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Mitchel is a reporter for MDedge based in the Philadelphia area. He started with the company in 1992, when it was International Medical News Group (IMNG), and has since covered a range of medical specialties. Mitchel trained as a virologist at Roswell Park Memorial Institute in Buffalo, and then worked briefly as a researcher at Boston Children's Hospital before pivoting to journalism as a AAAS Mass Media Fellow in 1980. His first reporting job was with Science Digest magazine, and from the mid-1980s to early-1990s he was a reporter with Medical World News. @mitchelzoler
MADIT-CHIC: CRT aids patients with chemotherapy-induced cardiomyopathy
SAN FRANCISCO – Patients with cardiomyopathy secondary to cancer chemotherapy who qualified for cardiac resynchronization therapy (CRT) by having a wide QRS interval showed a virtually uniform, positive response to this treatment in a multicenter study with 30 patients.
This is the first time this therapy has been prospectively assessed in this patient population.
The results “show for the first time that patients with chemotherapy-induced cardiomyopathy [CHIC] who meet criteria for CRT show significant improvement in left ventricular function and clinical symptoms in the short term” during follow-up of 6 months, Jagmeet P. Singh, MD, said at the annual scientific sessions of the Heart Rhythm Society.
Dr. Singh acknowledged that, with 30 patients, the study was small, uncontrolled, had a brief follow-up of 6 months, and was highly selective. It took collaborating investigators at 12 U.S. centers more than 3.5 years to find the 30 participating patients, who had to meet very specific criteria designed to identify true CHIC. Nonetheless, Dr. Singh considered the results convincing enough to shift practice.
Based on the results, “I would certainly feel comfortable using CRT in patients with CHIC,” said Dr. Singh, associate chief of cardiology at Massachusetts General Hospital and professor of medicine at Harvard Medical School, both in Boston. “If a patient has CHIC with a wide QRS interval and evidence for a conduction defect on their ECG, they are a great candidate for CRT. The results highlight that there is a cohort of patients who develop cardiomyopathy after chemotherapy, and these patients are often written off” and until now have generally received little follow-up for their potential development of cardiomyopathy. Dr. Singh expressed hope that the recent emergence of cardio-oncology as a subspecialty will focus attention on CHIC patients.
The MADIT-CHIC (Multicenter Automatic Defibrillator Implantation Trial – Chemotherapy-Induced Cardiomyopathy) study enrolled patients with a history of exposure to a cancer chemotherapy regimen known to cause cardiomyopathy who had no history of heart failure prior to the chemotherapy. All patients had developed clinically apparent heart failure (New York Heart Association functional class II, III, or IV) at least 6 months after completing chemotherapy, had no other apparent cause of the cardiomyopathy as ascertained by a cardio-oncologist, and were on guideline-directed medical therapy. Enrolled patients also had to have a class I or II indication for CRT, with a left ventricular ejection fraction of 35% or less, a QRS interval of at least 120 milliseconds, sinus rhythm and left bundle branch block, or no left bundle branch block and a QRS of at least 150 milliseconds.
Just over three-quarters of the patients had received an anthracycline drug, and 73% had a history of breast cancer, 20% a history of leukemia or lymphoma, and 7% had a history of sarcoma. The patients averaged 64 years of age, and 87% were women. CRT placement occurred 18-256 months after the end of chemotherapy, with a median of 188 months.
The study’s primary endpoint was the change in left ventricular ejection fraction after 6 months, which increased from an average of 28% at baseline to 39% at follow-up, a statistically significant change. Ejection fraction increased in 29 of the 30 patients, with one patient showing a flat response to CRT. Cardiac function and geometry significantly improved by seven other measures, including left ventricular mass and left atrial volume, and the improved ejection fraction was consistent across several subgroup analyses. Patients’ NYHA functional class improved by at least one level in 41% of patients, and 83% of the patients stopped showing clinical features of heart failure after 6 months on CRT.
MADIT-CHIC received funding from Boston Scientific. Dr. Singh has been a consultant to Abbott, Back Beat, Biotronik, Boston Scientific, EBR, Impulse Dynamics, Medtronic, Microport, St. Jude, and Toray, and he has received research support from Abbott and Boston Scientific.
SOURCE: Singh JP et al. HRS 2019, Abstract S-LBCT02-04.
No guideline currently addresses using cardiac resynchronization therapy to treat chemotherapy-induced cardiomyopathy. The findings from MADIT-CHIC showed a striking benefit from treatment with cardiac resynchronization therapy of a magnitude we would expect to see in patients with nonischemic cardiomyopathy. Patients showed improvements in all measures of cardiac performance.
It appears that CHIC can take as long as decades to appear in a patient, but we now need to have a high level of suspicion for this complication. We need to come up with better ways to monitor development of CHIC in patients who have received cancer chemotherapy so that we can give eligible patients this beneficial treatment. We can be optimistic about the potential for benefit from CRT in these patients.
Kenneth A. Ellenbogen, MD , is chief of cardiology and a professor of medicine at Virginia Commonwealth University in Richmond, Va. He has been a consultant to Boston Scientific, Medtronic, and St. Jude; he has received honoraria from Biotronik; and he has received research funding from Boston Scientific and Medtronic. He made these comments as the designated discussant for the MADIT-CHIC report.
No guideline currently addresses using cardiac resynchronization therapy to treat chemotherapy-induced cardiomyopathy. The findings from MADIT-CHIC showed a striking benefit from treatment with cardiac resynchronization therapy of a magnitude we would expect to see in patients with nonischemic cardiomyopathy. Patients showed improvements in all measures of cardiac performance.
It appears that CHIC can take as long as decades to appear in a patient, but we now need to have a high level of suspicion for this complication. We need to come up with better ways to monitor development of CHIC in patients who have received cancer chemotherapy so that we can give eligible patients this beneficial treatment. We can be optimistic about the potential for benefit from CRT in these patients.
Kenneth A. Ellenbogen, MD , is chief of cardiology and a professor of medicine at Virginia Commonwealth University in Richmond, Va. He has been a consultant to Boston Scientific, Medtronic, and St. Jude; he has received honoraria from Biotronik; and he has received research funding from Boston Scientific and Medtronic. He made these comments as the designated discussant for the MADIT-CHIC report.
No guideline currently addresses using cardiac resynchronization therapy to treat chemotherapy-induced cardiomyopathy. The findings from MADIT-CHIC showed a striking benefit from treatment with cardiac resynchronization therapy of a magnitude we would expect to see in patients with nonischemic cardiomyopathy. Patients showed improvements in all measures of cardiac performance.
It appears that CHIC can take as long as decades to appear in a patient, but we now need to have a high level of suspicion for this complication. We need to come up with better ways to monitor development of CHIC in patients who have received cancer chemotherapy so that we can give eligible patients this beneficial treatment. We can be optimistic about the potential for benefit from CRT in these patients.
Kenneth A. Ellenbogen, MD , is chief of cardiology and a professor of medicine at Virginia Commonwealth University in Richmond, Va. He has been a consultant to Boston Scientific, Medtronic, and St. Jude; he has received honoraria from Biotronik; and he has received research funding from Boston Scientific and Medtronic. He made these comments as the designated discussant for the MADIT-CHIC report.
SAN FRANCISCO – Patients with cardiomyopathy secondary to cancer chemotherapy who qualified for cardiac resynchronization therapy (CRT) by having a wide QRS interval showed a virtually uniform, positive response to this treatment in a multicenter study with 30 patients.
This is the first time this therapy has been prospectively assessed in this patient population.
The results “show for the first time that patients with chemotherapy-induced cardiomyopathy [CHIC] who meet criteria for CRT show significant improvement in left ventricular function and clinical symptoms in the short term” during follow-up of 6 months, Jagmeet P. Singh, MD, said at the annual scientific sessions of the Heart Rhythm Society.
Dr. Singh acknowledged that, with 30 patients, the study was small, uncontrolled, had a brief follow-up of 6 months, and was highly selective. It took collaborating investigators at 12 U.S. centers more than 3.5 years to find the 30 participating patients, who had to meet very specific criteria designed to identify true CHIC. Nonetheless, Dr. Singh considered the results convincing enough to shift practice.
Based on the results, “I would certainly feel comfortable using CRT in patients with CHIC,” said Dr. Singh, associate chief of cardiology at Massachusetts General Hospital and professor of medicine at Harvard Medical School, both in Boston. “If a patient has CHIC with a wide QRS interval and evidence for a conduction defect on their ECG, they are a great candidate for CRT. The results highlight that there is a cohort of patients who develop cardiomyopathy after chemotherapy, and these patients are often written off” and until now have generally received little follow-up for their potential development of cardiomyopathy. Dr. Singh expressed hope that the recent emergence of cardio-oncology as a subspecialty will focus attention on CHIC patients.
The MADIT-CHIC (Multicenter Automatic Defibrillator Implantation Trial – Chemotherapy-Induced Cardiomyopathy) study enrolled patients with a history of exposure to a cancer chemotherapy regimen known to cause cardiomyopathy who had no history of heart failure prior to the chemotherapy. All patients had developed clinically apparent heart failure (New York Heart Association functional class II, III, or IV) at least 6 months after completing chemotherapy, had no other apparent cause of the cardiomyopathy as ascertained by a cardio-oncologist, and were on guideline-directed medical therapy. Enrolled patients also had to have a class I or II indication for CRT, with a left ventricular ejection fraction of 35% or less, a QRS interval of at least 120 milliseconds, sinus rhythm and left bundle branch block, or no left bundle branch block and a QRS of at least 150 milliseconds.
Just over three-quarters of the patients had received an anthracycline drug, and 73% had a history of breast cancer, 20% a history of leukemia or lymphoma, and 7% had a history of sarcoma. The patients averaged 64 years of age, and 87% were women. CRT placement occurred 18-256 months after the end of chemotherapy, with a median of 188 months.
The study’s primary endpoint was the change in left ventricular ejection fraction after 6 months, which increased from an average of 28% at baseline to 39% at follow-up, a statistically significant change. Ejection fraction increased in 29 of the 30 patients, with one patient showing a flat response to CRT. Cardiac function and geometry significantly improved by seven other measures, including left ventricular mass and left atrial volume, and the improved ejection fraction was consistent across several subgroup analyses. Patients’ NYHA functional class improved by at least one level in 41% of patients, and 83% of the patients stopped showing clinical features of heart failure after 6 months on CRT.
MADIT-CHIC received funding from Boston Scientific. Dr. Singh has been a consultant to Abbott, Back Beat, Biotronik, Boston Scientific, EBR, Impulse Dynamics, Medtronic, Microport, St. Jude, and Toray, and he has received research support from Abbott and Boston Scientific.
SOURCE: Singh JP et al. HRS 2019, Abstract S-LBCT02-04.
SAN FRANCISCO – Patients with cardiomyopathy secondary to cancer chemotherapy who qualified for cardiac resynchronization therapy (CRT) by having a wide QRS interval showed a virtually uniform, positive response to this treatment in a multicenter study with 30 patients.
This is the first time this therapy has been prospectively assessed in this patient population.
The results “show for the first time that patients with chemotherapy-induced cardiomyopathy [CHIC] who meet criteria for CRT show significant improvement in left ventricular function and clinical symptoms in the short term” during follow-up of 6 months, Jagmeet P. Singh, MD, said at the annual scientific sessions of the Heart Rhythm Society.
Dr. Singh acknowledged that, with 30 patients, the study was small, uncontrolled, had a brief follow-up of 6 months, and was highly selective. It took collaborating investigators at 12 U.S. centers more than 3.5 years to find the 30 participating patients, who had to meet very specific criteria designed to identify true CHIC. Nonetheless, Dr. Singh considered the results convincing enough to shift practice.
Based on the results, “I would certainly feel comfortable using CRT in patients with CHIC,” said Dr. Singh, associate chief of cardiology at Massachusetts General Hospital and professor of medicine at Harvard Medical School, both in Boston. “If a patient has CHIC with a wide QRS interval and evidence for a conduction defect on their ECG, they are a great candidate for CRT. The results highlight that there is a cohort of patients who develop cardiomyopathy after chemotherapy, and these patients are often written off” and until now have generally received little follow-up for their potential development of cardiomyopathy. Dr. Singh expressed hope that the recent emergence of cardio-oncology as a subspecialty will focus attention on CHIC patients.
