Interventional Cardiology & Surgery

Left-handed cardiology trainees face unique challenges when it comes to learning how to perform common procedures, according to a new report.

About 10% of the world’s population is left-handed, and rates of left-handedness among medical students and practicing physicians is believed to be similar.

“Extrapolating this to 3,017 active general cardiovascular fellowship positions and 339 interventional cardiology fellowship positions for the year 2018-2019, it is estimated there are more than 300 LH [left-handed] trainees in U.S. cardiovascular fellowship programs at any given time. Despite this, any standard clinical setting is designed to be convenient for RH [right-handed] providers, thereby creating a variable amount of impediment for LH trainees,” wrote Prashant Patel, MD, and Mandira Patel, DO, from University of California, Riverside.

“With about 10% prevalence, left-handedness is far more common, including among cardiology trainees, than most people realize. Most of the procedural set-up is designed for the right-hand majority, and it may cause a variable amount of impediment for the left-handed trainees. It is very important for the academic cardiology community to recognize this,” Dr. Prashant Patel said in an interview.

The findings were published in the Jan.5 issue of the Journal of the American College of Cardiology.

Dr. Prashant Patel, who is left-handed, said he was prompted to look into the issue because of his own experience.

“In my first procedural rotation several years ago, I noticed that I was positioning myself somewhat differently than my attendings due to my preference for using my left hand for fine motor control,” he said. “I started looking up existing literature to see what other left-handed cardiologists have done in the past, but realized that nothing along this line was published.

“I started discussions with my colleagues and superiors and found that our small cardiology fellowship program contains about 20%-40% of left-handed trainees at any given time, and we felt it was important to elaborate on this,” he added.

Practice makes perfect, and repeated practice eventually leads to automation of motor procedures, but the learning curve may be more protracted for left-handed trainees. “Acquisition of procedural skills is a function of time and repetition. Eventually, most practicing left-handed cardiologists see that as a nonissue and do not even realize they may have gone through a differential learning curve based on their hand dominance,” Dr. Prashant Patel noted.

“South-paw” cardiology trainees face their first challenge in the examination room.

Physicians typically examine patients from the right-hand side of the bed. The majority of clinic offices are set up for the right-handed provider, with the examining table placed with the head of the bed distal from the door and the left side of the bed aligned in close proximity to the wall, leaving examination on the right side of the patient as the only option. In the hospital setting, monitors and intravenous poles are usually placed on the patient’s left-hand side of the bed.

“This practice, more than anything else, is born out of tradition. The same clinical examination can potentially be performed with the same accuracy and efficacy from the left-hand side,” said Dr. Prashant Patel.

In the echocardiography lab, some facilities perform transthoracic echocardiography from the right side of the patient, thereby requiring the operator to get the right scanning hand over and across the patient.

“This is ergonomically disadvantageous, as one has to sit on the table, reach over the patient, and twist the torso. Scanning from the left side of the patient is ergonomically superior in preventing back injuries and may be advantageous for the left-handed person as the probe is held in the dominant hand,” noted Dr. Prashant Patel.

In the cath lab, the difficulty for left-handed cardiologists starts with establishing arterial or venous access.

“The two most frequently used arterial-access sites are right radial and right femoral. Both of them pose unique challenges in terms of positioning for most left-handed trainees in the early part of their training. The right arm is kept adducted and externally rotated in a standard setup, which is difficult to access for a left-handed operator, and would require the operator to use their nondominant right hand awkwardly to gain access,” he said.

A solution could be to reposition the patient’s arm using a radial board into abduction of the arm at about 45 degrees, with external rotation.

“This creates room for the left-handed operator to stand caudal to the patient’s arm and approach the radial access site conveniently using their dominant hand,” Dr. Prashant Patel suggested.

For the femoral approach, the left-handed operator could stand left of the patient and either get left femoral access or reach out across to the right groin of the patient and obtain access in this manner, or alternatively, the operator could resort to using their right hand to gain right femoral access.

“The large size of the femoral vessels allows even the strongly left-handed operators to get accustomed to using their nondominant hand with practice. This may be preferable to switching to the left side,” he said.

There are also some advantages to being left-handed, Dr. Prashant Patel said.

This is true “especially in the cath lab, for example, establishing antegrade right femoral access for peripheral interventions,” he noted. “Having a left-handed operator can also come in handy when two operators need to simultaneously and quickly work on both groins, as is often the case in complex coronary or structural interventions. Left-handed operators are also at ease obtaining left radial access, which has been shown to have certain advantages over right radial access.”

“We hope to raise awareness among the academic cardiology community about left-handedness,” Dr. Prashant Patel added. “We hope that acknowledgment, support, and minor modifications in work flow will allow a lot of young trainees in the early part of their career to stay on course and realize their full potential in this procedural specialty.”
 

An insightful paper

“This paper by Dr. Prashant Patel and Dr. Mandira Patel is most insightful about the unique challenges and occasional opportunities for the left-handed cardiologist,” wrote Simon Kendall, MBBS, president of the Society for Cardiothoracic Surgery Great Britain and Ireland, London, in an accompanying response.

“As a left-handed cardiac surgeon, I am embarrassed not to have considered such significant issues for my cardiology colleagues: the edict of examining a patient from the right side, performing echocardiography with the right hand, and the complex arena of catheter laboratory that is designed around the right-handed majority. Before reading this paper, I had not appreciated that for my whole career I have had to use my less-favored right hand when inserting a balloon pump,” Dr. Kendall wrote.

“Dr. Patel and Dr. Patel have written very sensible conclusions, such as that left-handedness should be acknowledged and adapted for and the training environment has to help access the specific tips and tricks from others, as shared in cardiac surgery, for instance. They rightly describe this as not a binary phenomenon and that there is a spectrum of laterality, so that some left-handers will adapt with ease and others will need more time and patience to learn the necessary skills,” he wrote. “We are fortunate to live in an era of increasing awareness and tolerance. Left-handedness is one small example of such progress.”

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

Left-handed cardiology trainees face unique challenges when it comes to learning how to perform common procedures, according to a new report.

About 10% of the world’s population is left-handed, and rates of left-handedness among medical students and practicing physicians is believed to be similar.

“Extrapolating this to 3,017 active general cardiovascular fellowship positions and 339 interventional cardiology fellowship positions for the year 2018-2019, it is estimated there are more than 300 LH [left-handed] trainees in U.S. cardiovascular fellowship programs at any given time. Despite this, any standard clinical setting is designed to be convenient for RH [right-handed] providers, thereby creating a variable amount of impediment for LH trainees,” wrote Prashant Patel, MD, and Mandira Patel, DO, from University of California, Riverside.

“With about 10% prevalence, left-handedness is far more common, including among cardiology trainees, than most people realize. Most of the procedural set-up is designed for the right-hand majority, and it may cause a variable amount of impediment for the left-handed trainees. It is very important for the academic cardiology community to recognize this,” Dr. Prashant Patel said in an interview.

The findings were published in the Jan.5 issue of the Journal of the American College of Cardiology.

Dr. Prashant Patel, who is left-handed, said he was prompted to look into the issue because of his own experience.

“In my first procedural rotation several years ago, I noticed that I was positioning myself somewhat differently than my attendings due to my preference for using my left hand for fine motor control,” he said. “I started looking up existing literature to see what other left-handed cardiologists have done in the past, but realized that nothing along this line was published.

“I started discussions with my colleagues and superiors and found that our small cardiology fellowship program contains about 20%-40% of left-handed trainees at any given time, and we felt it was important to elaborate on this,” he added.

Practice makes perfect, and repeated practice eventually leads to automation of motor procedures, but the learning curve may be more protracted for left-handed trainees. “Acquisition of procedural skills is a function of time and repetition. Eventually, most practicing left-handed cardiologists see that as a nonissue and do not even realize they may have gone through a differential learning curve based on their hand dominance,” Dr. Prashant Patel noted.

“South-paw” cardiology trainees face their first challenge in the examination room.

Physicians typically examine patients from the right-hand side of the bed. The majority of clinic offices are set up for the right-handed provider, with the examining table placed with the head of the bed distal from the door and the left side of the bed aligned in close proximity to the wall, leaving examination on the right side of the patient as the only option. In the hospital setting, monitors and intravenous poles are usually placed on the patient’s left-hand side of the bed.

“This practice, more than anything else, is born out of tradition. The same clinical examination can potentially be performed with the same accuracy and efficacy from the left-hand side,” said Dr. Prashant Patel.

In the echocardiography lab, some facilities perform transthoracic echocardiography from the right side of the patient, thereby requiring the operator to get the right scanning hand over and across the patient.

“This is ergonomically disadvantageous, as one has to sit on the table, reach over the patient, and twist the torso. Scanning from the left side of the patient is ergonomically superior in preventing back injuries and may be advantageous for the left-handed person as the probe is held in the dominant hand,” noted Dr. Prashant Patel.

In the cath lab, the difficulty for left-handed cardiologists starts with establishing arterial or venous access.

“The two most frequently used arterial-access sites are right radial and right femoral. Both of them pose unique challenges in terms of positioning for most left-handed trainees in the early part of their training. The right arm is kept adducted and externally rotated in a standard setup, which is difficult to access for a left-handed operator, and would require the operator to use their nondominant right hand awkwardly to gain access,” he said.

A solution could be to reposition the patient’s arm using a radial board into abduction of the arm at about 45 degrees, with external rotation.

“This creates room for the left-handed operator to stand caudal to the patient’s arm and approach the radial access site conveniently using their dominant hand,” Dr. Prashant Patel suggested.

For the femoral approach, the left-handed operator could stand left of the patient and either get left femoral access or reach out across to the right groin of the patient and obtain access in this manner, or alternatively, the operator could resort to using their right hand to gain right femoral access.

“The large size of the femoral vessels allows even the strongly left-handed operators to get accustomed to using their nondominant hand with practice. This may be preferable to switching to the left side,” he said.

There are also some advantages to being left-handed, Dr. Prashant Patel said.

This is true “especially in the cath lab, for example, establishing antegrade right femoral access for peripheral interventions,” he noted. “Having a left-handed operator can also come in handy when two operators need to simultaneously and quickly work on both groins, as is often the case in complex coronary or structural interventions. Left-handed operators are also at ease obtaining left radial access, which has been shown to have certain advantages over right radial access.”

“We hope to raise awareness among the academic cardiology community about left-handedness,” Dr. Prashant Patel added. “We hope that acknowledgment, support, and minor modifications in work flow will allow a lot of young trainees in the early part of their career to stay on course and realize their full potential in this procedural specialty.”
 

An insightful paper

“This paper by Dr. Prashant Patel and Dr. Mandira Patel is most insightful about the unique challenges and occasional opportunities for the left-handed cardiologist,” wrote Simon Kendall, MBBS, president of the Society for Cardiothoracic Surgery Great Britain and Ireland, London, in an accompanying response.

“As a left-handed cardiac surgeon, I am embarrassed not to have considered such significant issues for my cardiology colleagues: the edict of examining a patient from the right side, performing echocardiography with the right hand, and the complex arena of catheter laboratory that is designed around the right-handed majority. Before reading this paper, I had not appreciated that for my whole career I have had to use my less-favored right hand when inserting a balloon pump,” Dr. Kendall wrote.

“Dr. Patel and Dr. Patel have written very sensible conclusions, such as that left-handedness should be acknowledged and adapted for and the training environment has to help access the specific tips and tricks from others, as shared in cardiac surgery, for instance. They rightly describe this as not a binary phenomenon and that there is a spectrum of laterality, so that some left-handers will adapt with ease and others will need more time and patience to learn the necessary skills,” he wrote. “We are fortunate to live in an era of increasing awareness and tolerance. Left-handedness is one small example of such progress.”

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

Left-handed cardiology trainees face unique challenges when it comes to learning how to perform common procedures, according to a new report.

About 10% of the world’s population is left-handed, and rates of left-handedness among medical students and practicing physicians is believed to be similar.

“Extrapolating this to 3,017 active general cardiovascular fellowship positions and 339 interventional cardiology fellowship positions for the year 2018-2019, it is estimated there are more than 300 LH [left-handed] trainees in U.S. cardiovascular fellowship programs at any given time. Despite this, any standard clinical setting is designed to be convenient for RH [right-handed] providers, thereby creating a variable amount of impediment for LH trainees,” wrote Prashant Patel, MD, and Mandira Patel, DO, from University of California, Riverside.

“With about 10% prevalence, left-handedness is far more common, including among cardiology trainees, than most people realize. Most of the procedural set-up is designed for the right-hand majority, and it may cause a variable amount of impediment for the left-handed trainees. It is very important for the academic cardiology community to recognize this,” Dr. Prashant Patel said in an interview.

The findings were published in the Jan.5 issue of the Journal of the American College of Cardiology.

Dr. Prashant Patel, who is left-handed, said he was prompted to look into the issue because of his own experience.

“In my first procedural rotation several years ago, I noticed that I was positioning myself somewhat differently than my attendings due to my preference for using my left hand for fine motor control,” he said. “I started looking up existing literature to see what other left-handed cardiologists have done in the past, but realized that nothing along this line was published.

“I started discussions with my colleagues and superiors and found that our small cardiology fellowship program contains about 20%-40% of left-handed trainees at any given time, and we felt it was important to elaborate on this,” he added.

Practice makes perfect, and repeated practice eventually leads to automation of motor procedures, but the learning curve may be more protracted for left-handed trainees. “Acquisition of procedural skills is a function of time and repetition. Eventually, most practicing left-handed cardiologists see that as a nonissue and do not even realize they may have gone through a differential learning curve based on their hand dominance,” Dr. Prashant Patel noted.

“South-paw” cardiology trainees face their first challenge in the examination room.

Physicians typically examine patients from the right-hand side of the bed. The majority of clinic offices are set up for the right-handed provider, with the examining table placed with the head of the bed distal from the door and the left side of the bed aligned in close proximity to the wall, leaving examination on the right side of the patient as the only option. In the hospital setting, monitors and intravenous poles are usually placed on the patient’s left-hand side of the bed.

“This practice, more than anything else, is born out of tradition. The same clinical examination can potentially be performed with the same accuracy and efficacy from the left-hand side,” said Dr. Prashant Patel.

In the echocardiography lab, some facilities perform transthoracic echocardiography from the right side of the patient, thereby requiring the operator to get the right scanning hand over and across the patient.

“This is ergonomically disadvantageous, as one has to sit on the table, reach over the patient, and twist the torso. Scanning from the left side of the patient is ergonomically superior in preventing back injuries and may be advantageous for the left-handed person as the probe is held in the dominant hand,” noted Dr. Prashant Patel.

In the cath lab, the difficulty for left-handed cardiologists starts with establishing arterial or venous access.

“The two most frequently used arterial-access sites are right radial and right femoral. Both of them pose unique challenges in terms of positioning for most left-handed trainees in the early part of their training. The right arm is kept adducted and externally rotated in a standard setup, which is difficult to access for a left-handed operator, and would require the operator to use their nondominant right hand awkwardly to gain access,” he said.

A solution could be to reposition the patient’s arm using a radial board into abduction of the arm at about 45 degrees, with external rotation.

“This creates room for the left-handed operator to stand caudal to the patient’s arm and approach the radial access site conveniently using their dominant hand,” Dr. Prashant Patel suggested.

