Interventional Cardiology & Surgery

The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.

A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.

“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.

The analysis was published online July 31 in the Journal of the American College of Cardiology.

The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”

The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).

Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”

He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.

“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”

As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”

He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.

The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.

Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.

“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.

“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
 

Stopped for lack of funding

Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.

The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.

Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.

The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.

Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.

“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.

In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.

At what cost? It will take years to sort that out, he said.

This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
 

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

The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.

A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.

“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.

The analysis was published online July 31 in the Journal of the American College of Cardiology.

The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”

The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).

Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”

He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.

“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”

As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”

He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.

The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.

Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.

“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.

“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
 

Stopped for lack of funding

Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.

The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.

Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.

The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.

Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.

“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.

In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.

At what cost? It will take years to sort that out, he said.

This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
 

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

The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.

A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.

“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.

The analysis was published online July 31 in the Journal of the American College of Cardiology.

The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”

The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).

Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”

He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.

“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”

As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”

He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.

The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.

Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.

“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.

“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
 

Stopped for lack of funding

Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.

The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.

Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.

The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.

Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.

“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.

In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.

At what cost? It will take years to sort that out, he said.

This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
 

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

Fractional flow reserve derived noninvasively from coronary CT angiography is a safe and accurate method for assessing the significance of coronary artery disease in patients with severe aortic stenosis who are headed for transcatheter aortic valve replacement (TAVR), according to results of the CAST-FFR prospective study.

Indeed, utilization of coronary CT angiography–derived fractional flow reserve (CT-FFR) for this purpose offers the advantage of using a single noninvasive imaging method to replace two invasive procedures: coronary angiography to assess the anatomy of coronary lesions, and conventional FFR using a pressure wire to determine the functional significance of a given coronary stenosis as a cause of ischemia, Michael Michail, MBBS, explained in reporting the results at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“Because up to 50% of patients with severe aortic stenosis undergoing TAVR have coexisting coronary artery disease, it remains common practice to perform prior invasive coronary angiography. However, this is associated with inherent risks, particularly in an elderly cohort with comorbidities. Additionally, coronary angiography provides no information on the functional impact of coronary stenoses, which may be important in guiding revascularization decisions prior to TAVR,” noted Dr. Michail, a cardiologist at Monash University, Melbourne.
 

Simulating FFR: ‘A one-stop shop cardiac CT’

Dr. Michail presented the results of the prospective CAST-FFR study, the first evaluation of CT-FFR for assessment of coronary arteries in patients with severe symptomatic aortic stenosis. This method uses computational fluid dynamics to transform data obtained noninvasively from a standard coronary CT angiography acquisition into a simulated FFR. And it offers the potential to streamline patient care.

“In current practice we see elderly patients with a long pre-TAVR assessment period, with numerous appointments and invasive procedures. Our vision is a one-stop shop cardiac CT that will provide the cardiologist with a complete assessment of the annular measurements, peripheral vasculature, and the coronary arteries ahead of their procedure,” according to Dr. Michail.

“We believe the ability to perform the requisite coronary assessment using CT-FFR will translate to improved patient care in several ways,” he continued. “Firstly, this will shorten the number of tests and overall diagnostic journey for patients. It will reduce the risk from unnecessary invasive procedures, and this will also reduce discomfort for the patient. Based on emerging evidence on the adverse prognostic impact of functionally significant coronary disease in aortic stenosis, this data has the potential to improve procedural risk stratification. And finally, contingent on further data, this may improve lesion selection for upfront revascularization.”

The CAST-FFR study was a small, single-center, proof-of-concept study in which 42 patients with severe aortic stenosis underwent both coronary CT angiography and conventional FFR with a pressure wire. The CT data was sent to a core laboratory for conversion into CT-FFR by evaluators blinded to the conventional FFR values.

Of the 42 participants, 39 (93%) had usable CT-FFR data on 60 coronary vessels. Dr. Michail and coinvestigators found a strong correlation between the conventional pressure wire FFR and CT-FFR findings, with a receiver operating characteristic area under the curve of 0.83 per vessel. CT-FFR had a diagnostic sensitivity and specificity of 73.9% and 78.4%, respectively, with a positive predictive value of 68%, a negative predictive value of 82.9%, and a diagnostic accuracy of 76.7%.

He cited as study limitations the small size, the fact that patients with previous revascularization or significant left ventricular impairment were excluded, and the study cohort’s relative youth.

“With a mean age of 76.2 years, it’s unclear whether these results can be extrapolated to very elderly patients with more calcified arteries undergoing TAVR. Encouragingly, though, a subgroup analysis based on calcium score showed no effect on accuracy,” according to the cardiologist.

CT-FFR may ‘shorten the diagnostic journey’ for fragile patients

Discussant Daniele Andreini, MD, PhD, praised the investigators’ concept of integrating the functional assessment provided by CT-FFR into a one-stop shop examination by cardiac CT angiography for TAVR planning.

“I would like to underline one of Dr. Michail’s messages: It’s really important to shorten the diagnostic journey for these fragile, older patients with aortic stenosis in order to improve safety, use less contrast, and avoid complications,” said Dr. Andreini, a cardiologist at the University of Milan and director of the cardiovascular CT and radiology unit at Monzino Cardiology Center, also in Milan.

Both Dr. Michail and Dr. Andreini reported having no financial conflicts of interest.

[email protected]

Fractional flow reserve derived noninvasively from coronary CT angiography is a safe and accurate method for assessing the significance of coronary artery disease in patients with severe aortic stenosis who are headed for transcatheter aortic valve replacement (TAVR), according to results of the CAST-FFR prospective study.

Indeed, utilization of coronary CT angiography–derived fractional flow reserve (CT-FFR) for this purpose offers the advantage of using a single noninvasive imaging method to replace two invasive procedures: coronary angiography to assess the anatomy of coronary lesions, and conventional FFR using a pressure wire to determine the functional significance of a given coronary stenosis as a cause of ischemia, Michael Michail, MBBS, explained in reporting the results at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“Because up to 50% of patients with severe aortic stenosis undergoing TAVR have coexisting coronary artery disease, it remains common practice to perform prior invasive coronary angiography. However, this is associated with inherent risks, particularly in an elderly cohort with comorbidities. Additionally, coronary angiography provides no information on the functional impact of coronary stenoses, which may be important in guiding revascularization decisions prior to TAVR,” noted Dr. Michail, a cardiologist at Monash University, Melbourne.
 

Simulating FFR: ‘A one-stop shop cardiac CT’

Dr. Michail presented the results of the prospective CAST-FFR study, the first evaluation of CT-FFR for assessment of coronary arteries in patients with severe symptomatic aortic stenosis. This method uses computational fluid dynamics to transform data obtained noninvasively from a standard coronary CT angiography acquisition into a simulated FFR. And it offers the potential to streamline patient care.

“In current practice we see elderly patients with a long pre-TAVR assessment period, with numerous appointments and invasive procedures. Our vision is a one-stop shop cardiac CT that will provide the cardiologist with a complete assessment of the annular measurements, peripheral vasculature, and the coronary arteries ahead of their procedure,” according to Dr. Michail.

“We believe the ability to perform the requisite coronary assessment using CT-FFR will translate to improved patient care in several ways,” he continued. “Firstly, this will shorten the number of tests and overall diagnostic journey for patients. It will reduce the risk from unnecessary invasive procedures, and this will also reduce discomfort for the patient. Based on emerging evidence on the adverse prognostic impact of functionally significant coronary disease in aortic stenosis, this data has the potential to improve procedural risk stratification. And finally, contingent on further data, this may improve lesion selection for upfront revascularization.”

The CAST-FFR study was a small, single-center, proof-of-concept study in which 42 patients with severe aortic stenosis underwent both coronary CT angiography and conventional FFR with a pressure wire. The CT data was sent to a core laboratory for conversion into CT-FFR by evaluators blinded to the conventional FFR values.

Of the 42 participants, 39 (93%) had usable CT-FFR data on 60 coronary vessels. Dr. Michail and coinvestigators found a strong correlation between the conventional pressure wire FFR and CT-FFR findings, with a receiver operating characteristic area under the curve of 0.83 per vessel. CT-FFR had a diagnostic sensitivity and specificity of 73.9% and 78.4%, respectively, with a positive predictive value of 68%, a negative predictive value of 82.9%, and a diagnostic accuracy of 76.7%.

He cited as study limitations the small size, the fact that patients with previous revascularization or significant left ventricular impairment were excluded, and the study cohort’s relative youth.

“With a mean age of 76.2 years, it’s unclear whether these results can be extrapolated to very elderly patients with more calcified arteries undergoing TAVR. Encouragingly, though, a subgroup analysis based on calcium score showed no effect on accuracy,” according to the cardiologist.

CT-FFR may ‘shorten the diagnostic journey’ for fragile patients

Discussant Daniele Andreini, MD, PhD, praised the investigators’ concept of integrating the functional assessment provided by CT-FFR into a one-stop shop examination by cardiac CT angiography for TAVR planning.

“I would like to underline one of Dr. Michail’s messages: It’s really important to shorten the diagnostic journey for these fragile, older patients with aortic stenosis in order to improve safety, use less contrast, and avoid complications,” said Dr. Andreini, a cardiologist at the University of Milan and director of the cardiovascular CT and radiology unit at Monzino Cardiology Center, also in Milan.

Both Dr. Michail and Dr. Andreini reported having no financial conflicts of interest.

[email protected]

Fractional flow reserve derived noninvasively from coronary CT angiography is a safe and accurate method for assessing the significance of coronary artery disease in patients with severe aortic stenosis who are headed for transcatheter aortic valve replacement (TAVR), according to results of the CAST-FFR prospective study.

Indeed, utilization of coronary CT angiography–derived fractional flow reserve (CT-FFR) for this purpose offers the advantage of using a single noninvasive imaging method to replace two invasive procedures: coronary angiography to assess the anatomy of coronary lesions, and conventional FFR using a pressure wire to determine the functional significance of a given coronary stenosis as a cause of ischemia, Michael Michail, MBBS, explained in reporting the results at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“Because up to 50% of patients with severe aortic stenosis undergoing TAVR have coexisting coronary artery disease, it remains common practice to perform prior invasive coronary angiography. However, this is associated with inherent risks, particularly in an elderly cohort with comorbidities. Additionally, coronary angiography provides no information on the functional impact of coronary stenoses, which may be important in guiding revascularization decisions prior to TAVR,” noted Dr. Michail, a cardiologist at Monash University, Melbourne.
 

Simulating FFR: ‘A one-stop shop cardiac CT’

Dr. Michail presented the results of the prospective CAST-FFR study, the first evaluation of CT-FFR for assessment of coronary arteries in patients with severe symptomatic aortic stenosis. This method uses computational fluid dynamics to transform data obtained noninvasively from a standard coronary CT angiography acquisition into a simulated FFR. And it offers the potential to streamline patient care.

“In current practice we see elderly patients with a long pre-TAVR assessment period, with numerous appointments and invasive procedures. Our vision is a one-stop shop cardiac CT that will provide the cardiologist with a complete assessment of the annular measurements, peripheral vasculature, and the coronary arteries ahead of their procedure,” according to Dr. Michail.

“We believe the ability to perform the requisite coronary assessment using CT-FFR will translate to improved patient care in several ways,” he continued. “Firstly, this will shorten the number of tests and overall diagnostic journey for patients. It will reduce the risk from unnecessary invasive procedures, and this will also reduce discomfort for the patient. Based on emerging evidence on the adverse prognostic impact of functionally significant coronary disease in aortic stenosis, this data has the potential to improve procedural risk stratification. And finally, contingent on further data, this may improve lesion selection for upfront revascularization.”

The CAST-FFR study was a small, single-center, proof-of-concept study in which 42 patients with severe aortic stenosis underwent both coronary CT angiography and conventional FFR with a pressure wire. The CT data was sent to a core laboratory for conversion into CT-FFR by evaluators blinded to the conventional FFR values.

Of the 42 participants, 39 (93%) had usable CT-FFR data on 60 coronary vessels. Dr. Michail and coinvestigators found a strong correlation between the conventional pressure wire FFR and CT-FFR findings, with a receiver operating characteristic area under the curve of 0.83 per vessel. CT-FFR had a diagnostic sensitivity and specificity of 73.9% and 78.4%, respectively, with a positive predictive value of 68%, a negative predictive value of 82.9%, and a diagnostic accuracy of 76.7%.

He cited as study limitations the small size, the fact that patients with previous revascularization or significant left ventricular impairment were excluded, and the study cohort’s relative youth.

“With a mean age of 76.2 years, it’s unclear whether these results can be extrapolated to very elderly patients with more calcified arteries undergoing TAVR. Encouragingly, though, a subgroup analysis based on calcium score showed no effect on accuracy,” according to the cardiologist.

CT-FFR may ‘shorten the diagnostic journey’ for fragile patients

Discussant Daniele Andreini, MD, PhD, praised the investigators’ concept of integrating the functional assessment provided by CT-FFR into a one-stop shop examination by cardiac CT angiography for TAVR planning.

“I would like to underline one of Dr. Michail’s messages: It’s really important to shorten the diagnostic journey for these fragile, older patients with aortic stenosis in order to improve safety, use less contrast, and avoid complications,” said Dr. Andreini, a cardiologist at the University of Milan and director of the cardiovascular CT and radiology unit at Monzino Cardiology Center, also in Milan.

Both Dr. Michail and Dr. Andreini reported having no financial conflicts of interest.

[email protected]

Monogenic disorders with heart and vascular effects are each pretty rare in clinical practice but collectively can make up a fair proportion of the patients cardiologists see. Still, the diagnosis is missed more often than not, even when the clinical signs are there, suggests an observational study, supporting broader genetic testing in cardiovascular patients.

In a cohort of more than 8,000 patients referred for cardiac catheterization, diagnosis of such a monogenic cardiovascular disease (MCVD) was made in only 35% of those with one related gene variant and signs of phenotypic expression in the electronic health record.

The findings are novel for measuring the field’s “burden of missed diagnoses” in patients with MCVD, which “represent a missed opportunity that could be addressed by genetic screening,” contended the study report, published in the Aug. 18 issue of the Journal of the American College of Cardiology.

“The underrecognition of these diseases underscores the importance of including monogenic diseases in the treating physician’s differential diagnosis,” say the authors, led by Jawan W. Abdulrahim, MD, Duke University, Durham, N.C.

Diagnosis of MCVDs can be important, the group wrote, because many, including familial transthyretin amyloidosis (TTR) and other disorders that pose an increased risk for sudden death, have evidence-based treatment modalities available or are clinically actionable. “Identification of patients with MCVD variants” is also “important for cascade screening of family members who are at risk of inheriting the pathogenic mutations.”

“We tend to ignore these monogenic diseases because they are so rare individually but, in aggregate, monogenic diseases are actually quite common,” senior author Svati H. Shah, MD, MHS, also of Duke University, said in an interview.

The results “support that the cardiology community over time adopt a genotype-forward approach,” one in which every patient presenting to a cardiovascular clinic is genotyped, she said.

One implication of such an approach, Dr. Shah agreed, is that “we would be able to pick these people up earlier in their disease, especially in the context of therapies that could improve certainly their progression, but even their survival.”

For now, she said, the study suggests that “these disorders are more frequent than perhaps all cardiologists are aware of, and we just need to keep our eyes open and know when to refer patients to a cardiovascular genetics clinic, which maybe has more time and can deal with all the nuances that go along with genetic testing.”

In the total cohort, 4.5% were found to carry a gene variant known or believed to cause such diseases. The most frequently represented conditions were familial TTR, hereditary hemochromatosis, heterozygous familial hypercholesterolemia, and various cardiomyopathies.