The MADIT-CHIC (Multicenter Automatic Defibrillator Implantation Trial – Chemotherapy-Induced Cardiomyopathy) study enrolled patients with a history of exposure to a cancer chemotherapy regimen known to cause cardiomyopathy who had no history of heart failure prior to the chemotherapy. All patients had developed clinically apparent heart failure (New York Heart Association functional class II, III, or IV) at least 6 months after completing chemotherapy, had no other apparent cause of the cardiomyopathy as ascertained by a cardio-oncologist, and were on guideline-directed medical therapy. Enrolled patients also had to have a class I or II indication for CRT, with a left ventricular ejection fraction of 35% or less, a QRS interval of at least 120 milliseconds, sinus rhythm and left bundle branch block, or no left bundle branch block and a QRS of at least 150 milliseconds.
Just over three-quarters of the patients had received an anthracycline drug, and 73% had a history of breast cancer, 20% a history of leukemia or lymphoma, and 7% had a history of sarcoma. The patients averaged 64 years of age, and 87% were women. CRT placement occurred 18-256 months after the end of chemotherapy, with a median of 188 months.
The study’s primary endpoint was the change in left ventricular ejection fraction after 6 months, which increased from an average of 28% at baseline to 39% at follow-up, a statistically significant change. Ejection fraction increased in 29 of the 30 patients, with one patient showing a flat response to CRT. Cardiac function and geometry significantly improved by seven other measures, including left ventricular mass and left atrial volume, and the improved ejection fraction was consistent across several subgroup analyses. Patients’ NYHA functional class improved by at least one level in 41% of patients, and 83% of the patients stopped showing clinical features of heart failure after 6 months on CRT.
MADIT-CHIC received funding from Boston Scientific. Dr. Singh has been a consultant to Abbott, Back Beat, Biotronik, Boston Scientific, EBR, Impulse Dynamics, Medtronic, Microport, St. Jude, and Toray, and he has received research support from Abbott and Boston Scientific.
SOURCE: Singh JP et al. HRS 2019, Abstract S-LBCT02-04.
REPORTING FROM HEART RHYTHM 2019
Transcatheter pulmonary valve shows 5-year durability in postapproval study
LAS VEGAS – that followed 65 patients, a majority of whom were children or teenagers.
After 5 years, 69% of the replacement valve recipients had no valvular hemodynamic dysfunction, compared with a 67% rate among patients enrolled in the original Investigational Device Exemption (IDE) study that led to Food and Drug Administration marketing approval for the Melody valve in 2010 under a humanitarian device exemption. (Full approval followed in 2017.)
The 5-year rate of any reintervention, including explants, was 78% in the postapproval study, again similar to the 76% rate reported in the IDE study after a median 4.5 year follow-up (Circulation. 2015 Jun 2;131[22]:1960-70), Aimee K. Armstrong, MD, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
The new 5-year postapproval study findings “confirm that the hemodynamic effectiveness achieved by real-world providers is equivalent to the historical control established in the IDE study,” concluded Dr. Armstrong, professor of pediatrics at the Ohio State University and director of cardiac catheterization and interventional therapies at Nationwide Children’s Hospital, both in Columbus.
The postapproval study ran at 10 U.S. centers, none of which were among the five U.S. centers that ran the IDE study. Today, the Melody transcatheter pulmonary valve “is very commonly used” at many additional U.S. sites, Dr. Armstrong said in an interview. And the outcomes achieved using the valve likely surpass those seen in the IDE and postapproval studies because of innovations in technique, such as more routine use of “prestenting,” placing a stent in the vascular site where the pulmonary valve conduit will sit to address stenosis at this location and prevent subsequent conduit fracture (JACC Cardiovasc Interv. 2017 Sep;10[17]:1760-2).
“In 2010 [when the postapproval study began], we didn’t understand the importance of prestenting the way we do now. In 2010, I did not prestent every patient; now I do,” she said. The results reported by Dr. Armstrong included a 5% cumulative rate of major stent fractures in the Melody devices.
The postapproval study results also documented a concerning 4.5% annualized incidence of endocarditis among pulmonary valve recipients, with a nearly 300% increased rate of endocarditis among patients aged 12 years or younger, compared with older patients. Dr. Armstrong cautioned that this age association may be confounded by other factors, such as a residual pressure gradient in the right ventricular outflow tract of 15 mm Hg or greater. “We are discovering that we need to reduce the pressure gradient as much as we can, to perhaps less than 15 mm Hg, to reduce endocarditis, and that is something we did not know even a year ago. Practice is still evolving.”
The Melody Transcatheter Pulmonary Valve Postapproval Study performed cardiac catheterization for valve placement in 121 patients, and successfully implanted the valve for at least 24 hours in 99 of these patients. Patient age ranged from 5 to 45 years, with a median of 17 years; two-thirds were boys or men. The median age of the patients in the postapproval study was about 2 years younger than in the IDE study. Dr. Armstrong and her associates had previously published the 1-year outcomes from the postapproval study (JACC Cardiovasc Interv. 2014 Nov;7[11]:1254-62).
The enrolled patients usually needed a new right ventricular outflow tract because of a congenital heart defect, such as tetralogy of Fallot with pulmonary atresia and truncus arteriosus. Patients also included those who underwent a Ross operation. These patients often receive surgical placement of a right ventricular-to-pulmonary artery conduit, which can over time develop stenosis, insufficiency, or both because of calcification, intimal proliferation, and graft degeneration.
Multiple conduit reoperations to restore right ventricular outflow tract function are usually needed over a patient’s lifetime because of conduit degeneration. This makes a transcatheter procedure in a child or adolescent an attractive option because the prosthetic conduit will need replacement relatively quickly, and the transcatheter approach avoids an episode of open-heart surgery.
The Melody system is not the only transcatheter option for treating a leak or stenosis in a right ventricular outflow tract. The Sapien XT Transcatheter Heart Valve, marketed by Edwards, has FDA labeling for replacement of a dysfunctional right ventricular outflow tract.
Because the Sapien XT system was designed for replacing an aortic valve it’s challenging to place the conduit in the pulmonary valve position, Dr. Armstrong said. Operators find the Sapien 3 valve, a more modern design of the XT model that’s also primarily intended for aortic valve replacement, easier to position than the XT for pulmonary valve replacement, but Sapien 3 does not have FDA labeling for the right ventricular outflow tract indication. The Sapien valves are attractive because they don’t fracture, but Melody is easier to place and operators can reduce the fracture risk by prestenting, she noted.
Overall, the 5-year results from the postapproval study represented success, because 78% of patients who received the Melody device avoided any further interventions during follow-up. “That’s a big deal to a 12, 15, or 18 year old,” said Dr. Armstrong. “A surgically placed valve won’t last long in a teen, so it’s nice to do something noninvasively. It’s great if you can delay surgery for a few years” and avoid having the patient grow out of a surgically placed conduit or developing lots of calcification in the conduit during a growth spurt.
The postapproval study was funded by Medtronic, the company that sells the Melody valve. Dr. Armstrong has received research funding from Medtronic as well as Abbott, Edwards, and Siemens, and she has been a consultant to Abbott.
LAS VEGAS – that followed 65 patients, a majority of whom were children or teenagers.
After 5 years, 69% of the replacement valve recipients had no valvular hemodynamic dysfunction, compared with a 67% rate among patients enrolled in the original Investigational Device Exemption (IDE) study that led to Food and Drug Administration marketing approval for the Melody valve in 2010 under a humanitarian device exemption. (Full approval followed in 2017.)
The 5-year rate of any reintervention, including explants, was 78% in the postapproval study, again similar to the 76% rate reported in the IDE study after a median 4.5 year follow-up (Circulation. 2015 Jun 2;131[22]:1960-70), Aimee K. Armstrong, MD, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
The new 5-year postapproval study findings “confirm that the hemodynamic effectiveness achieved by real-world providers is equivalent to the historical control established in the IDE study,” concluded Dr. Armstrong, professor of pediatrics at the Ohio State University and director of cardiac catheterization and interventional therapies at Nationwide Children’s Hospital, both in Columbus.
The postapproval study ran at 10 U.S. centers, none of which were among the five U.S. centers that ran the IDE study. Today, the Melody transcatheter pulmonary valve “is very commonly used” at many additional U.S. sites, Dr. Armstrong said in an interview. And the outcomes achieved using the valve likely surpass those seen in the IDE and postapproval studies because of innovations in technique, such as more routine use of “prestenting,” placing a stent in the vascular site where the pulmonary valve conduit will sit to address stenosis at this location and prevent subsequent conduit fracture (JACC Cardiovasc Interv. 2017 Sep;10[17]:1760-2).
“In 2010 [when the postapproval study began], we didn’t understand the importance of prestenting the way we do now. In 2010, I did not prestent every patient; now I do,” she said. The results reported by Dr. Armstrong included a 5% cumulative rate of major stent fractures in the Melody devices.
The postapproval study results also documented a concerning 4.5% annualized incidence of endocarditis among pulmonary valve recipients, with a nearly 300% increased rate of endocarditis among patients aged 12 years or younger, compared with older patients. Dr. Armstrong cautioned that this age association may be confounded by other factors, such as a residual pressure gradient in the right ventricular outflow tract of 15 mm Hg or greater. “We are discovering that we need to reduce the pressure gradient as much as we can, to perhaps less than 15 mm Hg, to reduce endocarditis, and that is something we did not know even a year ago. Practice is still evolving.”
The Melody Transcatheter Pulmonary Valve Postapproval Study performed cardiac catheterization for valve placement in 121 patients, and successfully implanted the valve for at least 24 hours in 99 of these patients. Patient age ranged from 5 to 45 years, with a median of 17 years; two-thirds were boys or men. The median age of the patients in the postapproval study was about 2 years younger than in the IDE study. Dr. Armstrong and her associates had previously published the 1-year outcomes from the postapproval study (JACC Cardiovasc Interv. 2014 Nov;7[11]:1254-62).
The enrolled patients usually needed a new right ventricular outflow tract because of a congenital heart defect, such as tetralogy of Fallot with pulmonary atresia and truncus arteriosus. Patients also included those who underwent a Ross operation. These patients often receive surgical placement of a right ventricular-to-pulmonary artery conduit, which can over time develop stenosis, insufficiency, or both because of calcification, intimal proliferation, and graft degeneration.
Multiple conduit reoperations to restore right ventricular outflow tract function are usually needed over a patient’s lifetime because of conduit degeneration. This makes a transcatheter procedure in a child or adolescent an attractive option because the prosthetic conduit will need replacement relatively quickly, and the transcatheter approach avoids an episode of open-heart surgery.
The Melody system is not the only transcatheter option for treating a leak or stenosis in a right ventricular outflow tract. The Sapien XT Transcatheter Heart Valve, marketed by Edwards, has FDA labeling for replacement of a dysfunctional right ventricular outflow tract.
Because the Sapien XT system was designed for replacing an aortic valve it’s challenging to place the conduit in the pulmonary valve position, Dr. Armstrong said. Operators find the Sapien 3 valve, a more modern design of the XT model that’s also primarily intended for aortic valve replacement, easier to position than the XT for pulmonary valve replacement, but Sapien 3 does not have FDA labeling for the right ventricular outflow tract indication. The Sapien valves are attractive because they don’t fracture, but Melody is easier to place and operators can reduce the fracture risk by prestenting, she noted.
Overall, the 5-year results from the postapproval study represented success, because 78% of patients who received the Melody device avoided any further interventions during follow-up. “That’s a big deal to a 12, 15, or 18 year old,” said Dr. Armstrong. “A surgically placed valve won’t last long in a teen, so it’s nice to do something noninvasively. It’s great if you can delay surgery for a few years” and avoid having the patient grow out of a surgically placed conduit or developing lots of calcification in the conduit during a growth spurt.
The postapproval study was funded by Medtronic, the company that sells the Melody valve. Dr. Armstrong has received research funding from Medtronic as well as Abbott, Edwards, and Siemens, and she has been a consultant to Abbott.