For the femoral approach, the left-handed operator could stand left of the patient and either get left femoral access or reach out across to the right groin of the patient and obtain access in this manner, or alternatively, the operator could resort to using their right hand to gain right femoral access.

“The large size of the femoral vessels allows even the strongly left-handed operators to get accustomed to using their nondominant hand with practice. This may be preferable to switching to the left side,” he said.

There are also some advantages to being left-handed, Dr. Prashant Patel said.

This is true “especially in the cath lab, for example, establishing antegrade right femoral access for peripheral interventions,” he noted. “Having a left-handed operator can also come in handy when two operators need to simultaneously and quickly work on both groins, as is often the case in complex coronary or structural interventions. Left-handed operators are also at ease obtaining left radial access, which has been shown to have certain advantages over right radial access.”

“We hope to raise awareness among the academic cardiology community about left-handedness,” Dr. Prashant Patel added. “We hope that acknowledgment, support, and minor modifications in work flow will allow a lot of young trainees in the early part of their career to stay on course and realize their full potential in this procedural specialty.”
 

An insightful paper

“This paper by Dr. Prashant Patel and Dr. Mandira Patel is most insightful about the unique challenges and occasional opportunities for the left-handed cardiologist,” wrote Simon Kendall, MBBS, president of the Society for Cardiothoracic Surgery Great Britain and Ireland, London, in an accompanying response.

“As a left-handed cardiac surgeon, I am embarrassed not to have considered such significant issues for my cardiology colleagues: the edict of examining a patient from the right side, performing echocardiography with the right hand, and the complex arena of catheter laboratory that is designed around the right-handed majority. Before reading this paper, I had not appreciated that for my whole career I have had to use my less-favored right hand when inserting a balloon pump,” Dr. Kendall wrote.

“Dr. Patel and Dr. Patel have written very sensible conclusions, such as that left-handedness should be acknowledged and adapted for and the training environment has to help access the specific tips and tricks from others, as shared in cardiac surgery, for instance. They rightly describe this as not a binary phenomenon and that there is a spectrum of laterality, so that some left-handers will adapt with ease and others will need more time and patience to learn the necessary skills,” he wrote. “We are fortunate to live in an era of increasing awareness and tolerance. Left-handedness is one small example of such progress.”

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

Intraoperative injection of calcium chloride into the four major atrial ganglionated plexi (GPs) reduced the incidence of early postoperative atrial fibrillation (POAF) in patients undergoing off-pump coronary artery bypass grafting (CABG) surgery, in a proof-of-concept study.

“[We] hypothesized that injecting [calcium chloride] into the major atrial GPs during isolated CABG can reduce the incidence of POAF by calcium-induced autonomic neurotoxicity,” wrote Huishan Wang, MD, of the General Hospital of Northern Theater Command in Shenyang, China, and colleagues. Their report was published in the Journal of the American College of Cardiology.

The single-center, sham-controlled, proof-of-concept study included 200 patients without a history of AF undergoing isolated, off-pump CABG surgery. Participants were randomized (1:1) to receive an injection of either 5% calcium chloride or 0.9% sodium chloride into the four major GPs during CABG.

Post surgery, patients were monitored for the occurrence of POAF using routine 12-lead ECG and 7-day continuous telemetry and Holter monitoring. The primary endpoint was the incidence of POAF lasting 30 seconds or longer through 7 days. Various secondary outcomes, including POAF burden and length of hospitalization, were also measured.

After analysis, the researchers found that 15 patients in the calcium chloride arm and 36 patients in the sodium chloride arm developed POAF during the first 7 days post CABG, corresponding to a POAF hazard reduction of 63% (hazard ratio, 0.37; 95% confidence interval, 0.21-0.64; P = .001) with no significant adverse effects observed among study patients.

The calcium chloride injection also resulted in reduced AF burden and lower rates of amiodarone and esmolol use to treat POAF; however, there was no difference in the length of hospitalization between the two groups. The incidences of nonsustained atrial tachyarrhythmia (less than 30 seconds) and atrial couplets were also significantly reduced in the calcium chloride group.

“We selected the 4 major atrial GPs as our targets because [of] their role in the initiation and maintenance of AF is more established than other cardiac neural plexi,” the researchers explained. “Interruption of the atrial neural network by Ca-mediated GP neurotoxicity may underlie the therapeutic effects.”
 

Is ‘nuisance’ arrhythmia worth targeting?

In an editorial accompanying the report, John H. Alexander, MD, MHS, wrote that intraoperative calcium chloride atrial ganglionic ablation can now be considered as an effective intervention to prevent POAF in patients undergoing cardiac surgery. “These investigators should be congratulated for studying post-operative atrial fibrillation in cardiac surgery,” he stated.

MDedge News

“However, this trial has two significant limitations. Firstly, it was conducted in a single center in a very homogeneous population; secondly, POAF, in and of itself, is largely a nuisance arrhythmia and hardly worth preventing, but is associated with a higher risk of other adverse outcomes,” Dr. Alexander, professor of medicine at Duke University, Durham, N.C., said in an interview.

“The unanswered question is whether preventing perioperative AF will prevent stroke, heart failure, and death,” he further explained. “Answering these questions would require a larger trial (or trials) with longer term (months to years) follow-up.”

Dr. Wang and colleagues acknowledged that the current study was underpowered for some secondary outcomes, such as length of hospitalization. They explained that a large sample size is needed to detect a difference in length of hospitalization, as well as other outcomes.

“Further studies are needed to confirm the safety and efficacy of calcium-induced atrial autonomic denervation in patients undergoing on-pump CABG and surgery for valvular heart disease,” they concluded.

The study was funded by the Provincial Key R & D Program in China. One author reported holding a U.S. patent related to the study. The remaining authors had no relevant relationships to disclose.

Intraoperative injection of calcium chloride into the four major atrial ganglionated plexi (GPs) reduced the incidence of early postoperative atrial fibrillation (POAF) in patients undergoing off-pump coronary artery bypass grafting (CABG) surgery, in a proof-of-concept study.

“[We] hypothesized that injecting [calcium chloride] into the major atrial GPs during isolated CABG can reduce the incidence of POAF by calcium-induced autonomic neurotoxicity,” wrote Huishan Wang, MD, of the General Hospital of Northern Theater Command in Shenyang, China, and colleagues. Their report was published in the Journal of the American College of Cardiology.

The single-center, sham-controlled, proof-of-concept study included 200 patients without a history of AF undergoing isolated, off-pump CABG surgery. Participants were randomized (1:1) to receive an injection of either 5% calcium chloride or 0.9% sodium chloride into the four major GPs during CABG.

Post surgery, patients were monitored for the occurrence of POAF using routine 12-lead ECG and 7-day continuous telemetry and Holter monitoring. The primary endpoint was the incidence of POAF lasting 30 seconds or longer through 7 days. Various secondary outcomes, including POAF burden and length of hospitalization, were also measured.

After analysis, the researchers found that 15 patients in the calcium chloride arm and 36 patients in the sodium chloride arm developed POAF during the first 7 days post CABG, corresponding to a POAF hazard reduction of 63% (hazard ratio, 0.37; 95% confidence interval, 0.21-0.64; P = .001) with no significant adverse effects observed among study patients.

The calcium chloride injection also resulted in reduced AF burden and lower rates of amiodarone and esmolol use to treat POAF; however, there was no difference in the length of hospitalization between the two groups. The incidences of nonsustained atrial tachyarrhythmia (less than 30 seconds) and atrial couplets were also significantly reduced in the calcium chloride group.

“We selected the 4 major atrial GPs as our targets because [of] their role in the initiation and maintenance of AF is more established than other cardiac neural plexi,” the researchers explained. “Interruption of the atrial neural network by Ca-mediated GP neurotoxicity may underlie the therapeutic effects.”
 

Is ‘nuisance’ arrhythmia worth targeting?

In an editorial accompanying the report, John H. Alexander, MD, MHS, wrote that intraoperative calcium chloride atrial ganglionic ablation can now be considered as an effective intervention to prevent POAF in patients undergoing cardiac surgery. “These investigators should be congratulated for studying post-operative atrial fibrillation in cardiac surgery,” he stated.

MDedge News

“However, this trial has two significant limitations. Firstly, it was conducted in a single center in a very homogeneous population; secondly, POAF, in and of itself, is largely a nuisance arrhythmia and hardly worth preventing, but is associated with a higher risk of other adverse outcomes,” Dr. Alexander, professor of medicine at Duke University, Durham, N.C., said in an interview.

“The unanswered question is whether preventing perioperative AF will prevent stroke, heart failure, and death,” he further explained. “Answering these questions would require a larger trial (or trials) with longer term (months to years) follow-up.”

Dr. Wang and colleagues acknowledged that the current study was underpowered for some secondary outcomes, such as length of hospitalization. They explained that a large sample size is needed to detect a difference in length of hospitalization, as well as other outcomes.

“Further studies are needed to confirm the safety and efficacy of calcium-induced atrial autonomic denervation in patients undergoing on-pump CABG and surgery for valvular heart disease,” they concluded.

The study was funded by the Provincial Key R & D Program in China. One author reported holding a U.S. patent related to the study. The remaining authors had no relevant relationships to disclose.

Intraoperative injection of calcium chloride into the four major atrial ganglionated plexi (GPs) reduced the incidence of early postoperative atrial fibrillation (POAF) in patients undergoing off-pump coronary artery bypass grafting (CABG) surgery, in a proof-of-concept study.

“[We] hypothesized that injecting [calcium chloride] into the major atrial GPs during isolated CABG can reduce the incidence of POAF by calcium-induced autonomic neurotoxicity,” wrote Huishan Wang, MD, of the General Hospital of Northern Theater Command in Shenyang, China, and colleagues. Their report was published in the Journal of the American College of Cardiology.

The single-center, sham-controlled, proof-of-concept study included 200 patients without a history of AF undergoing isolated, off-pump CABG surgery. Participants were randomized (1:1) to receive an injection of either 5% calcium chloride or 0.9% sodium chloride into the four major GPs during CABG.

Post surgery, patients were monitored for the occurrence of POAF using routine 12-lead ECG and 7-day continuous telemetry and Holter monitoring. The primary endpoint was the incidence of POAF lasting 30 seconds or longer through 7 days. Various secondary outcomes, including POAF burden and length of hospitalization, were also measured.

After analysis, the researchers found that 15 patients in the calcium chloride arm and 36 patients in the sodium chloride arm developed POAF during the first 7 days post CABG, corresponding to a POAF hazard reduction of 63% (hazard ratio, 0.37; 95% confidence interval, 0.21-0.64; P = .001) with no significant adverse effects observed among study patients.

The calcium chloride injection also resulted in reduced AF burden and lower rates of amiodarone and esmolol use to treat POAF; however, there was no difference in the length of hospitalization between the two groups. The incidences of nonsustained atrial tachyarrhythmia (less than 30 seconds) and atrial couplets were also significantly reduced in the calcium chloride group.

“We selected the 4 major atrial GPs as our targets because [of] their role in the initiation and maintenance of AF is more established than other cardiac neural plexi,” the researchers explained. “Interruption of the atrial neural network by Ca-mediated GP neurotoxicity may underlie the therapeutic effects.”
 

Is ‘nuisance’ arrhythmia worth targeting?

In an editorial accompanying the report, John H. Alexander, MD, MHS, wrote that intraoperative calcium chloride atrial ganglionic ablation can now be considered as an effective intervention to prevent POAF in patients undergoing cardiac surgery. “These investigators should be congratulated for studying post-operative atrial fibrillation in cardiac surgery,” he stated.

MDedge News

“However, this trial has two significant limitations. Firstly, it was conducted in a single center in a very homogeneous population; secondly, POAF, in and of itself, is largely a nuisance arrhythmia and hardly worth preventing, but is associated with a higher risk of other adverse outcomes,” Dr. Alexander, professor of medicine at Duke University, Durham, N.C., said in an interview.

“The unanswered question is whether preventing perioperative AF will prevent stroke, heart failure, and death,” he further explained. “Answering these questions would require a larger trial (or trials) with longer term (months to years) follow-up.”

Dr. Wang and colleagues acknowledged that the current study was underpowered for some secondary outcomes, such as length of hospitalization. They explained that a large sample size is needed to detect a difference in length of hospitalization, as well as other outcomes.

“Further studies are needed to confirm the safety and efficacy of calcium-induced atrial autonomic denervation in patients undergoing on-pump CABG and surgery for valvular heart disease,” they concluded.

The study was funded by the Provincial Key R & D Program in China. One author reported holding a U.S. patent related to the study. The remaining authors had no relevant relationships to disclose.

Left atrial appendage occlusion (LAAO) for high-risk atrial fibrillation seems to prevent stroke as well as direct oral anticoagulation (DOAC) with a lower risk of major bleeding, according to results of a European study.

And although some experts question the strength of the conclusions, a lead researcher contends the study may provide enough support for interventional cardiologists to consider LAAO in selected patients until randomized clinical trials yield stronger evidence.

“The results suggest LAAO to be superior to DOAC in AF patients who have a predicted high risk of stroke and bleeding and adds to the evidence that LAAO is a promising stroke prevention strategy in selected AF patients,” said lead investigator Jens Erik Nielsen-Kudsk, MD, DMSc, a cardiologist at Aarhus University Hospital in Denmark.

Dr. Nielsen-Kudsk and colleagues wrote in JACC: Cardiovascular Interventions that this is the largest comparative study of LAAO vs. DOAC to date, but they also acknowledged the study limitations: its observational design, unaccounted confounders, potential selection bias, and disparities in the nature of the comparative datasets (a multination cohort vs. a single national registry).

Observational registry study shows 43% reduction in primary outcome

The study compared outcomes of 1,078 patients from the Amulet Observational Study who had LAAO during June 2015–September 2016 with 1,184 patients on DOAC therapy selected by propensity score matching from two Danish national registries. The LAAO population was prospectively enrolled at 61 centers in 17 countries. The study population had a high risk of stroke and bleeding; about one-third had a previous stroke and about three-quarters had a prior bleeding episode. The average age was 75 years.

The LAAO group had almost half the rate of the primary outcome – either stroke, major bleeding, or all-cause death – 256 vs. 461 events in the DOAC group with median follow-up of 2 years. The annualized event rate was significantly lower for the LAAO group: 14.5 vs. 25.7 per 100 patient years in the DOAC group. The researchers calculated the LAAO group had a relative 43% reduction risk.

Of the LAAO group, 155 patients (14.5%) died in the follow-up period, 35% of them from a cardiovascular cause, whereas 308 (26%) of patients in the DOAC group died, with a similar percentage, 36%, from a cardiovascular cause.

Using data from the Danish Cause of Death Registry, the study determined cause of death in the DOAC patients on a more granular level: 9.5% of the deaths were from vascular disease and 4.5% from stroke (the remainder in both groups were from noncardiovascular events).

Stroke incidence was similar between the two groups: 39 in the LAAO group vs. 37 in DOAC patients, conferring an 11% greater risk in the former. The risk of major bleeding and all-cause mortality were significantly lower in LAAO patients, 37% and 47%, respectively. However, 50% of DOAC patients had discontinued therapy after a year of follow-up, and 58% had done so after 2 years.

Dr. Nielsen-Kudsk noted that the findings line up with those from the smaller PRAQUE-17 study comparing LAAO and DOAC. He added that his group is participating in two larger RCTs, CATALYST and CHAMPION-AF, evaluating LAAO and medical therapy in about 6,000 patients combined.