Of those patients, 52 received a clinical diagnosis of the monogenic disorder after an EHR review. Of the 290 without such a diagnosis, two-thirds showed no evidence in their EHR of the variant’s phenotypic signs. But the records of the other third featured at least some signs that the disease had manifested clinically.

“These data serve as a reminder that monogenic Mendelian disease, including heart and vascular disease, varies in penetrance from individual to individual and may not always present with clinically detectable phenotypes,” noted an editorial accompanying the report.

They also “provide a compelling basis for expanding the role of targeted genetic testing in patients with more traditional forms of heart and vascular disease,” wrote Scott M. Damrauer, MD, University of Pennsylvania, Philadelphia, and William S. Weintraub, MD, Medstar Washington Hospital Center and Georgetown University, Washington.

“Based on the current report, the number needed to screen in a complex cardiovascular patient population to detect 1 case of undiagnosed monogenic cardiovascular disease is 85,” they wrote. “This places targeted genetic testing well within what is considered to be efficacious for most screening programs and in the range of that of other common cardiovascular diseases and cancers.”

Among the 342 patients with a variant predicting a single MCVD – in addition to the 52 who received a diagnosis – 193 had records with no indication of phenotypic expression and so did not receive a diagnosis.

But the 97 patients without a diagnosis who nevertheless had documented signs of some phenotypic expression were deemed, on the basis of extent of expression, to represent a possibly, probably, or definitely missed diagnosis.

Familial TTR made up about 45% of such potentially missed diagnoses, the report noted.

Broader screening of patients with cardiovascular disease, Dr. Shah speculated, “might actually be not only a clinically useful endeavor, but – when we think about the aggregate burden of these monogenic disorders – potentially even cost-effective.”

As the price of genetic sequencing drops, she said, “I think we’ll start to see even more health systems wanting to incorporate the genotype-forward approach.”

Dr. Shah reports serving as primary investigator for research sponsored by Verily Life Sciences and AstraZeneca. Dr. Abdulrahim reports no relevant relationships. Disclosures for the other authors are in the report. Dr. Damrauer discloses receiving research support from RenalytixAI and consulting fees from Calico Labs. Dr. Weintraub had no relevant disclosures.

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

Monogenic disorders with heart and vascular effects are each pretty rare in clinical practice but collectively can make up a fair proportion of the patients cardiologists see. Still, the diagnosis is missed more often than not, even when the clinical signs are there, suggests an observational study, supporting broader genetic testing in cardiovascular patients.

In a cohort of more than 8,000 patients referred for cardiac catheterization, diagnosis of such a monogenic cardiovascular disease (MCVD) was made in only 35% of those with one related gene variant and signs of phenotypic expression in the electronic health record.

The findings are novel for measuring the field’s “burden of missed diagnoses” in patients with MCVD, which “represent a missed opportunity that could be addressed by genetic screening,” contended the study report, published in the Aug. 18 issue of the Journal of the American College of Cardiology.

“The underrecognition of these diseases underscores the importance of including monogenic diseases in the treating physician’s differential diagnosis,” say the authors, led by Jawan W. Abdulrahim, MD, Duke University, Durham, N.C.

Diagnosis of MCVDs can be important, the group wrote, because many, including familial transthyretin amyloidosis (TTR) and other disorders that pose an increased risk for sudden death, have evidence-based treatment modalities available or are clinically actionable. “Identification of patients with MCVD variants” is also “important for cascade screening of family members who are at risk of inheriting the pathogenic mutations.”

“We tend to ignore these monogenic diseases because they are so rare individually but, in aggregate, monogenic diseases are actually quite common,” senior author Svati H. Shah, MD, MHS, also of Duke University, said in an interview.

The results “support that the cardiology community over time adopt a genotype-forward approach,” one in which every patient presenting to a cardiovascular clinic is genotyped, she said.

One implication of such an approach, Dr. Shah agreed, is that “we would be able to pick these people up earlier in their disease, especially in the context of therapies that could improve certainly their progression, but even their survival.”

For now, she said, the study suggests that “these disorders are more frequent than perhaps all cardiologists are aware of, and we just need to keep our eyes open and know when to refer patients to a cardiovascular genetics clinic, which maybe has more time and can deal with all the nuances that go along with genetic testing.”

In the total cohort, 4.5% were found to carry a gene variant known or believed to cause such diseases. The most frequently represented conditions were familial TTR, hereditary hemochromatosis, heterozygous familial hypercholesterolemia, and various cardiomyopathies.

Of those patients, 52 received a clinical diagnosis of the monogenic disorder after an EHR review. Of the 290 without such a diagnosis, two-thirds showed no evidence in their EHR of the variant’s phenotypic signs. But the records of the other third featured at least some signs that the disease had manifested clinically.

“These data serve as a reminder that monogenic Mendelian disease, including heart and vascular disease, varies in penetrance from individual to individual and may not always present with clinically detectable phenotypes,” noted an editorial accompanying the report.

They also “provide a compelling basis for expanding the role of targeted genetic testing in patients with more traditional forms of heart and vascular disease,” wrote Scott M. Damrauer, MD, University of Pennsylvania, Philadelphia, and William S. Weintraub, MD, Medstar Washington Hospital Center and Georgetown University, Washington.

“Based on the current report, the number needed to screen in a complex cardiovascular patient population to detect 1 case of undiagnosed monogenic cardiovascular disease is 85,” they wrote. “This places targeted genetic testing well within what is considered to be efficacious for most screening programs and in the range of that of other common cardiovascular diseases and cancers.”

Among the 342 patients with a variant predicting a single MCVD – in addition to the 52 who received a diagnosis – 193 had records with no indication of phenotypic expression and so did not receive a diagnosis.

But the 97 patients without a diagnosis who nevertheless had documented signs of some phenotypic expression were deemed, on the basis of extent of expression, to represent a possibly, probably, or definitely missed diagnosis.

Familial TTR made up about 45% of such potentially missed diagnoses, the report noted.

Broader screening of patients with cardiovascular disease, Dr. Shah speculated, “might actually be not only a clinically useful endeavor, but – when we think about the aggregate burden of these monogenic disorders – potentially even cost-effective.”

As the price of genetic sequencing drops, she said, “I think we’ll start to see even more health systems wanting to incorporate the genotype-forward approach.”

Dr. Shah reports serving as primary investigator for research sponsored by Verily Life Sciences and AstraZeneca. Dr. Abdulrahim reports no relevant relationships. Disclosures for the other authors are in the report. Dr. Damrauer discloses receiving research support from RenalytixAI and consulting fees from Calico Labs. Dr. Weintraub had no relevant disclosures.

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

Monogenic disorders with heart and vascular effects are each pretty rare in clinical practice but collectively can make up a fair proportion of the patients cardiologists see. Still, the diagnosis is missed more often than not, even when the clinical signs are there, suggests an observational study, supporting broader genetic testing in cardiovascular patients.

In a cohort of more than 8,000 patients referred for cardiac catheterization, diagnosis of such a monogenic cardiovascular disease (MCVD) was made in only 35% of those with one related gene variant and signs of phenotypic expression in the electronic health record.

The findings are novel for measuring the field’s “burden of missed diagnoses” in patients with MCVD, which “represent a missed opportunity that could be addressed by genetic screening,” contended the study report, published in the Aug. 18 issue of the Journal of the American College of Cardiology.

“The underrecognition of these diseases underscores the importance of including monogenic diseases in the treating physician’s differential diagnosis,” say the authors, led by Jawan W. Abdulrahim, MD, Duke University, Durham, N.C.

Diagnosis of MCVDs can be important, the group wrote, because many, including familial transthyretin amyloidosis (TTR) and other disorders that pose an increased risk for sudden death, have evidence-based treatment modalities available or are clinically actionable. “Identification of patients with MCVD variants” is also “important for cascade screening of family members who are at risk of inheriting the pathogenic mutations.”

“We tend to ignore these monogenic diseases because they are so rare individually but, in aggregate, monogenic diseases are actually quite common,” senior author Svati H. Shah, MD, MHS, also of Duke University, said in an interview.

The results “support that the cardiology community over time adopt a genotype-forward approach,” one in which every patient presenting to a cardiovascular clinic is genotyped, she said.

One implication of such an approach, Dr. Shah agreed, is that “we would be able to pick these people up earlier in their disease, especially in the context of therapies that could improve certainly their progression, but even their survival.”

For now, she said, the study suggests that “these disorders are more frequent than perhaps all cardiologists are aware of, and we just need to keep our eyes open and know when to refer patients to a cardiovascular genetics clinic, which maybe has more time and can deal with all the nuances that go along with genetic testing.”

In the total cohort, 4.5% were found to carry a gene variant known or believed to cause such diseases. The most frequently represented conditions were familial TTR, hereditary hemochromatosis, heterozygous familial hypercholesterolemia, and various cardiomyopathies.

Of those patients, 52 received a clinical diagnosis of the monogenic disorder after an EHR review. Of the 290 without such a diagnosis, two-thirds showed no evidence in their EHR of the variant’s phenotypic signs. But the records of the other third featured at least some signs that the disease had manifested clinically.

“These data serve as a reminder that monogenic Mendelian disease, including heart and vascular disease, varies in penetrance from individual to individual and may not always present with clinically detectable phenotypes,” noted an editorial accompanying the report.

They also “provide a compelling basis for expanding the role of targeted genetic testing in patients with more traditional forms of heart and vascular disease,” wrote Scott M. Damrauer, MD, University of Pennsylvania, Philadelphia, and William S. Weintraub, MD, Medstar Washington Hospital Center and Georgetown University, Washington.

“Based on the current report, the number needed to screen in a complex cardiovascular patient population to detect 1 case of undiagnosed monogenic cardiovascular disease is 85,” they wrote. “This places targeted genetic testing well within what is considered to be efficacious for most screening programs and in the range of that of other common cardiovascular diseases and cancers.”

Among the 342 patients with a variant predicting a single MCVD – in addition to the 52 who received a diagnosis – 193 had records with no indication of phenotypic expression and so did not receive a diagnosis.

But the 97 patients without a diagnosis who nevertheless had documented signs of some phenotypic expression were deemed, on the basis of extent of expression, to represent a possibly, probably, or definitely missed diagnosis.

Familial TTR made up about 45% of such potentially missed diagnoses, the report noted.

Broader screening of patients with cardiovascular disease, Dr. Shah speculated, “might actually be not only a clinically useful endeavor, but – when we think about the aggregate burden of these monogenic disorders – potentially even cost-effective.”

As the price of genetic sequencing drops, she said, “I think we’ll start to see even more health systems wanting to incorporate the genotype-forward approach.”

Dr. Shah reports serving as primary investigator for research sponsored by Verily Life Sciences and AstraZeneca. Dr. Abdulrahim reports no relevant relationships. Disclosures for the other authors are in the report. Dr. Damrauer discloses receiving research support from RenalytixAI and consulting fees from Calico Labs. Dr. Weintraub had no relevant disclosures.

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

Most interventional cardiologists still rely solely upon angiography in making revascularization decisions about intermediate stenoses in the setting of stable coronary artery disease – and in doing so they end up making the wrong call nearly 40% of the time, according to the results of an international survey presented at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“We saw a strong tendency to visually overestimate the percent diameter stenosis,” reported Gabor G. Toth, MD, an interventional cardiologist at the Medical University of Graz (Austria).

The same tendency has been highlighted in numerous randomized trials and observational studies. That’s why both European and U.S. guidelines now strongly recommend invasive functional assessment, such as fractional-flow reserve (FFR) testing, in evaluating the significance of intermediate stenoses in the absence of noninvasive evidence of ischemia. The new survey findings point to an important disconnect between these guideline recommendations and current clinical practice, he noted.

Dr. Toth presented the results of the second web-based, international survey on interventional decision-making strategy sponsored by the European Association of Percutaneous Cardiovascular Interventions. He contrasted the findings with those of the previously reported first international online survey, conducted 6 years earlier, for which he was first author (Circ Cardiovasc Interv. 2014 Dec;7[6]:751-9).

The two surveys were identically designed. In both, participants answered questions that enabled investigators to place them into one of four categories based upon the extent of their experience in interventional cardiology. The participants were also presented with 5 angiograms of focal intermediate stenoses and asked to determine the stenosis significance of each lesion. No information on the functional significance of the stenoses was included; however, the respondents could request additional diagnostic information by “ordering” adjunctive invasive functional assessment tests, including FFR, quantitative coronary angiography, intravascular ultrasound, or optical coherence tomography. Importantly, participating cardiologists were asked to make their decisions based upon best possible clinical practice in a hypothetical scenario where financial constraints had no role.

The second international survey was conducted during the latter half of 2019. The 334 interventional cardiologists who responded performed a total of 978 case evaluations including 2,054 coronary lesion assessments.

About 59% of all decisions were made solely on the basis of angiographic appearance without any information as to the functional significance of a given stenosis: Indeed, 13% of all stenoses were thereby declared to be “certainly” nonsignificant, and 46% were deemed “certainly” significant. In total, that figure was down significantly from the 71% rate in the first survey. In the first survey, 47% of decisions based upon angiographic appearance alone were discordant with FFR results known to the investigators, compared with a 39% discordance rate in the second survey.

Of the physician decisions made in the second survey, 10% involved a request for intravascular imaging, essentially unchanged from the 9% rate in the first survey. However, there was a significant increase over time in requests for invasive functional assessment tests: 25% in the first survey, rising to 31% in the second. This increase was entirely driven by additional requests for data on nonhyperemic pressure ratios; there was no difference in requests for FFR testing between the 2013 and 2019 surveys.

Clinician experience played an interesting role in decision-making: “Experience does not have an impact on the accuracy of angiographically based decisions, but experience does have an impact on understanding the need for adjunctive functional diagnostic testing,” Dr. Toth explained.

Indeed, 21% of decisions made by the least-experienced interventional cardiologists involved a request for adjunctive invasive functional assessment, compared with 24% of decisions by physicians in the third quartile of experience, 32% in the second, and 37% of decisions made by the most experienced clinicians.

Discussant Michael Haude, MD, PhD, said that “these results clearly show that eyeball angioguidance is still the dominant tool used in decision-making, and that this eyeball angioguidance continuously overestimates the stenosis when you compare the results to quantitative coronary angiography.

“These results, surprisingly for me, show a quite low uptake of the invasive functional assessments despite overwhelming scientific data leading to clear guideline-based recommendations. Why is this the case, even after financial constraints are ruled out? Probably because FFR is still a complex invasive procedure. Maybe, in the future, quantitative flow-ratio angiography [which requires no pressure wire] or CT-based FFR will be more popular,” said Dr. Haude, an interventional cardiologist at the Rheinland Clinic in Neuss, Germany.

He reported receiving research grants from Biotronik and serving as a paid consultant to that company as well as Cardiac Dimensions, Orbus Neich, and Philips. Dr. Toth reported having no financial conflicts regarding the international survey.

[email protected]

Most interventional cardiologists still rely solely upon angiography in making revascularization decisions about intermediate stenoses in the setting of stable coronary artery disease – and in doing so they end up making the wrong call nearly 40% of the time, according to the results of an international survey presented at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“We saw a strong tendency to visually overestimate the percent diameter stenosis,” reported Gabor G. Toth, MD, an interventional cardiologist at the Medical University of Graz (Austria).

The same tendency has been highlighted in numerous randomized trials and observational studies. That’s why both European and U.S. guidelines now strongly recommend invasive functional assessment, such as fractional-flow reserve (FFR) testing, in evaluating the significance of intermediate stenoses in the absence of noninvasive evidence of ischemia. The new survey findings point to an important disconnect between these guideline recommendations and current clinical practice, he noted.

Dr. Toth presented the results of the second web-based, international survey on interventional decision-making strategy sponsored by the European Association of Percutaneous Cardiovascular Interventions. He contrasted the findings with those of the previously reported first international online survey, conducted 6 years earlier, for which he was first author (Circ Cardiovasc Interv. 2014 Dec;7[6]:751-9).