LAS VEGAS – that followed 65 patients, a majority of whom were children or teenagers.
After 5 years, 69% of the replacement valve recipients had no valvular hemodynamic dysfunction, compared with a 67% rate among patients enrolled in the original Investigational Device Exemption (IDE) study that led to Food and Drug Administration marketing approval for the Melody valve in 2010 under a humanitarian device exemption. (Full approval followed in 2017.)
The 5-year rate of any reintervention, including explants, was 78% in the postapproval study, again similar to the 76% rate reported in the IDE study after a median 4.5 year follow-up (Circulation. 2015 Jun 2;131[22]:1960-70), Aimee K. Armstrong, MD, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
The new 5-year postapproval study findings “confirm that the hemodynamic effectiveness achieved by real-world providers is equivalent to the historical control established in the IDE study,” concluded Dr. Armstrong, professor of pediatrics at the Ohio State University and director of cardiac catheterization and interventional therapies at Nationwide Children’s Hospital, both in Columbus.
The postapproval study ran at 10 U.S. centers, none of which were among the five U.S. centers that ran the IDE study. Today, the Melody transcatheter pulmonary valve “is very commonly used” at many additional U.S. sites, Dr. Armstrong said in an interview. And the outcomes achieved using the valve likely surpass those seen in the IDE and postapproval studies because of innovations in technique, such as more routine use of “prestenting,” placing a stent in the vascular site where the pulmonary valve conduit will sit to address stenosis at this location and prevent subsequent conduit fracture (JACC Cardiovasc Interv. 2017 Sep;10[17]:1760-2).
“In 2010 [when the postapproval study began], we didn’t understand the importance of prestenting the way we do now. In 2010, I did not prestent every patient; now I do,” she said. The results reported by Dr. Armstrong included a 5% cumulative rate of major stent fractures in the Melody devices.
The postapproval study results also documented a concerning 4.5% annualized incidence of endocarditis among pulmonary valve recipients, with a nearly 300% increased rate of endocarditis among patients aged 12 years or younger, compared with older patients. Dr. Armstrong cautioned that this age association may be confounded by other factors, such as a residual pressure gradient in the right ventricular outflow tract of 15 mm Hg or greater. “We are discovering that we need to reduce the pressure gradient as much as we can, to perhaps less than 15 mm Hg, to reduce endocarditis, and that is something we did not know even a year ago. Practice is still evolving.”
The Melody Transcatheter Pulmonary Valve Postapproval Study performed cardiac catheterization for valve placement in 121 patients, and successfully implanted the valve for at least 24 hours in 99 of these patients. Patient age ranged from 5 to 45 years, with a median of 17 years; two-thirds were boys or men. The median age of the patients in the postapproval study was about 2 years younger than in the IDE study. Dr. Armstrong and her associates had previously published the 1-year outcomes from the postapproval study (JACC Cardiovasc Interv. 2014 Nov;7[11]:1254-62).
The enrolled patients usually needed a new right ventricular outflow tract because of a congenital heart defect, such as tetralogy of Fallot with pulmonary atresia and truncus arteriosus. Patients also included those who underwent a Ross operation. These patients often receive surgical placement of a right ventricular-to-pulmonary artery conduit, which can over time develop stenosis, insufficiency, or both because of calcification, intimal proliferation, and graft degeneration.
Multiple conduit reoperations to restore right ventricular outflow tract function are usually needed over a patient’s lifetime because of conduit degeneration. This makes a transcatheter procedure in a child or adolescent an attractive option because the prosthetic conduit will need replacement relatively quickly, and the transcatheter approach avoids an episode of open-heart surgery.
The Melody system is not the only transcatheter option for treating a leak or stenosis in a right ventricular outflow tract. The Sapien XT Transcatheter Heart Valve, marketed by Edwards, has FDA labeling for replacement of a dysfunctional right ventricular outflow tract.
Because the Sapien XT system was designed for replacing an aortic valve it’s challenging to place the conduit in the pulmonary valve position, Dr. Armstrong said. Operators find the Sapien 3 valve, a more modern design of the XT model that’s also primarily intended for aortic valve replacement, easier to position than the XT for pulmonary valve replacement, but Sapien 3 does not have FDA labeling for the right ventricular outflow tract indication. The Sapien valves are attractive because they don’t fracture, but Melody is easier to place and operators can reduce the fracture risk by prestenting, she noted.
Overall, the 5-year results from the postapproval study represented success, because 78% of patients who received the Melody device avoided any further interventions during follow-up. “That’s a big deal to a 12, 15, or 18 year old,” said Dr. Armstrong. “A surgically placed valve won’t last long in a teen, so it’s nice to do something noninvasively. It’s great if you can delay surgery for a few years” and avoid having the patient grow out of a surgically placed conduit or developing lots of calcification in the conduit during a growth spurt.
The postapproval study was funded by Medtronic, the company that sells the Melody valve. Dr. Armstrong has received research funding from Medtronic as well as Abbott, Edwards, and Siemens, and she has been a consultant to Abbott.
REPORTING FROM SCAI 2019
FFR changes coronary management in one-third of patients
LAS VEGAS – Interventional cardiologists who used fractional flow reserve to assess coronary lesions with an uncertain hemodynamic impact by angiography alone changed their initial therapeutic decision based on angiography for 35% of patients, and for 30% of all lesions examined in a real-world registry with more than 2,200 patients enrolled at 70 worldwide centers.
“Use of fractional flow reserve in contemporary, real-world, global clinical practice changed treatment plans for more than one-third of all comers,” including both patients with stable coronary artery disease and those with acute coronary syndrome, Erick Schampaert, MD, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
The impact of fractional flow reserve (FFR) was greatest when operators used it to assess nonculprit lesions among the 31% of the 2,217 total patients enrolled who presented with acute coronary syndrome. In this subgroup, FFR changed the treatment plan for nonculprit lesions that had been based on angiography and clinical status for 36% of these lesions. The changes included an increase in lesions identified to receive medical management, rising from 53% of the nonculprit lesions before FFR to 65% after, while treatment with percutaneous coronary intervention (PCI) fell from 37% of nonculprit lesions before FFR to 28% after, with the remaining lesions designated for coronary artery bypass grafting. Among patients with stable coronary disease the angiography-based treatment decision changed for 28% of nonculprit lesions after FFR.
“These results may provide support to increase use of FFR,” said Dr. Schampaert, an interventional cardiologist and head of cardiology at Hôpital du Sacré-Cœur in Montreal. The analysis “was an attempt to see the current impact of FFR at places where its use is established,” when it’s routinely used to assess the need to treat nonculprit lesions with an uncertain impact on blood flow through a coronary artery. Dr. Schampaert estimated that about one-quarter of patients who present for angiography have nonculprit lesions that leave operators uncertain about their hemodynamic significance after angiography and are candidates for FFR assessment.
The findings “are a call to do more FFR,” agreed M. Chadi Alraies, MD, an interventional cardiologist at the Detroit Medical Center Heart Hospital. “We are underusing FFR and overstenting people, and that worsens outcomes. We don’t do enough FFR,” Dr. Alraies commented.
“We’ve known for some time that angiography alone can lead to overtreatment,” commented Philippe Généreux, MD, an interventional cardiologist at Morristown (N.J.) Medical Center. “With FFR, physiology is the key to optimizing outcomes.”
The PRESSUREwire study included 2,217 consecutive patients who underwent FFR assessment at 70 centers in 15 countries during October 2016–February 2018. The only exclusions were patients with extremely tortuous or calcified arteries or patients with a bypass graft to the target vessel. Enrolled patients averaged 65 years of age, and three-quarters were men; 63% had stable coronary disease, 31% had acute coronary syndrome, and the remainder had silent ischemia documented by noninvasive testing. A stenosis of 50%-69% occluded 54% of the tested coronaries; 24% had a 70%-90% occlusion; 20% had an occlusion of less than 50%; and the remaining patients had an occlusion of more than 90%.
While the overall percentage of patients whose treatment plan changed following FFR assessment shifted moderately, the changes within each treatment category were more striking. For example, among the 62% of all patients initially designated for medical management based on angiography, the FFR findings changed the management plan to PCI in 19% of this subgroup. Conversely, among the 33% of all patients initially designated for PCI based on angiography, 52% instead received medical management based only on their FFR results. Because shifts in treatment strategy following FFR had some patients go from medical management to PCI, and others went from PCI to medical, overall the percentage of patients who received medical management without immediate revascularization had just a modest up-tick, from 62% before FFR to 67% after, Dr. Schampaert said.
PRESSUREwire was funded by Abbott Vascular, a company that markets an FFR device. Dr. Schampaert has been a consultant to Abbott Vascular as well as AstraZeneca, Bayer, Medtronic, Volcano-Philips, Sanofi, and Servier. Dr. Alaries had no disclosures. Dr. Généreux has been a consultant to Abbott Vascular and to several other companies, and he has an equity interest in Saranas.
SOURCE: Schampaert E et al. SCAI 2019, Abstract.
LAS VEGAS – Interventional cardiologists who used fractional flow reserve to assess coronary lesions with an uncertain hemodynamic impact by angiography alone changed their initial therapeutic decision based on angiography for 35% of patients, and for 30% of all lesions examined in a real-world registry with more than 2,200 patients enrolled at 70 worldwide centers.
“Use of fractional flow reserve in contemporary, real-world, global clinical practice changed treatment plans for more than one-third of all comers,” including both patients with stable coronary artery disease and those with acute coronary syndrome, Erick Schampaert, MD, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
The impact of fractional flow reserve (FFR) was greatest when operators used it to assess nonculprit lesions among the 31% of the 2,217 total patients enrolled who presented with acute coronary syndrome. In this subgroup, FFR changed the treatment plan for nonculprit lesions that had been based on angiography and clinical status for 36% of these lesions. The changes included an increase in lesions identified to receive medical management, rising from 53% of the nonculprit lesions before FFR to 65% after, while treatment with percutaneous coronary intervention (PCI) fell from 37% of nonculprit lesions before FFR to 28% after, with the remaining lesions designated for coronary artery bypass grafting. Among patients with stable coronary disease the angiography-based treatment decision changed for 28% of nonculprit lesions after FFR.
“These results may provide support to increase use of FFR,” said Dr. Schampaert, an interventional cardiologist and head of cardiology at Hôpital du Sacré-Cœur in Montreal. The analysis “was an attempt to see the current impact of FFR at places where its use is established,” when it’s routinely used to assess the need to treat nonculprit lesions with an uncertain impact on blood flow through a coronary artery. Dr. Schampaert estimated that about one-quarter of patients who present for angiography have nonculprit lesions that leave operators uncertain about their hemodynamic significance after angiography and are candidates for FFR assessment.
The findings “are a call to do more FFR,” agreed M. Chadi Alraies, MD, an interventional cardiologist at the Detroit Medical Center Heart Hospital. “We are underusing FFR and overstenting people, and that worsens outcomes. We don’t do enough FFR,” Dr. Alraies commented.
“We’ve known for some time that angiography alone can lead to overtreatment,” commented Philippe Généreux, MD, an interventional cardiologist at Morristown (N.J.) Medical Center. “With FFR, physiology is the key to optimizing outcomes.”
The PRESSUREwire study included 2,217 consecutive patients who underwent FFR assessment at 70 centers in 15 countries during October 2016–February 2018. The only exclusions were patients with extremely tortuous or calcified arteries or patients with a bypass graft to the target vessel. Enrolled patients averaged 65 years of age, and three-quarters were men; 63% had stable coronary disease, 31% had acute coronary syndrome, and the remainder had silent ischemia documented by noninvasive testing. A stenosis of 50%-69% occluded 54% of the tested coronaries; 24% had a 70%-90% occlusion; 20% had an occlusion of less than 50%; and the remaining patients had an occlusion of more than 90%.