“It will take at least 2 to 5 years before we have data from these randomized LAAO trials,” Dr. Nielsen-Kudsk said. “Meanwhile, based on data from three prior randomized clinical trials, propensity-score matched studies and data from large registries, LAAO should be considered in clinical practice for patients who have a high risk of bleeding or who for any other reason are unsuitable for long-term DOAC treatment.”

Noncompliance to DOAC therapy a concern

In an invited commentary, Mohamad Alkhouli, MD, of the Mayo Medical School, Rochester, Minn., wrote, “These findings provide reassuring evidence supporting the efficacy of LAAO despite the remaining challenges with this therapy.”

However, Dr. Alkhouli pointed out that the high rate of noncompliance among AF patients on DOAC can be a confounding factor for interpreting the efficacy of therapy. “This highlights the challenges of comparing LAAO to DOAC, considering that many patients are actually not on effective anticoagulation, but also suggests a possible real important role for LAAO in addressing the unmet need in stroke prevention in nonvalvular atrial fibrillation,” he said in an interview.

“The study showed a very good safety profile for LAAO,” Dr. Alkhouli added. “However, we should remember that this was an observational study without routine temporal imaging and a relatively short-term follow- up.”

Methods ‘severely flawed’

John Mandrola, MD, an electrophysiologist at Baptist Health in Louisville, Ky., said the study methodology was “severely flawed,” citing its nonrandomized nature and enrollment of only patients with successful implants in the LAAO group. “You have to take all patients who had attempted implants,” he said. Further, the study may be subject to selection bias based on how patients were recruited for the Ampulet Observational Study.

“Comparing LAAO to DOAC is a vital clinical question,” said Dr. Mandrola. “It simply cannot be answered with observational methods like this. It requires a properly powered RCT.”

Dr. Alkhouli said he’s looking forward to results from five large RCTS evaluating LAAO due in 3-5 years. “Until the results of those trials are out, careful patient selection and shared decision-making should continue to govern the rational dissipation of LAAO as a stroke prevention strategy,” he said.

Novo Nordisk Research Foundation supported the study and Abbott provided a grant. Dr. Nielsen-Kudsk disclosed financial relationships with Abbott and Boston Scientific. Coauthors disclosed relationships with Abbott, Boston Scientific, Bayer Vital, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic, Pfizer, Portolo, and Sanofi.

Dr. Alkhouli disclosed a relationship with Boston Scientific. Dr. Mandrola has no relevant disclosures. He is chief cardiology correspondent for Medscape.com. MDedge is a member of the Medscape Professional Network.

Left atrial appendage occlusion (LAAO) for high-risk atrial fibrillation seems to prevent stroke as well as direct oral anticoagulation (DOAC) with a lower risk of major bleeding, according to results of a European study.

And although some experts question the strength of the conclusions, a lead researcher contends the study may provide enough support for interventional cardiologists to consider LAAO in selected patients until randomized clinical trials yield stronger evidence.

“The results suggest LAAO to be superior to DOAC in AF patients who have a predicted high risk of stroke and bleeding and adds to the evidence that LAAO is a promising stroke prevention strategy in selected AF patients,” said lead investigator Jens Erik Nielsen-Kudsk, MD, DMSc, a cardiologist at Aarhus University Hospital in Denmark.

Dr. Nielsen-Kudsk and colleagues wrote in JACC: Cardiovascular Interventions that this is the largest comparative study of LAAO vs. DOAC to date, but they also acknowledged the study limitations: its observational design, unaccounted confounders, potential selection bias, and disparities in the nature of the comparative datasets (a multination cohort vs. a single national registry).

Observational registry study shows 43% reduction in primary outcome

The study compared outcomes of 1,078 patients from the Amulet Observational Study who had LAAO during June 2015–September 2016 with 1,184 patients on DOAC therapy selected by propensity score matching from two Danish national registries. The LAAO population was prospectively enrolled at 61 centers in 17 countries. The study population had a high risk of stroke and bleeding; about one-third had a previous stroke and about three-quarters had a prior bleeding episode. The average age was 75 years.

The LAAO group had almost half the rate of the primary outcome – either stroke, major bleeding, or all-cause death – 256 vs. 461 events in the DOAC group with median follow-up of 2 years. The annualized event rate was significantly lower for the LAAO group: 14.5 vs. 25.7 per 100 patient years in the DOAC group. The researchers calculated the LAAO group had a relative 43% reduction risk.

Of the LAAO group, 155 patients (14.5%) died in the follow-up period, 35% of them from a cardiovascular cause, whereas 308 (26%) of patients in the DOAC group died, with a similar percentage, 36%, from a cardiovascular cause.

Using data from the Danish Cause of Death Registry, the study determined cause of death in the DOAC patients on a more granular level: 9.5% of the deaths were from vascular disease and 4.5% from stroke (the remainder in both groups were from noncardiovascular events).

Stroke incidence was similar between the two groups: 39 in the LAAO group vs. 37 in DOAC patients, conferring an 11% greater risk in the former. The risk of major bleeding and all-cause mortality were significantly lower in LAAO patients, 37% and 47%, respectively. However, 50% of DOAC patients had discontinued therapy after a year of follow-up, and 58% had done so after 2 years.

Dr. Nielsen-Kudsk noted that the findings line up with those from the smaller PRAQUE-17 study comparing LAAO and DOAC. He added that his group is participating in two larger RCTs, CATALYST and CHAMPION-AF, evaluating LAAO and medical therapy in about 6,000 patients combined.

“It will take at least 2 to 5 years before we have data from these randomized LAAO trials,” Dr. Nielsen-Kudsk said. “Meanwhile, based on data from three prior randomized clinical trials, propensity-score matched studies and data from large registries, LAAO should be considered in clinical practice for patients who have a high risk of bleeding or who for any other reason are unsuitable for long-term DOAC treatment.”

Noncompliance to DOAC therapy a concern

In an invited commentary, Mohamad Alkhouli, MD, of the Mayo Medical School, Rochester, Minn., wrote, “These findings provide reassuring evidence supporting the efficacy of LAAO despite the remaining challenges with this therapy.”

However, Dr. Alkhouli pointed out that the high rate of noncompliance among AF patients on DOAC can be a confounding factor for interpreting the efficacy of therapy. “This highlights the challenges of comparing LAAO to DOAC, considering that many patients are actually not on effective anticoagulation, but also suggests a possible real important role for LAAO in addressing the unmet need in stroke prevention in nonvalvular atrial fibrillation,” he said in an interview.

“The study showed a very good safety profile for LAAO,” Dr. Alkhouli added. “However, we should remember that this was an observational study without routine temporal imaging and a relatively short-term follow- up.”

Methods ‘severely flawed’

John Mandrola, MD, an electrophysiologist at Baptist Health in Louisville, Ky., said the study methodology was “severely flawed,” citing its nonrandomized nature and enrollment of only patients with successful implants in the LAAO group. “You have to take all patients who had attempted implants,” he said. Further, the study may be subject to selection bias based on how patients were recruited for the Ampulet Observational Study.

“Comparing LAAO to DOAC is a vital clinical question,” said Dr. Mandrola. “It simply cannot be answered with observational methods like this. It requires a properly powered RCT.”

Dr. Alkhouli said he’s looking forward to results from five large RCTS evaluating LAAO due in 3-5 years. “Until the results of those trials are out, careful patient selection and shared decision-making should continue to govern the rational dissipation of LAAO as a stroke prevention strategy,” he said.

Novo Nordisk Research Foundation supported the study and Abbott provided a grant. Dr. Nielsen-Kudsk disclosed financial relationships with Abbott and Boston Scientific. Coauthors disclosed relationships with Abbott, Boston Scientific, Bayer Vital, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic, Pfizer, Portolo, and Sanofi.

Dr. Alkhouli disclosed a relationship with Boston Scientific. Dr. Mandrola has no relevant disclosures. He is chief cardiology correspondent for Medscape.com. MDedge is a member of the Medscape Professional Network.

Left atrial appendage occlusion (LAAO) for high-risk atrial fibrillation seems to prevent stroke as well as direct oral anticoagulation (DOAC) with a lower risk of major bleeding, according to results of a European study.

And although some experts question the strength of the conclusions, a lead researcher contends the study may provide enough support for interventional cardiologists to consider LAAO in selected patients until randomized clinical trials yield stronger evidence.

“The results suggest LAAO to be superior to DOAC in AF patients who have a predicted high risk of stroke and bleeding and adds to the evidence that LAAO is a promising stroke prevention strategy in selected AF patients,” said lead investigator Jens Erik Nielsen-Kudsk, MD, DMSc, a cardiologist at Aarhus University Hospital in Denmark.

Dr. Nielsen-Kudsk and colleagues wrote in JACC: Cardiovascular Interventions that this is the largest comparative study of LAAO vs. DOAC to date, but they also acknowledged the study limitations: its observational design, unaccounted confounders, potential selection bias, and disparities in the nature of the comparative datasets (a multination cohort vs. a single national registry).

Observational registry study shows 43% reduction in primary outcome

The study compared outcomes of 1,078 patients from the Amulet Observational Study who had LAAO during June 2015–September 2016 with 1,184 patients on DOAC therapy selected by propensity score matching from two Danish national registries. The LAAO population was prospectively enrolled at 61 centers in 17 countries. The study population had a high risk of stroke and bleeding; about one-third had a previous stroke and about three-quarters had a prior bleeding episode. The average age was 75 years.

The LAAO group had almost half the rate of the primary outcome – either stroke, major bleeding, or all-cause death – 256 vs. 461 events in the DOAC group with median follow-up of 2 years. The annualized event rate was significantly lower for the LAAO group: 14.5 vs. 25.7 per 100 patient years in the DOAC group. The researchers calculated the LAAO group had a relative 43% reduction risk.

Of the LAAO group, 155 patients (14.5%) died in the follow-up period, 35% of them from a cardiovascular cause, whereas 308 (26%) of patients in the DOAC group died, with a similar percentage, 36%, from a cardiovascular cause.

Using data from the Danish Cause of Death Registry, the study determined cause of death in the DOAC patients on a more granular level: 9.5% of the deaths were from vascular disease and 4.5% from stroke (the remainder in both groups were from noncardiovascular events).

Stroke incidence was similar between the two groups: 39 in the LAAO group vs. 37 in DOAC patients, conferring an 11% greater risk in the former. The risk of major bleeding and all-cause mortality were significantly lower in LAAO patients, 37% and 47%, respectively. However, 50% of DOAC patients had discontinued therapy after a year of follow-up, and 58% had done so after 2 years.

Dr. Nielsen-Kudsk noted that the findings line up with those from the smaller PRAQUE-17 study comparing LAAO and DOAC. He added that his group is participating in two larger RCTs, CATALYST and CHAMPION-AF, evaluating LAAO and medical therapy in about 6,000 patients combined.

“It will take at least 2 to 5 years before we have data from these randomized LAAO trials,” Dr. Nielsen-Kudsk said. “Meanwhile, based on data from three prior randomized clinical trials, propensity-score matched studies and data from large registries, LAAO should be considered in clinical practice for patients who have a high risk of bleeding or who for any other reason are unsuitable for long-term DOAC treatment.”

Noncompliance to DOAC therapy a concern

In an invited commentary, Mohamad Alkhouli, MD, of the Mayo Medical School, Rochester, Minn., wrote, “These findings provide reassuring evidence supporting the efficacy of LAAO despite the remaining challenges with this therapy.”

However, Dr. Alkhouli pointed out that the high rate of noncompliance among AF patients on DOAC can be a confounding factor for interpreting the efficacy of therapy. “This highlights the challenges of comparing LAAO to DOAC, considering that many patients are actually not on effective anticoagulation, but also suggests a possible real important role for LAAO in addressing the unmet need in stroke prevention in nonvalvular atrial fibrillation,” he said in an interview.

“The study showed a very good safety profile for LAAO,” Dr. Alkhouli added. “However, we should remember that this was an observational study without routine temporal imaging and a relatively short-term follow- up.”

Methods ‘severely flawed’

John Mandrola, MD, an electrophysiologist at Baptist Health in Louisville, Ky., said the study methodology was “severely flawed,” citing its nonrandomized nature and enrollment of only patients with successful implants in the LAAO group. “You have to take all patients who had attempted implants,” he said. Further, the study may be subject to selection bias based on how patients were recruited for the Ampulet Observational Study.

“Comparing LAAO to DOAC is a vital clinical question,” said Dr. Mandrola. “It simply cannot be answered with observational methods like this. It requires a properly powered RCT.”

Dr. Alkhouli said he’s looking forward to results from five large RCTS evaluating LAAO due in 3-5 years. “Until the results of those trials are out, careful patient selection and shared decision-making should continue to govern the rational dissipation of LAAO as a stroke prevention strategy,” he said.

Novo Nordisk Research Foundation supported the study and Abbott provided a grant. Dr. Nielsen-Kudsk disclosed financial relationships with Abbott and Boston Scientific. Coauthors disclosed relationships with Abbott, Boston Scientific, Bayer Vital, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic, Pfizer, Portolo, and Sanofi.

Dr. Alkhouli disclosed a relationship with Boston Scientific. Dr. Mandrola has no relevant disclosures. He is chief cardiology correspondent for Medscape.com. MDedge is a member of the Medscape Professional Network.

The American College of Cardiology has released a new expert consensus decision pathway to provide practical guidance on same-day discharge after percutaneous coronary intervention (PCI).

“There’s been a lot of interest in people wanting to start these programs, so we thought this is an ideal topic for a consensus pathway that will help programs that want to implement these things – give them kind of a road map for how to do that,” writing committee chair Sunil Rao, MD, Duke University Medical Center, Durham, N.C., said.

Although the document reviews the evidence supporting same-day discharge much like a guideline, the focus is on implementation, he said in an interview. It features a checklist of patient- and systems-specific considerations along with key definitions and a series of clinical scenarios showing the rationale for same-day discharge or overnight monitoring.

The checklist can be used for anyone presenting for an elective PCI or for ad hoc cases that flow directly from the diagnostic cath lab and make up about 80% of procedures. It is not applicable for those presenting with ST-elevation myocardial infarction (STEMI) or non-STEMI, but can be used for staged procedures performed after their index PCI, according to the report, published online Jan. 7 in the Journal of the American College of Cardiology.

When establishing a new same-day discharge program, the basic approach can be distilled down to the “three Ps”– the patient, the procedure, and the program – Dr. Rao explained. The patient has to be the right patient, be willing to go home that night, and have some kind of support structure at home in case they run into trouble. The procedure itself should be without complications and the recovery unremarkable, with a stable access site and a return to baseline mental status and ambulation. Finally, “this all has to take place in the context of a program with buy-in from the different stakeholders,” he said.

The report points out that the need for administrative buy-in “should not be underestimated” and recommends physician-champions meet with staff administrators to present the data on PCI utility and safety and to communicate the need for staff to complete the checklist.

Implementing the checklist also requires buy-in from nurses and other team members who may be tasked with educating patients on issues like access site complications and ensuring they receive relevant discharge information, a loading dose of a P2Y12 inhibitor, and appropriate prescriptions.

“If you’re only going to observe the patient for 6 hours, you’ve got to make sure that they’re on all the secondary prevention medications and the referral to cardiac rehabilitation takes place,” Dr. Rao said. “So I think that, in a funny way, the implementation of same-day discharge allows us to actually focus a little bit more on these kinds of postprocedure aspects that I think we were taking for granted a little bit when patients were being observed overnight.”

