed.

Rates of the composite safety outcome of vascular complications, major bleeding, AKI, or stroke readmission at 6 months were not significantly different for invasive versus medical management for CKD stage 3 (both 3.3%), stage 4 (4.5% and 4.2%), stage 5 (3.9% vs. 4.3%), and ESRD (2.3% vs. 2.1%).

Besides the inherent limitations of observational studies and potential for selection bias, Dr. Kalra pointed out that the analysis relied on coding data for exact glomerular filtration rates and lacked information on contrast use, crystalloids before the procedure, and nephrotoxic medication use before or during admission. Out-of-hospital mortality was also not available in the database.

Co-moderator Allen Jeremias, MD, also with St. Francis Hospital & Heart Center, said one of the study’s strengths was that it included all comers, unlike randomized trials that typically exclude the highest risk patients.

“So, when we do these trials it’s very difficult to find the right balance, whereas this is a real-world analysis including everybody, and I think the benefits are clearly demonstrated,” he said. “So I think I’m bullish on doing complex [percutaneous coronary intervention] PCI in this patient population.”

Dr. Kalra reports having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.

American Heart Association

The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.

The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.

“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.

“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”

The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).

However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.

Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”

Other key recommendations of the statement include:

• Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
• Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
• Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
• Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.

The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”

The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.

Dr. Jacobs has no relevant relationships to disclose.

Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.

American Heart Association

The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.

The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.

“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.

“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”

The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).

However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.

Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”

Other key recommendations of the statement include:

• Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
• Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
• Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
• Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.

The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”

The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.

Dr. Jacobs has no relevant relationships to disclose.

Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.

American Heart Association

The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.

The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.

“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.

“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”

The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).

However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.

Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”

Other key recommendations of the statement include:

• Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
• Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
• Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
• Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.

The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”

The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.

Dr. Jacobs has no relevant relationships to disclose.

A comparison of long-term survival between patients who either did or did not undergo permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) revealed no differences, according to results of the SWEDEHEART observational study.

The nationwide population-based cohort study included all patients who underwent transfemoral TAVR in Sweden from 2008 to 2018.
 

Most frequent complications

While newer-generation aortic valve prostheses are less likely to necessitate PPI, the need for PPI is higher after TAVR than after surgical aortic valve replacement (SAVR), and the need for PPI remains the most frequent complication after TAVR, the study authors noted. Use of self-expandable valves, deep prosthetic valve implantation, preprocedural conduction disturbances, older age, and a high number of comorbidities are among the risk factors for PPI following TAVR.

With prior studies producing conflicting results, the authors stated, the impact of PPI after TAVR remains unknown. Expanding use of TAVR to include younger and low-risk patients with a long life expectancy underscores the importance of gaining greater understand of the impact of PPI after TAVR. Accordingly, the study was conducted to investigate long-term, clinically important outcomes in this post-TAVR population.

Out of 4,750 patients who underwent TAVR in the study period, 3,420 patients in SWEDEHEART met study criteria, with 481 (14.1%) undergoing PPI within 30 days after TAVR, and 2,939 not receiving a pacemaker. PPI exposure was defined as implantation of a permanent pacemaker or implantable cardioverter-defibrillator. The study primary outcome was all-cause mortality, with cardiovascular death, heart failure, and endocarditis as secondary outcomes. It was reported in JACC: Cardiovascular Interventions.
 

Similar survival

Mean patient age was 81.3 years (50.4% female). The rate for all-cause mortality in those with no pacemaker was 11.4 per 100 patient years and 13.1 for those with a pacemaker (hazard ratio, 1.04; 95% confidence interval, 0.89-1.23). The cardiovascular death rate in the no-pacemaker group was 6.0 per 100 patient years and 7.1 per 100 patient years in the pacemaker group (HR, 0.96; 95% CI, 0.75-1.23). For heart failure the rates were 4.5 per 100 patient years in the no pacemaker group and 6.3 in the pacemaker group (HR, 1.22; 95% CI, 0.93-1.672). Endocarditis rates were 1.2 and 1.1 per 100 patient years in the no pacemaker and pacemaker groups, respectively (HR, 0.93; 95% CI, 0.51-1.71).

The authors pointed out that their prior study had found PPI after SAVR in almost 25,000 patients to be associated with increased all-cause mortality and heart failure rates. Patients who undergo TAVR, however, are older and have more comorbidities than patients who undergo SAVR.

It is thus likely that patients who undergo TAVR die of other causes before the negative effects of their pacemaker become clinically evident.

Also, the incidence of conduction abnormalities increases with age, making it more likely that beneficial effects of pacemakers occur in older patients rather than younger ones, counterbalancing the detrimental effects to a larger extent.
 

Reduce PPI rates after TAVR

The study authors also observed that, although they did not find increased mortality or heart failure in patients who underwent PPI, PPI is associated with risks, including lead- and pocket-related complications, other traumatic complications, longer hospital stays and higher societal costs. These factors justify the search for strategies to reduce PPI rates after TAVR.

“Our study adds important information about the prognosis in patients who received a permanent pacemaker implantation following TAVR,” study author Natalie Glaser, MD, PhD, said in an interview. “Increased knowledge about prognosis after TAVR in different patient populations has important implications for preoperative risk stratification and can help to optimize postoperative follow-up and treatment for these patients.” Future studies, Dr. Glaser added, should include younger and low-risk patients with longer follow-up to confirm the present findings. 
 

Balancing factors

In an accompanying editorial, Antonio J. Muñoz-García, MD, PhD, and Erika Muñoz-García, MD also noted factors potentially counterbalancing and masking adverse effects of PPI, echoing some mentioned by the study authors. Among those without PPI, 10%-50% develop new-onset left bundle branch block (LBBB) after TAVR. LBBB is a known marker of low long-term survival in TAVR populations, producing intraventricular dyssynchrony leading potentially to left ventricular dysfunction or development of complete atrioventricular block with higher mortality risk in those without pacemakers. PPI, as well, can be protective against unexpected death in those with advanced conduction disorders. Still, they point out, PPI can entail lead dysfunction, need for generator replacement, infection, and tricuspid valve regurgitation.

Commenting in an interview that an observed trend of a greater increase in events in the group of patients with pacemakers for the first 4 years is consistent with prior studies, Dr. Antonio Muñoz-García said: “This can be explained because long-term survival in the TAVI population is conditioned by comorbidities. It is true that the presence of a pacemaker can cause left ventricular ejection fraction to deteriorate and therefore condition heart failure and increased mortality. But the involvement of the pacemaker in left ventricular function in patients with TAVI is multifactorial and depends on the indication of the pacemaker, whether prophylactic or absolute, on the time-dependent pacing, whether or not the patients prior to TAVI present with alterations in atrioventricular conduction [and therefore could benefit from the implantation of pacemakers], as well as the forms of pacing optimization [resynchronization, hisian pacing, etc]. All of these are issues to be considered in clinical practice.”

The editorialists concluded: “To date, the impact of PPI on late clinical outcomes after TAVR remains controversial; however, this study to some extent helps clarify this controversy.” In accord with the study authors, they called for reductions in PPI rates and long-term clinical follow-up.

The study was funded by several Swedish research organizations. The study investigators and editorial authors declared having no disclosures.

A comparison of long-term survival between patients who either did or did not undergo permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) revealed no differences, according to results of the SWEDEHEART observational study.

The nationwide population-based cohort study included all patients who underwent transfemoral TAVR in Sweden from 2008 to 2018.
 

Most frequent complications

While newer-generation aortic valve prostheses are less likely to necessitate PPI, the need for PPI is higher after TAVR than after surgical aortic valve replacement (SAVR), and the need for PPI remains the most frequent complication after TAVR, the study authors noted. Use of self-expandable valves, deep prosthetic valve implantation, preprocedural conduction disturbances, older age, and a high number of comorbidities are among the risk factors for PPI following TAVR.

With prior studies producing conflicting results, the authors stated, the impact of PPI after TAVR remains unknown. Expanding use of TAVR to include younger and low-risk patients with a long life expectancy underscores the importance of gaining greater understand of the impact of PPI after TAVR. Accordingly, the study was conducted to investigate long-term, clinically important outcomes in this post-TAVR population.

Out of 4,750 patients who underwent TAVR in the study period, 3,420 patients in SWEDEHEART met study criteria, with 481 (14.1%) undergoing PPI within 30 days after TAVR, and 2,939 not receiving a pacemaker. PPI exposure was defined as implantation of a permanent pacemaker or implantable cardioverter-defibrillator. The study primary outcome was all-cause mortality, with cardiovascular death, heart failure, and endocarditis as secondary outcomes. It was reported in JACC: Cardiovascular Interventions.
 