The two surveys were identically designed. In both, participants answered questions that enabled investigators to place them into one of four categories based upon the extent of their experience in interventional cardiology. The participants were also presented with 5 angiograms of focal intermediate stenoses and asked to determine the stenosis significance of each lesion. No information on the functional significance of the stenoses was included; however, the respondents could request additional diagnostic information by “ordering” adjunctive invasive functional assessment tests, including FFR, quantitative coronary angiography, intravascular ultrasound, or optical coherence tomography. Importantly, participating cardiologists were asked to make their decisions based upon best possible clinical practice in a hypothetical scenario where financial constraints had no role.

The second international survey was conducted during the latter half of 2019. The 334 interventional cardiologists who responded performed a total of 978 case evaluations including 2,054 coronary lesion assessments.

About 59% of all decisions were made solely on the basis of angiographic appearance without any information as to the functional significance of a given stenosis: Indeed, 13% of all stenoses were thereby declared to be “certainly” nonsignificant, and 46% were deemed “certainly” significant. In total, that figure was down significantly from the 71% rate in the first survey. In the first survey, 47% of decisions based upon angiographic appearance alone were discordant with FFR results known to the investigators, compared with a 39% discordance rate in the second survey.

Of the physician decisions made in the second survey, 10% involved a request for intravascular imaging, essentially unchanged from the 9% rate in the first survey. However, there was a significant increase over time in requests for invasive functional assessment tests: 25% in the first survey, rising to 31% in the second. This increase was entirely driven by additional requests for data on nonhyperemic pressure ratios; there was no difference in requests for FFR testing between the 2013 and 2019 surveys.

Clinician experience played an interesting role in decision-making: “Experience does not have an impact on the accuracy of angiographically based decisions, but experience does have an impact on understanding the need for adjunctive functional diagnostic testing,” Dr. Toth explained.

Indeed, 21% of decisions made by the least-experienced interventional cardiologists involved a request for adjunctive invasive functional assessment, compared with 24% of decisions by physicians in the third quartile of experience, 32% in the second, and 37% of decisions made by the most experienced clinicians.

Discussant Michael Haude, MD, PhD, said that “these results clearly show that eyeball angioguidance is still the dominant tool used in decision-making, and that this eyeball angioguidance continuously overestimates the stenosis when you compare the results to quantitative coronary angiography.

“These results, surprisingly for me, show a quite low uptake of the invasive functional assessments despite overwhelming scientific data leading to clear guideline-based recommendations. Why is this the case, even after financial constraints are ruled out? Probably because FFR is still a complex invasive procedure. Maybe, in the future, quantitative flow-ratio angiography [which requires no pressure wire] or CT-based FFR will be more popular,” said Dr. Haude, an interventional cardiologist at the Rheinland Clinic in Neuss, Germany.

He reported receiving research grants from Biotronik and serving as a paid consultant to that company as well as Cardiac Dimensions, Orbus Neich, and Philips. Dr. Toth reported having no financial conflicts regarding the international survey.

[email protected]

Most interventional cardiologists still rely solely upon angiography in making revascularization decisions about intermediate stenoses in the setting of stable coronary artery disease – and in doing so they end up making the wrong call nearly 40% of the time, according to the results of an international survey presented at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“We saw a strong tendency to visually overestimate the percent diameter stenosis,” reported Gabor G. Toth, MD, an interventional cardiologist at the Medical University of Graz (Austria).

The same tendency has been highlighted in numerous randomized trials and observational studies. That’s why both European and U.S. guidelines now strongly recommend invasive functional assessment, such as fractional-flow reserve (FFR) testing, in evaluating the significance of intermediate stenoses in the absence of noninvasive evidence of ischemia. The new survey findings point to an important disconnect between these guideline recommendations and current clinical practice, he noted.

Dr. Toth presented the results of the second web-based, international survey on interventional decision-making strategy sponsored by the European Association of Percutaneous Cardiovascular Interventions. He contrasted the findings with those of the previously reported first international online survey, conducted 6 years earlier, for which he was first author (Circ Cardiovasc Interv. 2014 Dec;7[6]:751-9).

The two surveys were identically designed. In both, participants answered questions that enabled investigators to place them into one of four categories based upon the extent of their experience in interventional cardiology. The participants were also presented with 5 angiograms of focal intermediate stenoses and asked to determine the stenosis significance of each lesion. No information on the functional significance of the stenoses was included; however, the respondents could request additional diagnostic information by “ordering” adjunctive invasive functional assessment tests, including FFR, quantitative coronary angiography, intravascular ultrasound, or optical coherence tomography. Importantly, participating cardiologists were asked to make their decisions based upon best possible clinical practice in a hypothetical scenario where financial constraints had no role.

The second international survey was conducted during the latter half of 2019. The 334 interventional cardiologists who responded performed a total of 978 case evaluations including 2,054 coronary lesion assessments.

About 59% of all decisions were made solely on the basis of angiographic appearance without any information as to the functional significance of a given stenosis: Indeed, 13% of all stenoses were thereby declared to be “certainly” nonsignificant, and 46% were deemed “certainly” significant. In total, that figure was down significantly from the 71% rate in the first survey. In the first survey, 47% of decisions based upon angiographic appearance alone were discordant with FFR results known to the investigators, compared with a 39% discordance rate in the second survey.

Of the physician decisions made in the second survey, 10% involved a request for intravascular imaging, essentially unchanged from the 9% rate in the first survey. However, there was a significant increase over time in requests for invasive functional assessment tests: 25% in the first survey, rising to 31% in the second. This increase was entirely driven by additional requests for data on nonhyperemic pressure ratios; there was no difference in requests for FFR testing between the 2013 and 2019 surveys.

Clinician experience played an interesting role in decision-making: “Experience does not have an impact on the accuracy of angiographically based decisions, but experience does have an impact on understanding the need for adjunctive functional diagnostic testing,” Dr. Toth explained.

Indeed, 21% of decisions made by the least-experienced interventional cardiologists involved a request for adjunctive invasive functional assessment, compared with 24% of decisions by physicians in the third quartile of experience, 32% in the second, and 37% of decisions made by the most experienced clinicians.

Discussant Michael Haude, MD, PhD, said that “these results clearly show that eyeball angioguidance is still the dominant tool used in decision-making, and that this eyeball angioguidance continuously overestimates the stenosis when you compare the results to quantitative coronary angiography.

“These results, surprisingly for me, show a quite low uptake of the invasive functional assessments despite overwhelming scientific data leading to clear guideline-based recommendations. Why is this the case, even after financial constraints are ruled out? Probably because FFR is still a complex invasive procedure. Maybe, in the future, quantitative flow-ratio angiography [which requires no pressure wire] or CT-based FFR will be more popular,” said Dr. Haude, an interventional cardiologist at the Rheinland Clinic in Neuss, Germany.

He reported receiving research grants from Biotronik and serving as a paid consultant to that company as well as Cardiac Dimensions, Orbus Neich, and Philips. Dr. Toth reported having no financial conflicts regarding the international survey.

[email protected]

When Virginia’s governor directed the postponement of all elective surgeries in late March, Wayne Batchelor, MD and his colleagues at the Inova Heart and Vascular Institute in Falls Church, Va., canceled about two-thirds of their transcatheter aortic valve replacement (TAVR) procedures.

Courtesy Wayne Batchelor, MD

They then categorized patients by tiers to gauge which procedures could safely be postponed and to guide triaging. And while they did not deviate from the practice of having both an interventional cardiologist and a cardiothoracic surgeon present for TAVR, they slimmed down preprocedural testing when feasible and delayed some 30-day post-TAVR echocardiographic assessments. “It was a delicate dance, very difficult dance. But luckily, we were able to navigate the challenges effectively,” said Dr. Batchelor, the institute’s director of interventional cardiology and interventional cardiology research.

A “system capacity dashboard” that merged bed and staffing data from interventional cardiology spaces with cardiovascular and noncardiovascular ICU beds, operating rooms, and other resources – and daily cross-department meetings – enabled them to proceed with the most urgent TAVR procedures while “keeping a buffer of ICU beds to accommodate an anticipated surge of COVID-19,” he explained.

Such adaptations in cardiac procedures and processes are occurring in hospitals across the country as efforts are made to minimize the risk of COVID-19 exposure for patients and staff. Dr. Batchelor is one of four cardiologists who shared their experiences and advice on common cardiac procedures across three locales: TAVR in Virginia, percutaneous coronary intervention (PCI) in New York City, and atrial fibrillation (AFib) ablation in Kentucky.
 

More on TAVR in Virginia

Inova’s framework for triaging structural heart disease interventions (largely TAVR and/or percutaneous mitral valve repair) comprised three tiers. Tier 1 captured “emergent cases that had to be done, no questions asked,” Dr. Batchelor said. For TAVR, these were inpatients with severe to critical symptomatic aortic stenosis and advanced congestive heart failure who could not safely be discharged, as well as other patients “with refractory symptoms of heart failure that were compelling.” Many had associated left ventricular systolic dysfunction.

Those who could delay 14-30 days were placed in tier 2, and patients who “we felt were fairly stable and could wait at least 30 days” were placed in tier 3. “For TAVR, a tier 3 patient might be the one … who has severe aortic stenosis but is walking around and doing well at home with only stable exertional symptoms,” he said.

Patients whose procedures were delayed were contacted weekly by the valve clinic’s advanced practice practitioners through video visits or telephone calls, and tier categorization was reevaluated if symptoms worsened. “We had to keep in close contact with them,” Dr. Batchelor said. “These patients can deteriorate quite rapidly and sometimes without much warning.”

Virtual video visits were often used for 30-day postprocedural follow-ups, taking the place of in-person visits during which post-TAVR echocardiographic assessments would normally be performed. “For follow-up, we’d often just do a quick visit to check the vascular access site within 7-10 days, and then, if they were doing okay we’d delay the 30-day echo to a later time frame,” he said.

Preprocedural testing was streamlined to minimize the number of patient-provider interactions, with pulmonary function testing and pre-TAVR catheterization omitted unless absolutely necessary. “A TAVR CT angiogram [performed within the prior year] is the only test you really absolutely need,” Dr. Batchelor said. “We were much less likely to order a heart catheterization unless the patient was having angina and high risk or suspicion for significant coronary artery disease.”

This approach was not associated with any compromise in postprocedural outcomes, he noted. Prior to the pandemic, Inova routinely employed a minimalist approach to TAVR with moderate conscious sedation and avoiding transesophageal echocardiography – steps that were recommended for structural heart procedures in the COVID-19 era in a published review by the heart team at New York-Presbyterian Hospital/Columbia University Irving Medical Center.

The New York review is useful for cardiologists in areas with rising case burdens of COVID-19, Dr. Batchelor said, as is a position statement he coauthored from the American College of Cardiology and the Society for Cardiology and Angiography Interventions (SCAI) on triage considerations for structural heart disease interventions during the pandemic.

TAVR’s resource-heavy nature made the “system capacity dashboard” and daily meetings critical, Dr. Batchelor explained. At one point during the hold on elective procedures, the Falls Church INOVA facility had approximately 300 patients with COVID-19, a significant proportion of whom were in cardiac ICU beds.

“Everyone has to be flexible and learn,” he said. “We trained our cardiologists on managing ventilators in case some of the [critical care] staff got ill or were overwhelmed by the surge.”

More than 2 months after the surge eased and the ban on elective surgery was lifted, Dr. Batchelor and his colleagues are still using the dashboard and continue to meet daily to discuss COVID-19 prevalence in the hospital and the community as they work through the backlog of delayed procedures. They also routinely review the status of COVID-19 testing for inpatients and outpatients and the donning and doffing of personal protective equipment.

“You have to communicate early and often across the whole system of care because you’re competing for the same resources,” he advised. “And you have to be flexible and reassess. A policy that works at the beginning of the pandemic might have to change.”
 

PCI in New York

Before the pandemic, the cardiac catheterization laboratory at Mount Sinai Morningside Hospital in New York handled a monthly average of 140-150 PCIs, including 6-10 primary PCIs for ST-segment elevation myocardial infarction.

Courtesy of Mount Sinai Morningside

When electives were halted by the hospital in March and the City became the global epicenter for COVID-19, the cath lab went quiet. “Even though we were still able to do urgent cases or emergent cases, the case volume dropped tremendously,” said Jacqueline E. Tamis-Holland, MD, associate director of the cardiac catheterization laboratory and director of the interventional cardiology fellowship. “There weren’t many outpatients in our hospital … and by late March and through April, there wasn’t a single acute infarction.”

She and Tak W. Kwan, MD, director of the cardiac catheterization laboratory and professor of medicine at Icahn School of Medicine at Mount Sinai, New York, were prepared to move true STEMI patients into the cath lab for primary PCI without delay unless the staff or system were overrun.

That primary PCI should remain the first-line treatment for STEMI even in cases of confirmed or suspected COVID-19 was recommended by SCAI guidance issued in March and by a consensus statement released by the SCAI, ACC, and American College of Emergency Physicians in April – and “we were very much of the same frame of mind,” Dr. Tamis-Holland said.

Deciding which elective cases could not be delayed required a completely individualized approach, the cardiologists emphasized. Dr. Tamis-Holland had a few patients scheduled for elective PCI when the hold began, and “we spoke every few days or once a week in the beginning, then transitioned to once every 2 weeks,” she said. “With medical therapy and given that they were relatively sedentary, my patients did okay [with the delays].”

For subsequent patients, she considered their symptoms or stress test results. “If it’s someone who I’d [normally] wait until next week to schedule the cath, then we would wait 2 or 3 more weeks, or a month more with careful monitoring,” she said. “Certainly, there was a decrease in the number of abnormal stress tests that I referred to the cath lab during [the surge period].”

Dr. Kwan described one patient who had new-onset congestive heart failure in late March “with a markedly positive nuclear stress test.” The patient was monitored with twice-weekly telemedicine visits and office visits, and a cardiac catheterization was performed in early May as an urgent elective case. “He had severe three-vessel and left main disease,” he said. “Subsequently, [coronary artery bypass surgery] was done.”

There were no changes in the PCI procedure itself in terms of hospital stay (most elective cases at Mt. Sinai are same-day procedures) or in staffing, other than a ban on visiting students or residents. The most important changes during the surge – in addition to stocking enough personal protective equipment – concerned testing. Patients undergoing elective PCI are tested for the novel coronavirus 72 hours before the procedure, and rapid testing is performed in the emergency room for STEMI patients to determine patient disposition after the procedure.

“Until we have the results back we should treat all patients as if they are a patient under investigation or have COVID,” said Dr. Tamis-Holland, who helped develop emergency guidance on STEMI systems of care during the pandemic for the American Heart Association.

In early May, the hospital freed up additional space for cardiac care, allowing more “urgent-elective” PCIs to be done. Some patients were reluctant to proceed, the cardiologists said, because of a no-visitor policy. In mid-June, the hold on elective procedures was lifted, and around the same time, the hospital shifted to a one-visitor policy. Still, some patients opted to continue longer with medical therapy.

Patients need to feel comfortable, and “there is a lag time from the time everything opens up and when patients get their stress tests and their evaluations, and then arrive for PCI,” said Dr. Tamis-Holland.

By mid-July, the cardiologists were anticipating an increase in complications from infarctions among patients who “waited them out at home” – heart failure or mitral valve regurgitation, for instance – but, in their hospital at least, “we haven’t really seen that,” she added.
 

AFib ablation in Kentucky

As New York experienced its surge, John Mandrola, MD, and other electrophysiologists across the Baptist Health system in Kentucky reached a consensus on how to categorize their procedures. Electrophysiology interventions were classified urgent, emergent, and truly elective in the event that the state’s relatively low case burden of COVID-19 were to significantly worsen.