The checklist is detailed but was designed so it can be tailored to the needs of individual institutions, writing committee member Connie N. Hess, MD, MHS, University of Colorado at Denver, Aurora, pointed out.

“At every level there is a lot of variance in institutional resources or even a patient’s resources,” she said. “So we didn’t want to seem too prescriptive.”

Some institutions, for example, may feel strongly that accessibility to a caregiver means someone staying in the house who can monitor the patient’s access site and call 911 if need be, whereas others may define it as having a neighbor who’s easy to reach by phone, Dr. Hess noted in an interview.

Exactly when the last patient can be eligible for same-day discharge may also vary between urban and rural settings where patients may drive hours for their care. The built-in flexibility also allows institutions to incorporate their own preexisting documents into the checklist.

“I don’t think the hospital buy-in is necessarily the hard part because there is a clear monetary benefit as long as you can show that it’s done safely and you’re not harming patients, which I think has been done,” Dr. Hess said. “I think then the next level down, you have the provider buy-in and that may be where there might be a little bit more work depending on the preexisting culture.”

Part of the hesitancy may reflect a generational gap, whereby younger interventionalists who trained in programs with same-day discharge may be more willing to support the checklist.

“This actually parallels radial artery access where data exists on its benefits but it’s not used,” Dr. Hess said. “And I think a lot of this has to do with provider comfort levels with sending patients home and just not necessarily knowing how to implement a program at their institution.”

Both Dr. Rao and Dr. Hess pointed out that uptake of same-day discharge PCI is low in the United States, compared with other part of the world, including the United Kingdom, with estimates at about 16%-20% of PCIs.

That said, the timing of the new expert consensus document is “fortuitous,” Dr. Rao noted. Since work on the document began 2 years ago, the Centers for Medicare & Medicaid Services’ greenlit reimbursement for PCI performed in an ambulatory surgical center and the pandemic walloped U.S. hospitals. “I think those two things really do highlight the importance of a document like this.”

“A potential advantage of the same-day discharge program is that you won’t be exposing patients to the hospital setting where COVID is a problem, and you’ll keep your beds open for the COVID patients that really do need it,” he said.

The ability to go home without an overnight stay may also encourage some patients to seek care. “Patients with cardiovascular disease really need to understand that you may be stable at one point but then obviously can become unstable, and we don’t want people to stay away from the hospital because they are worried about being admitted,” Dr. Rao said.

Dr. Rao and Dr. Hess report no relevant conflicts of interest.

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

The American College of Cardiology has released a new expert consensus decision pathway to provide practical guidance on same-day discharge after percutaneous coronary intervention (PCI).

“There’s been a lot of interest in people wanting to start these programs, so we thought this is an ideal topic for a consensus pathway that will help programs that want to implement these things – give them kind of a road map for how to do that,” writing committee chair Sunil Rao, MD, Duke University Medical Center, Durham, N.C., said.

Although the document reviews the evidence supporting same-day discharge much like a guideline, the focus is on implementation, he said in an interview. It features a checklist of patient- and systems-specific considerations along with key definitions and a series of clinical scenarios showing the rationale for same-day discharge or overnight monitoring.

The checklist can be used for anyone presenting for an elective PCI or for ad hoc cases that flow directly from the diagnostic cath lab and make up about 80% of procedures. It is not applicable for those presenting with ST-elevation myocardial infarction (STEMI) or non-STEMI, but can be used for staged procedures performed after their index PCI, according to the report, published online Jan. 7 in the Journal of the American College of Cardiology.

When establishing a new same-day discharge program, the basic approach can be distilled down to the “three Ps”– the patient, the procedure, and the program – Dr. Rao explained. The patient has to be the right patient, be willing to go home that night, and have some kind of support structure at home in case they run into trouble. The procedure itself should be without complications and the recovery unremarkable, with a stable access site and a return to baseline mental status and ambulation. Finally, “this all has to take place in the context of a program with buy-in from the different stakeholders,” he said.

The report points out that the need for administrative buy-in “should not be underestimated” and recommends physician-champions meet with staff administrators to present the data on PCI utility and safety and to communicate the need for staff to complete the checklist.

Implementing the checklist also requires buy-in from nurses and other team members who may be tasked with educating patients on issues like access site complications and ensuring they receive relevant discharge information, a loading dose of a P2Y12 inhibitor, and appropriate prescriptions.

“If you’re only going to observe the patient for 6 hours, you’ve got to make sure that they’re on all the secondary prevention medications and the referral to cardiac rehabilitation takes place,” Dr. Rao said. “So I think that, in a funny way, the implementation of same-day discharge allows us to actually focus a little bit more on these kinds of postprocedure aspects that I think we were taking for granted a little bit when patients were being observed overnight.”

The checklist is detailed but was designed so it can be tailored to the needs of individual institutions, writing committee member Connie N. Hess, MD, MHS, University of Colorado at Denver, Aurora, pointed out.

“At every level there is a lot of variance in institutional resources or even a patient’s resources,” she said. “So we didn’t want to seem too prescriptive.”

Some institutions, for example, may feel strongly that accessibility to a caregiver means someone staying in the house who can monitor the patient’s access site and call 911 if need be, whereas others may define it as having a neighbor who’s easy to reach by phone, Dr. Hess noted in an interview.

Exactly when the last patient can be eligible for same-day discharge may also vary between urban and rural settings where patients may drive hours for their care. The built-in flexibility also allows institutions to incorporate their own preexisting documents into the checklist.

“I don’t think the hospital buy-in is necessarily the hard part because there is a clear monetary benefit as long as you can show that it’s done safely and you’re not harming patients, which I think has been done,” Dr. Hess said. “I think then the next level down, you have the provider buy-in and that may be where there might be a little bit more work depending on the preexisting culture.”

Part of the hesitancy may reflect a generational gap, whereby younger interventionalists who trained in programs with same-day discharge may be more willing to support the checklist.

“This actually parallels radial artery access where data exists on its benefits but it’s not used,” Dr. Hess said. “And I think a lot of this has to do with provider comfort levels with sending patients home and just not necessarily knowing how to implement a program at their institution.”

Both Dr. Rao and Dr. Hess pointed out that uptake of same-day discharge PCI is low in the United States, compared with other part of the world, including the United Kingdom, with estimates at about 16%-20% of PCIs.

That said, the timing of the new expert consensus document is “fortuitous,” Dr. Rao noted. Since work on the document began 2 years ago, the Centers for Medicare & Medicaid Services’ greenlit reimbursement for PCI performed in an ambulatory surgical center and the pandemic walloped U.S. hospitals. “I think those two things really do highlight the importance of a document like this.”

“A potential advantage of the same-day discharge program is that you won’t be exposing patients to the hospital setting where COVID is a problem, and you’ll keep your beds open for the COVID patients that really do need it,” he said.

The ability to go home without an overnight stay may also encourage some patients to seek care. “Patients with cardiovascular disease really need to understand that you may be stable at one point but then obviously can become unstable, and we don’t want people to stay away from the hospital because they are worried about being admitted,” Dr. Rao said.

Dr. Rao and Dr. Hess report no relevant conflicts of interest.

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

The American College of Cardiology has released a new expert consensus decision pathway to provide practical guidance on same-day discharge after percutaneous coronary intervention (PCI).

“There’s been a lot of interest in people wanting to start these programs, so we thought this is an ideal topic for a consensus pathway that will help programs that want to implement these things – give them kind of a road map for how to do that,” writing committee chair Sunil Rao, MD, Duke University Medical Center, Durham, N.C., said.

Although the document reviews the evidence supporting same-day discharge much like a guideline, the focus is on implementation, he said in an interview. It features a checklist of patient- and systems-specific considerations along with key definitions and a series of clinical scenarios showing the rationale for same-day discharge or overnight monitoring.

The checklist can be used for anyone presenting for an elective PCI or for ad hoc cases that flow directly from the diagnostic cath lab and make up about 80% of procedures. It is not applicable for those presenting with ST-elevation myocardial infarction (STEMI) or non-STEMI, but can be used for staged procedures performed after their index PCI, according to the report, published online Jan. 7 in the Journal of the American College of Cardiology.

When establishing a new same-day discharge program, the basic approach can be distilled down to the “three Ps”– the patient, the procedure, and the program – Dr. Rao explained. The patient has to be the right patient, be willing to go home that night, and have some kind of support structure at home in case they run into trouble. The procedure itself should be without complications and the recovery unremarkable, with a stable access site and a return to baseline mental status and ambulation. Finally, “this all has to take place in the context of a program with buy-in from the different stakeholders,” he said.

The report points out that the need for administrative buy-in “should not be underestimated” and recommends physician-champions meet with staff administrators to present the data on PCI utility and safety and to communicate the need for staff to complete the checklist.

Implementing the checklist also requires buy-in from nurses and other team members who may be tasked with educating patients on issues like access site complications and ensuring they receive relevant discharge information, a loading dose of a P2Y12 inhibitor, and appropriate prescriptions.

“If you’re only going to observe the patient for 6 hours, you’ve got to make sure that they’re on all the secondary prevention medications and the referral to cardiac rehabilitation takes place,” Dr. Rao said. “So I think that, in a funny way, the implementation of same-day discharge allows us to actually focus a little bit more on these kinds of postprocedure aspects that I think we were taking for granted a little bit when patients were being observed overnight.”

The checklist is detailed but was designed so it can be tailored to the needs of individual institutions, writing committee member Connie N. Hess, MD, MHS, University of Colorado at Denver, Aurora, pointed out.

“At every level there is a lot of variance in institutional resources or even a patient’s resources,” she said. “So we didn’t want to seem too prescriptive.”

Some institutions, for example, may feel strongly that accessibility to a caregiver means someone staying in the house who can monitor the patient’s access site and call 911 if need be, whereas others may define it as having a neighbor who’s easy to reach by phone, Dr. Hess noted in an interview.

Exactly when the last patient can be eligible for same-day discharge may also vary between urban and rural settings where patients may drive hours for their care. The built-in flexibility also allows institutions to incorporate their own preexisting documents into the checklist.

“I don’t think the hospital buy-in is necessarily the hard part because there is a clear monetary benefit as long as you can show that it’s done safely and you’re not harming patients, which I think has been done,” Dr. Hess said. “I think then the next level down, you have the provider buy-in and that may be where there might be a little bit more work depending on the preexisting culture.”

Part of the hesitancy may reflect a generational gap, whereby younger interventionalists who trained in programs with same-day discharge may be more willing to support the checklist.

“This actually parallels radial artery access where data exists on its benefits but it’s not used,” Dr. Hess said. “And I think a lot of this has to do with provider comfort levels with sending patients home and just not necessarily knowing how to implement a program at their institution.”

Both Dr. Rao and Dr. Hess pointed out that uptake of same-day discharge PCI is low in the United States, compared with other part of the world, including the United Kingdom, with estimates at about 16%-20% of PCIs.

That said, the timing of the new expert consensus document is “fortuitous,” Dr. Rao noted. Since work on the document began 2 years ago, the Centers for Medicare & Medicaid Services’ greenlit reimbursement for PCI performed in an ambulatory surgical center and the pandemic walloped U.S. hospitals. “I think those two things really do highlight the importance of a document like this.”

“A potential advantage of the same-day discharge program is that you won’t be exposing patients to the hospital setting where COVID is a problem, and you’ll keep your beds open for the COVID patients that really do need it,” he said.

The ability to go home without an overnight stay may also encourage some patients to seek care. “Patients with cardiovascular disease really need to understand that you may be stable at one point but then obviously can become unstable, and we don’t want people to stay away from the hospital because they are worried about being admitted,” Dr. Rao said.

Dr. Rao and Dr. Hess report no relevant conflicts of interest.

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

The latest iteration of the American College of Cardiology/American Heart Association (ACC/AHA) Guideline for the Management of Patients With Valvular Heart Disease emphasizes a less invasive approach to the management of patients with valvular heart disease (VHD).

The 2020 ACC/AHA guideline now recommends transcatheter aortic valve implantation over surgical implantation for older individuals, a transcatheter edge-to-edge repair of the mitral valve for patients who are at high risk for surgery, and referral of patients with complicated conditions to designated centers.

The guideline was published online Dec. 17 in Circulation and was simultaneously published in the Journal of the American College of Cardiology. It replaces the 2014 guideline and the 2017 focused update of the guideline, both published in Circulation.

“A huge amount has changed,” Catherine M. Otto, MD, J. Ward Kennedy-Hamilton Endowed Chair in Cardiology and professor of medicine, University of Washington, Seattle, said in an interview.

Dr. Otto cochaired the 2020 Guideline Writing Committee with Rick A. Nishimura, MD, professor of medicine, Mayo Clinic, Rochester, Minn.
 

Expanded use of transcatheter procedures

“One major change is that the transcatheter valve, rather than the surgical valve, is now recommended for a large number of patients, primarily based upon the likelihood that the durability of the transcatheter valve is appropriate for the patient’s life expectancy. So, in most older adults, the transcatheter valve, rather than a surgical valve, would be the treatment for severe aortic stenosis,” she said.

“That’s a huge change,” she added. “Previously, patients had to have surgery to place a prosthetic valve, but now, many patients, particularly older adults, can have a nonsurgical approach when they are only in the hospital overnight, or sometimes even just for the day, to get their valve replaced.”

The 2020 guideline also recommends the transcatheter approach over the surgical approach for mitral valve repair or replacement for individuals who are not candidates for surgery.

“We continue to recommend surgical valve repair for the mitral valve, because we know that there are excellent long-term outcomes with surgical repair,” Dr. Otto said. “But, for people who are at high risk or prohibitive risk for surgery, we now have the option of again using a transcatheter approach or a transcatheter edge-to-edge repair of the valve. It’s a simpler procedure, doesn’t require a big incision, [and] doesn’t require a long hospital stay. Those two procedures are really changing patient management,” she said.
 

A tiered approach to VHD care

A third key change is a recommendation that the U.S. health care system move to a tiered approach, whereby patients with more complex conditions undergo their procedure at comprehensive, high-volume centers, and patients with simpler conditions undergo treatment at primary heart valve centers.

“More complex patients often require multidisciplinary care in order to be managed appropriately. It makes more sense to send them to a center that has the expertise and the teams in place already,” Dr. Otto said.

“Patients needing more straightforward, common procedures could be seen at a primary valve center. Those needing a more complicated procedure would go to the centers with higher volumes. So an important part of what this guideline is trying to do is to get doctors to refer their patients to the appropriate center,” she said.
 

Eagerly anticipated

The 2020 AHA/ACC guideline has been “eagerly anticipated,” Anthony A. Bavry, MD, MPH, UT Southwestern Medical Center, Dallas, Texas, and George J. Arnaoutakis, MD, University of Florida Health, Gainesville, wrote in a perspective article published with the guideline in Circulation.

Dr. Bavry and Dr. Arnaoutakis endorse the guideline recommendation that the U.S. health care system move to a tiered approach.

“To balance excellent outcomes and not compromise access to care, the 2020 Guideline recommends that our health care system move to a tiered approach in the treatment of valve disease, where we recognize level 1 and level 2 Centers,” they wrote.