Similar survival

Mean patient age was 81.3 years (50.4% female). The rate for all-cause mortality in those with no pacemaker was 11.4 per 100 patient years and 13.1 for those with a pacemaker (hazard ratio, 1.04; 95% confidence interval, 0.89-1.23). The cardiovascular death rate in the no-pacemaker group was 6.0 per 100 patient years and 7.1 per 100 patient years in the pacemaker group (HR, 0.96; 95% CI, 0.75-1.23). For heart failure the rates were 4.5 per 100 patient years in the no pacemaker group and 6.3 in the pacemaker group (HR, 1.22; 95% CI, 0.93-1.672). Endocarditis rates were 1.2 and 1.1 per 100 patient years in the no pacemaker and pacemaker groups, respectively (HR, 0.93; 95% CI, 0.51-1.71).

The authors pointed out that their prior study had found PPI after SAVR in almost 25,000 patients to be associated with increased all-cause mortality and heart failure rates. Patients who undergo TAVR, however, are older and have more comorbidities than patients who undergo SAVR.

It is thus likely that patients who undergo TAVR die of other causes before the negative effects of their pacemaker become clinically evident.

Also, the incidence of conduction abnormalities increases with age, making it more likely that beneficial effects of pacemakers occur in older patients rather than younger ones, counterbalancing the detrimental effects to a larger extent.
 

Reduce PPI rates after TAVR

The study authors also observed that, although they did not find increased mortality or heart failure in patients who underwent PPI, PPI is associated with risks, including lead- and pocket-related complications, other traumatic complications, longer hospital stays and higher societal costs. These factors justify the search for strategies to reduce PPI rates after TAVR.

“Our study adds important information about the prognosis in patients who received a permanent pacemaker implantation following TAVR,” study author Natalie Glaser, MD, PhD, said in an interview. “Increased knowledge about prognosis after TAVR in different patient populations has important implications for preoperative risk stratification and can help to optimize postoperative follow-up and treatment for these patients.” Future studies, Dr. Glaser added, should include younger and low-risk patients with longer follow-up to confirm the present findings. 
 

Balancing factors

In an accompanying editorial, Antonio J. Muñoz-García, MD, PhD, and Erika Muñoz-García, MD also noted factors potentially counterbalancing and masking adverse effects of PPI, echoing some mentioned by the study authors. Among those without PPI, 10%-50% develop new-onset left bundle branch block (LBBB) after TAVR. LBBB is a known marker of low long-term survival in TAVR populations, producing intraventricular dyssynchrony leading potentially to left ventricular dysfunction or development of complete atrioventricular block with higher mortality risk in those without pacemakers. PPI, as well, can be protective against unexpected death in those with advanced conduction disorders. Still, they point out, PPI can entail lead dysfunction, need for generator replacement, infection, and tricuspid valve regurgitation.

Commenting in an interview that an observed trend of a greater increase in events in the group of patients with pacemakers for the first 4 years is consistent with prior studies, Dr. Antonio Muñoz-García said: “This can be explained because long-term survival in the TAVI population is conditioned by comorbidities. It is true that the presence of a pacemaker can cause left ventricular ejection fraction to deteriorate and therefore condition heart failure and increased mortality. But the involvement of the pacemaker in left ventricular function in patients with TAVI is multifactorial and depends on the indication of the pacemaker, whether prophylactic or absolute, on the time-dependent pacing, whether or not the patients prior to TAVI present with alterations in atrioventricular conduction [and therefore could benefit from the implantation of pacemakers], as well as the forms of pacing optimization [resynchronization, hisian pacing, etc]. All of these are issues to be considered in clinical practice.”

The editorialists concluded: “To date, the impact of PPI on late clinical outcomes after TAVR remains controversial; however, this study to some extent helps clarify this controversy.” In accord with the study authors, they called for reductions in PPI rates and long-term clinical follow-up.

The study was funded by several Swedish research organizations. The study investigators and editorial authors declared having no disclosures.

A comparison of long-term survival between patients who either did or did not undergo permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) revealed no differences, according to results of the SWEDEHEART observational study.

The nationwide population-based cohort study included all patients who underwent transfemoral TAVR in Sweden from 2008 to 2018.
 

Most frequent complications

While newer-generation aortic valve prostheses are less likely to necessitate PPI, the need for PPI is higher after TAVR than after surgical aortic valve replacement (SAVR), and the need for PPI remains the most frequent complication after TAVR, the study authors noted. Use of self-expandable valves, deep prosthetic valve implantation, preprocedural conduction disturbances, older age, and a high number of comorbidities are among the risk factors for PPI following TAVR.

With prior studies producing conflicting results, the authors stated, the impact of PPI after TAVR remains unknown. Expanding use of TAVR to include younger and low-risk patients with a long life expectancy underscores the importance of gaining greater understand of the impact of PPI after TAVR. Accordingly, the study was conducted to investigate long-term, clinically important outcomes in this post-TAVR population.

Out of 4,750 patients who underwent TAVR in the study period, 3,420 patients in SWEDEHEART met study criteria, with 481 (14.1%) undergoing PPI within 30 days after TAVR, and 2,939 not receiving a pacemaker. PPI exposure was defined as implantation of a permanent pacemaker or implantable cardioverter-defibrillator. The study primary outcome was all-cause mortality, with cardiovascular death, heart failure, and endocarditis as secondary outcomes. It was reported in JACC: Cardiovascular Interventions.
 

Similar survival

Mean patient age was 81.3 years (50.4% female). The rate for all-cause mortality in those with no pacemaker was 11.4 per 100 patient years and 13.1 for those with a pacemaker (hazard ratio, 1.04; 95% confidence interval, 0.89-1.23). The cardiovascular death rate in the no-pacemaker group was 6.0 per 100 patient years and 7.1 per 100 patient years in the pacemaker group (HR, 0.96; 95% CI, 0.75-1.23). For heart failure the rates were 4.5 per 100 patient years in the no pacemaker group and 6.3 in the pacemaker group (HR, 1.22; 95% CI, 0.93-1.672). Endocarditis rates were 1.2 and 1.1 per 100 patient years in the no pacemaker and pacemaker groups, respectively (HR, 0.93; 95% CI, 0.51-1.71).

The authors pointed out that their prior study had found PPI after SAVR in almost 25,000 patients to be associated with increased all-cause mortality and heart failure rates. Patients who undergo TAVR, however, are older and have more comorbidities than patients who undergo SAVR.

It is thus likely that patients who undergo TAVR die of other causes before the negative effects of their pacemaker become clinically evident.

Also, the incidence of conduction abnormalities increases with age, making it more likely that beneficial effects of pacemakers occur in older patients rather than younger ones, counterbalancing the detrimental effects to a larger extent.
 

Reduce PPI rates after TAVR

The study authors also observed that, although they did not find increased mortality or heart failure in patients who underwent PPI, PPI is associated with risks, including lead- and pocket-related complications, other traumatic complications, longer hospital stays and higher societal costs. These factors justify the search for strategies to reduce PPI rates after TAVR.

“Our study adds important information about the prognosis in patients who received a permanent pacemaker implantation following TAVR,” study author Natalie Glaser, MD, PhD, said in an interview. “Increased knowledge about prognosis after TAVR in different patient populations has important implications for preoperative risk stratification and can help to optimize postoperative follow-up and treatment for these patients.” Future studies, Dr. Glaser added, should include younger and low-risk patients with longer follow-up to confirm the present findings. 
 

Balancing factors

In an accompanying editorial, Antonio J. Muñoz-García, MD, PhD, and Erika Muñoz-García, MD also noted factors potentially counterbalancing and masking adverse effects of PPI, echoing some mentioned by the study authors. Among those without PPI, 10%-50% develop new-onset left bundle branch block (LBBB) after TAVR. LBBB is a known marker of low long-term survival in TAVR populations, producing intraventricular dyssynchrony leading potentially to left ventricular dysfunction or development of complete atrioventricular block with higher mortality risk in those without pacemakers. PPI, as well, can be protective against unexpected death in those with advanced conduction disorders. Still, they point out, PPI can entail lead dysfunction, need for generator replacement, infection, and tricuspid valve regurgitation.

Commenting in an interview that an observed trend of a greater increase in events in the group of patients with pacemakers for the first 4 years is consistent with prior studies, Dr. Antonio Muñoz-García said: “This can be explained because long-term survival in the TAVI population is conditioned by comorbidities. It is true that the presence of a pacemaker can cause left ventricular ejection fraction to deteriorate and therefore condition heart failure and increased mortality. But the involvement of the pacemaker in left ventricular function in patients with TAVI is multifactorial and depends on the indication of the pacemaker, whether prophylactic or absolute, on the time-dependent pacing, whether or not the patients prior to TAVI present with alterations in atrioventricular conduction [and therefore could benefit from the implantation of pacemakers], as well as the forms of pacing optimization [resynchronization, hisian pacing, etc]. All of these are issues to be considered in clinical practice.”