There was no doubt where AFib ablation sat. “It’s one of the most elective procedures there is” in terms of scheduling under normal circumstances, and it almost always requires an overnight stay and general anesthesia – factors that upped the ante on an elective classification, said Dr. Mandrola.

All AF ablations were deemed elective unless the patient required immediate hospitalization. For 8-10 weeks during the state’s shutdown of elective care, Dr. Mandrola and his partner successfully monitored patients with phone calls. “To be honest,” he said, “most patients did not want to have their AFib ablation anyway until the pandemic slowed and they knew it was safe.”

In some cases, patients reported that their symptoms were improving: “There are so many things to speculate about. ... Was it that everyone took their foot off the accelerator?” Dr. Mandrola thinks that postpandemic outcomes analyses may drive more scrutiny of the necessity of some AFib ablations and other procedures and tests. AFib ablation “has its place but is probably overused,” he said.

During the pause on electives, “the vast majority of procedures we did were pacemaker procedures,” he said. “We also did some atrial flutter ablations, and ablations for ventricular tachycardia and supraventricular tachycardia.” In mid-July, as the COVID-19 case burden in Kentucky remained relatively low, Dr. Mandrola was “up to 120%” of his pre-COVID electrophysiology volume – but ready to scale back again if needed.

Dr. Batchelor reported consulting fees from Boston Scientific, Abbott Medical, Medtronic, and V-wave. Dr. Kwan, Dr. Mandrola, and Dr. Tamis-Holland reported no relevant financial disclosures.
 

This article is a collaboration between Medscape and MDedge. A version of it originally appeared on Medscape.com.

When Virginia’s governor directed the postponement of all elective surgeries in late March, Wayne Batchelor, MD and his colleagues at the Inova Heart and Vascular Institute in Falls Church, Va., canceled about two-thirds of their transcatheter aortic valve replacement (TAVR) procedures.

Courtesy Wayne Batchelor, MD

They then categorized patients by tiers to gauge which procedures could safely be postponed and to guide triaging. And while they did not deviate from the practice of having both an interventional cardiologist and a cardiothoracic surgeon present for TAVR, they slimmed down preprocedural testing when feasible and delayed some 30-day post-TAVR echocardiographic assessments. “It was a delicate dance, very difficult dance. But luckily, we were able to navigate the challenges effectively,” said Dr. Batchelor, the institute’s director of interventional cardiology and interventional cardiology research.

A “system capacity dashboard” that merged bed and staffing data from interventional cardiology spaces with cardiovascular and noncardiovascular ICU beds, operating rooms, and other resources – and daily cross-department meetings – enabled them to proceed with the most urgent TAVR procedures while “keeping a buffer of ICU beds to accommodate an anticipated surge of COVID-19,” he explained.

Such adaptations in cardiac procedures and processes are occurring in hospitals across the country as efforts are made to minimize the risk of COVID-19 exposure for patients and staff. Dr. Batchelor is one of four cardiologists who shared their experiences and advice on common cardiac procedures across three locales: TAVR in Virginia, percutaneous coronary intervention (PCI) in New York City, and atrial fibrillation (AFib) ablation in Kentucky.
 

More on TAVR in Virginia

Inova’s framework for triaging structural heart disease interventions (largely TAVR and/or percutaneous mitral valve repair) comprised three tiers. Tier 1 captured “emergent cases that had to be done, no questions asked,” Dr. Batchelor said. For TAVR, these were inpatients with severe to critical symptomatic aortic stenosis and advanced congestive heart failure who could not safely be discharged, as well as other patients “with refractory symptoms of heart failure that were compelling.” Many had associated left ventricular systolic dysfunction.

Those who could delay 14-30 days were placed in tier 2, and patients who “we felt were fairly stable and could wait at least 30 days” were placed in tier 3. “For TAVR, a tier 3 patient might be the one … who has severe aortic stenosis but is walking around and doing well at home with only stable exertional symptoms,” he said.

Patients whose procedures were delayed were contacted weekly by the valve clinic’s advanced practice practitioners through video visits or telephone calls, and tier categorization was reevaluated if symptoms worsened. “We had to keep in close contact with them,” Dr. Batchelor said. “These patients can deteriorate quite rapidly and sometimes without much warning.”

Virtual video visits were often used for 30-day postprocedural follow-ups, taking the place of in-person visits during which post-TAVR echocardiographic assessments would normally be performed. “For follow-up, we’d often just do a quick visit to check the vascular access site within 7-10 days, and then, if they were doing okay we’d delay the 30-day echo to a later time frame,” he said.

Preprocedural testing was streamlined to minimize the number of patient-provider interactions, with pulmonary function testing and pre-TAVR catheterization omitted unless absolutely necessary. “A TAVR CT angiogram [performed within the prior year] is the only test you really absolutely need,” Dr. Batchelor said. “We were much less likely to order a heart catheterization unless the patient was having angina and high risk or suspicion for significant coronary artery disease.”

This approach was not associated with any compromise in postprocedural outcomes, he noted. Prior to the pandemic, Inova routinely employed a minimalist approach to TAVR with moderate conscious sedation and avoiding transesophageal echocardiography – steps that were recommended for structural heart procedures in the COVID-19 era in a published review by the heart team at New York-Presbyterian Hospital/Columbia University Irving Medical Center.

The New York review is useful for cardiologists in areas with rising case burdens of COVID-19, Dr. Batchelor said, as is a position statement he coauthored from the American College of Cardiology and the Society for Cardiology and Angiography Interventions (SCAI) on triage considerations for structural heart disease interventions during the pandemic.

TAVR’s resource-heavy nature made the “system capacity dashboard” and daily meetings critical, Dr. Batchelor explained. At one point during the hold on elective procedures, the Falls Church INOVA facility had approximately 300 patients with COVID-19, a significant proportion of whom were in cardiac ICU beds.

“Everyone has to be flexible and learn,” he said. “We trained our cardiologists on managing ventilators in case some of the [critical care] staff got ill or were overwhelmed by the surge.”

More than 2 months after the surge eased and the ban on elective surgery was lifted, Dr. Batchelor and his colleagues are still using the dashboard and continue to meet daily to discuss COVID-19 prevalence in the hospital and the community as they work through the backlog of delayed procedures. They also routinely review the status of COVID-19 testing for inpatients and outpatients and the donning and doffing of personal protective equipment.

“You have to communicate early and often across the whole system of care because you’re competing for the same resources,” he advised. “And you have to be flexible and reassess. A policy that works at the beginning of the pandemic might have to change.”
 

PCI in New York

Before the pandemic, the cardiac catheterization laboratory at Mount Sinai Morningside Hospital in New York handled a monthly average of 140-150 PCIs, including 6-10 primary PCIs for ST-segment elevation myocardial infarction.

Courtesy of Mount Sinai Morningside

When electives were halted by the hospital in March and the City became the global epicenter for COVID-19, the cath lab went quiet. “Even though we were still able to do urgent cases or emergent cases, the case volume dropped tremendously,” said Jacqueline E. Tamis-Holland, MD, associate director of the cardiac catheterization laboratory and director of the interventional cardiology fellowship. “There weren’t many outpatients in our hospital … and by late March and through April, there wasn’t a single acute infarction.”

She and Tak W. Kwan, MD, director of the cardiac catheterization laboratory and professor of medicine at Icahn School of Medicine at Mount Sinai, New York, were prepared to move true STEMI patients into the cath lab for primary PCI without delay unless the staff or system were overrun.

That primary PCI should remain the first-line treatment for STEMI even in cases of confirmed or suspected COVID-19 was recommended by SCAI guidance issued in March and by a consensus statement released by the SCAI, ACC, and American College of Emergency Physicians in April – and “we were very much of the same frame of mind,” Dr. Tamis-Holland said.

Deciding which elective cases could not be delayed required a completely individualized approach, the cardiologists emphasized. Dr. Tamis-Holland had a few patients scheduled for elective PCI when the hold began, and “we spoke every few days or once a week in the beginning, then transitioned to once every 2 weeks,” she said. “With medical therapy and given that they were relatively sedentary, my patients did okay [with the delays].”

For subsequent patients, she considered their symptoms or stress test results. “If it’s someone who I’d [normally] wait until next week to schedule the cath, then we would wait 2 or 3 more weeks, or a month more with careful monitoring,” she said. “Certainly, there was a decrease in the number of abnormal stress tests that I referred to the cath lab during [the surge period].”

Dr. Kwan described one patient who had new-onset congestive heart failure in late March “with a markedly positive nuclear stress test.” The patient was monitored with twice-weekly telemedicine visits and office visits, and a cardiac catheterization was performed in early May as an urgent elective case. “He had severe three-vessel and left main disease,” he said. “Subsequently, [coronary artery bypass surgery] was done.”

There were no changes in the PCI procedure itself in terms of hospital stay (most elective cases at Mt. Sinai are same-day procedures) or in staffing, other than a ban on visiting students or residents. The most important changes during the surge – in addition to stocking enough personal protective equipment – concerned testing. Patients undergoing elective PCI are tested for the novel coronavirus 72 hours before the procedure, and rapid testing is performed in the emergency room for STEMI patients to determine patient disposition after the procedure.

“Until we have the results back we should treat all patients as if they are a patient under investigation or have COVID,” said Dr. Tamis-Holland, who helped develop emergency guidance on STEMI systems of care during the pandemic for the American Heart Association.

In early May, the hospital freed up additional space for cardiac care, allowing more “urgent-elective” PCIs to be done. Some patients were reluctant to proceed, the cardiologists said, because of a no-visitor policy. In mid-June, the hold on elective procedures was lifted, and around the same time, the hospital shifted to a one-visitor policy. Still, some patients opted to continue longer with medical therapy.

Patients need to feel comfortable, and “there is a lag time from the time everything opens up and when patients get their stress tests and their evaluations, and then arrive for PCI,” said Dr. Tamis-Holland.

By mid-July, the cardiologists were anticipating an increase in complications from infarctions among patients who “waited them out at home” – heart failure or mitral valve regurgitation, for instance – but, in their hospital at least, “we haven’t really seen that,” she added.
 

AFib ablation in Kentucky

As New York experienced its surge, John Mandrola, MD, and other electrophysiologists across the Baptist Health system in Kentucky reached a consensus on how to categorize their procedures. Electrophysiology interventions were classified urgent, emergent, and truly elective in the event that the state’s relatively low case burden of COVID-19 were to significantly worsen.

There was no doubt where AFib ablation sat. “It’s one of the most elective procedures there is” in terms of scheduling under normal circumstances, and it almost always requires an overnight stay and general anesthesia – factors that upped the ante on an elective classification, said Dr. Mandrola.

All AF ablations were deemed elective unless the patient required immediate hospitalization. For 8-10 weeks during the state’s shutdown of elective care, Dr. Mandrola and his partner successfully monitored patients with phone calls. “To be honest,” he said, “most patients did not want to have their AFib ablation anyway until the pandemic slowed and they knew it was safe.”

In some cases, patients reported that their symptoms were improving: “There are so many things to speculate about. ... Was it that everyone took their foot off the accelerator?” Dr. Mandrola thinks that postpandemic outcomes analyses may drive more scrutiny of the necessity of some AFib ablations and other procedures and tests. AFib ablation “has its place but is probably overused,” he said.

During the pause on electives, “the vast majority of procedures we did were pacemaker procedures,” he said. “We also did some atrial flutter ablations, and ablations for ventricular tachycardia and supraventricular tachycardia.” In mid-July, as the COVID-19 case burden in Kentucky remained relatively low, Dr. Mandrola was “up to 120%” of his pre-COVID electrophysiology volume – but ready to scale back again if needed.

Dr. Batchelor reported consulting fees from Boston Scientific, Abbott Medical, Medtronic, and V-wave. Dr. Kwan, Dr. Mandrola, and Dr. Tamis-Holland reported no relevant financial disclosures.
 

This article is a collaboration between Medscape and MDedge. A version of it originally appeared on Medscape.com.

When Virginia’s governor directed the postponement of all elective surgeries in late March, Wayne Batchelor, MD and his colleagues at the Inova Heart and Vascular Institute in Falls Church, Va., canceled about two-thirds of their transcatheter aortic valve replacement (TAVR) procedures.

Courtesy Wayne Batchelor, MD

They then categorized patients by tiers to gauge which procedures could safely be postponed and to guide triaging. And while they did not deviate from the practice of having both an interventional cardiologist and a cardiothoracic surgeon present for TAVR, they slimmed down preprocedural testing when feasible and delayed some 30-day post-TAVR echocardiographic assessments. “It was a delicate dance, very difficult dance. But luckily, we were able to navigate the challenges effectively,” said Dr. Batchelor, the institute’s director of interventional cardiology and interventional cardiology research.

A “system capacity dashboard” that merged bed and staffing data from interventional cardiology spaces with cardiovascular and noncardiovascular ICU beds, operating rooms, and other resources – and daily cross-department meetings – enabled them to proceed with the most urgent TAVR procedures while “keeping a buffer of ICU beds to accommodate an anticipated surge of COVID-19,” he explained.

Such adaptations in cardiac procedures and processes are occurring in hospitals across the country as efforts are made to minimize the risk of COVID-19 exposure for patients and staff. Dr. Batchelor is one of four cardiologists who shared their experiences and advice on common cardiac procedures across three locales: TAVR in Virginia, percutaneous coronary intervention (PCI) in New York City, and atrial fibrillation (AFib) ablation in Kentucky.
 

More on TAVR in Virginia

Inova’s framework for triaging structural heart disease interventions (largely TAVR and/or percutaneous mitral valve repair) comprised three tiers. Tier 1 captured “emergent cases that had to be done, no questions asked,” Dr. Batchelor said. For TAVR, these were inpatients with severe to critical symptomatic aortic stenosis and advanced congestive heart failure who could not safely be discharged, as well as other patients “with refractory symptoms of heart failure that were compelling.” Many had associated left ventricular systolic dysfunction.

Those who could delay 14-30 days were placed in tier 2, and patients who “we felt were fairly stable and could wait at least 30 days” were placed in tier 3. “For TAVR, a tier 3 patient might be the one … who has severe aortic stenosis but is walking around and doing well at home with only stable exertional symptoms,” he said.

Patients whose procedures were delayed were contacted weekly by the valve clinic’s advanced practice practitioners through video visits or telephone calls, and tier categorization was reevaluated if symptoms worsened. “We had to keep in close contact with them,” Dr. Batchelor said. “These patients can deteriorate quite rapidly and sometimes without much warning.”

Virtual video visits were often used for 30-day postprocedural follow-ups, taking the place of in-person visits during which post-TAVR echocardiographic assessments would normally be performed. “For follow-up, we’d often just do a quick visit to check the vascular access site within 7-10 days, and then, if they were doing okay we’d delay the 30-day echo to a later time frame,” he said.

Preprocedural testing was streamlined to minimize the number of patient-provider interactions, with pulmonary function testing and pre-TAVR catheterization omitted unless absolutely necessary. “A TAVR CT angiogram [performed within the prior year] is the only test you really absolutely need,” Dr. Batchelor said. “We were much less likely to order a heart catheterization unless the patient was having angina and high risk or suspicion for significant coronary artery disease.”

This approach was not associated with any compromise in postprocedural outcomes, he noted. Prior to the pandemic, Inova routinely employed a minimalist approach to TAVR with moderate conscious sedation and avoiding transesophageal echocardiography – steps that were recommended for structural heart procedures in the COVID-19 era in a published review by the heart team at New York-Presbyterian Hospital/Columbia University Irving Medical Center.

The New York review is useful for cardiologists in areas with rising case burdens of COVID-19, Dr. Batchelor said, as is a position statement he coauthored from the American College of Cardiology and the Society for Cardiology and Angiography Interventions (SCAI) on triage considerations for structural heart disease interventions during the pandemic.