While the overall percentage of patients whose treatment plan changed following FFR assessment shifted moderately, the changes within each treatment category were more striking. For example, among the 62% of all patients initially designated for medical management based on angiography, the FFR findings changed the management plan to PCI in 19% of this subgroup. Conversely, among the 33% of all patients initially designated for PCI based on angiography, 52% instead received medical management based only on their FFR results. Because shifts in treatment strategy following FFR had some patients go from medical management to PCI, and others went from PCI to medical, overall the percentage of patients who received medical management without immediate revascularization had just a modest up-tick, from 62% before FFR to 67% after, Dr. Schampaert said.
PRESSUREwire was funded by Abbott Vascular, a company that markets an FFR device. Dr. Schampaert has been a consultant to Abbott Vascular as well as AstraZeneca, Bayer, Medtronic, Volcano-Philips, Sanofi, and Servier. Dr. Alaries had no disclosures. Dr. Généreux has been a consultant to Abbott Vascular and to several other companies, and he has an equity interest in Saranas.
SOURCE: Schampaert E et al. SCAI 2019, Abstract.
LAS VEGAS – Interventional cardiologists who used fractional flow reserve to assess coronary lesions with an uncertain hemodynamic impact by angiography alone changed their initial therapeutic decision based on angiography for 35% of patients, and for 30% of all lesions examined in a real-world registry with more than 2,200 patients enrolled at 70 worldwide centers.
“Use of fractional flow reserve in contemporary, real-world, global clinical practice changed treatment plans for more than one-third of all comers,” including both patients with stable coronary artery disease and those with acute coronary syndrome, Erick Schampaert, MD, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
The impact of fractional flow reserve (FFR) was greatest when operators used it to assess nonculprit lesions among the 31% of the 2,217 total patients enrolled who presented with acute coronary syndrome. In this subgroup, FFR changed the treatment plan for nonculprit lesions that had been based on angiography and clinical status for 36% of these lesions. The changes included an increase in lesions identified to receive medical management, rising from 53% of the nonculprit lesions before FFR to 65% after, while treatment with percutaneous coronary intervention (PCI) fell from 37% of nonculprit lesions before FFR to 28% after, with the remaining lesions designated for coronary artery bypass grafting. Among patients with stable coronary disease the angiography-based treatment decision changed for 28% of nonculprit lesions after FFR.
“These results may provide support to increase use of FFR,” said Dr. Schampaert, an interventional cardiologist and head of cardiology at Hôpital du Sacré-Cœur in Montreal. The analysis “was an attempt to see the current impact of FFR at places where its use is established,” when it’s routinely used to assess the need to treat nonculprit lesions with an uncertain impact on blood flow through a coronary artery. Dr. Schampaert estimated that about one-quarter of patients who present for angiography have nonculprit lesions that leave operators uncertain about their hemodynamic significance after angiography and are candidates for FFR assessment.
The findings “are a call to do more FFR,” agreed M. Chadi Alraies, MD, an interventional cardiologist at the Detroit Medical Center Heart Hospital. “We are underusing FFR and overstenting people, and that worsens outcomes. We don’t do enough FFR,” Dr. Alraies commented.
“We’ve known for some time that angiography alone can lead to overtreatment,” commented Philippe Généreux, MD, an interventional cardiologist at Morristown (N.J.) Medical Center. “With FFR, physiology is the key to optimizing outcomes.”
The PRESSUREwire study included 2,217 consecutive patients who underwent FFR assessment at 70 centers in 15 countries during October 2016–February 2018. The only exclusions were patients with extremely tortuous or calcified arteries or patients with a bypass graft to the target vessel. Enrolled patients averaged 65 years of age, and three-quarters were men; 63% had stable coronary disease, 31% had acute coronary syndrome, and the remainder had silent ischemia documented by noninvasive testing. A stenosis of 50%-69% occluded 54% of the tested coronaries; 24% had a 70%-90% occlusion; 20% had an occlusion of less than 50%; and the remaining patients had an occlusion of more than 90%.
While the overall percentage of patients whose treatment plan changed following FFR assessment shifted moderately, the changes within each treatment category were more striking. For example, among the 62% of all patients initially designated for medical management based on angiography, the FFR findings changed the management plan to PCI in 19% of this subgroup. Conversely, among the 33% of all patients initially designated for PCI based on angiography, 52% instead received medical management based only on their FFR results. Because shifts in treatment strategy following FFR had some patients go from medical management to PCI, and others went from PCI to medical, overall the percentage of patients who received medical management without immediate revascularization had just a modest up-tick, from 62% before FFR to 67% after, Dr. Schampaert said.
PRESSUREwire was funded by Abbott Vascular, a company that markets an FFR device. Dr. Schampaert has been a consultant to Abbott Vascular as well as AstraZeneca, Bayer, Medtronic, Volcano-Philips, Sanofi, and Servier. Dr. Alaries had no disclosures. Dr. Généreux has been a consultant to Abbott Vascular and to several other companies, and he has an equity interest in Saranas.
SOURCE: Schampaert E et al. SCAI 2019, Abstract.
REPORTING FROM SCAI 2019
ProGlide outperformed Prostar for femoral closure after TAVR
LAS VEGAS – Comparison of two of the most commonly used vascular-access closure devices following transfemoral aortic valve replacement showed that Abbott’s ProGlide device led to significantly fewer vascular complications, especially minor complications; significantly less acute kidney injury; and may have also cut the average procedure duration and length of hospital stay, compared with the Prostar device sold by the same company, based on post hoc analysis of data collected from 746 patients.
The analysis also revealed that overall access-site vascular complications occurred in 24% of these patients, who were treated from October 2012 to May 2015 at any of 31 sites in seven countries, David A. Power, MBBCh, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
Although the results came from a nonrandomized (but multivariate-adjusted) comparison of data collected from a trial designed to address a completely different question, the findings appeared to support where the field has moved in recent years, toward greater reliance on the ProGlide device over Prostar, said Dr. Power, a researcher at the Icahn School of Medicine at Mount Sinai, New York.
“The preponderance of data is moving away from using Prostar. ProGlide appears to be coming out on top,” he said during a press briefing. Many operators familiar with both devices seem more comfortable using the ProGlide. But Dr. Power also noted that newer methods have become available for closing a femoral artery puncture following a transvascular procedure with a large-bore catheter, such as new types of plugs and patches.
The nearly 25% rate of vascular complications seen in the study “shows we have a way to go” in limiting and dealing with these adverse events, commented Timothy D. Henry, MD, an interventional cardiologist at the Christ Hospital in Cincinnati. The number of vascular complications from large-bore catheters will likely increase now that lower-risk patients will start to routinely undergo transcatheter aortic valve replacement. Methods for optimizing femoral artery closure after catheter puncture “have not received as much attention as they should, so this is a nice and important study,” Dr. Henry said.
Dr. Power and associates used data collected from patients in the BRAVO-3 (Effect of Bivalirudin on Aortic Valve Intervention Outcomes) study, which was designed to compare two different anticoagulants during transcatheter aortic valve replacement procedures. The trial found no statistically significant difference in patient outcomes regardless of the anticoagulant used (J Am Coll Cardiol. 2015 Dec 27;66[25]:2860-8). Review of the patient data showed that 352 of the 802 patients enrolled in BRAVO-3 had their femoral-artery puncture closed with a ProGlide device and 394 had their wound closed with Prostar. These 746 total patients accounted for 93% of all BRAVO-3 patients, highlighting the reliance that the operators on these cases had for these two closure devices in recent practice. The choice of vascular-access closure device in each BRAVO-3 case was at the discretion of the operator for that case.
A multivariate-adjusted analysis that took into account baseline differences between patients treated with ProGlide and Prostar showed that the ProGlide-treated patients had a significant 46% reduced rate of major or minor vascular complications, driven primarily by a reduction in minor complications, Dr. Power reported. The ProGlide-treated patients also showed a statistically significant 39% relative reduction in acute kidney injury, compared with the Prostar patients, a cut Dr. Powers attributed to a reduced need for contrast to check for residual bleeding. The results also showed that the ProGlide-treated patients had an average hospital length of stay about 20% shorter than the Prostar patients, and the average procedure time for the ProGlide-treated patients was about 30% shorter than with Prostar closure.
Concurrently with his report at the meeting, the results also appeared in an article published online (Catheter Cardiovasc Interv. 2019 May 22. doi: 10.1002/ccd.28295).
BRAVO-3 received funding from the Medicines Company. Dr. Power had no disclosures.
SOURCE: Power DA et al. SCAI 2019, Abstract 5743.
LAS VEGAS – Comparison of two of the most commonly used vascular-access closure devices following transfemoral aortic valve replacement showed that Abbott’s ProGlide device led to significantly fewer vascular complications, especially minor complications; significantly less acute kidney injury; and may have also cut the average procedure duration and length of hospital stay, compared with the Prostar device sold by the same company, based on post hoc analysis of data collected from 746 patients.
The analysis also revealed that overall access-site vascular complications occurred in 24% of these patients, who were treated from October 2012 to May 2015 at any of 31 sites in seven countries, David A. Power, MBBCh, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
Although the results came from a nonrandomized (but multivariate-adjusted) comparison of data collected from a trial designed to address a completely different question, the findings appeared to support where the field has moved in recent years, toward greater reliance on the ProGlide device over Prostar, said Dr. Power, a researcher at the Icahn School of Medicine at Mount Sinai, New York.
“The preponderance of data is moving away from using Prostar. ProGlide appears to be coming out on top,” he said during a press briefing. Many operators familiar with both devices seem more comfortable using the ProGlide. But Dr. Power also noted that newer methods have become available for closing a femoral artery puncture following a transvascular procedure with a large-bore catheter, such as new types of plugs and patches.
The nearly 25% rate of vascular complications seen in the study “shows we have a way to go” in limiting and dealing with these adverse events, commented Timothy D. Henry, MD, an interventional cardiologist at the Christ Hospital in Cincinnati. The number of vascular complications from large-bore catheters will likely increase now that lower-risk patients will start to routinely undergo transcatheter aortic valve replacement. Methods for optimizing femoral artery closure after catheter puncture “have not received as much attention as they should, so this is a nice and important study,” Dr. Henry said.
Dr. Power and associates used data collected from patients in the BRAVO-3 (Effect of Bivalirudin on Aortic Valve Intervention Outcomes) study, which was designed to compare two different anticoagulants during transcatheter aortic valve replacement procedures. The trial found no statistically significant difference in patient outcomes regardless of the anticoagulant used (J Am Coll Cardiol. 2015 Dec 27;66[25]:2860-8). Review of the patient data showed that 352 of the 802 patients enrolled in BRAVO-3 had their femoral-artery puncture closed with a ProGlide device and 394 had their wound closed with Prostar. These 746 total patients accounted for 93% of all BRAVO-3 patients, highlighting the reliance that the operators on these cases had for these two closure devices in recent practice. The choice of vascular-access closure device in each BRAVO-3 case was at the discretion of the operator for that case.
A multivariate-adjusted analysis that took into account baseline differences between patients treated with ProGlide and Prostar showed that the ProGlide-treated patients had a significant 46% reduced rate of major or minor vascular complications, driven primarily by a reduction in minor complications, Dr. Power reported. The ProGlide-treated patients also showed a statistically significant 39% relative reduction in acute kidney injury, compared with the Prostar patients, a cut Dr. Powers attributed to a reduced need for contrast to check for residual bleeding. The results also showed that the ProGlide-treated patients had an average hospital length of stay about 20% shorter than the Prostar patients, and the average procedure time for the ProGlide-treated patients was about 30% shorter than with Prostar closure.
Concurrently with his report at the meeting, the results also appeared in an article published online (Catheter Cardiovasc Interv. 2019 May 22. doi: 10.1002/ccd.28295).
BRAVO-3 received funding from the Medicines Company. Dr. Power had no disclosures.
SOURCE: Power DA et al. SCAI 2019, Abstract 5743.
LAS VEGAS – Comparison of two of the most commonly used vascular-access closure devices following transfemoral aortic valve replacement showed that Abbott’s ProGlide device led to significantly fewer vascular complications, especially minor complications; significantly less acute kidney injury; and may have also cut the average procedure duration and length of hospital stay, compared with the Prostar device sold by the same company, based on post hoc analysis of data collected from 746 patients.