The editorialists concluded: “To date, the impact of PPI on late clinical outcomes after TAVR remains controversial; however, this study to some extent helps clarify this controversy.” In accord with the study authors, they called for reductions in PPI rates and long-term clinical follow-up.

The study was funded by several Swedish research organizations. The study investigators and editorial authors declared having no disclosures.

The U.S. Food and Drug Administration is informing health care providers of potential differences in procedural outcomes between men and women undergoing transcatheter left atrial appendage occlusion (LAAO).

The agency said it is evaluating a real-world study, published in JAMA Cardiology, of 49,357 patients in the National Cardiovascular Data Registry LAAO Registry that suggested women might be at greater risk than men for procedural outcomes, including major adverse events after device implant.

“The FDA recognizes the limitations of these data, including that the study was not randomized, only included one LAAO device (the first-generation Watchman device), and did not include longer-term outcomes beyond in-hospital events. However, the analysis provides results from a large registry of patients treated with LAAO implants in the U.S.,” the agency said in its letter to health care providers Sept. 27.

As reported last month, the study by Darden et al showed a significantly higher rate of adverse procedural events in women than in men, including any adverse events (6.3% vs. 3.9%; P < .001), any major adverse events (4.1% vs. 2.0%; P < .001), and hospital stay longer than 1 day (16.0% vs. 11.6%; P < .001). Procedure-associated death was 0.3% in women and 0.1% in men.

The agency noted that the number of patients in the LAAO Registry analysis was much larger than the number of patients in the premarket studies of the Watchman device that supported its approval and in the premarket studies for the other approved LAAO devices.

LAAO devices are indicated to reduce the risk for thromboembolism from the left atrial appendage in patients with nonvalvular atrial fibrillation who are not good candidates for long-term anticoagulation. LAAO devices currently marketed in the United States are Boston Scientific’s Watchman and Watchman FLX devices and Abbott Medical’s Amplatzer Amulet device.

“Currently, the FDA believes the benefits continue to outweigh the risks for approved LAAO devices when used in accordance with their instructions for use,” the letter states.

The FDA will work with device manufacturers to evaluate the potential issue, including a review of available premarket and postapproval study data and other available real-world, postmarket datasets, the letter notes.

The agency will also work with device manufacturers, investigators, and the LAAO Registry to try to identify the causes of procedural outcome differences between women and men.

In the letter, the FDA recommends health care providers continue monitoring patients who have been treated with LAAO devices in accordance with the current standard of care. They should also discuss the risks and benefits of all available options for stroke prevention in patients with atrial fibrillation as part of shared clinical decision-making.

Any adverse events or suspected adverse events experienced by patients with LAAO devices should also be reported to the FDA through MedWatch, its adverse event reporting program.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration is informing health care providers of potential differences in procedural outcomes between men and women undergoing transcatheter left atrial appendage occlusion (LAAO).

The agency said it is evaluating a real-world study, published in JAMA Cardiology, of 49,357 patients in the National Cardiovascular Data Registry LAAO Registry that suggested women might be at greater risk than men for procedural outcomes, including major adverse events after device implant.

“The FDA recognizes the limitations of these data, including that the study was not randomized, only included one LAAO device (the first-generation Watchman device), and did not include longer-term outcomes beyond in-hospital events. However, the analysis provides results from a large registry of patients treated with LAAO implants in the U.S.,” the agency said in its letter to health care providers Sept. 27.

As reported last month, the study by Darden et al showed a significantly higher rate of adverse procedural events in women than in men, including any adverse events (6.3% vs. 3.9%; P < .001), any major adverse events (4.1% vs. 2.0%; P < .001), and hospital stay longer than 1 day (16.0% vs. 11.6%; P < .001). Procedure-associated death was 0.3% in women and 0.1% in men.

The agency noted that the number of patients in the LAAO Registry analysis was much larger than the number of patients in the premarket studies of the Watchman device that supported its approval and in the premarket studies for the other approved LAAO devices.

LAAO devices are indicated to reduce the risk for thromboembolism from the left atrial appendage in patients with nonvalvular atrial fibrillation who are not good candidates for long-term anticoagulation. LAAO devices currently marketed in the United States are Boston Scientific’s Watchman and Watchman FLX devices and Abbott Medical’s Amplatzer Amulet device.

“Currently, the FDA believes the benefits continue to outweigh the risks for approved LAAO devices when used in accordance with their instructions for use,” the letter states.

The FDA will work with device manufacturers to evaluate the potential issue, including a review of available premarket and postapproval study data and other available real-world, postmarket datasets, the letter notes.

The agency will also work with device manufacturers, investigators, and the LAAO Registry to try to identify the causes of procedural outcome differences between women and men.

In the letter, the FDA recommends health care providers continue monitoring patients who have been treated with LAAO devices in accordance with the current standard of care. They should also discuss the risks and benefits of all available options for stroke prevention in patients with atrial fibrillation as part of shared clinical decision-making.

Any adverse events or suspected adverse events experienced by patients with LAAO devices should also be reported to the FDA through MedWatch, its adverse event reporting program.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration is informing health care providers of potential differences in procedural outcomes between men and women undergoing transcatheter left atrial appendage occlusion (LAAO).

The agency said it is evaluating a real-world study, published in JAMA Cardiology, of 49,357 patients in the National Cardiovascular Data Registry LAAO Registry that suggested women might be at greater risk than men for procedural outcomes, including major adverse events after device implant.

“The FDA recognizes the limitations of these data, including that the study was not randomized, only included one LAAO device (the first-generation Watchman device), and did not include longer-term outcomes beyond in-hospital events. However, the analysis provides results from a large registry of patients treated with LAAO implants in the U.S.,” the agency said in its letter to health care providers Sept. 27.

As reported last month, the study by Darden et al showed a significantly higher rate of adverse procedural events in women than in men, including any adverse events (6.3% vs. 3.9%; P < .001), any major adverse events (4.1% vs. 2.0%; P < .001), and hospital stay longer than 1 day (16.0% vs. 11.6%; P < .001). Procedure-associated death was 0.3% in women and 0.1% in men.

The agency noted that the number of patients in the LAAO Registry analysis was much larger than the number of patients in the premarket studies of the Watchman device that supported its approval and in the premarket studies for the other approved LAAO devices.

LAAO devices are indicated to reduce the risk for thromboembolism from the left atrial appendage in patients with nonvalvular atrial fibrillation who are not good candidates for long-term anticoagulation. LAAO devices currently marketed in the United States are Boston Scientific’s Watchman and Watchman FLX devices and Abbott Medical’s Amplatzer Amulet device.

“Currently, the FDA believes the benefits continue to outweigh the risks for approved LAAO devices when used in accordance with their instructions for use,” the letter states.

The FDA will work with device manufacturers to evaluate the potential issue, including a review of available premarket and postapproval study data and other available real-world, postmarket datasets, the letter notes.

The agency will also work with device manufacturers, investigators, and the LAAO Registry to try to identify the causes of procedural outcome differences between women and men.

In the letter, the FDA recommends health care providers continue monitoring patients who have been treated with LAAO devices in accordance with the current standard of care. They should also discuss the risks and benefits of all available options for stroke prevention in patients with atrial fibrillation as part of shared clinical decision-making.

Any adverse events or suspected adverse events experienced by patients with LAAO devices should also be reported to the FDA through MedWatch, its adverse event reporting program.

A version of this article first appeared on Medscape.com.

A large multicenter study provides further evidence supporting the rationale for multidisciplinary teams for cardiogenic shock, one of the most lethal diseases in cardiovascular medicine.

The analysis of 24 critical care ICUs in the Critical Care Cardiology Trials Network showed that the presence of a shock team was independently associated with a 28% lower risk for CICU mortality (23% vs. 29%; odds ratio, 0.72; P = .016).

Patients treated by a shock team also had significantly shorter CICU stays and less need for mechanical ventilation or renal replacement therapy, as reported in the Journal of the American College of Cardiology.

“It’s observational, but the association that we’re seeing here, just because of our sample size, is the strongest that’s been published yet,” lead author Alexander Papolos, MD, MedStar Washington Hospital Center, said in an interview.

Although a causal relationship cannot be drawn, the authors suggest several factors that could explain the findings, including a shock team’s ability to rapidly diagnose and treat cardiogenic shock before multiorgan dysfunction occurs.

Centers with shock teams also used significantly more pulmonary artery catheters (60% vs. 49%; adjusted OR, 1.86; P < .001) and placed them earlier (0.3 vs. 0.66 days; P = .019).

Pulmonary artery catheter (PAC) use has declined after earlier trials like ESCAPE showed little or no benefit in other acutely ill patient groups, but positive results have been reported recently in cardiogenic shock, where a PAC is needed to determine the severity of the lesion and the phenotype, Dr. Papolos observed.