“The level 1 Comprehensive Heart Valve Center is an important and new introduction to the Guideline,” they noted. “The level 1 Center is defined by the depth and breadth of the procedures offered. While excellent outcomes are possible at lower volume centers, literature supports that higher center and operator volumes of valve procedures are associated with excellent results and low mortality.”

The authors pointed out that level 2 primary valve centers offer many of the same valve procedures as the level 1 centers but are limited by the scope of procedures they can offer.

“For example, specialized procedures such as alternative access TAVR, valve-in-valve TAVR, transcatheter edge-to-edge mitral valve repair, paravalvular leak closure, and percutaneous mitral balloon commissurotomy are recommended to be performed at a level 1 Center,” they wrote.

Transcatheter valve therapies remain “an exciting and dynamic field which offers patients a less invasive treatment option,” Dr. Bavry and Dr. Arnaoutakis concluded. They also cautioned that the pros and cons of the newer, less invasive therapies need to be weighed against the benefits of surgical procedures that have been studied and refined for more than 50 years.

Patients with VHD have many choices and will require help making informed decisions about such things as a mechanical valve vs. a bioprosthetic valve or undergoing a traditional surgical procedure vs. a catheter-based approach. “Other patients, at the extremes of age or risk status, will lean more clearly to one direction or another,” Dr. Bavry and Dr. Arnaoutakis add.

“Overall, the 2020 Guideline is a comprehensive document that should provide a useful framework for the Heart Valve Team,” they concluded.

The authors have disclosed no relevant financial relationships.

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

The latest iteration of the American College of Cardiology/American Heart Association (ACC/AHA) Guideline for the Management of Patients With Valvular Heart Disease emphasizes a less invasive approach to the management of patients with valvular heart disease (VHD).

The 2020 ACC/AHA guideline now recommends transcatheter aortic valve implantation over surgical implantation for older individuals, a transcatheter edge-to-edge repair of the mitral valve for patients who are at high risk for surgery, and referral of patients with complicated conditions to designated centers.

The guideline was published online Dec. 17 in Circulation and was simultaneously published in the Journal of the American College of Cardiology. It replaces the 2014 guideline and the 2017 focused update of the guideline, both published in Circulation.

“A huge amount has changed,” Catherine M. Otto, MD, J. Ward Kennedy-Hamilton Endowed Chair in Cardiology and professor of medicine, University of Washington, Seattle, said in an interview.

Dr. Otto cochaired the 2020 Guideline Writing Committee with Rick A. Nishimura, MD, professor of medicine, Mayo Clinic, Rochester, Minn.
 

Expanded use of transcatheter procedures

“One major change is that the transcatheter valve, rather than the surgical valve, is now recommended for a large number of patients, primarily based upon the likelihood that the durability of the transcatheter valve is appropriate for the patient’s life expectancy. So, in most older adults, the transcatheter valve, rather than a surgical valve, would be the treatment for severe aortic stenosis,” she said.

“That’s a huge change,” she added. “Previously, patients had to have surgery to place a prosthetic valve, but now, many patients, particularly older adults, can have a nonsurgical approach when they are only in the hospital overnight, or sometimes even just for the day, to get their valve replaced.”

The 2020 guideline also recommends the transcatheter approach over the surgical approach for mitral valve repair or replacement for individuals who are not candidates for surgery.

“We continue to recommend surgical valve repair for the mitral valve, because we know that there are excellent long-term outcomes with surgical repair,” Dr. Otto said. “But, for people who are at high risk or prohibitive risk for surgery, we now have the option of again using a transcatheter approach or a transcatheter edge-to-edge repair of the valve. It’s a simpler procedure, doesn’t require a big incision, [and] doesn’t require a long hospital stay. Those two procedures are really changing patient management,” she said.
 

A tiered approach to VHD care

A third key change is a recommendation that the U.S. health care system move to a tiered approach, whereby patients with more complex conditions undergo their procedure at comprehensive, high-volume centers, and patients with simpler conditions undergo treatment at primary heart valve centers.

“More complex patients often require multidisciplinary care in order to be managed appropriately. It makes more sense to send them to a center that has the expertise and the teams in place already,” Dr. Otto said.

“Patients needing more straightforward, common procedures could be seen at a primary valve center. Those needing a more complicated procedure would go to the centers with higher volumes. So an important part of what this guideline is trying to do is to get doctors to refer their patients to the appropriate center,” she said.
 

Eagerly anticipated

The 2020 AHA/ACC guideline has been “eagerly anticipated,” Anthony A. Bavry, MD, MPH, UT Southwestern Medical Center, Dallas, Texas, and George J. Arnaoutakis, MD, University of Florida Health, Gainesville, wrote in a perspective article published with the guideline in Circulation.

Dr. Bavry and Dr. Arnaoutakis endorse the guideline recommendation that the U.S. health care system move to a tiered approach.

“To balance excellent outcomes and not compromise access to care, the 2020 Guideline recommends that our health care system move to a tiered approach in the treatment of valve disease, where we recognize level 1 and level 2 Centers,” they wrote.

“The level 1 Comprehensive Heart Valve Center is an important and new introduction to the Guideline,” they noted. “The level 1 Center is defined by the depth and breadth of the procedures offered. While excellent outcomes are possible at lower volume centers, literature supports that higher center and operator volumes of valve procedures are associated with excellent results and low mortality.”

The authors pointed out that level 2 primary valve centers offer many of the same valve procedures as the level 1 centers but are limited by the scope of procedures they can offer.

“For example, specialized procedures such as alternative access TAVR, valve-in-valve TAVR, transcatheter edge-to-edge mitral valve repair, paravalvular leak closure, and percutaneous mitral balloon commissurotomy are recommended to be performed at a level 1 Center,” they wrote.

Transcatheter valve therapies remain “an exciting and dynamic field which offers patients a less invasive treatment option,” Dr. Bavry and Dr. Arnaoutakis concluded. They also cautioned that the pros and cons of the newer, less invasive therapies need to be weighed against the benefits of surgical procedures that have been studied and refined for more than 50 years.

Patients with VHD have many choices and will require help making informed decisions about such things as a mechanical valve vs. a bioprosthetic valve or undergoing a traditional surgical procedure vs. a catheter-based approach. “Other patients, at the extremes of age or risk status, will lean more clearly to one direction or another,” Dr. Bavry and Dr. Arnaoutakis add.

“Overall, the 2020 Guideline is a comprehensive document that should provide a useful framework for the Heart Valve Team,” they concluded.

The authors have disclosed no relevant financial relationships.

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

The latest iteration of the American College of Cardiology/American Heart Association (ACC/AHA) Guideline for the Management of Patients With Valvular Heart Disease emphasizes a less invasive approach to the management of patients with valvular heart disease (VHD).

The 2020 ACC/AHA guideline now recommends transcatheter aortic valve implantation over surgical implantation for older individuals, a transcatheter edge-to-edge repair of the mitral valve for patients who are at high risk for surgery, and referral of patients with complicated conditions to designated centers.

The guideline was published online Dec. 17 in Circulation and was simultaneously published in the Journal of the American College of Cardiology. It replaces the 2014 guideline and the 2017 focused update of the guideline, both published in Circulation.

“A huge amount has changed,” Catherine M. Otto, MD, J. Ward Kennedy-Hamilton Endowed Chair in Cardiology and professor of medicine, University of Washington, Seattle, said in an interview.

Dr. Otto cochaired the 2020 Guideline Writing Committee with Rick A. Nishimura, MD, professor of medicine, Mayo Clinic, Rochester, Minn.
 

Expanded use of transcatheter procedures

“One major change is that the transcatheter valve, rather than the surgical valve, is now recommended for a large number of patients, primarily based upon the likelihood that the durability of the transcatheter valve is appropriate for the patient’s life expectancy. So, in most older adults, the transcatheter valve, rather than a surgical valve, would be the treatment for severe aortic stenosis,” she said.

“That’s a huge change,” she added. “Previously, patients had to have surgery to place a prosthetic valve, but now, many patients, particularly older adults, can have a nonsurgical approach when they are only in the hospital overnight, or sometimes even just for the day, to get their valve replaced.”

The 2020 guideline also recommends the transcatheter approach over the surgical approach for mitral valve repair or replacement for individuals who are not candidates for surgery.

“We continue to recommend surgical valve repair for the mitral valve, because we know that there are excellent long-term outcomes with surgical repair,” Dr. Otto said. “But, for people who are at high risk or prohibitive risk for surgery, we now have the option of again using a transcatheter approach or a transcatheter edge-to-edge repair of the valve. It’s a simpler procedure, doesn’t require a big incision, [and] doesn’t require a long hospital stay. Those two procedures are really changing patient management,” she said.
 

A tiered approach to VHD care

A third key change is a recommendation that the U.S. health care system move to a tiered approach, whereby patients with more complex conditions undergo their procedure at comprehensive, high-volume centers, and patients with simpler conditions undergo treatment at primary heart valve centers.

“More complex patients often require multidisciplinary care in order to be managed appropriately. It makes more sense to send them to a center that has the expertise and the teams in place already,” Dr. Otto said.

“Patients needing more straightforward, common procedures could be seen at a primary valve center. Those needing a more complicated procedure would go to the centers with higher volumes. So an important part of what this guideline is trying to do is to get doctors to refer their patients to the appropriate center,” she said.
 

Eagerly anticipated

The 2020 AHA/ACC guideline has been “eagerly anticipated,” Anthony A. Bavry, MD, MPH, UT Southwestern Medical Center, Dallas, Texas, and George J. Arnaoutakis, MD, University of Florida Health, Gainesville, wrote in a perspective article published with the guideline in Circulation.

Dr. Bavry and Dr. Arnaoutakis endorse the guideline recommendation that the U.S. health care system move to a tiered approach.

“To balance excellent outcomes and not compromise access to care, the 2020 Guideline recommends that our health care system move to a tiered approach in the treatment of valve disease, where we recognize level 1 and level 2 Centers,” they wrote.

“The level 1 Comprehensive Heart Valve Center is an important and new introduction to the Guideline,” they noted. “The level 1 Center is defined by the depth and breadth of the procedures offered. While excellent outcomes are possible at lower volume centers, literature supports that higher center and operator volumes of valve procedures are associated with excellent results and low mortality.”

The authors pointed out that level 2 primary valve centers offer many of the same valve procedures as the level 1 centers but are limited by the scope of procedures they can offer.

“For example, specialized procedures such as alternative access TAVR, valve-in-valve TAVR, transcatheter edge-to-edge mitral valve repair, paravalvular leak closure, and percutaneous mitral balloon commissurotomy are recommended to be performed at a level 1 Center,” they wrote.

Transcatheter valve therapies remain “an exciting and dynamic field which offers patients a less invasive treatment option,” Dr. Bavry and Dr. Arnaoutakis concluded. They also cautioned that the pros and cons of the newer, less invasive therapies need to be weighed against the benefits of surgical procedures that have been studied and refined for more than 50 years.

Patients with VHD have many choices and will require help making informed decisions about such things as a mechanical valve vs. a bioprosthetic valve or undergoing a traditional surgical procedure vs. a catheter-based approach. “Other patients, at the extremes of age or risk status, will lean more clearly to one direction or another,” Dr. Bavry and Dr. Arnaoutakis add.

“Overall, the 2020 Guideline is a comprehensive document that should provide a useful framework for the Heart Valve Team,” they concluded.

The authors have disclosed no relevant financial relationships.

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

Heart transplant recipients infected with SARS-CoV-2 are about twice as likely to die from COVID-19 and should be immediately referred to a transplant center for care, according to transplant experts from Northern Italy.

In a COVID Rapid Report published Dec. 9 in JACC Heart Failure, a group led by Tomaso Bottio, MD, PhD, from the University of Padua, Italy, presented findings on 47 heart transplant recipients who tested positive for SARS-Cov-2 between Feb. 21 and June 30.

The investigators found a case fatality rate of 29.7%, compared with 15.4% in the general population. Prevalence of infection was also much higher at 18 cases (vs. 7) per 1,000 population.

“In our opinion, prompt referral to a heart transplant center is crucial for immunosuppressive therapy optimization and cardiologic follow-up,” Dr. Bottio said in an interview.

Beyond the need for careful adjustment of immunosuppression, graft function should be assessed to “avoid acute rejection or decompensation,” he added.

Dr. Bottio and colleagues tracked COVID-19 cases from among the 2,676 heart transplant recipients alive before the onset of the pandemic at seven heart transplant centers in Northern Italy.

Of the 47 recipients who contracted SARS-CoV-2, 38 required hospitalization while 9 remained at home and 14 died. Mean length of stay in hospital was 17.8 days, much longer in survivors than nonsurvivors (23.2 days vs. 8.5 days; P < .001).  

Nonsurvivors were significantly older than survivors (72 vs. 58 years; P = .002). Nonsurvivors were also more likely to present with diabetes (P = .04), extra-cardiac arteriopathy (P = .04), previous percutaneous coronary intervention (P = .04), more allograft vasculopathy (P = .04), and more symptoms of heart failure (P = .02).

Although the authors said the high case fatality rate was, unfortunately, expected, they did not expect so many patients to do well at home.

“What most surprised us was the proportion of a- or pauci-symptomatic heart transplanted patients who did well being treated at home without any therapy modifications,” Dr. Bottio shared. They were also surprised to see there were no cases of graft failure caused by infection-related myocarditis.

These findings from Northern Italy are not dissimilar from the 25% case fatality rate seen in a cohort of heart transplant recipients who caught COVID-19 in New York City early in the pandemic.

In another study, this time looking at a wider group of solid organ transplant recipients with SARS-CoV-2 infection at two centers during the first 3 weeks of the outbreak in New York City, 16 of 90 patients (18%) died.
 

Treatment recommendations?

Recognizing that there is no randomized trial data informing the treatment of this vulnerable patient population, Dr. Bottio and colleagues suggested that, based on their experience, no change in immunosuppression is needed in those who are “pauci-symptomatic” (mildly symptomatic).

“On the other hand, in hospitalized patients a partial reduction in immunosuppressive therapy avoiding full discontinuation and risk of graft rejection seems to be a common strategy in facing the viral infection,” he said. “In addition, the introduction of corticosteroids could help to suspend the onset of the inflammatory cascade responsible for severe forms of the disease.”

Antibiotic prophylaxis appears to be “fundamental,” he added, particularly in hospitalized patients, but “the role of specific antiviral therapies is still not fully understood in our population.”

Since July 1, they’ve seen an additional six patients with a positive test for SARS-CoV-2. Five were asymptomatic and quarantined at home without changing their immunosuppressive therapy. One patient was hospitalized for pneumonia and had immunosuppressive therapy reduced.

Dr. Bottio and the study coauthors have disclosed no relevant financial relationships.

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

Heart transplant recipients infected with SARS-CoV-2 are about twice as likely to die from COVID-19 and should be immediately referred to a transplant center for care, according to transplant experts from Northern Italy.

In a COVID Rapid Report published Dec. 9 in JACC Heart Failure, a group led by Tomaso Bottio, MD, PhD, from the University of Padua, Italy, presented findings on 47 heart transplant recipients who tested positive for SARS-Cov-2 between Feb. 21 and June 30.

The investigators found a case fatality rate of 29.7%, compared with 15.4% in the general population. Prevalence of infection was also much higher at 18 cases (vs. 7) per 1,000 population.

“In our opinion, prompt referral to a heart transplant center is crucial for immunosuppressive therapy optimization and cardiologic follow-up,” Dr. Bottio said in an interview.