The analysis also revealed that overall access-site vascular complications occurred in 24% of these patients, who were treated from October 2012 to May 2015 at any of 31 sites in seven countries, David A. Power, MBBCh, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
Although the results came from a nonrandomized (but multivariate-adjusted) comparison of data collected from a trial designed to address a completely different question, the findings appeared to support where the field has moved in recent years, toward greater reliance on the ProGlide device over Prostar, said Dr. Power, a researcher at the Icahn School of Medicine at Mount Sinai, New York.
“The preponderance of data is moving away from using Prostar. ProGlide appears to be coming out on top,” he said during a press briefing. Many operators familiar with both devices seem more comfortable using the ProGlide. But Dr. Power also noted that newer methods have become available for closing a femoral artery puncture following a transvascular procedure with a large-bore catheter, such as new types of plugs and patches.
The nearly 25% rate of vascular complications seen in the study “shows we have a way to go” in limiting and dealing with these adverse events, commented Timothy D. Henry, MD, an interventional cardiologist at the Christ Hospital in Cincinnati. The number of vascular complications from large-bore catheters will likely increase now that lower-risk patients will start to routinely undergo transcatheter aortic valve replacement. Methods for optimizing femoral artery closure after catheter puncture “have not received as much attention as they should, so this is a nice and important study,” Dr. Henry said.
Dr. Power and associates used data collected from patients in the BRAVO-3 (Effect of Bivalirudin on Aortic Valve Intervention Outcomes) study, which was designed to compare two different anticoagulants during transcatheter aortic valve replacement procedures. The trial found no statistically significant difference in patient outcomes regardless of the anticoagulant used (J Am Coll Cardiol. 2015 Dec 27;66[25]:2860-8). Review of the patient data showed that 352 of the 802 patients enrolled in BRAVO-3 had their femoral-artery puncture closed with a ProGlide device and 394 had their wound closed with Prostar. These 746 total patients accounted for 93% of all BRAVO-3 patients, highlighting the reliance that the operators on these cases had for these two closure devices in recent practice. The choice of vascular-access closure device in each BRAVO-3 case was at the discretion of the operator for that case.
A multivariate-adjusted analysis that took into account baseline differences between patients treated with ProGlide and Prostar showed that the ProGlide-treated patients had a significant 46% reduced rate of major or minor vascular complications, driven primarily by a reduction in minor complications, Dr. Power reported. The ProGlide-treated patients also showed a statistically significant 39% relative reduction in acute kidney injury, compared with the Prostar patients, a cut Dr. Powers attributed to a reduced need for contrast to check for residual bleeding. The results also showed that the ProGlide-treated patients had an average hospital length of stay about 20% shorter than the Prostar patients, and the average procedure time for the ProGlide-treated patients was about 30% shorter than with Prostar closure.
Concurrently with his report at the meeting, the results also appeared in an article published online (Catheter Cardiovasc Interv. 2019 May 22. doi: 10.1002/ccd.28295).
BRAVO-3 received funding from the Medicines Company. Dr. Power had no disclosures.
SOURCE: Power DA et al. SCAI 2019, Abstract 5743.
REPORTING FROM SCAI 2019
Key clinical point:
Major finding: ProGlide closure produced 46% fewer vascular complications than Prostar in a multivariate-adjusted analysis.
Study details: Post hoc analysis of data collected in the BRAVO-3 trial, with data from 746 of the 802 patients enrolled in BRAVO-3.
Disclosures: BRAVO-3 received funding from the Medicines Company. Dr. Power had no disclosures.
Source: Power DA et al. SCAI 2019, Abstract 5743.
Novel vascular sheath detects periprocedural bleeds
LAS VEGAS – A set of electrodes arrayed in a standard, vascular-access catheter sheath accurately alerted operators to access-site bleeding in a first-in-human study with 60 patients treated at any of five U.S. centers.
“The Early Bird bleed-monitoring system was safe, easily incorporated in standard flow of work, and demonstrated the capacity to detect bleeding before progression to a more severe or symptomatic phase,” Philippe Généreux, MD, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions. The study in 60 patients undergoing standard intravascular procedures via femoral-artery access – most often transcatheter aortic valve replacement – showed that an alert for access-site bleeding occurred with a Cohen’s kappa of 0.84, compared with CT imaging for bleeding, a score that shows “almost perfect” concordance between the two methods, noted Dr. Généreux, an interventional cardiologist and director of the structural heart program at Morristown (N.J.) Medical Center.
The study protocol called for keeping the sheath in place for up to 12 hours post procedure, and in practice the sheath remained in place for an average of about 160 minutes post procedure; 31% of the bleeds occurred during the procedure, with the remaining 69% occurring later. Another notable finding from the CT imaging at the time of sheath removal was that only 4 of the 60 patients had absolutely no bleeding, while 34 patients (57%) had blood infiltration at the access site and 22 patients (37%) had an access-site hematoma. No patients had retroperitoneal bleeding, but the system is designed to also detect bleeding within that space.
The Early Bird system received de novo classification as a new device from the Food and Drug Administration in March 2019; based on this, Saranas – the company developing the device – will likely start U.S. marketing before the end of 2019, Dr. Généreux said during a press briefing. The company is planning a registry of cases that use the device to collect data on patient outcomes to try to eventually document the clinical impact and cost-effectiveness of the system. Until now, standard of care has been to identify vascular-access associated bleeds once they become overt or symptomatic. If bleeds are identified at an earlier stage they could potentially be resolved before symptoms develop or become severe and hence provide a potential opportunity for cost savings.
Although the current study did not target specific types of patients, it makes sense in routine practice to target the device to patients at high risk for either developing a bleed or complications secondary to a bleed, such as patients undergoing transcatheter aortic valve replacement, patients receiving a mechanical circulatory assist device, or patients scheduled for complex procedures that will use multiple sheaths, he said.
The Early Bird sheath is 30 cm long, and is placed through the left or right femoral vein to the bifurcation of the iliac artery. (In the current study, more than 80% of the 60 treated patients had the sheath placed in their right femoral vein.) The access sheath for the catheters involved in the procedures themselves were most often placed in the left or right femoral artery. Electrodes within the Early Bird sheath detect leaked blood by its impact on bioimpedance of the tissue surrounding the sheath, with the system able to roughly gauge the volume of released blood based on the local level of bioimpedance change.
A couple of years ago, Dr. Généreux and his associates documented an 18% incidence of bleeding complications among 17,672 U.S. patients who underwent a transcatheter procedure with a large-bore catheter during 2013-2014 using data collected by the National Inpatient Sample (JAMA Cardiol. 2017 Jul;2[7]:798-802). Their analysis also documented that the patients with bleeding-related complications had in-hospital costs that averaged more than 50% higher than the costs for patients without bleeding complications, findings that raised the possibility that earlier identification of a bleed, before severe complications ensured, could be both cost effective and beneficial to patients, Dr. Généreux said.
Dr. Généreux has been a consultant to Saranas and to several other companies. He is also chief medical officer for Saranas and has an equity interest in the company.
SOURCE: Généreux P. SCAI 2019, Abstract 5713.
LAS VEGAS – A set of electrodes arrayed in a standard, vascular-access catheter sheath accurately alerted operators to access-site bleeding in a first-in-human study with 60 patients treated at any of five U.S. centers.
“The Early Bird bleed-monitoring system was safe, easily incorporated in standard flow of work, and demonstrated the capacity to detect bleeding before progression to a more severe or symptomatic phase,” Philippe Généreux, MD, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions. The study in 60 patients undergoing standard intravascular procedures via femoral-artery access – most often transcatheter aortic valve replacement – showed that an alert for access-site bleeding occurred with a Cohen’s kappa of 0.84, compared with CT imaging for bleeding, a score that shows “almost perfect” concordance between the two methods, noted Dr. Généreux, an interventional cardiologist and director of the structural heart program at Morristown (N.J.) Medical Center.
The study protocol called for keeping the sheath in place for up to 12 hours post procedure, and in practice the sheath remained in place for an average of about 160 minutes post procedure; 31% of the bleeds occurred during the procedure, with the remaining 69% occurring later. Another notable finding from the CT imaging at the time of sheath removal was that only 4 of the 60 patients had absolutely no bleeding, while 34 patients (57%) had blood infiltration at the access site and 22 patients (37%) had an access-site hematoma. No patients had retroperitoneal bleeding, but the system is designed to also detect bleeding within that space.
The Early Bird system received de novo classification as a new device from the Food and Drug Administration in March 2019; based on this, Saranas – the company developing the device – will likely start U.S. marketing before the end of 2019, Dr. Généreux said during a press briefing. The company is planning a registry of cases that use the device to collect data on patient outcomes to try to eventually document the clinical impact and cost-effectiveness of the system. Until now, standard of care has been to identify vascular-access associated bleeds once they become overt or symptomatic. If bleeds are identified at an earlier stage they could potentially be resolved before symptoms develop or become severe and hence provide a potential opportunity for cost savings.
Although the current study did not target specific types of patients, it makes sense in routine practice to target the device to patients at high risk for either developing a bleed or complications secondary to a bleed, such as patients undergoing transcatheter aortic valve replacement, patients receiving a mechanical circulatory assist device, or patients scheduled for complex procedures that will use multiple sheaths, he said.
The Early Bird sheath is 30 cm long, and is placed through the left or right femoral vein to the bifurcation of the iliac artery. (In the current study, more than 80% of the 60 treated patients had the sheath placed in their right femoral vein.) The access sheath for the catheters involved in the procedures themselves were most often placed in the left or right femoral artery. Electrodes within the Early Bird sheath detect leaked blood by its impact on bioimpedance of the tissue surrounding the sheath, with the system able to roughly gauge the volume of released blood based on the local level of bioimpedance change.
A couple of years ago, Dr. Généreux and his associates documented an 18% incidence of bleeding complications among 17,672 U.S. patients who underwent a transcatheter procedure with a large-bore catheter during 2013-2014 using data collected by the National Inpatient Sample (JAMA Cardiol. 2017 Jul;2[7]:798-802). Their analysis also documented that the patients with bleeding-related complications had in-hospital costs that averaged more than 50% higher than the costs for patients without bleeding complications, findings that raised the possibility that earlier identification of a bleed, before severe complications ensured, could be both cost effective and beneficial to patients, Dr. Généreux said.
Dr. Généreux has been a consultant to Saranas and to several other companies. He is also chief medical officer for Saranas and has an equity interest in the company.
SOURCE: Généreux P. SCAI 2019, Abstract 5713.
LAS VEGAS – A set of electrodes arrayed in a standard, vascular-access catheter sheath accurately alerted operators to access-site bleeding in a first-in-human study with 60 patients treated at any of five U.S. centers.
“The Early Bird bleed-monitoring system was safe, easily incorporated in standard flow of work, and demonstrated the capacity to detect bleeding before progression to a more severe or symptomatic phase,” Philippe Généreux, MD, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions. The study in 60 patients undergoing standard intravascular procedures via femoral-artery access – most often transcatheter aortic valve replacement – showed that an alert for access-site bleeding occurred with a Cohen’s kappa of 0.84, compared with CT imaging for bleeding, a score that shows “almost perfect” concordance between the two methods, noted Dr. Généreux, an interventional cardiologist and director of the structural heart program at Morristown (N.J.) Medical Center.
The study protocol called for keeping the sheath in place for up to 12 hours post procedure, and in practice the sheath remained in place for an average of about 160 minutes post procedure; 31% of the bleeds occurred during the procedure, with the remaining 69% occurring later. Another notable finding from the CT imaging at the time of sheath removal was that only 4 of the 60 patients had absolutely no bleeding, while 34 patients (57%) had blood infiltration at the access site and 22 patients (37%) had an access-site hematoma. No patients had retroperitoneal bleeding, but the system is designed to also detect bleeding within that space.
The Early Bird system received de novo classification as a new device from the Food and Drug Administration in March 2019; based on this, Saranas – the company developing the device – will likely start U.S. marketing before the end of 2019, Dr. Généreux said during a press briefing. The company is planning a registry of cases that use the device to collect data on patient outcomes to try to eventually document the clinical impact and cost-effectiveness of the system. Until now, standard of care has been to identify vascular-access associated bleeds once they become overt or symptomatic. If bleeds are identified at an earlier stage they could potentially be resolved before symptoms develop or become severe and hence provide a potential opportunity for cost savings.