TAVR’s resource-heavy nature made the “system capacity dashboard” and daily meetings critical, Dr. Batchelor explained. At one point during the hold on elective procedures, the Falls Church INOVA facility had approximately 300 patients with COVID-19, a significant proportion of whom were in cardiac ICU beds.

“Everyone has to be flexible and learn,” he said. “We trained our cardiologists on managing ventilators in case some of the [critical care] staff got ill or were overwhelmed by the surge.”

More than 2 months after the surge eased and the ban on elective surgery was lifted, Dr. Batchelor and his colleagues are still using the dashboard and continue to meet daily to discuss COVID-19 prevalence in the hospital and the community as they work through the backlog of delayed procedures. They also routinely review the status of COVID-19 testing for inpatients and outpatients and the donning and doffing of personal protective equipment.

“You have to communicate early and often across the whole system of care because you’re competing for the same resources,” he advised. “And you have to be flexible and reassess. A policy that works at the beginning of the pandemic might have to change.”
 

PCI in New York

Before the pandemic, the cardiac catheterization laboratory at Mount Sinai Morningside Hospital in New York handled a monthly average of 140-150 PCIs, including 6-10 primary PCIs for ST-segment elevation myocardial infarction.

Courtesy of Mount Sinai Morningside

When electives were halted by the hospital in March and the City became the global epicenter for COVID-19, the cath lab went quiet. “Even though we were still able to do urgent cases or emergent cases, the case volume dropped tremendously,” said Jacqueline E. Tamis-Holland, MD, associate director of the cardiac catheterization laboratory and director of the interventional cardiology fellowship. “There weren’t many outpatients in our hospital … and by late March and through April, there wasn’t a single acute infarction.”

She and Tak W. Kwan, MD, director of the cardiac catheterization laboratory and professor of medicine at Icahn School of Medicine at Mount Sinai, New York, were prepared to move true STEMI patients into the cath lab for primary PCI without delay unless the staff or system were overrun.

That primary PCI should remain the first-line treatment for STEMI even in cases of confirmed or suspected COVID-19 was recommended by SCAI guidance issued in March and by a consensus statement released by the SCAI, ACC, and American College of Emergency Physicians in April – and “we were very much of the same frame of mind,” Dr. Tamis-Holland said.

Deciding which elective cases could not be delayed required a completely individualized approach, the cardiologists emphasized. Dr. Tamis-Holland had a few patients scheduled for elective PCI when the hold began, and “we spoke every few days or once a week in the beginning, then transitioned to once every 2 weeks,” she said. “With medical therapy and given that they were relatively sedentary, my patients did okay [with the delays].”

For subsequent patients, she considered their symptoms or stress test results. “If it’s someone who I’d [normally] wait until next week to schedule the cath, then we would wait 2 or 3 more weeks, or a month more with careful monitoring,” she said. “Certainly, there was a decrease in the number of abnormal stress tests that I referred to the cath lab during [the surge period].”

Dr. Kwan described one patient who had new-onset congestive heart failure in late March “with a markedly positive nuclear stress test.” The patient was monitored with twice-weekly telemedicine visits and office visits, and a cardiac catheterization was performed in early May as an urgent elective case. “He had severe three-vessel and left main disease,” he said. “Subsequently, [coronary artery bypass surgery] was done.”

There were no changes in the PCI procedure itself in terms of hospital stay (most elective cases at Mt. Sinai are same-day procedures) or in staffing, other than a ban on visiting students or residents. The most important changes during the surge – in addition to stocking enough personal protective equipment – concerned testing. Patients undergoing elective PCI are tested for the novel coronavirus 72 hours before the procedure, and rapid testing is performed in the emergency room for STEMI patients to determine patient disposition after the procedure.

“Until we have the results back we should treat all patients as if they are a patient under investigation or have COVID,” said Dr. Tamis-Holland, who helped develop emergency guidance on STEMI systems of care during the pandemic for the American Heart Association.

In early May, the hospital freed up additional space for cardiac care, allowing more “urgent-elective” PCIs to be done. Some patients were reluctant to proceed, the cardiologists said, because of a no-visitor policy. In mid-June, the hold on elective procedures was lifted, and around the same time, the hospital shifted to a one-visitor policy. Still, some patients opted to continue longer with medical therapy.

Patients need to feel comfortable, and “there is a lag time from the time everything opens up and when patients get their stress tests and their evaluations, and then arrive for PCI,” said Dr. Tamis-Holland.

By mid-July, the cardiologists were anticipating an increase in complications from infarctions among patients who “waited them out at home” – heart failure or mitral valve regurgitation, for instance – but, in their hospital at least, “we haven’t really seen that,” she added.
 

AFib ablation in Kentucky

As New York experienced its surge, John Mandrola, MD, and other electrophysiologists across the Baptist Health system in Kentucky reached a consensus on how to categorize their procedures. Electrophysiology interventions were classified urgent, emergent, and truly elective in the event that the state’s relatively low case burden of COVID-19 were to significantly worsen.

There was no doubt where AFib ablation sat. “It’s one of the most elective procedures there is” in terms of scheduling under normal circumstances, and it almost always requires an overnight stay and general anesthesia – factors that upped the ante on an elective classification, said Dr. Mandrola.

All AF ablations were deemed elective unless the patient required immediate hospitalization. For 8-10 weeks during the state’s shutdown of elective care, Dr. Mandrola and his partner successfully monitored patients with phone calls. “To be honest,” he said, “most patients did not want to have their AFib ablation anyway until the pandemic slowed and they knew it was safe.”

In some cases, patients reported that their symptoms were improving: “There are so many things to speculate about. ... Was it that everyone took their foot off the accelerator?” Dr. Mandrola thinks that postpandemic outcomes analyses may drive more scrutiny of the necessity of some AFib ablations and other procedures and tests. AFib ablation “has its place but is probably overused,” he said.

During the pause on electives, “the vast majority of procedures we did were pacemaker procedures,” he said. “We also did some atrial flutter ablations, and ablations for ventricular tachycardia and supraventricular tachycardia.” In mid-July, as the COVID-19 case burden in Kentucky remained relatively low, Dr. Mandrola was “up to 120%” of his pre-COVID electrophysiology volume – but ready to scale back again if needed.

Dr. Batchelor reported consulting fees from Boston Scientific, Abbott Medical, Medtronic, and V-wave. Dr. Kwan, Dr. Mandrola, and Dr. Tamis-Holland reported no relevant financial disclosures.
 

This article is a collaboration between Medscape and MDedge. A version of it originally appeared on Medscape.com.

Two-year outcomes following transcatheter mitral valve replacement with the Tendyne prosthesis showed durable control of mitral regurgitation, sustained improvement in quality of life and functional capacity, and a marked drop-off in the rate of hospitalization for heart failure, David W.M. Muller, MBBS, MD, reported at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“The outcomes can be considered very acceptable considering the advanced age and underlying comorbidities. The data show that, at 2 years, we still have excellent control of the MR [mitral regurgitation], with more than 93% of patients having no MR at all, and there were no patients with 1+ or greater MR,” said Dr. Muller, director of cardiac catheterization laboratories at St. Vincent’s Hospital in Sydney.

He presented for the first time the 2-year results for the first 100 patients enrolled in the long-term Tendyne Expanded Clinical Study. The 1-year outcomes were reported previously (J Am Coll Cardiol. 2019 Mar 26;73[11]:1250-60).

The transcatheter Tendyne mitral valve system received European marketing approval in early 2020 for commercial use in patients with severe symptomatic MR who aren’t candidates for open surgery or transcatheter mitral repair using the MitraClip device. The Tendyne remains investigational in the United States, where a large phase 3 randomized head-to-head trial of the Tendyne device and the FDA-approved MitraClip is ongoing.

At enrollment, the first 100 patients in the long-term prospective Tendyne study averaged 75 years of age, 66% were New York Heart Association functional class III or IV, 89% had secondary or mixed etiology MR, and 39% had been hospitalized for heart failure during the preceding 6 months. Ninety-two percent of participants had 4+ MR before implantation. The group’s average Society of Thoracic Surgeons Predicted Risk of Mortality score was 7.8%.

The all-cause mortality rate was 27% at 1 year and 39% at 2 years, with 87% of deaths being attributable to cardiovascular causes. At 2 years, 82% of survivors were NYHA class I or II. Their Kansas City Cardiomyopathy Questionnaire score improved by 19.1 points from an average of 49 at baseline. There was no evidence of structural valve dysfunction. Their heart failure hospitalization rate improved from 1.3 events per patient per year to 0.6 per patient-year at 1 year and 0.51 at 2 years.

Discussant Francesco Maisano, MD, was favorably impressed by the acute outcomes of transcatheter mitral valve replacement with the Tendyne device.

“There were very few procedural or in-hospital complications. Success was obtained in almost every patient. There was no procedural mortality. The 30-day mortality of 6.0% was reasonable in patients with a baseline STS score of 7.8%; that’s pretty good, I would say,” observed Dr. Maisano, professor of cardiac surgery at the University of Zürich and a pioneer of catheter-based mitral and tricuspid interventions.

However, he voiced concerns about the 35% incidence of major bleeding and 5% rate of disabling stroke at 2 years, which he deemed “pretty high.”

“This underlies the open issue of anticoagulation following these kinds of procedures. This obviously requires further work in the next years,” he said.

Dr. Muller reported receiving research grants from and serving as a consultant to Abbott, which markets the MitraClip and is developing the Tendyne system. He also serves as a consultant to Edwards Lifesciences and Medtronic. Dr. Maisano also reported serving as a consultant to several medical device companies.

[email protected]

Two-year outcomes following transcatheter mitral valve replacement with the Tendyne prosthesis showed durable control of mitral regurgitation, sustained improvement in quality of life and functional capacity, and a marked drop-off in the rate of hospitalization for heart failure, David W.M. Muller, MBBS, MD, reported at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“The outcomes can be considered very acceptable considering the advanced age and underlying comorbidities. The data show that, at 2 years, we still have excellent control of the MR [mitral regurgitation], with more than 93% of patients having no MR at all, and there were no patients with 1+ or greater MR,” said Dr. Muller, director of cardiac catheterization laboratories at St. Vincent’s Hospital in Sydney.

He presented for the first time the 2-year results for the first 100 patients enrolled in the long-term Tendyne Expanded Clinical Study. The 1-year outcomes were reported previously (J Am Coll Cardiol. 2019 Mar 26;73[11]:1250-60).

The transcatheter Tendyne mitral valve system received European marketing approval in early 2020 for commercial use in patients with severe symptomatic MR who aren’t candidates for open surgery or transcatheter mitral repair using the MitraClip device. The Tendyne remains investigational in the United States, where a large phase 3 randomized head-to-head trial of the Tendyne device and the FDA-approved MitraClip is ongoing.

At enrollment, the first 100 patients in the long-term prospective Tendyne study averaged 75 years of age, 66% were New York Heart Association functional class III or IV, 89% had secondary or mixed etiology MR, and 39% had been hospitalized for heart failure during the preceding 6 months. Ninety-two percent of participants had 4+ MR before implantation. The group’s average Society of Thoracic Surgeons Predicted Risk of Mortality score was 7.8%.

The all-cause mortality rate was 27% at 1 year and 39% at 2 years, with 87% of deaths being attributable to cardiovascular causes. At 2 years, 82% of survivors were NYHA class I or II. Their Kansas City Cardiomyopathy Questionnaire score improved by 19.1 points from an average of 49 at baseline. There was no evidence of structural valve dysfunction. Their heart failure hospitalization rate improved from 1.3 events per patient per year to 0.6 per patient-year at 1 year and 0.51 at 2 years.

Discussant Francesco Maisano, MD, was favorably impressed by the acute outcomes of transcatheter mitral valve replacement with the Tendyne device.

“There were very few procedural or in-hospital complications. Success was obtained in almost every patient. There was no procedural mortality. The 30-day mortality of 6.0% was reasonable in patients with a baseline STS score of 7.8%; that’s pretty good, I would say,” observed Dr. Maisano, professor of cardiac surgery at the University of Zürich and a pioneer of catheter-based mitral and tricuspid interventions.

However, he voiced concerns about the 35% incidence of major bleeding and 5% rate of disabling stroke at 2 years, which he deemed “pretty high.”

“This underlies the open issue of anticoagulation following these kinds of procedures. This obviously requires further work in the next years,” he said.

Dr. Muller reported receiving research grants from and serving as a consultant to Abbott, which markets the MitraClip and is developing the Tendyne system. He also serves as a consultant to Edwards Lifesciences and Medtronic. Dr. Maisano also reported serving as a consultant to several medical device companies.

[email protected]

Two-year outcomes following transcatheter mitral valve replacement with the Tendyne prosthesis showed durable control of mitral regurgitation, sustained improvement in quality of life and functional capacity, and a marked drop-off in the rate of hospitalization for heart failure, David W.M. Muller, MBBS, MD, reported at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“The outcomes can be considered very acceptable considering the advanced age and underlying comorbidities. The data show that, at 2 years, we still have excellent control of the MR [mitral regurgitation], with more than 93% of patients having no MR at all, and there were no patients with 1+ or greater MR,” said Dr. Muller, director of cardiac catheterization laboratories at St. Vincent’s Hospital in Sydney.

He presented for the first time the 2-year results for the first 100 patients enrolled in the long-term Tendyne Expanded Clinical Study. The 1-year outcomes were reported previously (J Am Coll Cardiol. 2019 Mar 26;73[11]:1250-60).

The transcatheter Tendyne mitral valve system received European marketing approval in early 2020 for commercial use in patients with severe symptomatic MR who aren’t candidates for open surgery or transcatheter mitral repair using the MitraClip device. The Tendyne remains investigational in the United States, where a large phase 3 randomized head-to-head trial of the Tendyne device and the FDA-approved MitraClip is ongoing.

At enrollment, the first 100 patients in the long-term prospective Tendyne study averaged 75 years of age, 66% were New York Heart Association functional class III or IV, 89% had secondary or mixed etiology MR, and 39% had been hospitalized for heart failure during the preceding 6 months. Ninety-two percent of participants had 4+ MR before implantation. The group’s average Society of Thoracic Surgeons Predicted Risk of Mortality score was 7.8%.

The all-cause mortality rate was 27% at 1 year and 39% at 2 years, with 87% of deaths being attributable to cardiovascular causes. At 2 years, 82% of survivors were NYHA class I or II. Their Kansas City Cardiomyopathy Questionnaire score improved by 19.1 points from an average of 49 at baseline. There was no evidence of structural valve dysfunction. Their heart failure hospitalization rate improved from 1.3 events per patient per year to 0.6 per patient-year at 1 year and 0.51 at 2 years.

Discussant Francesco Maisano, MD, was favorably impressed by the acute outcomes of transcatheter mitral valve replacement with the Tendyne device.

“There were very few procedural or in-hospital complications. Success was obtained in almost every patient. There was no procedural mortality. The 30-day mortality of 6.0% was reasonable in patients with a baseline STS score of 7.8%; that’s pretty good, I would say,” observed Dr. Maisano, professor of cardiac surgery at the University of Zürich and a pioneer of catheter-based mitral and tricuspid interventions.

However, he voiced concerns about the 35% incidence of major bleeding and 5% rate of disabling stroke at 2 years, which he deemed “pretty high.”

“This underlies the open issue of anticoagulation following these kinds of procedures. This obviously requires further work in the next years,” he said.

Dr. Muller reported receiving research grants from and serving as a consultant to Abbott, which markets the MitraClip and is developing the Tendyne system. He also serves as a consultant to Edwards Lifesciences and Medtronic. Dr. Maisano also reported serving as a consultant to several medical device companies.