Beyond the need for careful adjustment of immunosuppression, graft function should be assessed to “avoid acute rejection or decompensation,” he added.

Dr. Bottio and colleagues tracked COVID-19 cases from among the 2,676 heart transplant recipients alive before the onset of the pandemic at seven heart transplant centers in Northern Italy.

Of the 47 recipients who contracted SARS-CoV-2, 38 required hospitalization while 9 remained at home and 14 died. Mean length of stay in hospital was 17.8 days, much longer in survivors than nonsurvivors (23.2 days vs. 8.5 days; P < .001).  

Nonsurvivors were significantly older than survivors (72 vs. 58 years; P = .002). Nonsurvivors were also more likely to present with diabetes (P = .04), extra-cardiac arteriopathy (P = .04), previous percutaneous coronary intervention (P = .04), more allograft vasculopathy (P = .04), and more symptoms of heart failure (P = .02).

Although the authors said the high case fatality rate was, unfortunately, expected, they did not expect so many patients to do well at home.

“What most surprised us was the proportion of a- or pauci-symptomatic heart transplanted patients who did well being treated at home without any therapy modifications,” Dr. Bottio shared. They were also surprised to see there were no cases of graft failure caused by infection-related myocarditis.

These findings from Northern Italy are not dissimilar from the 25% case fatality rate seen in a cohort of heart transplant recipients who caught COVID-19 in New York City early in the pandemic.

In another study, this time looking at a wider group of solid organ transplant recipients with SARS-CoV-2 infection at two centers during the first 3 weeks of the outbreak in New York City, 16 of 90 patients (18%) died.
 

Treatment recommendations?

Recognizing that there is no randomized trial data informing the treatment of this vulnerable patient population, Dr. Bottio and colleagues suggested that, based on their experience, no change in immunosuppression is needed in those who are “pauci-symptomatic” (mildly symptomatic).

“On the other hand, in hospitalized patients a partial reduction in immunosuppressive therapy avoiding full discontinuation and risk of graft rejection seems to be a common strategy in facing the viral infection,” he said. “In addition, the introduction of corticosteroids could help to suspend the onset of the inflammatory cascade responsible for severe forms of the disease.”

Antibiotic prophylaxis appears to be “fundamental,” he added, particularly in hospitalized patients, but “the role of specific antiviral therapies is still not fully understood in our population.”

Since July 1, they’ve seen an additional six patients with a positive test for SARS-CoV-2. Five were asymptomatic and quarantined at home without changing their immunosuppressive therapy. One patient was hospitalized for pneumonia and had immunosuppressive therapy reduced.

Dr. Bottio and the study coauthors have disclosed no relevant financial relationships.

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

Heart transplant recipients infected with SARS-CoV-2 are about twice as likely to die from COVID-19 and should be immediately referred to a transplant center for care, according to transplant experts from Northern Italy.

In a COVID Rapid Report published Dec. 9 in JACC Heart Failure, a group led by Tomaso Bottio, MD, PhD, from the University of Padua, Italy, presented findings on 47 heart transplant recipients who tested positive for SARS-Cov-2 between Feb. 21 and June 30.

The investigators found a case fatality rate of 29.7%, compared with 15.4% in the general population. Prevalence of infection was also much higher at 18 cases (vs. 7) per 1,000 population.

“In our opinion, prompt referral to a heart transplant center is crucial for immunosuppressive therapy optimization and cardiologic follow-up,” Dr. Bottio said in an interview.

Beyond the need for careful adjustment of immunosuppression, graft function should be assessed to “avoid acute rejection or decompensation,” he added.

Dr. Bottio and colleagues tracked COVID-19 cases from among the 2,676 heart transplant recipients alive before the onset of the pandemic at seven heart transplant centers in Northern Italy.

Of the 47 recipients who contracted SARS-CoV-2, 38 required hospitalization while 9 remained at home and 14 died. Mean length of stay in hospital was 17.8 days, much longer in survivors than nonsurvivors (23.2 days vs. 8.5 days; P < .001).  

Nonsurvivors were significantly older than survivors (72 vs. 58 years; P = .002). Nonsurvivors were also more likely to present with diabetes (P = .04), extra-cardiac arteriopathy (P = .04), previous percutaneous coronary intervention (P = .04), more allograft vasculopathy (P = .04), and more symptoms of heart failure (P = .02).

Although the authors said the high case fatality rate was, unfortunately, expected, they did not expect so many patients to do well at home.

“What most surprised us was the proportion of a- or pauci-symptomatic heart transplanted patients who did well being treated at home without any therapy modifications,” Dr. Bottio shared. They were also surprised to see there were no cases of graft failure caused by infection-related myocarditis.

These findings from Northern Italy are not dissimilar from the 25% case fatality rate seen in a cohort of heart transplant recipients who caught COVID-19 in New York City early in the pandemic.

In another study, this time looking at a wider group of solid organ transplant recipients with SARS-CoV-2 infection at two centers during the first 3 weeks of the outbreak in New York City, 16 of 90 patients (18%) died.
 

Treatment recommendations?

Recognizing that there is no randomized trial data informing the treatment of this vulnerable patient population, Dr. Bottio and colleagues suggested that, based on their experience, no change in immunosuppression is needed in those who are “pauci-symptomatic” (mildly symptomatic).

“On the other hand, in hospitalized patients a partial reduction in immunosuppressive therapy avoiding full discontinuation and risk of graft rejection seems to be a common strategy in facing the viral infection,” he said. “In addition, the introduction of corticosteroids could help to suspend the onset of the inflammatory cascade responsible for severe forms of the disease.”

Antibiotic prophylaxis appears to be “fundamental,” he added, particularly in hospitalized patients, but “the role of specific antiviral therapies is still not fully understood in our population.”

Since July 1, they’ve seen an additional six patients with a positive test for SARS-CoV-2. Five were asymptomatic and quarantined at home without changing their immunosuppressive therapy. One patient was hospitalized for pneumonia and had immunosuppressive therapy reduced.

Dr. Bottio and the study coauthors have disclosed no relevant financial relationships.

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

Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 reperfusion catheter with Xtra Flex technology (JET 7 Xtra Flex), owing to the risk for “unexpected death or serious injury” during use for clot removal in stroke patients.

“All users should stop using this device, and facilities should remove these devices from inventory,” the recall notice, posted on the U.S. Food and Drug Administration website, advises.

The recall covers the JET 7 Xtra Flex catheter, which was cleared for use in June 2019, and the JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX delivery device), which was cleared in February of this year.

The recall does not apply to the Penumbra JET 7 reperfusion catheter with standard tip.

The FDA says it has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including reports of deaths, serious injuries, and malfunctions.

Twenty of these MDRs describe 14 unique patient deaths. Other MDRs describe serious patient injury, such as vessel damage, hemorrhage, and cerebral infarction.

Device malfunctions described in the reports include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.

According to the FDA, bench testing by the manufacturer, in which the catheter distal tip is plugged and pressurized to failure, indicates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large-bore aspiration catheters used to remove thrombus for patients with acute ischemic stroke.

Penumbra’s urgent medical device recall letter advises health care providers and facilities to remove and quarantine all unused devices covered by this recall, to complete the product identification and return form, and to return all products to Penumbra in accordance with instructions provided.

For questions regarding this recall, contact Penumbra customer service by phone at 888-272-4606 or by email at [email protected].

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

Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 reperfusion catheter with Xtra Flex technology (JET 7 Xtra Flex), owing to the risk for “unexpected death or serious injury” during use for clot removal in stroke patients.

“All users should stop using this device, and facilities should remove these devices from inventory,” the recall notice, posted on the U.S. Food and Drug Administration website, advises.

The recall covers the JET 7 Xtra Flex catheter, which was cleared for use in June 2019, and the JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX delivery device), which was cleared in February of this year.

The recall does not apply to the Penumbra JET 7 reperfusion catheter with standard tip.

The FDA says it has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including reports of deaths, serious injuries, and malfunctions.

Twenty of these MDRs describe 14 unique patient deaths. Other MDRs describe serious patient injury, such as vessel damage, hemorrhage, and cerebral infarction.

Device malfunctions described in the reports include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.

According to the FDA, bench testing by the manufacturer, in which the catheter distal tip is plugged and pressurized to failure, indicates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large-bore aspiration catheters used to remove thrombus for patients with acute ischemic stroke.

Penumbra’s urgent medical device recall letter advises health care providers and facilities to remove and quarantine all unused devices covered by this recall, to complete the product identification and return form, and to return all products to Penumbra in accordance with instructions provided.

For questions regarding this recall, contact Penumbra customer service by phone at 888-272-4606 or by email at [email protected].

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

Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 reperfusion catheter with Xtra Flex technology (JET 7 Xtra Flex), owing to the risk for “unexpected death or serious injury” during use for clot removal in stroke patients.

“All users should stop using this device, and facilities should remove these devices from inventory,” the recall notice, posted on the U.S. Food and Drug Administration website, advises.

The recall covers the JET 7 Xtra Flex catheter, which was cleared for use in June 2019, and the JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX delivery device), which was cleared in February of this year.

The recall does not apply to the Penumbra JET 7 reperfusion catheter with standard tip.

The FDA says it has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including reports of deaths, serious injuries, and malfunctions.

Twenty of these MDRs describe 14 unique patient deaths. Other MDRs describe serious patient injury, such as vessel damage, hemorrhage, and cerebral infarction.

Device malfunctions described in the reports include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.

According to the FDA, bench testing by the manufacturer, in which the catheter distal tip is plugged and pressurized to failure, indicates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large-bore aspiration catheters used to remove thrombus for patients with acute ischemic stroke.

Penumbra’s urgent medical device recall letter advises health care providers and facilities to remove and quarantine all unused devices covered by this recall, to complete the product identification and return form, and to return all products to Penumbra in accordance with instructions provided.

For questions regarding this recall, contact Penumbra customer service by phone at 888-272-4606 or by email at [email protected].

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

The interventional cardiology community is mourning the loss of Anthony “Tony” Gershlick, MBBS, who died Nov. 20 of COVID-19. He was 69 years old.

Dr. Gershlick was a “talented, dedicated and much loved colleague,” reads a statement issued by the University of Leicester (England), where he was affiliated for more than 3 decades.

Dr. Gershlick, a consultant cardiologist at Glenfield Hospital and professor of interventional cardiology, University of Leicester, passed away in the intensive care unit of the hospital where he worked.

Nishan Canagarajah, PhD, president and vice-chancellor, University of Leicester, said Dr. Gershlick “left an indelible mark on the life of the University. He will be remembered with great affection by all and will be sorely missed.”

In 2017, Dr. Gershlick was honored with the inaugural British Cardiovascular Intervention Society (BCIS) Lifetime Achievement Career Award for his “outstanding contribution to the specialty of coronary intervention.”

Gershlick was a pioneer in the field of percutaneous coronary intervention. He was the first UK cardiologist to implant a drug-eluting stent and a bioabsorbable stent, according to an article in the European Heart Journal.

Throughout his career, Dr. Gershlick had been involved in “practice-changing” research that changed the way patients are treated and led to national and international guidelines. He was the UK lead for more than 10 international trials, the university said.

“Tony was determined to push the boundaries of clinical care, to make a difference for his patients, and indeed, patients around the world,” said Philip Baker, DM, FMedSci, head of the College of Life Science, University of Leicester.

Andrew Furlong, medical director at the University Hospitals of Leicester, noted that Dr. Gershlick was “deeply committed to the training and development of junior doctors and registrars and known for his dedication to his field and his patients. He made a difference to many, many lives.”

According to the university, Dr. Gershlick had been working in non-COVID environments since April and was doing much of his work via virtual consultations. He took on cases from other consultants to help during the pandemic and had been working “tirelessly” to provide continuing care to cardiology patients.

The news of Dr. Gershlick’s passing prompted an outpouring of sadness and remembrances of him on Twitter.

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

The interventional cardiology community is mourning the loss of Anthony “Tony” Gershlick, MBBS, who died Nov. 20 of COVID-19. He was 69 years old.

Dr. Gershlick was a “talented, dedicated and much loved colleague,” reads a statement issued by the University of Leicester (England), where he was affiliated for more than 3 decades.

Dr. Gershlick, a consultant cardiologist at Glenfield Hospital and professor of interventional cardiology, University of Leicester, passed away in the intensive care unit of the hospital where he worked.

Nishan Canagarajah, PhD, president and vice-chancellor, University of Leicester, said Dr. Gershlick “left an indelible mark on the life of the University. He will be remembered with great affection by all and will be sorely missed.”

In 2017, Dr. Gershlick was honored with the inaugural British Cardiovascular Intervention Society (BCIS) Lifetime Achievement Career Award for his “outstanding contribution to the specialty of coronary intervention.”

Gershlick was a pioneer in the field of percutaneous coronary intervention. He was the first UK cardiologist to implant a drug-eluting stent and a bioabsorbable stent, according to an article in the European Heart Journal.

Throughout his career, Dr. Gershlick had been involved in “practice-changing” research that changed the way patients are treated and led to national and international guidelines. He was the UK lead for more than 10 international trials, the university said.

“Tony was determined to push the boundaries of clinical care, to make a difference for his patients, and indeed, patients around the world,” said Philip Baker, DM, FMedSci, head of the College of Life Science, University of Leicester.

Andrew Furlong, medical director at the University Hospitals of Leicester, noted that Dr. Gershlick was “deeply committed to the training and development of junior doctors and registrars and known for his dedication to his field and his patients. He made a difference to many, many lives.”

According to the university, Dr. Gershlick had been working in non-COVID environments since April and was doing much of his work via virtual consultations. He took on cases from other consultants to help during the pandemic and had been working “tirelessly” to provide continuing care to cardiology patients.

The news of Dr. Gershlick’s passing prompted an outpouring of sadness and remembrances of him on Twitter.

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

The interventional cardiology community is mourning the loss of Anthony “Tony” Gershlick, MBBS, who died Nov. 20 of COVID-19. He was 69 years old.

Dr. Gershlick was a “talented, dedicated and much loved colleague,” reads a statement issued by the University of Leicester (England), where he was affiliated for more than 3 decades.

Dr. Gershlick, a consultant cardiologist at Glenfield Hospital and professor of interventional cardiology, University of Leicester, passed away in the intensive care unit of the hospital where he worked.

Nishan Canagarajah, PhD, president and vice-chancellor, University of Leicester, said Dr. Gershlick “left an indelible mark on the life of the University. He will be remembered with great affection by all and will be sorely missed.”

In 2017, Dr. Gershlick was honored with the inaugural British Cardiovascular Intervention Society (BCIS) Lifetime Achievement Career Award for his “outstanding contribution to the specialty of coronary intervention.”

Gershlick was a pioneer in the field of percutaneous coronary intervention. He was the first UK cardiologist to implant a drug-eluting stent and a bioabsorbable stent, according to an article in the European Heart Journal.

Throughout his career, Dr. Gershlick had been involved in “practice-changing” research that changed the way patients are treated and led to national and international guidelines. He was the UK lead for more than 10 international trials, the university said.

“Tony was determined to push the boundaries of clinical care, to make a difference for his patients, and indeed, patients around the world,” said Philip Baker, DM, FMedSci, head of the College of Life Science, University of Leicester.

Andrew Furlong, medical director at the University Hospitals of Leicester, noted that Dr. Gershlick was “deeply committed to the training and development of junior doctors and registrars and known for his dedication to his field and his patients. He made a difference to many, many lives.”