A 2018 study showed PAC use was tied to increased survival among patients with acute myocardial infarction cardiogenic shock (AMI-CS) supported with the Impella (Abiomed) device. Additionally, a 2021 study by the Cardiogenic Shock Working Group demonstrated a dose-dependent survival response based on the completeness of hemodynamic assessment by PAC prior to initiating mechanical circulatory support (MCS).

A third factor might be that a structured, team-based evaluation can facilitate timely and optimal MCS device selection, deployment, and management, suggested Dr. Papolos.

Centers with shock teams used more advanced types of MCS – defined as Impella, TandemHeart (LivaNova), extracorporeal membrane oxygenation, and temporary or durable surgical ventricular assist devices – than those without a shock team (53% vs. 43%; adjusted OR, 1.73; P = .005) and did so more often as the initial device (42% vs. 28%; P = .002).

Overall MCS use was lower at shock team centers (35% vs. 43%), driven by less frequent use of intra-aortic balloon pumps (58% vs. 72%).

“The standard, basic MCS has always been the balloon pump because it’s something that’s easy to put in at the cath lab or at the bedside,” Dr. Papolos said. “So, if you take away having all of the information and having the right people at the table to discuss what the best level of support is, then you’re going to end up with balloon pumps, and that’s what we saw here.”

The study involved 6,872 consecutive medical admissions at 24 level 1 CICU centers during an annual 2-month period from 2017 to 2019. Of these, 1,242 admissions were for cardiogenic shock and 546 (44%) were treated at one of 10 centers with a shock team.

Shock team centers had higher-acuity patients than centers without a shock team (Sequential Organ Failure Assessment score, 4 vs. 3) but a similar proportion of patients with AMI-CS (27% vs. 28%).

Among all admissions, CICU mortality was not significantly different between centers with and without a shock team.

For cardiogenic shock patients treated at centers with and without a shock team, the median CICU stay was 4.0 and 5.1 days, respectively, mechanical ventilation was used in 41% and 52%, respectively, and new renal replacement therapy in 11% and 19%, respectively (P < .001 for all).

Shock team centers used significantly more PACs for AMI-CS and non–AMI-CS admissions; advanced MCS therapy was also greater in the AMI-CS subgroup.

Lower CICU mortality at shock team centers persisted among patients with non-AMI-CS (adjusted OR, 0.67; P = .017) and AMI-CS (adjusted OR, 0.79; P = .344).

“This analysis supports that all AHA level 1 cardiac ICUs should strongly consider having a shock team,” Dr. Papolos said.

Evidence from single centers and the National Cardiogenic Shock Initiative has shown improved survival with a cardiogenic shock algorithm, but this is the first report specifically comparing no shock teams with shock teams, Perwaiz Meraj, MD, Northwell Health, Manhansett, N.Y., told this news organization.

“People may say that it’s just another paper that’s saying, ‘shock teams, shock teams, rah, rah, rah,’ but it’s important for all of us to really take a close look under the covers and see how are we best managing these patients, what teams are we putting together, and to create systems of care, where if you’re at a center that really doesn’t have the capabilities of doing this, then you should partner up with a center that does,” he said.

Notably, the 10 shock teams were present only in medium or large urban, academic medical centers with more than 500 beds. Although they followed individual protocols, survey results show service-line representation, structure, and operations were similar across centers.

They all had a centralized way to activate the shock team, the service was 24/7, and members came from areas such as critical care cardiology (100%), cardiac surgery (100%), interventional cardiology (90%), advanced heart failure (80%), and extracorporeal membrane oxygenation service (70%).

Limitations of the study include the possibility of residual confounding, the fact that the registry did not capture patients with cardiogenic shock managed outside the CICU or the time of onset of cardiogenic shock, and data were limited on inotropic strategies, sedation practices, and ventilator management, the authors wrote.

“Although many critics will continue to discuss the lack of randomized controlled trials in cardiogenic shock, this paper supports the process previously outlined of a multidisciplinary team-based approach improving survival,” Dr. Meraj and William W. O’Neill, MD, director of the Center for Structural Heart Disease and Henry Ford Health System, Detroit, and the force behind the National Cardiogenic Shock Initiative, wrote in an accompanying editorial.

They point out that the report doesn’t address the escalation of care based on invasive hemodynamics in the CICU and the protocols to prevent acute vascular/limb complications (ALI) that can arise from the use of MCS.

“Many procedural techniques and novel CICU models exist to mitigate the risk of ALI in CS patients with MCS,” they wrote. “Finally, escalation of care and support is vital to the continued success of any shock team and center.”

One coauthor has served as a consultant to Abbott. Another has served as a consultant to the Abiomed critical care advisory board. All other authors reported having no relevant financial relationships. Dr. Meraj has received research and grant funding from Abiomed, Medtronic, CSI, and Boston Scientific. Dr. O’Neill has received consulting/speaker honoraria from Abiomed, Boston Scientific, and Abbott.

A version of this article first appeared on Medscape.com.

A large multicenter study provides further evidence supporting the rationale for multidisciplinary teams for cardiogenic shock, one of the most lethal diseases in cardiovascular medicine.

The analysis of 24 critical care ICUs in the Critical Care Cardiology Trials Network showed that the presence of a shock team was independently associated with a 28% lower risk for CICU mortality (23% vs. 29%; odds ratio, 0.72; P = .016).

Patients treated by a shock team also had significantly shorter CICU stays and less need for mechanical ventilation or renal replacement therapy, as reported in the Journal of the American College of Cardiology.

“It’s observational, but the association that we’re seeing here, just because of our sample size, is the strongest that’s been published yet,” lead author Alexander Papolos, MD, MedStar Washington Hospital Center, said in an interview.

Although a causal relationship cannot be drawn, the authors suggest several factors that could explain the findings, including a shock team’s ability to rapidly diagnose and treat cardiogenic shock before multiorgan dysfunction occurs.

Centers with shock teams also used significantly more pulmonary artery catheters (60% vs. 49%; adjusted OR, 1.86; P < .001) and placed them earlier (0.3 vs. 0.66 days; P = .019).

Pulmonary artery catheter (PAC) use has declined after earlier trials like ESCAPE showed little or no benefit in other acutely ill patient groups, but positive results have been reported recently in cardiogenic shock, where a PAC is needed to determine the severity of the lesion and the phenotype, Dr. Papolos observed.

A 2018 study showed PAC use was tied to increased survival among patients with acute myocardial infarction cardiogenic shock (AMI-CS) supported with the Impella (Abiomed) device. Additionally, a 2021 study by the Cardiogenic Shock Working Group demonstrated a dose-dependent survival response based on the completeness of hemodynamic assessment by PAC prior to initiating mechanical circulatory support (MCS).

A third factor might be that a structured, team-based evaluation can facilitate timely and optimal MCS device selection, deployment, and management, suggested Dr. Papolos.

Centers with shock teams used more advanced types of MCS – defined as Impella, TandemHeart (LivaNova), extracorporeal membrane oxygenation, and temporary or durable surgical ventricular assist devices – than those without a shock team (53% vs. 43%; adjusted OR, 1.73; P = .005) and did so more often as the initial device (42% vs. 28%; P = .002).

Overall MCS use was lower at shock team centers (35% vs. 43%), driven by less frequent use of intra-aortic balloon pumps (58% vs. 72%).

“The standard, basic MCS has always been the balloon pump because it’s something that’s easy to put in at the cath lab or at the bedside,” Dr. Papolos said. “So, if you take away having all of the information and having the right people at the table to discuss what the best level of support is, then you’re going to end up with balloon pumps, and that’s what we saw here.”

The study involved 6,872 consecutive medical admissions at 24 level 1 CICU centers during an annual 2-month period from 2017 to 2019. Of these, 1,242 admissions were for cardiogenic shock and 546 (44%) were treated at one of 10 centers with a shock team.

Shock team centers had higher-acuity patients than centers without a shock team (Sequential Organ Failure Assessment score, 4 vs. 3) but a similar proportion of patients with AMI-CS (27% vs. 28%).

Among all admissions, CICU mortality was not significantly different between centers with and without a shock team.

For cardiogenic shock patients treated at centers with and without a shock team, the median CICU stay was 4.0 and 5.1 days, respectively, mechanical ventilation was used in 41% and 52%, respectively, and new renal replacement therapy in 11% and 19%, respectively (P < .001 for all).

Shock team centers used significantly more PACs for AMI-CS and non–AMI-CS admissions; advanced MCS therapy was also greater in the AMI-CS subgroup.

Lower CICU mortality at shock team centers persisted among patients with non-AMI-CS (adjusted OR, 0.67; P = .017) and AMI-CS (adjusted OR, 0.79; P = .344).

“This analysis supports that all AHA level 1 cardiac ICUs should strongly consider having a shock team,” Dr. Papolos said.

Evidence from single centers and the National Cardiogenic Shock Initiative has shown improved survival with a cardiogenic shock algorithm, but this is the first report specifically comparing no shock teams with shock teams, Perwaiz Meraj, MD, Northwell Health, Manhansett, N.Y., told this news organization.