[email protected]

In elderly or low-weight patients with acute coronary syndrome (ACS), a reduced dose of prasugrel relative to a full-dose of ticagrelor is associated with lower numerical rates of ischemic events and bleeding events, according to a prespecified substudy of the ISAR-REACT 5 trial.

“The present study provides the strongest support for reduced-dose prasugrel as the standard for elderly and low-weight patients with ACS undergoing an invasive treatment strategy,” according to the senior author, Adnan Kastrati, MD, professor of cardiology and head of the Catheterization Laboratory at Deutsches Herzzentrum, Technical University of Munich.

The main results of ISAR-REACT 5, an open-label, head-to-head comparison of prasugrel and ticagrelor in patients with ACS, showed that the risk of the composite primary endpoint of death, myocardial infarction, or stroke 1 year after randomization was significantly higher for those on ticagrelor than prasugrel (hazard ratio, 1.39; P = .006). The bleeding risk on ticagrelor was also higher but not significantly different (5.4% vs. 4.8%; P = .46) (Schüpke S et al. N Engl J Med. 2019 Oct;381:1524-34).

In this substudy newly published in Annals of Internal Medicine, outcomes were compared in the 1,099 patients who were 75 years or older or weighed less than 60 kg. In this group, unlike those younger or weighing more, patients were randomized to receive a reduced maintenance dose of 5 mg of once-daily prasugrel (rather than 10 mg) or full dose ticagrelor (90 mg twice daily).

At 1 year, the low-dose prasugrel strategy relative to ticagrelor was associated with a lower rate of events (12.7% vs. 14.6%) and a lower rate of bleeding (8.1% vs. 10.6%), defined as Bleeding Academic Research Consortium (BARC) type 3-5 events.

Neither the 18% reduction for the efficacy endpoint (HR, 0.82; 95% CI 0.60-1.14) nor the 28% reduction in the bleeding endpoint (HR, 0.72; 95% CI 0.46-1.12) reached significance, but Dr. Kastrati reported that there was a significant “treatment effect-by-study-group interaction” for BARC 1-5 bleeding (P = .004) favoring prasugrel. This supports low-dose prasugrel as a strategy to prevent the excess bleeding risk previously observed with the standard 10-mg dose of prasugrel.

In other words, a reduced dose of prasugrel, compared with the standard dose of ticagrelor, in low-weight and elderly patients “is associated with maintained anti-ischemic efficacy while protecting these patients against the excess risk of bleeding,” he and his coinvestigators concluded.

Low-weight and older patients represented 27% of those enrolled in ISAR-REACT 5. When compared to the study population as a whole, the risk for both ischemic and bleeding events was at least twice as high, the authors of an accompanying editorial observed. They praised this effort to refine the optimal antiplatelet regimen in a very-high-risk ACS population.

“The current analysis suggests that the prasugrel dose reduction regimen for elderly or underweight patients with ACS is effective and safe,” according to the editorial coauthors, David Conen, MD, and P.J. Devereaux, MD, PhD, who are affiliated with the Population Health Research Institute, Hamilton, Ontario.

This substudy was underpowered to show superiority for the efficacy and safety outcomes in elderly and low-weight ACS patients, which makes these results “hypothesis generating,” but the authors believe that they provide the best available evidence for selecting antiplatelet therapy in this challenging subgroup. Although the exclusion of patients at very high risk of bleeding from ISAR-REACT 5 suggest findings might not be relevant to all elderly and low-weight individuals, the investigators believe the data do inform clinical practice.

“Our study is the first head-to-head randomized comparison of the reduced dose of prasugrel against standard dose of ticagrelor in elderly and low-weight patients,” said Dr. Kastrati in an interview. “Specifically designed studies for this subset of patients are very unlikely to be conducted in the future.”

Dr. Kastrati reported no potential conflicts of interest relevant to this study.

SOURCE: Menichelli M et al. Ann Intern Med. 2020 Jul 21. doi: 10.7326/M20-1806.

In elderly or low-weight patients with acute coronary syndrome (ACS), a reduced dose of prasugrel relative to a full-dose of ticagrelor is associated with lower numerical rates of ischemic events and bleeding events, according to a prespecified substudy of the ISAR-REACT 5 trial.

“The present study provides the strongest support for reduced-dose prasugrel as the standard for elderly and low-weight patients with ACS undergoing an invasive treatment strategy,” according to the senior author, Adnan Kastrati, MD, professor of cardiology and head of the Catheterization Laboratory at Deutsches Herzzentrum, Technical University of Munich.

The main results of ISAR-REACT 5, an open-label, head-to-head comparison of prasugrel and ticagrelor in patients with ACS, showed that the risk of the composite primary endpoint of death, myocardial infarction, or stroke 1 year after randomization was significantly higher for those on ticagrelor than prasugrel (hazard ratio, 1.39; P = .006). The bleeding risk on ticagrelor was also higher but not significantly different (5.4% vs. 4.8%; P = .46) (Schüpke S et al. N Engl J Med. 2019 Oct;381:1524-34).

In this substudy newly published in Annals of Internal Medicine, outcomes were compared in the 1,099 patients who were 75 years or older or weighed less than 60 kg. In this group, unlike those younger or weighing more, patients were randomized to receive a reduced maintenance dose of 5 mg of once-daily prasugrel (rather than 10 mg) or full dose ticagrelor (90 mg twice daily).

At 1 year, the low-dose prasugrel strategy relative to ticagrelor was associated with a lower rate of events (12.7% vs. 14.6%) and a lower rate of bleeding (8.1% vs. 10.6%), defined as Bleeding Academic Research Consortium (BARC) type 3-5 events.

Neither the 18% reduction for the efficacy endpoint (HR, 0.82; 95% CI 0.60-1.14) nor the 28% reduction in the bleeding endpoint (HR, 0.72; 95% CI 0.46-1.12) reached significance, but Dr. Kastrati reported that there was a significant “treatment effect-by-study-group interaction” for BARC 1-5 bleeding (P = .004) favoring prasugrel. This supports low-dose prasugrel as a strategy to prevent the excess bleeding risk previously observed with the standard 10-mg dose of prasugrel.

In other words, a reduced dose of prasugrel, compared with the standard dose of ticagrelor, in low-weight and elderly patients “is associated with maintained anti-ischemic efficacy while protecting these patients against the excess risk of bleeding,” he and his coinvestigators concluded.

Low-weight and older patients represented 27% of those enrolled in ISAR-REACT 5. When compared to the study population as a whole, the risk for both ischemic and bleeding events was at least twice as high, the authors of an accompanying editorial observed. They praised this effort to refine the optimal antiplatelet regimen in a very-high-risk ACS population.

“The current analysis suggests that the prasugrel dose reduction regimen for elderly or underweight patients with ACS is effective and safe,” according to the editorial coauthors, David Conen, MD, and P.J. Devereaux, MD, PhD, who are affiliated with the Population Health Research Institute, Hamilton, Ontario.

This substudy was underpowered to show superiority for the efficacy and safety outcomes in elderly and low-weight ACS patients, which makes these results “hypothesis generating,” but the authors believe that they provide the best available evidence for selecting antiplatelet therapy in this challenging subgroup. Although the exclusion of patients at very high risk of bleeding from ISAR-REACT 5 suggest findings might not be relevant to all elderly and low-weight individuals, the investigators believe the data do inform clinical practice.

“Our study is the first head-to-head randomized comparison of the reduced dose of prasugrel against standard dose of ticagrelor in elderly and low-weight patients,” said Dr. Kastrati in an interview. “Specifically designed studies for this subset of patients are very unlikely to be conducted in the future.”

Dr. Kastrati reported no potential conflicts of interest relevant to this study.

SOURCE: Menichelli M et al. Ann Intern Med. 2020 Jul 21. doi: 10.7326/M20-1806.

In elderly or low-weight patients with acute coronary syndrome (ACS), a reduced dose of prasugrel relative to a full-dose of ticagrelor is associated with lower numerical rates of ischemic events and bleeding events, according to a prespecified substudy of the ISAR-REACT 5 trial.

“The present study provides the strongest support for reduced-dose prasugrel as the standard for elderly and low-weight patients with ACS undergoing an invasive treatment strategy,” according to the senior author, Adnan Kastrati, MD, professor of cardiology and head of the Catheterization Laboratory at Deutsches Herzzentrum, Technical University of Munich.

The main results of ISAR-REACT 5, an open-label, head-to-head comparison of prasugrel and ticagrelor in patients with ACS, showed that the risk of the composite primary endpoint of death, myocardial infarction, or stroke 1 year after randomization was significantly higher for those on ticagrelor than prasugrel (hazard ratio, 1.39; P = .006). The bleeding risk on ticagrelor was also higher but not significantly different (5.4% vs. 4.8%; P = .46) (Schüpke S et al. N Engl J Med. 2019 Oct;381:1524-34).

In this substudy newly published in Annals of Internal Medicine, outcomes were compared in the 1,099 patients who were 75 years or older or weighed less than 60 kg. In this group, unlike those younger or weighing more, patients were randomized to receive a reduced maintenance dose of 5 mg of once-daily prasugrel (rather than 10 mg) or full dose ticagrelor (90 mg twice daily).

At 1 year, the low-dose prasugrel strategy relative to ticagrelor was associated with a lower rate of events (12.7% vs. 14.6%) and a lower rate of bleeding (8.1% vs. 10.6%), defined as Bleeding Academic Research Consortium (BARC) type 3-5 events.

Neither the 18% reduction for the efficacy endpoint (HR, 0.82; 95% CI 0.60-1.14) nor the 28% reduction in the bleeding endpoint (HR, 0.72; 95% CI 0.46-1.12) reached significance, but Dr. Kastrati reported that there was a significant “treatment effect-by-study-group interaction” for BARC 1-5 bleeding (P = .004) favoring prasugrel. This supports low-dose prasugrel as a strategy to prevent the excess bleeding risk previously observed with the standard 10-mg dose of prasugrel.

In other words, a reduced dose of prasugrel, compared with the standard dose of ticagrelor, in low-weight and elderly patients “is associated with maintained anti-ischemic efficacy while protecting these patients against the excess risk of bleeding,” he and his coinvestigators concluded.

Low-weight and older patients represented 27% of those enrolled in ISAR-REACT 5. When compared to the study population as a whole, the risk for both ischemic and bleeding events was at least twice as high, the authors of an accompanying editorial observed. They praised this effort to refine the optimal antiplatelet regimen in a very-high-risk ACS population.

“The current analysis suggests that the prasugrel dose reduction regimen for elderly or underweight patients with ACS is effective and safe,” according to the editorial coauthors, David Conen, MD, and P.J. Devereaux, MD, PhD, who are affiliated with the Population Health Research Institute, Hamilton, Ontario.

This substudy was underpowered to show superiority for the efficacy and safety outcomes in elderly and low-weight ACS patients, which makes these results “hypothesis generating,” but the authors believe that they provide the best available evidence for selecting antiplatelet therapy in this challenging subgroup. Although the exclusion of patients at very high risk of bleeding from ISAR-REACT 5 suggest findings might not be relevant to all elderly and low-weight individuals, the investigators believe the data do inform clinical practice.

“Our study is the first head-to-head randomized comparison of the reduced dose of prasugrel against standard dose of ticagrelor in elderly and low-weight patients,” said Dr. Kastrati in an interview. “Specifically designed studies for this subset of patients are very unlikely to be conducted in the future.”

Dr. Kastrati reported no potential conflicts of interest relevant to this study.

SOURCE: Menichelli M et al. Ann Intern Med. 2020 Jul 21. doi: 10.7326/M20-1806.

The first order of business in the long-awaited, recently released Centers for Medicare & Medicaid Services (CMS) proposed national coverage decision (NCD) for transcatheter mitral valve repair (TMVR) was to get rid of its familiar moniker.

The document tosses the term TMVR in favor of transcatheter edge-to-edge repair (TEER) “to more precisely define the treatment addressed in this NCD” and differentiate it from other therapies that repair or replace the mitral valve.

(In an off-the-cuff Twitter poll launched right after the CMS document’s release, 80.3% of respondents answered that they “hate” the new acronym and the remainder said they “love” it; those two were the poll’s only choices.)

The NCD proposal goes on to say that CMS coverage of TEER would expand to include treatment of symptomatic moderate-to-severe or severe functional mitral regurgitation (MR) when used with maximally tolerated guideline-directed medical therapy.

The proposed NCD has been expected since March 2019 when the US Food and Drug Administration (FDA) approved the MitraClip (Abbott Vascular) for secondary functional MR. Medicare has covered MitraClip for primary degenerative MR since 2014.

Abbott announced in October 2019 that it would ramp up production of the MitraClip, which is currently the only FDA-approved TEER device.

Further specifications

Even as the new proposed NCD would add CMS coverage for functional MR, it would also decline a coverage statement for degenerative MR. Instead, it proposes to leave such coverage decisions to local Medical Administrative Contractors (MACs), given a relatively low incidence of clip intervention for degenerative MR. Less than 1% of the Medicare population undergo TEER of the mitral valve for that indication, the document says.

“The MACs are structured to be able to take into account local patient, physician, and institutional factors, which are especially important when overall prevalence is very low.”

The proposal also emphasizes that patients undergoing such covered TEER procedures be “under the care of a heart failure physician specialist experienced in the care and treatment of mitral valve disease,» with additional care provided by a heart team that includes a cardiac surgeon, interventional cardiologist, interventional echocardiographer.

The new document is generally consistent with a Consensus Statement from the American Association for Thoracic Surgery, the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons published in December 2019 and covered then by theheart.org / Medscape Cardiology.

In anticipation the CMS coverage proposal, the ACC earlier this year published a Focused Update of the 2017 Expert Consensus Decision Pathway on the Management of Mitral Regurgitation to reflect new evidence in the field, mainly the recent clinical trial data on functional MR from the MITRA-FR and COAPT trials.

“The proposed criteria are nicely guided by the multisociety consensus document, which sought to foster optimal patient outcomes while also maintaining access to TEER,” Sammy Elmariah, MD, MPH, from Massachusetts General Hospital in Boston, commented by email.

“These criteria, in conjunction with results of the COAPT trial, establish TEER as the standard of care for patients with symptomatic functional MR despite guideline-directed medical therapy who do not possess an alternative indication for cardiac surgery,” said Elmariah, a coauthor on both the Consensus Statement and the Focused Update.

The proposed NCD seems “reasonable,” cardiothoracic surgeon Michael J. Reardon, MD, Houston Methodist Hospital, said by email. But he thought there might be some objections to the requirement for TEER centers to have a surgery program with a minimum annual volume for mitral-valve surgeries.

The proposed NCD says a hospital must have “a surgical program that performs ≥25 total mitral valve surgical procedures for severe MR per year, of which at least 10 must be mitral valve repairs.”

“There is a very definite relationship between mitral valve surgery volume and surgical outcomes and between TEER volume and TEER outcomes, but no real relationship between mitral valve surgery volumes and TEER outcomes,” Reardon said. “A mitral valve surgery program is important, but how many cases do you need to be able to start and run a TEER program?”

Edwards Lifesciences is currently testing its own device for TEER: the PASCAL transcatheter mitral valve repair system. Early findings from the company’s ongoing CLASP IID trial, a head-to-head comparison of Pascal and MitraClip, are expected in December 2023.

CMS is seeking comments on the proposed national coverage determination, and will render a final decision within 60 days of the end of the 30-day public comment period.

Elmariah discloses receiving research grants from the American Heart Association, the National Institutes of Health, Edwards Lifesciences, Svelte Medical, and Medtronic, and consulting fees from AstraZeneca. Reardon recently reported no relevant conflicts of interest.

This article first appeared on Medscape.com.

The first order of business in the long-awaited, recently released Centers for Medicare & Medicaid Services (CMS) proposed national coverage decision (NCD) for transcatheter mitral valve repair (TMVR) was to get rid of its familiar moniker.