According to the university, Dr. Gershlick had been working in non-COVID environments since April and was doing much of his work via virtual consultations. He took on cases from other consultants to help during the pandemic and had been working “tirelessly” to provide continuing care to cardiology patients.

The news of Dr. Gershlick’s passing prompted an outpouring of sadness and remembrances of him on Twitter.

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

One month of dual-antiplatelet therapy followed by aspirin monotherapy in patients who’ve received a drug-eluting stent proved noninferior to 6-12 months of DAPT for a composite 1-year endpoint of cardiovascular events or major bleeding in the large, randomized One-Month DAPT trial.

Svisio/Thinkstock

This is the first test of such a strategy. Other trials of short-course DAPT, such as the successful TWILIGHT trial, have dropped the aspirin and continued the P2Y12 inhibitor. But aspirin monotherapy after a single month of DAPT is an attractive alternative in patients undergoing PCI for noncomplex lesions, Myeong-Ki Hong, MD, PhD, said in presenting his results at the American Heart Association scientific sessions.

“In everyday clinical practice, people receiving P2Y12 receptor blockers usually complain of several episodes of minor bleeding. And the cost. Those are strong factors in patient noncompliance,” he said, adding, “I think aspirin monotherapy is more comfortable for the physician and the patient.”

The One-Month DAPT trial included 3,020 patients who underwent percutaneous coronary intervention with drug-eluting stents (DES) at 23 Korean centers. They were split roughly 60/40 between patients with stable angina and those with acute coronary syndrome involving unstable angina. Patients with complex coronary lesions or acute MI were not eligible for enrollment. Participants were randomized to receive either the polymer-free drug-coated BioFreedom stent, in which case they got 1 month of DAPT followed by 11 months of aspirin antiplatelet monotherapy, or they received 6 or 12 months of DAPT in conjunction with a thick-strut BioMatrix or an Ultimaster polymer-based DES. The reason for using different stents in the two study arms is that only the polymer-free stent completes drug release within 1 month; other contemporary DESs release their drug for 3-4 months, and it’s risky to discontinue one of the antiplatelet agents during drug elution, said Dr. Hong, professor of cardiology at Yonsei University in Seoul, South Korea.
 

Patients with stable angina fared best

The primary endpoint in this noninferiority trial was the 1-year composite of cardiac death, MI, target vessel revascularization, stroke, or major bleeding. The incidence was 5.9% in the 1-month DAPT group, statistically noninferior to the 6.5% figure in the 6- or 12-month DAPT group. The major bleeding rate at 1 year was 1.7% with 1 month of DAPT and 2.5% with 6-12 months of DAPT, a nonsignificant difference. Of note, the primary composite endpoint occurred in 5.1% of patients with stable angina who were randomized to 1 month of DAPT, compared with 7.6% with 6 or 12 months of DAPT, a statistically significant difference that translated into a 33% relative risk reduction. In contrast, in patients with unstable angina the primary endpoint occurred in 7.2% of those on 1 month of DAPT and 5.1% with 6 or 12 months of DAPT, a trend that didn’t reach significance.

Roughly 75% of patients in the long-DAPT arm were assigned to 12 months of DAPT. That’s because the trial began in 2015, before clinical practice guidelines declared 6 months of DAPT to be the recommendation in patients with stable coronary artery disease. The choice of 6 versus 12 months of DAPT in the trial was left up to the patient’s physician.

Discussant Roisin Colleran, MBBCh, said the study addresses “an unmet clinical need” for improved antiplatelet regimens following PCI with DES.
 

Trial’s shortcomings temper reaction

“After a period of short DAPT, aspirin monotherapy may be preferable to P2Y12 monotherapy because it’s cheaper, with fewer off-target side effects, less variation in treatment response, and fewer contraindications,” said Dr. Colleran, a cardiologist at Mater Private Hospital, Dublin.

That being said, she shared several reservations about the study. For one, none of the three stents used in the trial is approved by the Food and Drug Administration. The results may not be generalizable to non–East Asian populations. The use of 12 months of DAPT in stable angina patients is out of step with current U.S. and European practice guidelines, which recommend 6 months. And 17% of patients in the 1-month DAPT group were noncompliant with that strategy, meaning they continued on DAPT; had that reverse noncompliance rate been lower, the between-group difference in the primary endpoint might have become statistically significant.

Dr. Hong said he thinks the study findings are applicable elsewhere in the world. The 1-month DAPT followed by aspirin monotherapy strategy is attractive in elderly patients, those on oral anticoagulation for atrial fibrillation, individuals who need to undergo noncardiac surgery, and in the large group of stable patients with noncomplex coronary lesions.

“Let’s provide these patients with some options,” the cardiologist urged.

He is particularly keen on the combination of a polymer-free stent with a drug-elution period of less than 1 month.

“Is polymer perfect? I don’t think so. The polymer is a foreign body. It’s fantastic, but in 5 or 10 years the polymer may cause irritation and chronic inflammation and a new lesion,” Dr. Hong said.

Session moderator Wayne B. Batchelor, MD, commented on the battle for stent market share: “It almost appears that we’re getting to a ceiling point with coronary interventions whereby at a year we’re getting such low ischemic event rates – they’re often in the 5%-7% range – that all of these [head-to-head] studies are noninferiority studies, because it’s just the only way to do these comparisons nowadays. We can’t do 10-, 15-, or 20,000-patient trials. But these noninferiority margins are quite broad.”

“Are we stuck just saying: ‘All stents are equal,’ or are we going to be able to get to the point that we can show that a healing stent is superior?” asked Dr. Batchelor, director of interventional cardiology and interventional cardiology research at the Inova Medical Group in Falls Church, Va.

“I think it’s going to be very hard to beat the current technology,” observed panelist Alexandre Abizaid, MD, PhD, of the Dante Pazzanese Institute of Cardiology in São Paulo. “Even though the polymers are durable, they’re biocompatible, and they’re hard to beat. It’s not going to be easy to show superiority. Maybe in patient subsets.”

Dr. Hong reported having no financial conflicts of interest regarding the One-Month DAPT trial, funded by DIO, Cardinal Health Korea, and Terumo.

[email protected]

One month of dual-antiplatelet therapy followed by aspirin monotherapy in patients who’ve received a drug-eluting stent proved noninferior to 6-12 months of DAPT for a composite 1-year endpoint of cardiovascular events or major bleeding in the large, randomized One-Month DAPT trial.

Svisio/Thinkstock

This is the first test of such a strategy. Other trials of short-course DAPT, such as the successful TWILIGHT trial, have dropped the aspirin and continued the P2Y12 inhibitor. But aspirin monotherapy after a single month of DAPT is an attractive alternative in patients undergoing PCI for noncomplex lesions, Myeong-Ki Hong, MD, PhD, said in presenting his results at the American Heart Association scientific sessions.

“In everyday clinical practice, people receiving P2Y12 receptor blockers usually complain of several episodes of minor bleeding. And the cost. Those are strong factors in patient noncompliance,” he said, adding, “I think aspirin monotherapy is more comfortable for the physician and the patient.”

The One-Month DAPT trial included 3,020 patients who underwent percutaneous coronary intervention with drug-eluting stents (DES) at 23 Korean centers. They were split roughly 60/40 between patients with stable angina and those with acute coronary syndrome involving unstable angina. Patients with complex coronary lesions or acute MI were not eligible for enrollment. Participants were randomized to receive either the polymer-free drug-coated BioFreedom stent, in which case they got 1 month of DAPT followed by 11 months of aspirin antiplatelet monotherapy, or they received 6 or 12 months of DAPT in conjunction with a thick-strut BioMatrix or an Ultimaster polymer-based DES. The reason for using different stents in the two study arms is that only the polymer-free stent completes drug release within 1 month; other contemporary DESs release their drug for 3-4 months, and it’s risky to discontinue one of the antiplatelet agents during drug elution, said Dr. Hong, professor of cardiology at Yonsei University in Seoul, South Korea.
 

Patients with stable angina fared best

The primary endpoint in this noninferiority trial was the 1-year composite of cardiac death, MI, target vessel revascularization, stroke, or major bleeding. The incidence was 5.9% in the 1-month DAPT group, statistically noninferior to the 6.5% figure in the 6- or 12-month DAPT group. The major bleeding rate at 1 year was 1.7% with 1 month of DAPT and 2.5% with 6-12 months of DAPT, a nonsignificant difference. Of note, the primary composite endpoint occurred in 5.1% of patients with stable angina who were randomized to 1 month of DAPT, compared with 7.6% with 6 or 12 months of DAPT, a statistically significant difference that translated into a 33% relative risk reduction. In contrast, in patients with unstable angina the primary endpoint occurred in 7.2% of those on 1 month of DAPT and 5.1% with 6 or 12 months of DAPT, a trend that didn’t reach significance.

Roughly 75% of patients in the long-DAPT arm were assigned to 12 months of DAPT. That’s because the trial began in 2015, before clinical practice guidelines declared 6 months of DAPT to be the recommendation in patients with stable coronary artery disease. The choice of 6 versus 12 months of DAPT in the trial was left up to the patient’s physician.

Discussant Roisin Colleran, MBBCh, said the study addresses “an unmet clinical need” for improved antiplatelet regimens following PCI with DES.
 

Trial’s shortcomings temper reaction

“After a period of short DAPT, aspirin monotherapy may be preferable to P2Y12 monotherapy because it’s cheaper, with fewer off-target side effects, less variation in treatment response, and fewer contraindications,” said Dr. Colleran, a cardiologist at Mater Private Hospital, Dublin.

That being said, she shared several reservations about the study. For one, none of the three stents used in the trial is approved by the Food and Drug Administration. The results may not be generalizable to non–East Asian populations. The use of 12 months of DAPT in stable angina patients is out of step with current U.S. and European practice guidelines, which recommend 6 months. And 17% of patients in the 1-month DAPT group were noncompliant with that strategy, meaning they continued on DAPT; had that reverse noncompliance rate been lower, the between-group difference in the primary endpoint might have become statistically significant.

Dr. Hong said he thinks the study findings are applicable elsewhere in the world. The 1-month DAPT followed by aspirin monotherapy strategy is attractive in elderly patients, those on oral anticoagulation for atrial fibrillation, individuals who need to undergo noncardiac surgery, and in the large group of stable patients with noncomplex coronary lesions.

“Let’s provide these patients with some options,” the cardiologist urged.

He is particularly keen on the combination of a polymer-free stent with a drug-elution period of less than 1 month.

“Is polymer perfect? I don’t think so. The polymer is a foreign body. It’s fantastic, but in 5 or 10 years the polymer may cause irritation and chronic inflammation and a new lesion,” Dr. Hong said.

Session moderator Wayne B. Batchelor, MD, commented on the battle for stent market share: “It almost appears that we’re getting to a ceiling point with coronary interventions whereby at a year we’re getting such low ischemic event rates – they’re often in the 5%-7% range – that all of these [head-to-head] studies are noninferiority studies, because it’s just the only way to do these comparisons nowadays. We can’t do 10-, 15-, or 20,000-patient trials. But these noninferiority margins are quite broad.”

“Are we stuck just saying: ‘All stents are equal,’ or are we going to be able to get to the point that we can show that a healing stent is superior?” asked Dr. Batchelor, director of interventional cardiology and interventional cardiology research at the Inova Medical Group in Falls Church, Va.

“I think it’s going to be very hard to beat the current technology,” observed panelist Alexandre Abizaid, MD, PhD, of the Dante Pazzanese Institute of Cardiology in São Paulo. “Even though the polymers are durable, they’re biocompatible, and they’re hard to beat. It’s not going to be easy to show superiority. Maybe in patient subsets.”

Dr. Hong reported having no financial conflicts of interest regarding the One-Month DAPT trial, funded by DIO, Cardinal Health Korea, and Terumo.

[email protected]

One month of dual-antiplatelet therapy followed by aspirin monotherapy in patients who’ve received a drug-eluting stent proved noninferior to 6-12 months of DAPT for a composite 1-year endpoint of cardiovascular events or major bleeding in the large, randomized One-Month DAPT trial.

Svisio/Thinkstock

This is the first test of such a strategy. Other trials of short-course DAPT, such as the successful TWILIGHT trial, have dropped the aspirin and continued the P2Y12 inhibitor. But aspirin monotherapy after a single month of DAPT is an attractive alternative in patients undergoing PCI for noncomplex lesions, Myeong-Ki Hong, MD, PhD, said in presenting his results at the American Heart Association scientific sessions.

“In everyday clinical practice, people receiving P2Y12 receptor blockers usually complain of several episodes of minor bleeding. And the cost. Those are strong factors in patient noncompliance,” he said, adding, “I think aspirin monotherapy is more comfortable for the physician and the patient.”

The One-Month DAPT trial included 3,020 patients who underwent percutaneous coronary intervention with drug-eluting stents (DES) at 23 Korean centers. They were split roughly 60/40 between patients with stable angina and those with acute coronary syndrome involving unstable angina. Patients with complex coronary lesions or acute MI were not eligible for enrollment. Participants were randomized to receive either the polymer-free drug-coated BioFreedom stent, in which case they got 1 month of DAPT followed by 11 months of aspirin antiplatelet monotherapy, or they received 6 or 12 months of DAPT in conjunction with a thick-strut BioMatrix or an Ultimaster polymer-based DES. The reason for using different stents in the two study arms is that only the polymer-free stent completes drug release within 1 month; other contemporary DESs release their drug for 3-4 months, and it’s risky to discontinue one of the antiplatelet agents during drug elution, said Dr. Hong, professor of cardiology at Yonsei University in Seoul, South Korea.
 

Patients with stable angina fared best

The primary endpoint in this noninferiority trial was the 1-year composite of cardiac death, MI, target vessel revascularization, stroke, or major bleeding. The incidence was 5.9% in the 1-month DAPT group, statistically noninferior to the 6.5% figure in the 6- or 12-month DAPT group. The major bleeding rate at 1 year was 1.7% with 1 month of DAPT and 2.5% with 6-12 months of DAPT, a nonsignificant difference. Of note, the primary composite endpoint occurred in 5.1% of patients with stable angina who were randomized to 1 month of DAPT, compared with 7.6% with 6 or 12 months of DAPT, a statistically significant difference that translated into a 33% relative risk reduction. In contrast, in patients with unstable angina the primary endpoint occurred in 7.2% of those on 1 month of DAPT and 5.1% with 6 or 12 months of DAPT, a trend that didn’t reach significance.

Roughly 75% of patients in the long-DAPT arm were assigned to 12 months of DAPT. That’s because the trial began in 2015, before clinical practice guidelines declared 6 months of DAPT to be the recommendation in patients with stable coronary artery disease. The choice of 6 versus 12 months of DAPT in the trial was left up to the patient’s physician.

Discussant Roisin Colleran, MBBCh, said the study addresses “an unmet clinical need” for improved antiplatelet regimens following PCI with DES.
 

Trial’s shortcomings temper reaction

“After a period of short DAPT, aspirin monotherapy may be preferable to P2Y12 monotherapy because it’s cheaper, with fewer off-target side effects, less variation in treatment response, and fewer contraindications,” said Dr. Colleran, a cardiologist at Mater Private Hospital, Dublin.