Although the current study did not target specific types of patients, it makes sense in routine practice to target the device to patients at high risk for either developing a bleed or complications secondary to a bleed, such as patients undergoing transcatheter aortic valve replacement, patients receiving a mechanical circulatory assist device, or patients scheduled for complex procedures that will use multiple sheaths, he said.
The Early Bird sheath is 30 cm long, and is placed through the left or right femoral vein to the bifurcation of the iliac artery. (In the current study, more than 80% of the 60 treated patients had the sheath placed in their right femoral vein.) The access sheath for the catheters involved in the procedures themselves were most often placed in the left or right femoral artery. Electrodes within the Early Bird sheath detect leaked blood by its impact on bioimpedance of the tissue surrounding the sheath, with the system able to roughly gauge the volume of released blood based on the local level of bioimpedance change.
A couple of years ago, Dr. Généreux and his associates documented an 18% incidence of bleeding complications among 17,672 U.S. patients who underwent a transcatheter procedure with a large-bore catheter during 2013-2014 using data collected by the National Inpatient Sample (JAMA Cardiol. 2017 Jul;2[7]:798-802). Their analysis also documented that the patients with bleeding-related complications had in-hospital costs that averaged more than 50% higher than the costs for patients without bleeding complications, findings that raised the possibility that earlier identification of a bleed, before severe complications ensured, could be both cost effective and beneficial to patients, Dr. Généreux said.
Dr. Généreux has been a consultant to Saranas and to several other companies. He is also chief medical officer for Saranas and has an equity interest in the company.
SOURCE: Généreux P. SCAI 2019, Abstract 5713.
REPORTING FROM SCAI 2019
Novel cardiogenic shock, PCI protocol nets 72% acute survival
LAS VEGAS – A novel protocol for acute management of patients in cardiogenic shock secondary to an acute MI that started hemodynamic support prior to coronary revascularization produced an unprecedented in-hospital survival rate of 72% in 171 patients treated at any of 35 U.S. centers.
The 72% acute survival compares with historical rates of roughly 50% starting with the landmark SHOCK trial from 1999 (N Engl J Med. 1999 Aug 26;341[9]:625-34) and continuing in much more recent reports (J Am Coll Cardiol. 2017 Jan 24;69[3]:278-87)
“This is a first step toward reducing the futility in treating a disease where management has not changed for more than 20 years,” Mir B. Basir, D.O., said at the annual scientific sessions of the Society for Cardiovascular Angiography and Interventions. While Dr. Basir acknowledged that the new protocol needs further testing, as well as further improvement, a need exists to immediately implement changes in the routine management of cardiogenic shock caused by an acute MI because “50% in-hospital survival is no longer acceptable,” said Dr. Basir, an interventional cardiologist at the Henry Ford Health System in Detroit.
The National Cardiogenic Shock Initiative operates as a single-arm study with no control group. The novel management protocol used by the Initiative in the current study included the following five key best-practice steps, Dr. Basir said in a video interview:
1. Begin hemodynamic support before increasing dosages of vasopressors or inotropes.
2. Use right-heart catheterization to monitor the patient’s hemodynamics, which shows the efficacy of the hemodynamic support and guides tapering down of vasopressor and inotrope drugs.
3. Apply hemodynamic support before starting percutaneous coronary intervention (PCI).
4. Act fast, with a goal of less than 90 minutes from door to hemodynamic support. In the 171 patients that Dr. Basir reviewed, the average door-to-support time was 85 minutes.
5. Mitigate complications from the devices and vascular access.
This protocol started at four hospitals in the Detroit region, and then expanded to the National Cardiogenic Shock Initiative that now includes 68 U.S. sites and more than 200 patients treated, with another 23 U.S. hospitals about to join. The 68 active sites include 26 academic centers and 42 community hospitals. The initiative has enrolled patients who match the enrollment criteria of the SHOCK trial so that historical comparisons are possible. The initiative’s patients would be classified as class C, D, or E patients based on the society’s newly published cardiogenic shock classification scheme (Catheter Cardiovasc Interv. 2019 May 19. doi: 10.1002/ccd.28329).
“The numbers that Dr. Basir has reported are very encouraging and provocative,” commented Chandanreddy M. Devireddy, MD, an interventional cardiologist at Emory Healthcare in Atlanta. “In light of the fact that we have had few solutions for these patients, this will accelerate the discussion.”
Several barriers exist for widespread adoption of the initiative’s protocol, Dr. Basir said. The protocol requires a lot of resources and the ability to deliver this care 24/7. Currently, hemodynamic support is “greatly underused,” and right-heart catheterization is not standard of care for these patients at many U.S. centers, he noted.
A few weeks before Dr. Basir’s report at the meeting, his data from the National Cardiogenic Shock Initiative appeared in an article published online (Catheter Cardiovasc Interv. 2019 Apr 25. doi: 10.1002/ccd.28307).
LAS VEGAS – A novel protocol for acute management of patients in cardiogenic shock secondary to an acute MI that started hemodynamic support prior to coronary revascularization produced an unprecedented in-hospital survival rate of 72% in 171 patients treated at any of 35 U.S. centers.
The 72% acute survival compares with historical rates of roughly 50% starting with the landmark SHOCK trial from 1999 (N Engl J Med. 1999 Aug 26;341[9]:625-34) and continuing in much more recent reports (J Am Coll Cardiol. 2017 Jan 24;69[3]:278-87)
“This is a first step toward reducing the futility in treating a disease where management has not changed for more than 20 years,” Mir B. Basir, D.O., said at the annual scientific sessions of the Society for Cardiovascular Angiography and Interventions. While Dr. Basir acknowledged that the new protocol needs further testing, as well as further improvement, a need exists to immediately implement changes in the routine management of cardiogenic shock caused by an acute MI because “50% in-hospital survival is no longer acceptable,” said Dr. Basir, an interventional cardiologist at the Henry Ford Health System in Detroit.
The National Cardiogenic Shock Initiative operates as a single-arm study with no control group. The novel management protocol used by the Initiative in the current study included the following five key best-practice steps, Dr. Basir said in a video interview:
1. Begin hemodynamic support before increasing dosages of vasopressors or inotropes.
2. Use right-heart catheterization to monitor the patient’s hemodynamics, which shows the efficacy of the hemodynamic support and guides tapering down of vasopressor and inotrope drugs.
3. Apply hemodynamic support before starting percutaneous coronary intervention (PCI).
4. Act fast, with a goal of less than 90 minutes from door to hemodynamic support. In the 171 patients that Dr. Basir reviewed, the average door-to-support time was 85 minutes.
5. Mitigate complications from the devices and vascular access.
This protocol started at four hospitals in the Detroit region, and then expanded to the National Cardiogenic Shock Initiative that now includes 68 U.S. sites and more than 200 patients treated, with another 23 U.S. hospitals about to join. The 68 active sites include 26 academic centers and 42 community hospitals. The initiative has enrolled patients who match the enrollment criteria of the SHOCK trial so that historical comparisons are possible. The initiative’s patients would be classified as class C, D, or E patients based on the society’s newly published cardiogenic shock classification scheme (Catheter Cardiovasc Interv. 2019 May 19. doi: 10.1002/ccd.28329).
“The numbers that Dr. Basir has reported are very encouraging and provocative,” commented Chandanreddy M. Devireddy, MD, an interventional cardiologist at Emory Healthcare in Atlanta. “In light of the fact that we have had few solutions for these patients, this will accelerate the discussion.”
Several barriers exist for widespread adoption of the initiative’s protocol, Dr. Basir said. The protocol requires a lot of resources and the ability to deliver this care 24/7. Currently, hemodynamic support is “greatly underused,” and right-heart catheterization is not standard of care for these patients at many U.S. centers, he noted.
A few weeks before Dr. Basir’s report at the meeting, his data from the National Cardiogenic Shock Initiative appeared in an article published online (Catheter Cardiovasc Interv. 2019 Apr 25. doi: 10.1002/ccd.28307).
LAS VEGAS – A novel protocol for acute management of patients in cardiogenic shock secondary to an acute MI that started hemodynamic support prior to coronary revascularization produced an unprecedented in-hospital survival rate of 72% in 171 patients treated at any of 35 U.S. centers.
The 72% acute survival compares with historical rates of roughly 50% starting with the landmark SHOCK trial from 1999 (N Engl J Med. 1999 Aug 26;341[9]:625-34) and continuing in much more recent reports (J Am Coll Cardiol. 2017 Jan 24;69[3]:278-87)
“This is a first step toward reducing the futility in treating a disease where management has not changed for more than 20 years,” Mir B. Basir, D.O., said at the annual scientific sessions of the Society for Cardiovascular Angiography and Interventions. While Dr. Basir acknowledged that the new protocol needs further testing, as well as further improvement, a need exists to immediately implement changes in the routine management of cardiogenic shock caused by an acute MI because “50% in-hospital survival is no longer acceptable,” said Dr. Basir, an interventional cardiologist at the Henry Ford Health System in Detroit.
The National Cardiogenic Shock Initiative operates as a single-arm study with no control group. The novel management protocol used by the Initiative in the current study included the following five key best-practice steps, Dr. Basir said in a video interview:
1. Begin hemodynamic support before increasing dosages of vasopressors or inotropes.
2. Use right-heart catheterization to monitor the patient’s hemodynamics, which shows the efficacy of the hemodynamic support and guides tapering down of vasopressor and inotrope drugs.
3. Apply hemodynamic support before starting percutaneous coronary intervention (PCI).
4. Act fast, with a goal of less than 90 minutes from door to hemodynamic support. In the 171 patients that Dr. Basir reviewed, the average door-to-support time was 85 minutes.
5. Mitigate complications from the devices and vascular access.
This protocol started at four hospitals in the Detroit region, and then expanded to the National Cardiogenic Shock Initiative that now includes 68 U.S. sites and more than 200 patients treated, with another 23 U.S. hospitals about to join. The 68 active sites include 26 academic centers and 42 community hospitals. The initiative has enrolled patients who match the enrollment criteria of the SHOCK trial so that historical comparisons are possible. The initiative’s patients would be classified as class C, D, or E patients based on the society’s newly published cardiogenic shock classification scheme (Catheter Cardiovasc Interv. 2019 May 19. doi: 10.1002/ccd.28329).
“The numbers that Dr. Basir has reported are very encouraging and provocative,” commented Chandanreddy M. Devireddy, MD, an interventional cardiologist at Emory Healthcare in Atlanta. “In light of the fact that we have had few solutions for these patients, this will accelerate the discussion.”
Several barriers exist for widespread adoption of the initiative’s protocol, Dr. Basir said. The protocol requires a lot of resources and the ability to deliver this care 24/7. Currently, hemodynamic support is “greatly underused,” and right-heart catheterization is not standard of care for these patients at many U.S. centers, he noted.
A few weeks before Dr. Basir’s report at the meeting, his data from the National Cardiogenic Shock Initiative appeared in an article published online (Catheter Cardiovasc Interv. 2019 Apr 25. doi: 10.1002/ccd.28307).
REPORTING FROM SCAI 2019
SCAI releases first definition of cardiogenic shock
LAS VEGAS – The Society for Cardiovascular Angiography & Interventions released on May 19 the first-ever classification scheme for cardiogenic shock, dividing the condition into five severity levels.
The expert consensus panel that devised the new definition and classification model hopes it will spearhead a reset of research into the management of cardiogenic shock so that clinicians can assess interventions and introduce them into practice in a more precise, reproducible, and systematic way, Srihari S. Naidu, MD, said while presenting the proposal at the society’s annual scientific sessions.
The writing panel’s hope is that the new definition will “drive earlier recognition of shock and at a more precise stage to guide appropriate and timely escalation of care” and to “better define prospectively the value of mechanical circulatory support, extracorporeal membrane oxygenation, and other therapies,” said Dr. Naidu, chair of the writing group, as well as professor of medicine at New York Medical College and director of the cardiac catheterization laboratory at Westchester Medical Center, both in Valhalla, N.Y.