The document tosses the term TMVR in favor of transcatheter edge-to-edge repair (TEER) “to more precisely define the treatment addressed in this NCD” and differentiate it from other therapies that repair or replace the mitral valve.

(In an off-the-cuff Twitter poll launched right after the CMS document’s release, 80.3% of respondents answered that they “hate” the new acronym and the remainder said they “love” it; those two were the poll’s only choices.)

The NCD proposal goes on to say that CMS coverage of TEER would expand to include treatment of symptomatic moderate-to-severe or severe functional mitral regurgitation (MR) when used with maximally tolerated guideline-directed medical therapy.

The proposed NCD has been expected since March 2019 when the US Food and Drug Administration (FDA) approved the MitraClip (Abbott Vascular) for secondary functional MR. Medicare has covered MitraClip for primary degenerative MR since 2014.

Abbott announced in October 2019 that it would ramp up production of the MitraClip, which is currently the only FDA-approved TEER device.

Further specifications

Even as the new proposed NCD would add CMS coverage for functional MR, it would also decline a coverage statement for degenerative MR. Instead, it proposes to leave such coverage decisions to local Medical Administrative Contractors (MACs), given a relatively low incidence of clip intervention for degenerative MR. Less than 1% of the Medicare population undergo TEER of the mitral valve for that indication, the document says.

“The MACs are structured to be able to take into account local patient, physician, and institutional factors, which are especially important when overall prevalence is very low.”

The proposal also emphasizes that patients undergoing such covered TEER procedures be “under the care of a heart failure physician specialist experienced in the care and treatment of mitral valve disease,» with additional care provided by a heart team that includes a cardiac surgeon, interventional cardiologist, interventional echocardiographer.

The new document is generally consistent with a Consensus Statement from the American Association for Thoracic Surgery, the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons published in December 2019 and covered then by theheart.org / Medscape Cardiology.

In anticipation the CMS coverage proposal, the ACC earlier this year published a Focused Update of the 2017 Expert Consensus Decision Pathway on the Management of Mitral Regurgitation to reflect new evidence in the field, mainly the recent clinical trial data on functional MR from the MITRA-FR and COAPT trials.

“The proposed criteria are nicely guided by the multisociety consensus document, which sought to foster optimal patient outcomes while also maintaining access to TEER,” Sammy Elmariah, MD, MPH, from Massachusetts General Hospital in Boston, commented by email.

“These criteria, in conjunction with results of the COAPT trial, establish TEER as the standard of care for patients with symptomatic functional MR despite guideline-directed medical therapy who do not possess an alternative indication for cardiac surgery,” said Elmariah, a coauthor on both the Consensus Statement and the Focused Update.

The proposed NCD seems “reasonable,” cardiothoracic surgeon Michael J. Reardon, MD, Houston Methodist Hospital, said by email. But he thought there might be some objections to the requirement for TEER centers to have a surgery program with a minimum annual volume for mitral-valve surgeries.

The proposed NCD says a hospital must have “a surgical program that performs ≥25 total mitral valve surgical procedures for severe MR per year, of which at least 10 must be mitral valve repairs.”

“There is a very definite relationship between mitral valve surgery volume and surgical outcomes and between TEER volume and TEER outcomes, but no real relationship between mitral valve surgery volumes and TEER outcomes,” Reardon said. “A mitral valve surgery program is important, but how many cases do you need to be able to start and run a TEER program?”

Edwards Lifesciences is currently testing its own device for TEER: the PASCAL transcatheter mitral valve repair system. Early findings from the company’s ongoing CLASP IID trial, a head-to-head comparison of Pascal and MitraClip, are expected in December 2023.

CMS is seeking comments on the proposed national coverage determination, and will render a final decision within 60 days of the end of the 30-day public comment period.

Elmariah discloses receiving research grants from the American Heart Association, the National Institutes of Health, Edwards Lifesciences, Svelte Medical, and Medtronic, and consulting fees from AstraZeneca. Reardon recently reported no relevant conflicts of interest.

This article first appeared on Medscape.com.

The first order of business in the long-awaited, recently released Centers for Medicare & Medicaid Services (CMS) proposed national coverage decision (NCD) for transcatheter mitral valve repair (TMVR) was to get rid of its familiar moniker.

The document tosses the term TMVR in favor of transcatheter edge-to-edge repair (TEER) “to more precisely define the treatment addressed in this NCD” and differentiate it from other therapies that repair or replace the mitral valve.

(In an off-the-cuff Twitter poll launched right after the CMS document’s release, 80.3% of respondents answered that they “hate” the new acronym and the remainder said they “love” it; those two were the poll’s only choices.)

The NCD proposal goes on to say that CMS coverage of TEER would expand to include treatment of symptomatic moderate-to-severe or severe functional mitral regurgitation (MR) when used with maximally tolerated guideline-directed medical therapy.

The proposed NCD has been expected since March 2019 when the US Food and Drug Administration (FDA) approved the MitraClip (Abbott Vascular) for secondary functional MR. Medicare has covered MitraClip for primary degenerative MR since 2014.

Abbott announced in October 2019 that it would ramp up production of the MitraClip, which is currently the only FDA-approved TEER device.

Further specifications

Even as the new proposed NCD would add CMS coverage for functional MR, it would also decline a coverage statement for degenerative MR. Instead, it proposes to leave such coverage decisions to local Medical Administrative Contractors (MACs), given a relatively low incidence of clip intervention for degenerative MR. Less than 1% of the Medicare population undergo TEER of the mitral valve for that indication, the document says.

“The MACs are structured to be able to take into account local patient, physician, and institutional factors, which are especially important when overall prevalence is very low.”

The proposal also emphasizes that patients undergoing such covered TEER procedures be “under the care of a heart failure physician specialist experienced in the care and treatment of mitral valve disease,» with additional care provided by a heart team that includes a cardiac surgeon, interventional cardiologist, interventional echocardiographer.

The new document is generally consistent with a Consensus Statement from the American Association for Thoracic Surgery, the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons published in December 2019 and covered then by theheart.org / Medscape Cardiology.

In anticipation the CMS coverage proposal, the ACC earlier this year published a Focused Update of the 2017 Expert Consensus Decision Pathway on the Management of Mitral Regurgitation to reflect new evidence in the field, mainly the recent clinical trial data on functional MR from the MITRA-FR and COAPT trials.

“The proposed criteria are nicely guided by the multisociety consensus document, which sought to foster optimal patient outcomes while also maintaining access to TEER,” Sammy Elmariah, MD, MPH, from Massachusetts General Hospital in Boston, commented by email.

“These criteria, in conjunction with results of the COAPT trial, establish TEER as the standard of care for patients with symptomatic functional MR despite guideline-directed medical therapy who do not possess an alternative indication for cardiac surgery,” said Elmariah, a coauthor on both the Consensus Statement and the Focused Update.

The proposed NCD seems “reasonable,” cardiothoracic surgeon Michael J. Reardon, MD, Houston Methodist Hospital, said by email. But he thought there might be some objections to the requirement for TEER centers to have a surgery program with a minimum annual volume for mitral-valve surgeries.

The proposed NCD says a hospital must have “a surgical program that performs ≥25 total mitral valve surgical procedures for severe MR per year, of which at least 10 must be mitral valve repairs.”

“There is a very definite relationship between mitral valve surgery volume and surgical outcomes and between TEER volume and TEER outcomes, but no real relationship between mitral valve surgery volumes and TEER outcomes,” Reardon said. “A mitral valve surgery program is important, but how many cases do you need to be able to start and run a TEER program?”

Edwards Lifesciences is currently testing its own device for TEER: the PASCAL transcatheter mitral valve repair system. Early findings from the company’s ongoing CLASP IID trial, a head-to-head comparison of Pascal and MitraClip, are expected in December 2023.

CMS is seeking comments on the proposed national coverage determination, and will render a final decision within 60 days of the end of the 30-day public comment period.

Elmariah discloses receiving research grants from the American Heart Association, the National Institutes of Health, Edwards Lifesciences, Svelte Medical, and Medtronic, and consulting fees from AstraZeneca. Reardon recently reported no relevant conflicts of interest.

This article first appeared on Medscape.com.

The DynamX Bioadaptor – arguably the most original concept in coronary stent design to come along in 3 decades – demonstrated excellent safety and efficacy in a 12-month international, proof-of-concept study, Stefan Verheye, MD, said at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“There has been no fundamental change in stent design in over 30 years,” declared Dr. Verheye, codirector of the Antwerp (Belgium) Cardiovascular Center. “The DynamX Bioadaptor is a fundamental innovation in device design.”

The investigational device is a 71-mcm-thick, cobalt-chromium metal platform that elutes novolimus from a biodegradable polymer. Circumferential rings in low-stress sections of the device are held together by polymer connectors, and when the polymer erodes at about 6 months the stent segments are able to disengage from each other while maintaining longitudinal continuity. Dr. Verheye called this process “uncaging” the stented artery. The result is restoration of normal vessel angulation and compliance; the artery is no longer artificially straightened and constrained by a relatively stiff stent. Positive adaptive remodeling is preserved with enhanced vessel pulsatility and maintenance of lumenal area for good blood flow.

Dr. Verheye said the impetus for developing this outside-the-box novel stent platform lies in the recognition of a major unmet need for better drug-eluting stent (DES) performance. “Despite excellent acute outcomes, data with current-generation DES show long-term event rates are high and accrue at a rate of 2%-3% per year without a plateau.”

He was coprincipal investigator for the international study, which included 50 patients who received a DynamX Bioadaptor for a single de novo coronary artery lesion no more than 24 mm in length. The acute performance of the device was similar to that of second-generation DES, with a mean acute gain post procedure of 1.63 mm by quantitative coronary angiography and a mean late lumen loss of 0.12 mm when measured again at 9 or 12 months.

Intravascular ultrasound imaging showed a 3% increase in mean target vessel area and a 5% increase in the stented area from post procedure to 9 or 12 months’ follow-up, with no change in mean lumen area, all of which translates into maintenance of good blood flow over time. In contrast, what typically occurs following implantation of current DES is maintenance of target vessel and device areas, but with a loss in mean lumen area, the cardiologist noted.

There were two cardiac deaths but no cases of target lesion revascularization, device thrombosis, or strut fracture within 12 months of the procedure.

“The Bioadaptor performs similarly to second-generation DES in terms of implantation technique, deliverability, conformability, and radial strength during the healing phase, while showing the promise of mitigating the 2%-3% annualized event rate beyond 1 year,” Dr. Verheye concluded, adding, “Obviously, longer-term follow-up in comparative studies will be needed to show a reduction in the device-oriented events that have been observed with current DES.”

Session cochair Davide Capodanno, MD, PhD, of the University of Catania (Italy), declared: “This is an intriguing device because it’s metal, but it’s a kind of pulsatile metal after the biodegradation of the connectors. It’s something I’ve never seen.”

Discussant William Wijns, MD, PhD, said he was “thrilled” by the innovative aspect of the DynamX Bioadaptor, but he’s a long way from being persuaded that the device’s potential physiological advantages will translate into improved clinical outcomes relative to current DES.

“Don’t we all have a strange feeling of deja vu because all these anticipated benefits are the same as those we were told we would see with fully bioresorbable scaffolds? And we know so much after 10 years of experience with bioresorbable scaffolds that probably we will not accept this great story unless we get more and more evidence,” cautioned Dr. Wijns, professor of interventional cardiology at the National University of Ireland, Galway, and chairman of EuroPCR.

The claim regarding bioresorbable scaffolds was that, even though the acute results weren’t as good as with DES, that disadvantage would be outweighed by superior long-term clinical outcomes. But in fact the long-term outcomes turned out to be worse as well.

“We had to give up immediate results with the bioresorbable scaffolds. I don’t think we want to go that route again this time,” the cardiologist said.

Thus, the first thing that’s needed in order to make a convincing case for the Bioadaptor is evidence from a large, randomized, comparative trial demonstrating that the acute performance of the novel device is noninferior to that of current DES, including data on complex lesions. Such a study was supposed to be underway now but has been delayed by the COVID-19 pandemic, he noted.

Once there is evidence that the acute results with the Bioadaptor are truly comparable with those achieved with current DES, there will be a need for long-term data showing that the device reduces the 2%-3% annualized event rate seen with DES beyond 1 year, Dr. Wijns added.

Dr. Verheye reported receiving consultation fees from study sponsor Elixir Medical as well as from Biotronik. Dr. Wijns reported receiving research grants from MicroPort.

[email protected]

The DynamX Bioadaptor – arguably the most original concept in coronary stent design to come along in 3 decades – demonstrated excellent safety and efficacy in a 12-month international, proof-of-concept study, Stefan Verheye, MD, said at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“There has been no fundamental change in stent design in over 30 years,” declared Dr. Verheye, codirector of the Antwerp (Belgium) Cardiovascular Center. “The DynamX Bioadaptor is a fundamental innovation in device design.”

The investigational device is a 71-mcm-thick, cobalt-chromium metal platform that elutes novolimus from a biodegradable polymer. Circumferential rings in low-stress sections of the device are held together by polymer connectors, and when the polymer erodes at about 6 months the stent segments are able to disengage from each other while maintaining longitudinal continuity. Dr. Verheye called this process “uncaging” the stented artery. The result is restoration of normal vessel angulation and compliance; the artery is no longer artificially straightened and constrained by a relatively stiff stent. Positive adaptive remodeling is preserved with enhanced vessel pulsatility and maintenance of lumenal area for good blood flow.

Dr. Verheye said the impetus for developing this outside-the-box novel stent platform lies in the recognition of a major unmet need for better drug-eluting stent (DES) performance. “Despite excellent acute outcomes, data with current-generation DES show long-term event rates are high and accrue at a rate of 2%-3% per year without a plateau.”

He was coprincipal investigator for the international study, which included 50 patients who received a DynamX Bioadaptor for a single de novo coronary artery lesion no more than 24 mm in length. The acute performance of the device was similar to that of second-generation DES, with a mean acute gain post procedure of 1.63 mm by quantitative coronary angiography and a mean late lumen loss of 0.12 mm when measured again at 9 or 12 months.

Intravascular ultrasound imaging showed a 3% increase in mean target vessel area and a 5% increase in the stented area from post procedure to 9 or 12 months’ follow-up, with no change in mean lumen area, all of which translates into maintenance of good blood flow over time. In contrast, what typically occurs following implantation of current DES is maintenance of target vessel and device areas, but with a loss in mean lumen area, the cardiologist noted.

There were two cardiac deaths but no cases of target lesion revascularization, device thrombosis, or strut fracture within 12 months of the procedure.

“The Bioadaptor performs similarly to second-generation DES in terms of implantation technique, deliverability, conformability, and radial strength during the healing phase, while showing the promise of mitigating the 2%-3% annualized event rate beyond 1 year,” Dr. Verheye concluded, adding, “Obviously, longer-term follow-up in comparative studies will be needed to show a reduction in the device-oriented events that have been observed with current DES.”

Session cochair Davide Capodanno, MD, PhD, of the University of Catania (Italy), declared: “This is an intriguing device because it’s metal, but it’s a kind of pulsatile metal after the biodegradation of the connectors. It’s something I’ve never seen.”

Discussant William Wijns, MD, PhD, said he was “thrilled” by the innovative aspect of the DynamX Bioadaptor, but he’s a long way from being persuaded that the device’s potential physiological advantages will translate into improved clinical outcomes relative to current DES.

“Don’t we all have a strange feeling of deja vu because all these anticipated benefits are the same as those we were told we would see with fully bioresorbable scaffolds? And we know so much after 10 years of experience with bioresorbable scaffolds that probably we will not accept this great story unless we get more and more evidence,” cautioned Dr. Wijns, professor of interventional cardiology at the National University of Ireland, Galway, and chairman of EuroPCR.