That being said, she shared several reservations about the study. For one, none of the three stents used in the trial is approved by the Food and Drug Administration. The results may not be generalizable to non–East Asian populations. The use of 12 months of DAPT in stable angina patients is out of step with current U.S. and European practice guidelines, which recommend 6 months. And 17% of patients in the 1-month DAPT group were noncompliant with that strategy, meaning they continued on DAPT; had that reverse noncompliance rate been lower, the between-group difference in the primary endpoint might have become statistically significant.

Dr. Hong said he thinks the study findings are applicable elsewhere in the world. The 1-month DAPT followed by aspirin monotherapy strategy is attractive in elderly patients, those on oral anticoagulation for atrial fibrillation, individuals who need to undergo noncardiac surgery, and in the large group of stable patients with noncomplex coronary lesions.

“Let’s provide these patients with some options,” the cardiologist urged.

He is particularly keen on the combination of a polymer-free stent with a drug-elution period of less than 1 month.

“Is polymer perfect? I don’t think so. The polymer is a foreign body. It’s fantastic, but in 5 or 10 years the polymer may cause irritation and chronic inflammation and a new lesion,” Dr. Hong said.

Session moderator Wayne B. Batchelor, MD, commented on the battle for stent market share: “It almost appears that we’re getting to a ceiling point with coronary interventions whereby at a year we’re getting such low ischemic event rates – they’re often in the 5%-7% range – that all of these [head-to-head] studies are noninferiority studies, because it’s just the only way to do these comparisons nowadays. We can’t do 10-, 15-, or 20,000-patient trials. But these noninferiority margins are quite broad.”

“Are we stuck just saying: ‘All stents are equal,’ or are we going to be able to get to the point that we can show that a healing stent is superior?” asked Dr. Batchelor, director of interventional cardiology and interventional cardiology research at the Inova Medical Group in Falls Church, Va.

“I think it’s going to be very hard to beat the current technology,” observed panelist Alexandre Abizaid, MD, PhD, of the Dante Pazzanese Institute of Cardiology in São Paulo. “Even though the polymers are durable, they’re biocompatible, and they’re hard to beat. It’s not going to be easy to show superiority. Maybe in patient subsets.”

Dr. Hong reported having no financial conflicts of interest regarding the One-Month DAPT trial, funded by DIO, Cardinal Health Korea, and Terumo.

[email protected]

Restricting percutaneous interventions (PCI) to only those stenotic lesions that are ischemic by fractional flow reserve (FFR) thresholds is associated with better 5-year outcomes whether or not PCI is deployed, according to a cohort study presented at the American Heart Association scientific sessions.

For those that met the FFR threshold for ischemia, defined as up to 0.80, PCI reduced the risk of a major adverse cardiac event (MACE) at 5 years by 23% (hazard ratio, 0.77) relative to no PCI. Conversely, those not indicated for PCI because of a higher FFR had a 37% higher risk of MACE (HR, 1.37) at 5 years if treated with PCI relative to those who were not.

“The story of overuse of PCI is important,” reported the senior author Dennis Ko, MD, a scientist affiliated with the Schulich Heart Research Program, Sunnybrook Research Institute, University of Toronto, Canada. “We as interventionalists often think that putting in a stent is not harmful, and that turned out not to be the case.”

The FFR threshold for intervening with PCI is evidence based. Several trials, including one published in 2014, have associated PCI with better outcomes relative to medical therapy when FFR is 0.80 or lower. Other evidence suggests no advantage and possible harm for PCI performed if FFR is higher. Multiple guidelines, including those from the AHA, recommend against PCI if FFR is more than 0.80.

“As FRR is gaining in popularity, we were interested in whether physicians follow the thresholds in routine clinical practice and what happens to patient outcomes [if they are or are not followed],” Dr. Ko explained.

In this retrospective study by Dr. Ko’s trainee, Maneesh Sud, MD, and simultaneously published in JAMA, the answer was that there is deviation, and deviation leads to bad outcomes.

The 9,106 coronary artery disease patients included in the study underwent single-vessel FFR assessment within a 5-year period in Canada. The two cohorts evaluated were those with a lesional FFR of 0.80 or less, defined as ischemic, and those with a lesion with higher FFR, defined as nonischemic. The primary MACE outcome comprised death, myocardial infarction, unstable angina, or urgent coronary revascularization.

Of the 2,693 patients who met the FFR threshold of ischemia, 75.3% received PCI, and 24.7% were treated with medical therapy only. Of the 6,413 patients with nonischemic FFR, 87.4% were treated with medical therapy and 12.6% received PCI.

In those with ischemic FFR, event curves for MACE separated rapidly. At 30 days, the risk of MACE was 53% lower (HR, 0.47) in those receiving PCI. By 1 year, the advantage was less (HR, 0.76), but it was steady thereafter and remained about the same at 5 years (HR, 0.77; 95% confidence interval, 0.63-0.94). Relative advantages for each component of MACE went in the same direction. At 5 years, PCI exerted its greatest numerical advantage for the outcome or urgent coronary revascularization (HR, 0.71) and its least numerical advantage for MI (HR, 0.92), but none of these differences reached statistical significance.

In those with nonischemic coronary lesions on FFR, PCI was associated with more than twice the risk for MACE at 30 days (HR, 2.11), but the increase in risk relative to medical management fell at 1 year (HR 1.67) and 5 years (HR, 1.37). All of the individual components of MACE were numerically increased at all time points except for death, which was numerically lower at 30 days (HR, 0.41) and 5 years (HR, 0.94), even though these differences were not significant.

It could not be ascertained from these data why PCI was not performed when there was an indication or why it was performed when there was not. The investigators speculated that some clinicians may decide against PCI for ischemic lesions in the absence of symptoms or when concerned about comorbidities. They might offer PCI in nonischemic lesions because of symptoms, positive tests other than FFR, or FFR values near the threshold.

“I think the main message of our paper is that adherence of the FFR threshold as established by clinical trials is important,” Dr. Ko said in an interview. This not only means performing PCI when it is indicated, but refraining from PCI when it is not.

Basically, this study confirms that the guideline thresholds are valid, according to Jared M. O’Leary, MD, who is experienced with FFR and is Medical Director for Quality at the Vanderbilt Heart and Vascular Institute, Nashville, Tenn.

“It confirms the utility of FFR in the real world,” he said, adding that the results are “totally consistent with our practice.” He called FFR “an important tool in the cardiac cath lab” not only for determining when revascularization will benefit the patient but the opposite.

“The flip side is also true: Stenting should be avoided if a negative FFR is obtained,” he said, calling this technique “particularly useful for lesions that appear borderline by visual estimation alone.”
 

SOURCE: Sud M et al. AHA 2020. JAMA. 2020 Nov 13. doi: 10.1001/jama.2020.22708.

Restricting percutaneous interventions (PCI) to only those stenotic lesions that are ischemic by fractional flow reserve (FFR) thresholds is associated with better 5-year outcomes whether or not PCI is deployed, according to a cohort study presented at the American Heart Association scientific sessions.

For those that met the FFR threshold for ischemia, defined as up to 0.80, PCI reduced the risk of a major adverse cardiac event (MACE) at 5 years by 23% (hazard ratio, 0.77) relative to no PCI. Conversely, those not indicated for PCI because of a higher FFR had a 37% higher risk of MACE (HR, 1.37) at 5 years if treated with PCI relative to those who were not.

“The story of overuse of PCI is important,” reported the senior author Dennis Ko, MD, a scientist affiliated with the Schulich Heart Research Program, Sunnybrook Research Institute, University of Toronto, Canada. “We as interventionalists often think that putting in a stent is not harmful, and that turned out not to be the case.”

The FFR threshold for intervening with PCI is evidence based. Several trials, including one published in 2014, have associated PCI with better outcomes relative to medical therapy when FFR is 0.80 or lower. Other evidence suggests no advantage and possible harm for PCI performed if FFR is higher. Multiple guidelines, including those from the AHA, recommend against PCI if FFR is more than 0.80.

“As FRR is gaining in popularity, we were interested in whether physicians follow the thresholds in routine clinical practice and what happens to patient outcomes [if they are or are not followed],” Dr. Ko explained.

In this retrospective study by Dr. Ko’s trainee, Maneesh Sud, MD, and simultaneously published in JAMA, the answer was that there is deviation, and deviation leads to bad outcomes.

The 9,106 coronary artery disease patients included in the study underwent single-vessel FFR assessment within a 5-year period in Canada. The two cohorts evaluated were those with a lesional FFR of 0.80 or less, defined as ischemic, and those with a lesion with higher FFR, defined as nonischemic. The primary MACE outcome comprised death, myocardial infarction, unstable angina, or urgent coronary revascularization.

Of the 2,693 patients who met the FFR threshold of ischemia, 75.3% received PCI, and 24.7% were treated with medical therapy only. Of the 6,413 patients with nonischemic FFR, 87.4% were treated with medical therapy and 12.6% received PCI.

In those with ischemic FFR, event curves for MACE separated rapidly. At 30 days, the risk of MACE was 53% lower (HR, 0.47) in those receiving PCI. By 1 year, the advantage was less (HR, 0.76), but it was steady thereafter and remained about the same at 5 years (HR, 0.77; 95% confidence interval, 0.63-0.94). Relative advantages for each component of MACE went in the same direction. At 5 years, PCI exerted its greatest numerical advantage for the outcome or urgent coronary revascularization (HR, 0.71) and its least numerical advantage for MI (HR, 0.92), but none of these differences reached statistical significance.

In those with nonischemic coronary lesions on FFR, PCI was associated with more than twice the risk for MACE at 30 days (HR, 2.11), but the increase in risk relative to medical management fell at 1 year (HR 1.67) and 5 years (HR, 1.37). All of the individual components of MACE were numerically increased at all time points except for death, which was numerically lower at 30 days (HR, 0.41) and 5 years (HR, 0.94), even though these differences were not significant.

It could not be ascertained from these data why PCI was not performed when there was an indication or why it was performed when there was not. The investigators speculated that some clinicians may decide against PCI for ischemic lesions in the absence of symptoms or when concerned about comorbidities. They might offer PCI in nonischemic lesions because of symptoms, positive tests other than FFR, or FFR values near the threshold.

“I think the main message of our paper is that adherence of the FFR threshold as established by clinical trials is important,” Dr. Ko said in an interview. This not only means performing PCI when it is indicated, but refraining from PCI when it is not.

Basically, this study confirms that the guideline thresholds are valid, according to Jared M. O’Leary, MD, who is experienced with FFR and is Medical Director for Quality at the Vanderbilt Heart and Vascular Institute, Nashville, Tenn.

“It confirms the utility of FFR in the real world,” he said, adding that the results are “totally consistent with our practice.” He called FFR “an important tool in the cardiac cath lab” not only for determining when revascularization will benefit the patient but the opposite.

“The flip side is also true: Stenting should be avoided if a negative FFR is obtained,” he said, calling this technique “particularly useful for lesions that appear borderline by visual estimation alone.”
 

SOURCE: Sud M et al. AHA 2020. JAMA. 2020 Nov 13. doi: 10.1001/jama.2020.22708.

Restricting percutaneous interventions (PCI) to only those stenotic lesions that are ischemic by fractional flow reserve (FFR) thresholds is associated with better 5-year outcomes whether or not PCI is deployed, according to a cohort study presented at the American Heart Association scientific sessions.

For those that met the FFR threshold for ischemia, defined as up to 0.80, PCI reduced the risk of a major adverse cardiac event (MACE) at 5 years by 23% (hazard ratio, 0.77) relative to no PCI. Conversely, those not indicated for PCI because of a higher FFR had a 37% higher risk of MACE (HR, 1.37) at 5 years if treated with PCI relative to those who were not.

“The story of overuse of PCI is important,” reported the senior author Dennis Ko, MD, a scientist affiliated with the Schulich Heart Research Program, Sunnybrook Research Institute, University of Toronto, Canada. “We as interventionalists often think that putting in a stent is not harmful, and that turned out not to be the case.”

The FFR threshold for intervening with PCI is evidence based. Several trials, including one published in 2014, have associated PCI with better outcomes relative to medical therapy when FFR is 0.80 or lower. Other evidence suggests no advantage and possible harm for PCI performed if FFR is higher. Multiple guidelines, including those from the AHA, recommend against PCI if FFR is more than 0.80.

“As FRR is gaining in popularity, we were interested in whether physicians follow the thresholds in routine clinical practice and what happens to patient outcomes [if they are or are not followed],” Dr. Ko explained.

In this retrospective study by Dr. Ko’s trainee, Maneesh Sud, MD, and simultaneously published in JAMA, the answer was that there is deviation, and deviation leads to bad outcomes.

The 9,106 coronary artery disease patients included in the study underwent single-vessel FFR assessment within a 5-year period in Canada. The two cohorts evaluated were those with a lesional FFR of 0.80 or less, defined as ischemic, and those with a lesion with higher FFR, defined as nonischemic. The primary MACE outcome comprised death, myocardial infarction, unstable angina, or urgent coronary revascularization.

Of the 2,693 patients who met the FFR threshold of ischemia, 75.3% received PCI, and 24.7% were treated with medical therapy only. Of the 6,413 patients with nonischemic FFR, 87.4% were treated with medical therapy and 12.6% received PCI.

In those with ischemic FFR, event curves for MACE separated rapidly. At 30 days, the risk of MACE was 53% lower (HR, 0.47) in those receiving PCI. By 1 year, the advantage was less (HR, 0.76), but it was steady thereafter and remained about the same at 5 years (HR, 0.77; 95% confidence interval, 0.63-0.94). Relative advantages for each component of MACE went in the same direction. At 5 years, PCI exerted its greatest numerical advantage for the outcome or urgent coronary revascularization (HR, 0.71) and its least numerical advantage for MI (HR, 0.92), but none of these differences reached statistical significance.

In those with nonischemic coronary lesions on FFR, PCI was associated with more than twice the risk for MACE at 30 days (HR, 2.11), but the increase in risk relative to medical management fell at 1 year (HR 1.67) and 5 years (HR, 1.37). All of the individual components of MACE were numerically increased at all time points except for death, which was numerically lower at 30 days (HR, 0.41) and 5 years (HR, 0.94), even though these differences were not significant.

It could not be ascertained from these data why PCI was not performed when there was an indication or why it was performed when there was not. The investigators speculated that some clinicians may decide against PCI for ischemic lesions in the absence of symptoms or when concerned about comorbidities. They might offer PCI in nonischemic lesions because of symptoms, positive tests other than FFR, or FFR values near the threshold.

“I think the main message of our paper is that adherence of the FFR threshold as established by clinical trials is important,” Dr. Ko said in an interview. This not only means performing PCI when it is indicated, but refraining from PCI when it is not.

Basically, this study confirms that the guideline thresholds are valid, according to Jared M. O’Leary, MD, who is experienced with FFR and is Medical Director for Quality at the Vanderbilt Heart and Vascular Institute, Nashville, Tenn.

“It confirms the utility of FFR in the real world,” he said, adding that the results are “totally consistent with our practice.” He called FFR “an important tool in the cardiac cath lab” not only for determining when revascularization will benefit the patient but the opposite.

“The flip side is also true: Stenting should be avoided if a negative FFR is obtained,” he said, calling this technique “particularly useful for lesions that appear borderline by visual estimation alone.”
 

SOURCE: Sud M et al. AHA 2020. JAMA. 2020 Nov 13. doi: 10.1001/jama.2020.22708.