At the core of the classification scheme are the definitions for five strata of disease, which start at stage A, the “at-risk” patients before shock onset, and progress through stage B, “beginning”; stage C, “classic”; stage D, “deteriorating”; and stage E, “extremis,” which defines a patient with circulatory collapse (Catheter Cardiovasc Interv. 2019 May 19; doi: 10.1002/ccd.28329). Another key element of the classification model is the cardiac arrest “modifier,” designated by a subscripted letter A, which identifies patients who have had a cardiac arrest, regardless of duration. So a patient could be a stage BA, which identifies a patient with clinical evidence of relative hypotension or tachycardia without hypoperfusion and with a history of cardiac arrest.
The statement also itemizes several biomarkers and hemodynamic measurements that need regular, serial monitoring, such as blood lactate and right arterial pressure. Although the document leaves specific, defining values for some of these measures vaguely defined – the intent is that future research will fill in these gaps – the overall message is that clinicians caring for cardiogenic shock patients “need to be aggressive and look for these things,” Dr. Naidu said in a video interview.
“Until we agree on a definition of cardiogenic shock, we can’t go anywhere,” commented Larry S. Dean, MD, professor of medicine at and director of the Regional Heart Center of the University of Washington in Seattle. “There are a lot of conflicting data out there, and until we have a shared definition, we can’t advance our practice. We need to start looking at shock patients in a more precise way.”
“Without a clear definition of cardiogenic shock we will never improve patient outcomes. Every shock trial must define shock. If investigators just say ‘patients were in shock,’ I don’t know what that means,” noted Navin K. Kapur, MD, director of the Interventional Research Laboratories at Tufts Medical Center in Boston and a member of the writing panel.
Dr. Naidu and others on the panel highlighted the need to now validate the classification scheme’s ability to consistently categorize patients and predict their disease trajectories. They have begun the validation process with a 10,000-patient database of “all-comers” with cardiogenic shock maintained by the Mayo Clinic. Full results from this analysis will be out soon, but Dr. Naidu revealed in passing that it successfully provided validation of the proposed scheme.
The new definition received endorsements from the American College of Cardiology, the American Heart Association, the Society of Critical Care Medicine, and the Society of Thoracic Surgeons.
Dr. Naidu had no disclosures.
LAS VEGAS – The Society for Cardiovascular Angiography & Interventions released on May 19 the first-ever classification scheme for cardiogenic shock, dividing the condition into five severity levels.
The expert consensus panel that devised the new definition and classification model hopes it will spearhead a reset of research into the management of cardiogenic shock so that clinicians can assess interventions and introduce them into practice in a more precise, reproducible, and systematic way, Srihari S. Naidu, MD, said while presenting the proposal at the society’s annual scientific sessions.
The writing panel’s hope is that the new definition will “drive earlier recognition of shock and at a more precise stage to guide appropriate and timely escalation of care” and to “better define prospectively the value of mechanical circulatory support, extracorporeal membrane oxygenation, and other therapies,” said Dr. Naidu, chair of the writing group, as well as professor of medicine at New York Medical College and director of the cardiac catheterization laboratory at Westchester Medical Center, both in Valhalla, N.Y.
At the core of the classification scheme are the definitions for five strata of disease, which start at stage A, the “at-risk” patients before shock onset, and progress through stage B, “beginning”; stage C, “classic”; stage D, “deteriorating”; and stage E, “extremis,” which defines a patient with circulatory collapse (Catheter Cardiovasc Interv. 2019 May 19; doi: 10.1002/ccd.28329). Another key element of the classification model is the cardiac arrest “modifier,” designated by a subscripted letter A, which identifies patients who have had a cardiac arrest, regardless of duration. So a patient could be a stage BA, which identifies a patient with clinical evidence of relative hypotension or tachycardia without hypoperfusion and with a history of cardiac arrest.
The statement also itemizes several biomarkers and hemodynamic measurements that need regular, serial monitoring, such as blood lactate and right arterial pressure. Although the document leaves specific, defining values for some of these measures vaguely defined – the intent is that future research will fill in these gaps – the overall message is that clinicians caring for cardiogenic shock patients “need to be aggressive and look for these things,” Dr. Naidu said in a video interview.
“Until we agree on a definition of cardiogenic shock, we can’t go anywhere,” commented Larry S. Dean, MD, professor of medicine at and director of the Regional Heart Center of the University of Washington in Seattle. “There are a lot of conflicting data out there, and until we have a shared definition, we can’t advance our practice. We need to start looking at shock patients in a more precise way.”
“Without a clear definition of cardiogenic shock we will never improve patient outcomes. Every shock trial must define shock. If investigators just say ‘patients were in shock,’ I don’t know what that means,” noted Navin K. Kapur, MD, director of the Interventional Research Laboratories at Tufts Medical Center in Boston and a member of the writing panel.
Dr. Naidu and others on the panel highlighted the need to now validate the classification scheme’s ability to consistently categorize patients and predict their disease trajectories. They have begun the validation process with a 10,000-patient database of “all-comers” with cardiogenic shock maintained by the Mayo Clinic. Full results from this analysis will be out soon, but Dr. Naidu revealed in passing that it successfully provided validation of the proposed scheme.
The new definition received endorsements from the American College of Cardiology, the American Heart Association, the Society of Critical Care Medicine, and the Society of Thoracic Surgeons.
Dr. Naidu had no disclosures.
LAS VEGAS – The Society for Cardiovascular Angiography & Interventions released on May 19 the first-ever classification scheme for cardiogenic shock, dividing the condition into five severity levels.
The expert consensus panel that devised the new definition and classification model hopes it will spearhead a reset of research into the management of cardiogenic shock so that clinicians can assess interventions and introduce them into practice in a more precise, reproducible, and systematic way, Srihari S. Naidu, MD, said while presenting the proposal at the society’s annual scientific sessions.
The writing panel’s hope is that the new definition will “drive earlier recognition of shock and at a more precise stage to guide appropriate and timely escalation of care” and to “better define prospectively the value of mechanical circulatory support, extracorporeal membrane oxygenation, and other therapies,” said Dr. Naidu, chair of the writing group, as well as professor of medicine at New York Medical College and director of the cardiac catheterization laboratory at Westchester Medical Center, both in Valhalla, N.Y.
At the core of the classification scheme are the definitions for five strata of disease, which start at stage A, the “at-risk” patients before shock onset, and progress through stage B, “beginning”; stage C, “classic”; stage D, “deteriorating”; and stage E, “extremis,” which defines a patient with circulatory collapse (Catheter Cardiovasc Interv. 2019 May 19; doi: 10.1002/ccd.28329). Another key element of the classification model is the cardiac arrest “modifier,” designated by a subscripted letter A, which identifies patients who have had a cardiac arrest, regardless of duration. So a patient could be a stage BA, which identifies a patient with clinical evidence of relative hypotension or tachycardia without hypoperfusion and with a history of cardiac arrest.
The statement also itemizes several biomarkers and hemodynamic measurements that need regular, serial monitoring, such as blood lactate and right arterial pressure. Although the document leaves specific, defining values for some of these measures vaguely defined – the intent is that future research will fill in these gaps – the overall message is that clinicians caring for cardiogenic shock patients “need to be aggressive and look for these things,” Dr. Naidu said in a video interview.
“Until we agree on a definition of cardiogenic shock, we can’t go anywhere,” commented Larry S. Dean, MD, professor of medicine at and director of the Regional Heart Center of the University of Washington in Seattle. “There are a lot of conflicting data out there, and until we have a shared definition, we can’t advance our practice. We need to start looking at shock patients in a more precise way.”
“Without a clear definition of cardiogenic shock we will never improve patient outcomes. Every shock trial must define shock. If investigators just say ‘patients were in shock,’ I don’t know what that means,” noted Navin K. Kapur, MD, director of the Interventional Research Laboratories at Tufts Medical Center in Boston and a member of the writing panel.
Dr. Naidu and others on the panel highlighted the need to now validate the classification scheme’s ability to consistently categorize patients and predict their disease trajectories. They have begun the validation process with a 10,000-patient database of “all-comers” with cardiogenic shock maintained by the Mayo Clinic. Full results from this analysis will be out soon, but Dr. Naidu revealed in passing that it successfully provided validation of the proposed scheme.
The new definition received endorsements from the American College of Cardiology, the American Heart Association, the Society of Critical Care Medicine, and the Society of Thoracic Surgeons.
Dr. Naidu had no disclosures.
REPORTING FROM SCAI 2019
CABANA: Heart failure patients got biggest bang from AFib ablation
SAN FRANCISCO – Catheter ablation of atrial fibrillation (AFib) in the roughly one-third of patients with heart failure enrolled in the CABANA multicenter, randomized trial produced striking, statistically significant improvements both in the study’s primary, combined endpoint and in all-cause mortality in intention-to-treat analyses.
These findings, from prespecified secondary analyses, contrasted with the study’s overall result, which showed no benefit in the primary endpoint analysis in the total study population of 2,204 patients with AFib (JAMA. 2019 Apr 2;321[13]:1261-74). They are also at odds with the primary endpoint result in the two-thirds of enrolled patients without heart failure, which showed no significant between-group differences in these two outcome measures among the patients assigned to the catheter ablation arm and the study’s control, which was medical management arm.
Among the 778 AFib patients enrolled in CABANA with any form of heart failure (35% of the total study enrollment), the incidence of the study’s primary endpoint – the combined rate of death, disabling stroke, serious bleeding, or cardiac arrest during a median follow-up of slightly more than 4 years – was 36% lower among the catheter-ablated heart failure patients than in the heart failure patients assigned to medical treatment, according to an intention-to-treat analysis, which was a statistically significant difference. The incidence of all-cause mortality during follow-up was 43% lower in the ablated heart failure patients, compared with the controls, Douglas L. Packer, MD, said at the annual scientific sessions of the Heart Rhythm Society.
In contrast, among enrolled patients without heart failure, the intention-to-treat primary endpoint was 6% higher in the ablated patients, and all-cause mortality was a relative 27% higher, although neither difference was statistically significant.
It’s a “little surprising” that the results showed this much benefit in the patients with heart failure, said Dr. Packer, professor of medicine at the Mayo Clinic in Rochester, Minn., and lead investigator of the CABANA (Catheter Ablation vs Anti-Arrhythmic Drug Therapy for Atrial Fibrillation) trial. “I think these data confirm the results of the CASTLE-AF trial, but without some of the glitches some people have cited” about that study, such as concerns about a high level of patient selection in CASTLE-AF and its relatively modest number of enrolled patients, he said in an interview.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) study, run entirely in patients with heart failure with reduced ejection fraction and AFib, showed a statistically significant improvement in patient survival and heart failure hospitalization after catheter ablation compared with medical management (N Engl J Med. 2018 Feb 1;378[5]:417-27). Prior to the CASTLE-AF report, results from several other small studies (J Interv Card Electrophysiol. 2018 Oct;53[1]:19-29), as well as those from the AATAC trial (Circulation. 2016 Apr 26;133[17]:1637-44), also showed consistent evidence for benefit from catheter ablation in patients with heart failure and AFib, noted CABANA coinvestigator Jonathan P. Piccini, MD, during a separate talk at the meeting.
“The improvement of cardiovascular outcomes with ablation in patients with heart failure and AFib is consistent across multiple trials, at least with respect to heart failure with reduced ejection fraction” concluded Dr. Piccini, a cardiac electrophysiologist at Duke University in Durham, N.C.
As a result of the new heart failure analysis, “I think the guidelines will change,” predicted Dr. Packer, with catheter ablation receiving a firmer endorsement for patients with heart failure the next time U.S. guidelines for heart failure and AFib management are updated. The findings say “there is substantial benefit of catheter ablation in heart failure patients, but I don’t think our findings lessen the utility of ablation in patients without heart failure,” he stressed. Even patients without heart failure showed reduction in AFib burden and improvement in quality of life that were similar to what was seen in the heart failure patients.