“People may say that it’s just another paper that’s saying, ‘shock teams, shock teams, rah, rah, rah,’ but it’s important for all of us to really take a close look under the covers and see how are we best managing these patients, what teams are we putting together, and to create systems of care, where if you’re at a center that really doesn’t have the capabilities of doing this, then you should partner up with a center that does,” he said.

Notably, the 10 shock teams were present only in medium or large urban, academic medical centers with more than 500 beds. Although they followed individual protocols, survey results show service-line representation, structure, and operations were similar across centers.

They all had a centralized way to activate the shock team, the service was 24/7, and members came from areas such as critical care cardiology (100%), cardiac surgery (100%), interventional cardiology (90%), advanced heart failure (80%), and extracorporeal membrane oxygenation service (70%).

Limitations of the study include the possibility of residual confounding, the fact that the registry did not capture patients with cardiogenic shock managed outside the CICU or the time of onset of cardiogenic shock, and data were limited on inotropic strategies, sedation practices, and ventilator management, the authors wrote.

“Although many critics will continue to discuss the lack of randomized controlled trials in cardiogenic shock, this paper supports the process previously outlined of a multidisciplinary team-based approach improving survival,” Dr. Meraj and William W. O’Neill, MD, director of the Center for Structural Heart Disease and Henry Ford Health System, Detroit, and the force behind the National Cardiogenic Shock Initiative, wrote in an accompanying editorial.

They point out that the report doesn’t address the escalation of care based on invasive hemodynamics in the CICU and the protocols to prevent acute vascular/limb complications (ALI) that can arise from the use of MCS.

“Many procedural techniques and novel CICU models exist to mitigate the risk of ALI in CS patients with MCS,” they wrote. “Finally, escalation of care and support is vital to the continued success of any shock team and center.”

One coauthor has served as a consultant to Abbott. Another has served as a consultant to the Abiomed critical care advisory board. All other authors reported having no relevant financial relationships. Dr. Meraj has received research and grant funding from Abiomed, Medtronic, CSI, and Boston Scientific. Dr. O’Neill has received consulting/speaker honoraria from Abiomed, Boston Scientific, and Abbott.

A version of this article first appeared on Medscape.com.

A large multicenter study provides further evidence supporting the rationale for multidisciplinary teams for cardiogenic shock, one of the most lethal diseases in cardiovascular medicine.

The analysis of 24 critical care ICUs in the Critical Care Cardiology Trials Network showed that the presence of a shock team was independently associated with a 28% lower risk for CICU mortality (23% vs. 29%; odds ratio, 0.72; P = .016).

Patients treated by a shock team also had significantly shorter CICU stays and less need for mechanical ventilation or renal replacement therapy, as reported in the Journal of the American College of Cardiology.

“It’s observational, but the association that we’re seeing here, just because of our sample size, is the strongest that’s been published yet,” lead author Alexander Papolos, MD, MedStar Washington Hospital Center, said in an interview.

Although a causal relationship cannot be drawn, the authors suggest several factors that could explain the findings, including a shock team’s ability to rapidly diagnose and treat cardiogenic shock before multiorgan dysfunction occurs.

Centers with shock teams also used significantly more pulmonary artery catheters (60% vs. 49%; adjusted OR, 1.86; P < .001) and placed them earlier (0.3 vs. 0.66 days; P = .019).

Pulmonary artery catheter (PAC) use has declined after earlier trials like ESCAPE showed little or no benefit in other acutely ill patient groups, but positive results have been reported recently in cardiogenic shock, where a PAC is needed to determine the severity of the lesion and the phenotype, Dr. Papolos observed.

A 2018 study showed PAC use was tied to increased survival among patients with acute myocardial infarction cardiogenic shock (AMI-CS) supported with the Impella (Abiomed) device. Additionally, a 2021 study by the Cardiogenic Shock Working Group demonstrated a dose-dependent survival response based on the completeness of hemodynamic assessment by PAC prior to initiating mechanical circulatory support (MCS).

A third factor might be that a structured, team-based evaluation can facilitate timely and optimal MCS device selection, deployment, and management, suggested Dr. Papolos.

Centers with shock teams used more advanced types of MCS – defined as Impella, TandemHeart (LivaNova), extracorporeal membrane oxygenation, and temporary or durable surgical ventricular assist devices – than those without a shock team (53% vs. 43%; adjusted OR, 1.73; P = .005) and did so more often as the initial device (42% vs. 28%; P = .002).

Overall MCS use was lower at shock team centers (35% vs. 43%), driven by less frequent use of intra-aortic balloon pumps (58% vs. 72%).

“The standard, basic MCS has always been the balloon pump because it’s something that’s easy to put in at the cath lab or at the bedside,” Dr. Papolos said. “So, if you take away having all of the information and having the right people at the table to discuss what the best level of support is, then you’re going to end up with balloon pumps, and that’s what we saw here.”

The study involved 6,872 consecutive medical admissions at 24 level 1 CICU centers during an annual 2-month period from 2017 to 2019. Of these, 1,242 admissions were for cardiogenic shock and 546 (44%) were treated at one of 10 centers with a shock team.

Shock team centers had higher-acuity patients than centers without a shock team (Sequential Organ Failure Assessment score, 4 vs. 3) but a similar proportion of patients with AMI-CS (27% vs. 28%).

Among all admissions, CICU mortality was not significantly different between centers with and without a shock team.

For cardiogenic shock patients treated at centers with and without a shock team, the median CICU stay was 4.0 and 5.1 days, respectively, mechanical ventilation was used in 41% and 52%, respectively, and new renal replacement therapy in 11% and 19%, respectively (P < .001 for all).

Shock team centers used significantly more PACs for AMI-CS and non–AMI-CS admissions; advanced MCS therapy was also greater in the AMI-CS subgroup.

Lower CICU mortality at shock team centers persisted among patients with non-AMI-CS (adjusted OR, 0.67; P = .017) and AMI-CS (adjusted OR, 0.79; P = .344).

“This analysis supports that all AHA level 1 cardiac ICUs should strongly consider having a shock team,” Dr. Papolos said.

Evidence from single centers and the National Cardiogenic Shock Initiative has shown improved survival with a cardiogenic shock algorithm, but this is the first report specifically comparing no shock teams with shock teams, Perwaiz Meraj, MD, Northwell Health, Manhansett, N.Y., told this news organization.

“People may say that it’s just another paper that’s saying, ‘shock teams, shock teams, rah, rah, rah,’ but it’s important for all of us to really take a close look under the covers and see how are we best managing these patients, what teams are we putting together, and to create systems of care, where if you’re at a center that really doesn’t have the capabilities of doing this, then you should partner up with a center that does,” he said.

Notably, the 10 shock teams were present only in medium or large urban, academic medical centers with more than 500 beds. Although they followed individual protocols, survey results show service-line representation, structure, and operations were similar across centers.

They all had a centralized way to activate the shock team, the service was 24/7, and members came from areas such as critical care cardiology (100%), cardiac surgery (100%), interventional cardiology (90%), advanced heart failure (80%), and extracorporeal membrane oxygenation service (70%).

Limitations of the study include the possibility of residual confounding, the fact that the registry did not capture patients with cardiogenic shock managed outside the CICU or the time of onset of cardiogenic shock, and data were limited on inotropic strategies, sedation practices, and ventilator management, the authors wrote.

“Although many critics will continue to discuss the lack of randomized controlled trials in cardiogenic shock, this paper supports the process previously outlined of a multidisciplinary team-based approach improving survival,” Dr. Meraj and William W. O’Neill, MD, director of the Center for Structural Heart Disease and Henry Ford Health System, Detroit, and the force behind the National Cardiogenic Shock Initiative, wrote in an accompanying editorial.

They point out that the report doesn’t address the escalation of care based on invasive hemodynamics in the CICU and the protocols to prevent acute vascular/limb complications (ALI) that can arise from the use of MCS.

“Many procedural techniques and novel CICU models exist to mitigate the risk of ALI in CS patients with MCS,” they wrote. “Finally, escalation of care and support is vital to the continued success of any shock team and center.”

One coauthor has served as a consultant to Abbott. Another has served as a consultant to the Abiomed critical care advisory board. All other authors reported having no relevant financial relationships. Dr. Meraj has received research and grant funding from Abiomed, Medtronic, CSI, and Boston Scientific. Dr. O’Neill has received consulting/speaker honoraria from Abiomed, Boston Scientific, and Abbott.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the Portico with FlexNav (Abbott) transcatheter aortic valve replacement (TAVR) system for patients with “symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery,” the company has announced.

Olivier Le Moal/Getty Images

The approval indication is in line with the entry criteria of PORTICO IDE, the investigational device exemption trial from which the FDA largely made its decision.