The claim regarding bioresorbable scaffolds was that, even though the acute results weren’t as good as with DES, that disadvantage would be outweighed by superior long-term clinical outcomes. But in fact the long-term outcomes turned out to be worse as well.

“We had to give up immediate results with the bioresorbable scaffolds. I don’t think we want to go that route again this time,” the cardiologist said.

Thus, the first thing that’s needed in order to make a convincing case for the Bioadaptor is evidence from a large, randomized, comparative trial demonstrating that the acute performance of the novel device is noninferior to that of current DES, including data on complex lesions. Such a study was supposed to be underway now but has been delayed by the COVID-19 pandemic, he noted.

Once there is evidence that the acute results with the Bioadaptor are truly comparable with those achieved with current DES, there will be a need for long-term data showing that the device reduces the 2%-3% annualized event rate seen with DES beyond 1 year, Dr. Wijns added.

Dr. Verheye reported receiving consultation fees from study sponsor Elixir Medical as well as from Biotronik. Dr. Wijns reported receiving research grants from MicroPort.

[email protected]

The DynamX Bioadaptor – arguably the most original concept in coronary stent design to come along in 3 decades – demonstrated excellent safety and efficacy in a 12-month international, proof-of-concept study, Stefan Verheye, MD, said at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“There has been no fundamental change in stent design in over 30 years,” declared Dr. Verheye, codirector of the Antwerp (Belgium) Cardiovascular Center. “The DynamX Bioadaptor is a fundamental innovation in device design.”

The investigational device is a 71-mcm-thick, cobalt-chromium metal platform that elutes novolimus from a biodegradable polymer. Circumferential rings in low-stress sections of the device are held together by polymer connectors, and when the polymer erodes at about 6 months the stent segments are able to disengage from each other while maintaining longitudinal continuity. Dr. Verheye called this process “uncaging” the stented artery. The result is restoration of normal vessel angulation and compliance; the artery is no longer artificially straightened and constrained by a relatively stiff stent. Positive adaptive remodeling is preserved with enhanced vessel pulsatility and maintenance of lumenal area for good blood flow.

Dr. Verheye said the impetus for developing this outside-the-box novel stent platform lies in the recognition of a major unmet need for better drug-eluting stent (DES) performance. “Despite excellent acute outcomes, data with current-generation DES show long-term event rates are high and accrue at a rate of 2%-3% per year without a plateau.”

He was coprincipal investigator for the international study, which included 50 patients who received a DynamX Bioadaptor for a single de novo coronary artery lesion no more than 24 mm in length. The acute performance of the device was similar to that of second-generation DES, with a mean acute gain post procedure of 1.63 mm by quantitative coronary angiography and a mean late lumen loss of 0.12 mm when measured again at 9 or 12 months.

Intravascular ultrasound imaging showed a 3% increase in mean target vessel area and a 5% increase in the stented area from post procedure to 9 or 12 months’ follow-up, with no change in mean lumen area, all of which translates into maintenance of good blood flow over time. In contrast, what typically occurs following implantation of current DES is maintenance of target vessel and device areas, but with a loss in mean lumen area, the cardiologist noted.

There were two cardiac deaths but no cases of target lesion revascularization, device thrombosis, or strut fracture within 12 months of the procedure.

“The Bioadaptor performs similarly to second-generation DES in terms of implantation technique, deliverability, conformability, and radial strength during the healing phase, while showing the promise of mitigating the 2%-3% annualized event rate beyond 1 year,” Dr. Verheye concluded, adding, “Obviously, longer-term follow-up in comparative studies will be needed to show a reduction in the device-oriented events that have been observed with current DES.”

Session cochair Davide Capodanno, MD, PhD, of the University of Catania (Italy), declared: “This is an intriguing device because it’s metal, but it’s a kind of pulsatile metal after the biodegradation of the connectors. It’s something I’ve never seen.”

Discussant William Wijns, MD, PhD, said he was “thrilled” by the innovative aspect of the DynamX Bioadaptor, but he’s a long way from being persuaded that the device’s potential physiological advantages will translate into improved clinical outcomes relative to current DES.

“Don’t we all have a strange feeling of deja vu because all these anticipated benefits are the same as those we were told we would see with fully bioresorbable scaffolds? And we know so much after 10 years of experience with bioresorbable scaffolds that probably we will not accept this great story unless we get more and more evidence,” cautioned Dr. Wijns, professor of interventional cardiology at the National University of Ireland, Galway, and chairman of EuroPCR.

The claim regarding bioresorbable scaffolds was that, even though the acute results weren’t as good as with DES, that disadvantage would be outweighed by superior long-term clinical outcomes. But in fact the long-term outcomes turned out to be worse as well.

“We had to give up immediate results with the bioresorbable scaffolds. I don’t think we want to go that route again this time,” the cardiologist said.

Thus, the first thing that’s needed in order to make a convincing case for the Bioadaptor is evidence from a large, randomized, comparative trial demonstrating that the acute performance of the novel device is noninferior to that of current DES, including data on complex lesions. Such a study was supposed to be underway now but has been delayed by the COVID-19 pandemic, he noted.

Once there is evidence that the acute results with the Bioadaptor are truly comparable with those achieved with current DES, there will be a need for long-term data showing that the device reduces the 2%-3% annualized event rate seen with DES beyond 1 year, Dr. Wijns added.

Dr. Verheye reported receiving consultation fees from study sponsor Elixir Medical as well as from Biotronik. Dr. Wijns reported receiving research grants from MicroPort.

[email protected]

With a median follow-up of 10 years after coronary artery bypass grafting (CABG), patients who received a radial artery graft rather than a saphenous vein graft as a second conduit were less likely to experience death, MI, or repeat revascularization, according to pooled data from five randomized trials.

The same result from the same set of data was produced after a median of 5 years, but the longer follow-up provides a more compelling case for the superiority of the radial artery graft, according to the authors of this meta-analysis, led by Mario F.L. Gaudino, MD, professor of cardiothoracic surgery at Weill Cornell Medicine, New York.

For the primary composite endpoint of death, MI, or repeat revascularization, the favorable hazard ratio at 5 years corresponded to a 33% risk reduction (HR, 0.67; P = .01), according to the previously published results (Gaudino M et al. N Engl J Med. 2018;378:2069-77).

The new data at 10 years show about the same risk reduction for the primary endpoint, but with more robust statistical significance (HR, 0.73; P < .001).

More importantly, because of the greater number of events by 10 years, the advantage of radial artery graft for the secondary composite outcome of death or MI has now reached statistical significance (HR, 0.77; P = .01).

In addition, there was a 27% reduction in risk of all-cause mortality (HR, 0.73; 95% confidence interval, 0.57-0.93) at 10 years associated with the radial artery graft. But this was not a prespecified endpoint, and so this is a hypothesis-generating post hoc finding.

The data was drawn from five randomized trials with a total of 1,036 patients. When used as an additional conduit to an internal thoracic artery in CABG, radial artery grafts relative to saphenous vein grafts were associated with a lower but nonsignificant risk of adverse outcomes in all five trials.

The advantage of radial artery grafts in the meta-analysis at 5 and now 10 years supports a series of observational studies that have also claimed better results with radial artery grafts.

The analysis was published July 14 in JAMA with essentially the same outcomes reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation in March.

However, a editorial that accompanied this meta-analysis in JAMA raised fundamental questions about revascularization.

“Intuitively, high-severity coronary lesions with significant ischemic burden, poor collateralization, and significant myocardium at risk may benefit from a durable revascularization option,” observed the editorial coauthors, Steven E. Nissen, MD, and Faisal G. Bakaeen, MD, both of the Cleveland Clinic. However, they cautioned that there is no definitive evidence that “any revascularization procedure reduces cardiovascular morbidity or mortality in patients with anatomically and physiologically stable coronary artery disease.”

They called the 10-year outcomes from the meta-analysis “the best available long-term data on the potential value of using the radial artery as a bypass conduit,” but warned that no randomized trial has confirmed that two or more conduits are superior to a single internal thoracic artery in CABG to for preventing death and major adverse cardiovascular events.

Such a trial, called ROMA, is now underway (Eur J Cardiothorac Surg. 2017;52:1031-40), but results are not expected until 2025.

In the meantime, placement of second conduits remains common in CABG procedures, about 400,000 of which are performed each year in the United States. According to Dr. Gaudino, there are indications and contraindications for second conduits, but radial artery should be the preferred standard when these are considered.

“Our data indicate that the radial artery graft should be used to complement the left internal thoracic artery in all patients who meet the indications for radial artery grafts,” he explained in an interview.

“Unfortunately, at the moment radial artery grafts are used in less than 10% of CABG cases in the U.S.,” he reported. “Hopefully, our data will lead to a larger use of this conduit by the surgical community.”

Dr. Gaudino, the principal investigator, reported no potential conflicts of interest relevant to this study.

SOURCE: Gaudino MFL et al. JAMA. 2020;324:179-87.

With a median follow-up of 10 years after coronary artery bypass grafting (CABG), patients who received a radial artery graft rather than a saphenous vein graft as a second conduit were less likely to experience death, MI, or repeat revascularization, according to pooled data from five randomized trials.

The same result from the same set of data was produced after a median of 5 years, but the longer follow-up provides a more compelling case for the superiority of the radial artery graft, according to the authors of this meta-analysis, led by Mario F.L. Gaudino, MD, professor of cardiothoracic surgery at Weill Cornell Medicine, New York.

For the primary composite endpoint of death, MI, or repeat revascularization, the favorable hazard ratio at 5 years corresponded to a 33% risk reduction (HR, 0.67; P = .01), according to the previously published results (Gaudino M et al. N Engl J Med. 2018;378:2069-77).

The new data at 10 years show about the same risk reduction for the primary endpoint, but with more robust statistical significance (HR, 0.73; P < .001).

More importantly, because of the greater number of events by 10 years, the advantage of radial artery graft for the secondary composite outcome of death or MI has now reached statistical significance (HR, 0.77; P = .01).

In addition, there was a 27% reduction in risk of all-cause mortality (HR, 0.73; 95% confidence interval, 0.57-0.93) at 10 years associated with the radial artery graft. But this was not a prespecified endpoint, and so this is a hypothesis-generating post hoc finding.

The data was drawn from five randomized trials with a total of 1,036 patients. When used as an additional conduit to an internal thoracic artery in CABG, radial artery grafts relative to saphenous vein grafts were associated with a lower but nonsignificant risk of adverse outcomes in all five trials.

The advantage of radial artery grafts in the meta-analysis at 5 and now 10 years supports a series of observational studies that have also claimed better results with radial artery grafts.

The analysis was published July 14 in JAMA with essentially the same outcomes reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation in March.

However, a editorial that accompanied this meta-analysis in JAMA raised fundamental questions about revascularization.

“Intuitively, high-severity coronary lesions with significant ischemic burden, poor collateralization, and significant myocardium at risk may benefit from a durable revascularization option,” observed the editorial coauthors, Steven E. Nissen, MD, and Faisal G. Bakaeen, MD, both of the Cleveland Clinic. However, they cautioned that there is no definitive evidence that “any revascularization procedure reduces cardiovascular morbidity or mortality in patients with anatomically and physiologically stable coronary artery disease.”

They called the 10-year outcomes from the meta-analysis “the best available long-term data on the potential value of using the radial artery as a bypass conduit,” but warned that no randomized trial has confirmed that two or more conduits are superior to a single internal thoracic artery in CABG to for preventing death and major adverse cardiovascular events.

Such a trial, called ROMA, is now underway (Eur J Cardiothorac Surg. 2017;52:1031-40), but results are not expected until 2025.

In the meantime, placement of second conduits remains common in CABG procedures, about 400,000 of which are performed each year in the United States. According to Dr. Gaudino, there are indications and contraindications for second conduits, but radial artery should be the preferred standard when these are considered.

“Our data indicate that the radial artery graft should be used to complement the left internal thoracic artery in all patients who meet the indications for radial artery grafts,” he explained in an interview.

“Unfortunately, at the moment radial artery grafts are used in less than 10% of CABG cases in the U.S.,” he reported. “Hopefully, our data will lead to a larger use of this conduit by the surgical community.”

Dr. Gaudino, the principal investigator, reported no potential conflicts of interest relevant to this study.

SOURCE: Gaudino MFL et al. JAMA. 2020;324:179-87.

With a median follow-up of 10 years after coronary artery bypass grafting (CABG), patients who received a radial artery graft rather than a saphenous vein graft as a second conduit were less likely to experience death, MI, or repeat revascularization, according to pooled data from five randomized trials.

The same result from the same set of data was produced after a median of 5 years, but the longer follow-up provides a more compelling case for the superiority of the radial artery graft, according to the authors of this meta-analysis, led by Mario F.L. Gaudino, MD, professor of cardiothoracic surgery at Weill Cornell Medicine, New York.

For the primary composite endpoint of death, MI, or repeat revascularization, the favorable hazard ratio at 5 years corresponded to a 33% risk reduction (HR, 0.67; P = .01), according to the previously published results (Gaudino M et al. N Engl J Med. 2018;378:2069-77).

The new data at 10 years show about the same risk reduction for the primary endpoint, but with more robust statistical significance (HR, 0.73; P < .001).

More importantly, because of the greater number of events by 10 years, the advantage of radial artery graft for the secondary composite outcome of death or MI has now reached statistical significance (HR, 0.77; P = .01).

In addition, there was a 27% reduction in risk of all-cause mortality (HR, 0.73; 95% confidence interval, 0.57-0.93) at 10 years associated with the radial artery graft. But this was not a prespecified endpoint, and so this is a hypothesis-generating post hoc finding.

The data was drawn from five randomized trials with a total of 1,036 patients. When used as an additional conduit to an internal thoracic artery in CABG, radial artery grafts relative to saphenous vein grafts were associated with a lower but nonsignificant risk of adverse outcomes in all five trials.

The advantage of radial artery grafts in the meta-analysis at 5 and now 10 years supports a series of observational studies that have also claimed better results with radial artery grafts.

The analysis was published July 14 in JAMA with essentially the same outcomes reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation in March.

However, a editorial that accompanied this meta-analysis in JAMA raised fundamental questions about revascularization.

“Intuitively, high-severity coronary lesions with significant ischemic burden, poor collateralization, and significant myocardium at risk may benefit from a durable revascularization option,” observed the editorial coauthors, Steven E. Nissen, MD, and Faisal G. Bakaeen, MD, both of the Cleveland Clinic. However, they cautioned that there is no definitive evidence that “any revascularization procedure reduces cardiovascular morbidity or mortality in patients with anatomically and physiologically stable coronary artery disease.”

They called the 10-year outcomes from the meta-analysis “the best available long-term data on the potential value of using the radial artery as a bypass conduit,” but warned that no randomized trial has confirmed that two or more conduits are superior to a single internal thoracic artery in CABG to for preventing death and major adverse cardiovascular events.

Such a trial, called ROMA, is now underway (Eur J Cardiothorac Surg. 2017;52:1031-40), but results are not expected until 2025.

In the meantime, placement of second conduits remains common in CABG procedures, about 400,000 of which are performed each year in the United States. According to Dr. Gaudino, there are indications and contraindications for second conduits, but radial artery should be the preferred standard when these are considered.

“Our data indicate that the radial artery graft should be used to complement the left internal thoracic artery in all patients who meet the indications for radial artery grafts,” he explained in an interview.

“Unfortunately, at the moment radial artery grafts are used in less than 10% of CABG cases in the U.S.,” he reported. “Hopefully, our data will lead to a larger use of this conduit by the surgical community.”

Dr. Gaudino, the principal investigator, reported no potential conflicts of interest relevant to this study.

SOURCE: Gaudino MFL et al. JAMA. 2020;324:179-87.