With the self-expanding Portico valve, Abbott joins two other companies with TAVR valves on the U.S. market: Medtronic with the self-expanding Corevalve Evolut (Medtronic) line, and Edwards Lifesciences with its Sapien (Edwards Lifesciences) valves, both of which can be used in patients at low surgical risk.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the Portico with FlexNav (Abbott) transcatheter aortic valve replacement (TAVR) system for patients with “symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery,” the company has announced.

Olivier Le Moal/Getty Images

The approval indication is in line with the entry criteria of PORTICO IDE, the investigational device exemption trial from which the FDA largely made its decision.

With the self-expanding Portico valve, Abbott joins two other companies with TAVR valves on the U.S. market: Medtronic with the self-expanding Corevalve Evolut (Medtronic) line, and Edwards Lifesciences with its Sapien (Edwards Lifesciences) valves, both of which can be used in patients at low surgical risk.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the Portico with FlexNav (Abbott) transcatheter aortic valve replacement (TAVR) system for patients with “symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery,” the company has announced.

Olivier Le Moal/Getty Images

The approval indication is in line with the entry criteria of PORTICO IDE, the investigational device exemption trial from which the FDA largely made its decision.

With the self-expanding Portico valve, Abbott joins two other companies with TAVR valves on the U.S. market: Medtronic with the self-expanding Corevalve Evolut (Medtronic) line, and Edwards Lifesciences with its Sapien (Edwards Lifesciences) valves, both of which can be used in patients at low surgical risk.

A version of this article first appeared on Medscape.com.

Patients with chronic lymphocytic leukemia have similar outcomes following cardiac operations as patients without CLL, but commonly require more blood transfusions, according to the results of retrospective cohort study using the 2010-2017 Nationwide Readmissions Database (NRD).

The researchers assessed all adult patients undergoing elective coronary artery bypass grafting, valve repair, or valve replacement as identified using the NRD.

Patients were stratified by history of CLL and the incidence of in-hospital mortality, perioperative complications, blood transfusions, and readmission within 90 days were examined. A 3:1 nearest-neighbor matching was performed between patients with and without CLL for all primary and secondary outcomes of interest, according to the report, published online in Annals of Thoracic Surgery.
 

Comparable results

A total of 1,250,882 patients in the database were found who underwent cardiac operations. Of these, 0.23% had a diagnosis of CLL. Among 11,237 propensity-matched patients, those with CLL had similar rates of in-hospital mortality (3.8% vs. 2.6%, P = .08) and perioperative complications (33.4% vs. 33.6%, P = .92), compared with their non-CLL counterparts. However, the incidence of infection was comparable (8.5% vs. 9.4%, P = .38).

However, patients with CLL required blood transfusions more frequently (33.7% vs. 28.4%, P = .003) than did patients without CLL. In addition, patients with CLL were more likely to be readmitted within 90 days of discharge, compared with their counterparts, and “respiratory reasons, including pneumonia, contributed significantly to the readmission burden in this cohort,” the researchers, led by Josef Madrigal, BS, of the University of California, Los Angeles, stated.

“The inherent risk of transfusion and the possible benefits of blood conservation interventions must be considered in this patient population. Increased risk of rehospitalization in patients with CLL suggests the need for measures aimed at mitigating the risk of respiratory complications,” the researchers concluded.

There were no conflicts of interest reported in the article.

[email protected]

Patients with chronic lymphocytic leukemia have similar outcomes following cardiac operations as patients without CLL, but commonly require more blood transfusions, according to the results of retrospective cohort study using the 2010-2017 Nationwide Readmissions Database (NRD).

The researchers assessed all adult patients undergoing elective coronary artery bypass grafting, valve repair, or valve replacement as identified using the NRD.

Patients were stratified by history of CLL and the incidence of in-hospital mortality, perioperative complications, blood transfusions, and readmission within 90 days were examined. A 3:1 nearest-neighbor matching was performed between patients with and without CLL for all primary and secondary outcomes of interest, according to the report, published online in Annals of Thoracic Surgery.
 

Comparable results

A total of 1,250,882 patients in the database were found who underwent cardiac operations. Of these, 0.23% had a diagnosis of CLL. Among 11,237 propensity-matched patients, those with CLL had similar rates of in-hospital mortality (3.8% vs. 2.6%, P = .08) and perioperative complications (33.4% vs. 33.6%, P = .92), compared with their non-CLL counterparts. However, the incidence of infection was comparable (8.5% vs. 9.4%, P = .38).

However, patients with CLL required blood transfusions more frequently (33.7% vs. 28.4%, P = .003) than did patients without CLL. In addition, patients with CLL were more likely to be readmitted within 90 days of discharge, compared with their counterparts, and “respiratory reasons, including pneumonia, contributed significantly to the readmission burden in this cohort,” the researchers, led by Josef Madrigal, BS, of the University of California, Los Angeles, stated.

“The inherent risk of transfusion and the possible benefits of blood conservation interventions must be considered in this patient population. Increased risk of rehospitalization in patients with CLL suggests the need for measures aimed at mitigating the risk of respiratory complications,” the researchers concluded.

There were no conflicts of interest reported in the article.

[email protected]

Patients with chronic lymphocytic leukemia have similar outcomes following cardiac operations as patients without CLL, but commonly require more blood transfusions, according to the results of retrospective cohort study using the 2010-2017 Nationwide Readmissions Database (NRD).

The researchers assessed all adult patients undergoing elective coronary artery bypass grafting, valve repair, or valve replacement as identified using the NRD.

Patients were stratified by history of CLL and the incidence of in-hospital mortality, perioperative complications, blood transfusions, and readmission within 90 days were examined. A 3:1 nearest-neighbor matching was performed between patients with and without CLL for all primary and secondary outcomes of interest, according to the report, published online in Annals of Thoracic Surgery.
 

Comparable results

A total of 1,250,882 patients in the database were found who underwent cardiac operations. Of these, 0.23% had a diagnosis of CLL. Among 11,237 propensity-matched patients, those with CLL had similar rates of in-hospital mortality (3.8% vs. 2.6%, P = .08) and perioperative complications (33.4% vs. 33.6%, P = .92), compared with their non-CLL counterparts. However, the incidence of infection was comparable (8.5% vs. 9.4%, P = .38).

However, patients with CLL required blood transfusions more frequently (33.7% vs. 28.4%, P = .003) than did patients without CLL. In addition, patients with CLL were more likely to be readmitted within 90 days of discharge, compared with their counterparts, and “respiratory reasons, including pneumonia, contributed significantly to the readmission burden in this cohort,” the researchers, led by Josef Madrigal, BS, of the University of California, Los Angeles, stated.

“The inherent risk of transfusion and the possible benefits of blood conservation interventions must be considered in this patient population. Increased risk of rehospitalization in patients with CLL suggests the need for measures aimed at mitigating the risk of respiratory complications,” the researchers concluded.

There were no conflicts of interest reported in the article.

[email protected]

Treatment with acetylsalicylic acid (ASA) or heparin is associated with an increased risk for symptomatic intracranial hemorrhage (sICH) in patients with ischemic stroke who are undergoing endovascular therapy (EVT), new data show.

In this population, ASA and heparin are each associated with an approximately doubled risk for sICH when administered during EVT.

“We did not find any evidence for a beneficial effect on functional outcome,” investigator Wouter van der Steen, MD, research physician and PhD student at Erasmus University Medical Center, Rotterdam, the Netherlands, told this news organization. The possibility that a positive effect would be observed if the trial were continued was considered negligible, he added.

The researchers stopped the trial for safety reasons and recommend avoiding the evaluated dosages of both medications during EVT for ischemic stroke, said Dr. van der Steen.

He presented the findings from the MR CLEAN-MED trial at the European Stroke Organisation Conference (ESOC) 2021, which was held online.
 

Trial stopped for safety

Previous research has supported the safety and efficacy of EVT for ischemic stroke. Still, more than 30% of patients do not recover, despite fast and complete recanalization. Incomplete microvascular reperfusion (IMR) could explain this incomplete recovery, the researchers note.

Microthrombi, which occlude distal vessels, and neutrophil extracellular traps can cause IMR. This problem can be reduced through treatment with ASA, which has an antithrombotic effect, or with heparin, which dissolves neutrophil extracellular traps, they add. Although these drugs are associated with good clinical outcomes, they entail an increased risk for sICH.

The investigators conducted the multicenter, randomized controlled MR CLEAN-MED trial to evaluate the effect of intravenous (IV) ASA and heparin, alone or in combination, during EVT for acute ischemic stroke. Treatment was open label, but outcome assessment was blinded. Eligible participants were adults with a National Institutes of Health Stroke Scale (NIHSS) score of greater than or equal to 2 and an anterior circulation large-vessel occlusion for whom EVT could be initiated in fewer than 6 hours.

Investigators randomly assigned patients to receive or not to receive ASA. Within each of these two treatment groups, patients were randomly assigned to receive no heparin, low-dose heparin, or moderate-dose heparin.

ASA was given in a loading dose of 300 mg. Patients who were given low-dose heparin received a loading dose of 5,000 IU followed by 500 IU/h for 6 hours. Patients who received moderate-dose heparin were given a loading dose of 5,000 IU followed by 1,250 IU/h for 6 hours.

The study’s primary outcome was Modified Rankin Scale (mRS) score at 90 days. Secondary outcomes were NIHSS score at 24 hours, NIHSS score at 5 to 7 days, and recanalization grade at 24 hours on CT angiography or MRI. The primary safety outcomes were sICH and death within 90 days.

An independent, unblinded data and safety monitoring board (DSMB) assessed the risk for the primary safety outcomes throughout the trial. The board performed interim analyses of safety and efficacy for every 300 patients.

After the fourth safety assessment, the DSMB recommended that enrollment in the moderate-dose heparin arm be discontinued for safety reasons. Enrollment in other arms continued.

After the second interim analysis, the DSMB advised that the trial steering committee be unblinded to decide whether to stop or continue the trial. The steering committee decided to stop the trial for reasons of safety.
 

Increased risk for sICH

In all, 628 patients were included in the study. The ASA groups included 310 patients, and the no-ASA groups included 318 patients. In all, 332 participants received heparin, and 296 received no heparin.

The demographic characteristics were well balanced between groups. The population’s median age was 73 years, and about 53% were men. The median baseline NIHSS score was approximately 15. About 74% of patients received IV thrombolysis. The median baseline Alberta Stroke Program Early CT Scan score was 9.

The investigators observed a slight shift toward worse outcome in the ASA group, compared with the no-ASA group (adjusted OR, 0.91). In addition, the ASA group had a significantly increased risk for sICH, compared with the no-ASA group (14% vs. 7.2%; aOR, 1.95).

Patients in the ASA group were less likely to have good functional outcome (mRS of 0 to 2; aOR, 0.76), and the mortality rate tended to be higher.

The researchers found a nonsignificant shift toward a worse functional outcome in the heparin group, compared with the no-heparin group (aOR, 0.81). The risk for sICH was significantly higher in the heparin group, compared with the no-heparin group (13% vs. 7.4%; aOR, 2.00).

Patients in the heparin group were also less likely to have a good functional outcome (aOR, 0.78), and there was a nonsignificant increase in risk for death among those patients.

The rate of sICH was 11% in the group that received low-dose heparin; it was 26% in the group that received moderate-dose heparin (aOR, 6.05). The mortality rate was 23% in the low-dose group and 47% in the moderate-dose group (aOR, 5.45).

There was no significant interaction between ASA and heparin on the primary outcome and on sICH occurrence.
 

‘A unique trial’

“MR CLEAN-MED is a unique trial because it investigated a widely used treatment but until now without any proof of effectiveness,” said Dr. van der Steen. The researchers expect that their findings will have a strong impact on the management of patients with acute ischemic stroke. They suggest that the administration of antithrombotic agents during EVT be avoided.

“We consider it probable that the increased risk of sICH explains at least a part of the nonsignificant shift towards a worse functional outcome,” co-investigator Bob Roozenbeek, MD, PhD, a neurologist at the Erasmus Medical Center, said in an interview. “However, to make more definite statements, we will have to do more in-depth analyses.”

It remains unclear whether the periprocedural use of lower dosages of antithrombotic agents or of a single bolus of heparin could be safe and effective, said Dr. van der Steen.

To gain insight into these questions, the investigators will evaluate the effect of the medications and dosages examined in this trial on primary hemostasis and coagulation activity in the trial population. They also plan to examine the effect of primary hemostasis and coagulation activity on risk for sICH and functional outcome.

Enhancing the effectiveness of thrombectomy for acute ischemic stroke continues to be an important goal for stroke therapy, said Mark Fisher, MD, professor of neurology and pathology and laboratory medicine at the University of California, Irvine, who commented on the findings for this news organization.

At least three strategies are available: The use of ancillary antithrombotic medications, neuroprotection, and modulation of the vasoconstrictive properties of the microcirculation.

“Results of MR CLEAN-MED argue against the antithrombotic strategy,” said Dr. Fisher. “The alternate strategies remain viable, and results of interventions using those approaches are awaited with great interest.”

The study was funded by the CONTRAST consortium, which is supported by the Netherlands Cardiovascular Research Initiative and the Brain Foundation Netherlands. Funding also was provided by Stryker, Medtronic, and Cerenovus. Dr. van der Steen and Dr. Fisher have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Treatment with acetylsalicylic acid (ASA) or heparin is associated with an increased risk for symptomatic intracranial hemorrhage (sICH) in patients with ischemic stroke who are undergoing endovascular therapy (EVT), new data show.

In this population, ASA and heparin are each associated with an approximately doubled risk for sICH when administered during EVT.

“We did not find any evidence for a beneficial effect on functional outcome,” investigator Wouter van der Steen, MD, research physician and PhD student at Erasmus University Medical Center, Rotterdam, the Netherlands, told this news organization. The possibility that a positive effect would be observed if the trial were continued was considered negligible, he added.

The researchers stopped the trial for safety reasons and recommend avoiding the evaluated dosages of both medications during EVT for ischemic stroke, said Dr. van der Steen.

He presented the findings from the MR CLEAN-MED trial at the European Stroke Organisation Conference (ESOC) 2021, which was held online.
 

Trial stopped for safety

Previous research has supported the safety and efficacy of EVT for ischemic stroke. Still, more than 30% of patients do not recover, despite fast and complete recanalization. Incomplete microvascular reperfusion (IMR) could explain this incomplete recovery, the researchers note.

Microthrombi, which occlude distal vessels, and neutrophil extracellular traps can cause IMR. This problem can be reduced through treatment with ASA, which has an antithrombotic effect, or with heparin, which dissolves neutrophil extracellular traps, they add. Although these drugs are associated with good clinical outcomes, they entail an increased risk for sICH.

The investigators conducted the multicenter, randomized controlled MR CLEAN-MED trial to evaluate the effect of intravenous (IV) ASA and heparin, alone or in combination, during EVT for acute ischemic stroke. Treatment was open label, but outcome assessment was blinded. Eligible participants were adults with a National Institutes of Health Stroke Scale (NIHSS) score of greater than or equal to 2 and an anterior circulation large-vessel occlusion for whom EVT could be initiated in fewer than 6 hours.

Investigators randomly assigned patients to receive or not to receive ASA. Within each of these two treatment groups, patients were randomly assigned to receive no heparin, low-dose heparin, or moderate-dose heparin.

ASA was given in a loading dose of 300 mg. Patients who were given low-dose heparin received a loading dose of 5,000 IU followed by 500 IU/h for 6 hours. Patients who received moderate-dose heparin were given a loading dose of 5,000 IU followed by 1,250 IU/h for 6 hours.

The study’s primary outcome was Modified Rankin Scale (mRS) score at 90 days. Secondary outcomes were NIHSS score at 24 hours, NIHSS score at 5 to 7 days, and recanalization grade at 24 hours on CT angiography or MRI. The primary safety outcomes were sICH and death within 90 days.

An independent, unblinded data and safety monitoring board (DSMB) assessed the risk for the primary safety outcomes throughout the trial. The board performed interim analyses of safety and efficacy for every 300 patients.

After the fourth safety assessment, the DSMB recommended that enrollment in the moderate-dose heparin arm be discontinued for safety reasons. Enrollment in other arms continued.

After the second interim analysis, the DSMB advised that the trial steering committee be unblinded to decide whether to stop or continue the trial. The steering committee decided to stop the trial for reasons of safety.
 

Increased risk for sICH

In all, 628 patients were included in the study. The ASA groups included 310 patients, and the no-ASA groups included 318 patients. In all, 332 participants received heparin, and 296 received no heparin.

The demographic characteristics were well balanced between groups. The population’s median age was 73 years, and about 53% were men. The median baseline NIHSS score was approximately 15. About 74% of patients received IV thrombolysis. The median baseline Alberta Stroke Program Early CT Scan score was 9.

The investigators observed a slight shift toward worse outcome in the ASA group, compared with the no-ASA group (adjusted OR, 0.91). In addition, the ASA group had a significantly increased risk for sICH, compared with the no-ASA group (14% vs. 7.2%; aOR, 1.95).

Patients in the ASA group were less likely to have good functional outcome (mRS of 0 to 2; aOR, 0.76), and the mortality rate tended to be higher.

The researchers found a nonsignificant shift toward a worse functional outcome in the heparin group, compared with the no-heparin group (aOR, 0.81). The risk for sICH was significantly higher in the heparin group, compared with the no-heparin group (13% vs. 7.4%; aOR, 2.00).

Patients in the heparin group were also less likely to have a good functional outcome (aOR, 0.78), and there was a nonsignificant increase in risk for death among those patients.

The rate of sICH was 11% in the group that received low-dose heparin; it was 26% in the group that received moderate-dose heparin (aOR, 6.05). The mortality rate was 23% in the low-dose group and 47% in the moderate-dose group (aOR, 5.45).

There was no significant interaction between ASA and heparin on the primary outcome and on sICH occurrence.
 

‘A unique trial’

“MR CLEAN-MED is a unique trial because it investigated a widely used treatment but until now without any proof of effectiveness,” said Dr. van der Steen. The researchers expect that their findings will have a strong impact on the management of patients with acute ischemic stroke. They suggest that the administration of antithrombotic agents during EVT be avoided.

“We consider it probable that the increased risk of sICH explains at least a part of the nonsignificant shift towards a worse functional outcome,” co-investigator Bob Roozenbeek, MD, PhD, a neurologist at the Erasmus Medical Center, said in an interview. “However, to make more definite statements, we will have to do more in-depth analyses.”

It remains unclear whether the periprocedural use of lower dosages of antithrombotic agents or of a single bolus of heparin could be safe and effective, said Dr. van der Steen.

To gain insight into these questions, the investigators will evaluate the effect of the medications and dosages examined in this trial on primary hemostasis and coagulation activity in the trial population. They also plan to examine the effect of primary hemostasis and coagulation activity on risk for sICH and functional outcome.

Enhancing the effectiveness of thrombectomy for acute ischemic stroke continues to be an important goal for stroke therapy, said Mark Fisher, MD, professor of neurology and pathology and laboratory medicine at the University of California, Irvine, who commented on the findings for this news organization.

At least three strategies are available: The use of ancillary antithrombotic medications, neuroprotection, and modulation of the vasoconstrictive properties of the microcirculation.

“Results of MR CLEAN-MED argue against the antithrombotic strategy,” said Dr. Fisher. “The alternate strategies remain viable, and results of interventions using those approaches are awaited with great interest.”

The study was funded by the CONTRAST consortium, which is supported by the Netherlands Cardiovascular Research Initiative and the Brain Foundation Netherlands. Funding also was provided by Stryker, Medtronic, and Cerenovus. Dr. van der Steen and Dr. Fisher have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Treatment with acetylsalicylic acid (ASA) or heparin is associated with an increased risk for symptomatic intracranial hemorrhage (sICH) in patients with ischemic stroke who are undergoing endovascular therapy (EVT), new data show.

In this population, ASA and heparin are each associated with an approximately doubled risk for sICH when administered during EVT.

“We did not find any evidence for a beneficial effect on functional outcome,” investigator Wouter van der Steen, MD, research physician and PhD student at Erasmus University Medical Center, Rotterdam, the Netherlands, told this news organization. The possibility that a positive effect would be observed if the trial were continued was considered negligible, he added.

The researchers stopped the trial for safety reasons and recommend avoiding the evaluated dosages of both medications during EVT for ischemic stroke, said Dr. van der Steen.

He presented the findings from the MR CLEAN-MED trial at the European Stroke Organisation Conference (ESOC) 2021, which was held online.
 

Trial stopped for safety

Previous research has supported the safety and efficacy of EVT for ischemic stroke. Still, more than 30% of patients do not recover, despite fast and complete recanalization. Incomplete microvascular reperfusion (IMR) could explain this incomplete recovery, the researchers note.

Microthrombi, which occlude distal vessels, and neutrophil extracellular traps can cause IMR. This problem can be reduced through treatment with ASA, which has an antithrombotic effect, or with heparin, which dissolves neutrophil extracellular traps, they add. Although these drugs are associated with good clinical outcomes, they entail an increased risk for sICH.

The investigators conducted the multicenter, randomized controlled MR CLEAN-MED trial to evaluate the effect of intravenous (IV) ASA and heparin, alone or in combination, during EVT for acute ischemic stroke. Treatment was open label, but outcome assessment was blinded. Eligible participants were adults with a National Institutes of Health Stroke Scale (NIHSS) score of greater than or equal to 2 and an anterior circulation large-vessel occlusion for whom EVT could be initiated in fewer than 6 hours.

Investigators randomly assigned patients to receive or not to receive ASA. Within each of these two treatment groups, patients were randomly assigned to receive no heparin, low-dose heparin, or moderate-dose heparin.

ASA was given in a loading dose of 300 mg. Patients who were given low-dose heparin received a loading dose of 5,000 IU followed by 500 IU/h for 6 hours. Patients who received moderate-dose heparin were given a loading dose of 5,000 IU followed by 1,250 IU/h for 6 hours.

The study’s primary outcome was Modified Rankin Scale (mRS) score at 90 days. Secondary outcomes were NIHSS score at 24 hours, NIHSS score at 5 to 7 days, and recanalization grade at 24 hours on CT angiography or MRI. The primary safety outcomes were sICH and death within 90 days.

An independent, unblinded data and safety monitoring board (DSMB) assessed the risk for the primary safety outcomes throughout the trial. The board performed interim analyses of safety and efficacy for every 300 patients.

After the fourth safety assessment, the DSMB recommended that enrollment in the moderate-dose heparin arm be discontinued for safety reasons. Enrollment in other arms continued.

After the second interim analysis, the DSMB advised that the trial steering committee be unblinded to decide whether to stop or continue the trial. The steering committee decided to stop the trial for reasons of safety.
 

Increased risk for sICH

In all, 628 patients were included in the study. The ASA groups included 310 patients, and the no-ASA groups included 318 patients. In all, 332 participants received heparin, and 296 received no heparin.

The demographic characteristics were well balanced between groups. The population’s median age was 73 years, and about 53% were men. The median baseline NIHSS score was approximately 15. About 74% of patients received IV thrombolysis. The median baseline Alberta Stroke Program Early CT Scan score was 9.

The investigators observed a slight shift toward worse outcome in the ASA group, compared with the no-ASA group (adjusted OR, 0.91). In addition, the ASA group had a significantly increased risk for sICH, compared with the no-ASA group (14% vs. 7.2%; aOR, 1.95).

Patients in the ASA group were less likely to have good functional outcome (mRS of 0 to 2; aOR, 0.76), and the mortality rate tended to be higher.

The researchers found a nonsignificant shift toward a worse functional outcome in the heparin group, compared with the no-heparin group (aOR, 0.81). The risk for sICH was significantly higher in the heparin group, compared with the no-heparin group (13% vs. 7.4%; aOR, 2.00).

Patients in the heparin group were also less likely to have a good functional outcome (aOR, 0.78), and there was a nonsignificant increase in risk for death among those patients.

The rate of sICH was 11% in the group that received low-dose heparin; it was 26% in the group that received moderate-dose heparin (aOR, 6.05). The mortality rate was 23% in the low-dose group and 47% in the moderate-dose group (aOR, 5.45).

There was no significant interaction between ASA and heparin on the primary outcome and on sICH occurrence.
 

‘A unique trial’

“MR CLEAN-MED is a unique trial because it investigated a widely used treatment but until now without any proof of effectiveness,” said Dr. van der Steen. The researchers expect that their findings will have a strong impact on the management of patients with acute ischemic stroke. They suggest that the administration of antithrombotic agents during EVT be avoided.

“We consider it probable that the increased risk of sICH explains at least a part of the nonsignificant shift towards a worse functional outcome,” co-investigator Bob Roozenbeek, MD, PhD, a neurologist at the Erasmus Medical Center, said in an interview. “However, to make more definite statements, we will have to do more in-depth analyses.”

It remains unclear whether the periprocedural use of lower dosages of antithrombotic agents or of a single bolus of heparin could be safe and effective, said Dr. van der Steen.

To gain insight into these questions, the investigators will evaluate the effect of the medications and dosages examined in this trial on primary hemostasis and coagulation activity in the trial population. They also plan to examine the effect of primary hemostasis and coagulation activity on risk for sICH and functional outcome.

Enhancing the effectiveness of thrombectomy for acute ischemic stroke continues to be an important goal for stroke therapy, said Mark Fisher, MD, professor of neurology and pathology and laboratory medicine at the University of California, Irvine, who commented on the findings for this news organization.

At least three strategies are available: The use of ancillary antithrombotic medications, neuroprotection, and modulation of the vasoconstrictive properties of the microcirculation.

“Results of MR CLEAN-MED argue against the antithrombotic strategy,” said Dr. Fisher. “The alternate strategies remain viable, and results of interventions using those approaches are awaited with great interest.”

The study was funded by the CONTRAST consortium, which is supported by the Netherlands Cardiovascular Research Initiative and the Brain Foundation Netherlands. Funding also was provided by Stryker, Medtronic, and Cerenovus. Dr. van der Steen and Dr. Fisher have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.