The new report from CABANA of benefit from AFib catheter ablation in patients with heart failure “absolutely advances the evidence,” commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago. “A number of us were quite circumspect about this based on the CASTLE-AF data, but the new CABANA analyses have addressed our anxiety that the CASTLE-AF results were just by chance.” The new CABANA analyses “may not confirm CASTLE-AF, but it enriches the conversation and makes it possible that we are seeing benefit in some patients with heart failure who get ablated.”
Dr. Yancy, who chaired the most recent update to the U.S. heart failure management guideline (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803) stopped short of saying that the cumulative evidence now supports a guideline change, but he acknowledged in an interview that the evidence could legitimately influence practice. Catheter ablation should now be “strongly considered” in patients with heart failure and AFib, he said, although he also had three qualifications for opting for this approach: Patients must already be on guideline-directed medical therapy for their heart failure, the catheter ablation needs to be performed by an experienced and skilled operator, and follow-up surveillance must focus on both the patient’s AFib and heart failure. “It’s absolutely appropriate to consider catheter ablation” for heart failure patients, but the evidence is not yet there for guideline change, Dr. Yancy concluded.
It remains uncertain why catheter ablation of AFib should be more effective in patients with heart failure than in those without. Dr. Packer speculated that one reason may be the heart rate reduction that AFib ablation produces may especially benefit heart failure patients. An additional helpful effect of ablation in heart failure patients may be reducing heart rate variability. Another notable finding of the new analysis was that 79% of patients with heart failure in CABANA had heart failure with preserved ejection fraction, with a left ventricular ejection fraction of at least 50%. “Getting rid of AFib in patients with heart failure with preserved ejection fraction will be more important than we have thought,” Dr. Packer said.
Other new CABANA analyses presented for the first time in separate talks at the meeting also showed that, while catheter ablation had no meaningful difference in effect on outcomes based on the sex of patients, both age and minority ethnic and racial status appeared to make a substantial difference. For CABANA’s primary endpoint, catheter ablation was especially effective for improving outcomes in patients 64 years old or younger, and the analysis showed a signal of possibly worse outcomes in patients who were at least 75 years old. The “substantially” better outcomes in minority-group patients represented the largest between-group difference among subgroups seen in CABANA and is a “big deal,” said Dr. Packer, who predicted that future catheter ablation use will likely rise in patients with heart failure, in younger patients, and in minority patients.
Dr. Piccini noted that, “it’s possible that CABANA identified some patient subgroups that do really well after ablation, but the problem is that, in the United States, we now often don’t treat” minority patients or those with reduced left ventricular ejection fractions with ablation, according to recent registry findings.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Dr. Piccini has ties Boston Scientific, Medtronic, and numerous other drug and device companies, and disclosed an unspecified relationship with GlaxoSmithKline. Dr. Yancy disclosed an unspecified relationship with Abbott Laboratories.
SOURCE: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
SAN FRANCISCO – Catheter ablation of atrial fibrillation (AFib) in the roughly one-third of patients with heart failure enrolled in the CABANA multicenter, randomized trial produced striking, statistically significant improvements both in the study’s primary, combined endpoint and in all-cause mortality in intention-to-treat analyses.
These findings, from prespecified secondary analyses, contrasted with the study’s overall result, which showed no benefit in the primary endpoint analysis in the total study population of 2,204 patients with AFib (JAMA. 2019 Apr 2;321[13]:1261-74). They are also at odds with the primary endpoint result in the two-thirds of enrolled patients without heart failure, which showed no significant between-group differences in these two outcome measures among the patients assigned to the catheter ablation arm and the study’s control, which was medical management arm.
Among the 778 AFib patients enrolled in CABANA with any form of heart failure (35% of the total study enrollment), the incidence of the study’s primary endpoint – the combined rate of death, disabling stroke, serious bleeding, or cardiac arrest during a median follow-up of slightly more than 4 years – was 36% lower among the catheter-ablated heart failure patients than in the heart failure patients assigned to medical treatment, according to an intention-to-treat analysis, which was a statistically significant difference. The incidence of all-cause mortality during follow-up was 43% lower in the ablated heart failure patients, compared with the controls, Douglas L. Packer, MD, said at the annual scientific sessions of the Heart Rhythm Society.
In contrast, among enrolled patients without heart failure, the intention-to-treat primary endpoint was 6% higher in the ablated patients, and all-cause mortality was a relative 27% higher, although neither difference was statistically significant.
It’s a “little surprising” that the results showed this much benefit in the patients with heart failure, said Dr. Packer, professor of medicine at the Mayo Clinic in Rochester, Minn., and lead investigator of the CABANA (Catheter Ablation vs Anti-Arrhythmic Drug Therapy for Atrial Fibrillation) trial. “I think these data confirm the results of the CASTLE-AF trial, but without some of the glitches some people have cited” about that study, such as concerns about a high level of patient selection in CASTLE-AF and its relatively modest number of enrolled patients, he said in an interview.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) study, run entirely in patients with heart failure with reduced ejection fraction and AFib, showed a statistically significant improvement in patient survival and heart failure hospitalization after catheter ablation compared with medical management (N Engl J Med. 2018 Feb 1;378[5]:417-27). Prior to the CASTLE-AF report, results from several other small studies (J Interv Card Electrophysiol. 2018 Oct;53[1]:19-29), as well as those from the AATAC trial (Circulation. 2016 Apr 26;133[17]:1637-44), also showed consistent evidence for benefit from catheter ablation in patients with heart failure and AFib, noted CABANA coinvestigator Jonathan P. Piccini, MD, during a separate talk at the meeting.
“The improvement of cardiovascular outcomes with ablation in patients with heart failure and AFib is consistent across multiple trials, at least with respect to heart failure with reduced ejection fraction” concluded Dr. Piccini, a cardiac electrophysiologist at Duke University in Durham, N.C.
As a result of the new heart failure analysis, “I think the guidelines will change,” predicted Dr. Packer, with catheter ablation receiving a firmer endorsement for patients with heart failure the next time U.S. guidelines for heart failure and AFib management are updated. The findings say “there is substantial benefit of catheter ablation in heart failure patients, but I don’t think our findings lessen the utility of ablation in patients without heart failure,” he stressed. Even patients without heart failure showed reduction in AFib burden and improvement in quality of life that were similar to what was seen in the heart failure patients.
The new report from CABANA of benefit from AFib catheter ablation in patients with heart failure “absolutely advances the evidence,” commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago. “A number of us were quite circumspect about this based on the CASTLE-AF data, but the new CABANA analyses have addressed our anxiety that the CASTLE-AF results were just by chance.” The new CABANA analyses “may not confirm CASTLE-AF, but it enriches the conversation and makes it possible that we are seeing benefit in some patients with heart failure who get ablated.”
Dr. Yancy, who chaired the most recent update to the U.S. heart failure management guideline (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803) stopped short of saying that the cumulative evidence now supports a guideline change, but he acknowledged in an interview that the evidence could legitimately influence practice. Catheter ablation should now be “strongly considered” in patients with heart failure and AFib, he said, although he also had three qualifications for opting for this approach: Patients must already be on guideline-directed medical therapy for their heart failure, the catheter ablation needs to be performed by an experienced and skilled operator, and follow-up surveillance must focus on both the patient’s AFib and heart failure. “It’s absolutely appropriate to consider catheter ablation” for heart failure patients, but the evidence is not yet there for guideline change, Dr. Yancy concluded.
It remains uncertain why catheter ablation of AFib should be more effective in patients with heart failure than in those without. Dr. Packer speculated that one reason may be the heart rate reduction that AFib ablation produces may especially benefit heart failure patients. An additional helpful effect of ablation in heart failure patients may be reducing heart rate variability. Another notable finding of the new analysis was that 79% of patients with heart failure in CABANA had heart failure with preserved ejection fraction, with a left ventricular ejection fraction of at least 50%. “Getting rid of AFib in patients with heart failure with preserved ejection fraction will be more important than we have thought,” Dr. Packer said.
Other new CABANA analyses presented for the first time in separate talks at the meeting also showed that, while catheter ablation had no meaningful difference in effect on outcomes based on the sex of patients, both age and minority ethnic and racial status appeared to make a substantial difference. For CABANA’s primary endpoint, catheter ablation was especially effective for improving outcomes in patients 64 years old or younger, and the analysis showed a signal of possibly worse outcomes in patients who were at least 75 years old. The “substantially” better outcomes in minority-group patients represented the largest between-group difference among subgroups seen in CABANA and is a “big deal,” said Dr. Packer, who predicted that future catheter ablation use will likely rise in patients with heart failure, in younger patients, and in minority patients.
Dr. Piccini noted that, “it’s possible that CABANA identified some patient subgroups that do really well after ablation, but the problem is that, in the United States, we now often don’t treat” minority patients or those with reduced left ventricular ejection fractions with ablation, according to recent registry findings.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Dr. Piccini has ties Boston Scientific, Medtronic, and numerous other drug and device companies, and disclosed an unspecified relationship with GlaxoSmithKline. Dr. Yancy disclosed an unspecified relationship with Abbott Laboratories.
SOURCE: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
SAN FRANCISCO – Catheter ablation of atrial fibrillation (AFib) in the roughly one-third of patients with heart failure enrolled in the CABANA multicenter, randomized trial produced striking, statistically significant improvements both in the study’s primary, combined endpoint and in all-cause mortality in intention-to-treat analyses.
These findings, from prespecified secondary analyses, contrasted with the study’s overall result, which showed no benefit in the primary endpoint analysis in the total study population of 2,204 patients with AFib (JAMA. 2019 Apr 2;321[13]:1261-74). They are also at odds with the primary endpoint result in the two-thirds of enrolled patients without heart failure, which showed no significant between-group differences in these two outcome measures among the patients assigned to the catheter ablation arm and the study’s control, which was medical management arm.
Among the 778 AFib patients enrolled in CABANA with any form of heart failure (35% of the total study enrollment), the incidence of the study’s primary endpoint – the combined rate of death, disabling stroke, serious bleeding, or cardiac arrest during a median follow-up of slightly more than 4 years – was 36% lower among the catheter-ablated heart failure patients than in the heart failure patients assigned to medical treatment, according to an intention-to-treat analysis, which was a statistically significant difference. The incidence of all-cause mortality during follow-up was 43% lower in the ablated heart failure patients, compared with the controls, Douglas L. Packer, MD, said at the annual scientific sessions of the Heart Rhythm Society.
In contrast, among enrolled patients without heart failure, the intention-to-treat primary endpoint was 6% higher in the ablated patients, and all-cause mortality was a relative 27% higher, although neither difference was statistically significant.
It’s a “little surprising” that the results showed this much benefit in the patients with heart failure, said Dr. Packer, professor of medicine at the Mayo Clinic in Rochester, Minn., and lead investigator of the CABANA (Catheter Ablation vs Anti-Arrhythmic Drug Therapy for Atrial Fibrillation) trial. “I think these data confirm the results of the CASTLE-AF trial, but without some of the glitches some people have cited” about that study, such as concerns about a high level of patient selection in CASTLE-AF and its relatively modest number of enrolled patients, he said in an interview.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) study, run entirely in patients with heart failure with reduced ejection fraction and AFib, showed a statistically significant improvement in patient survival and heart failure hospitalization after catheter ablation compared with medical management (N Engl J Med. 2018 Feb 1;378[5]:417-27). Prior to the CASTLE-AF report, results from several other small studies (J Interv Card Electrophysiol. 2018 Oct;53[1]:19-29), as well as those from the AATAC trial (Circulation. 2016 Apr 26;133[17]:1637-44), also showed consistent evidence for benefit from catheter ablation in patients with heart failure and AFib, noted CABANA coinvestigator Jonathan P. Piccini, MD, during a separate talk at the meeting.
“The improvement of cardiovascular outcomes with ablation in patients with heart failure and AFib is consistent across multiple trials, at least with respect to heart failure with reduced ejection fraction” concluded Dr. Piccini, a cardiac electrophysiologist at Duke University in Durham, N.C.
As a result of the new heart failure analysis, “I think the guidelines will change,” predicted Dr. Packer, with catheter ablation receiving a firmer endorsement for patients with heart failure the next time U.S. guidelines for heart failure and AFib management are updated. The findings say “there is substantial benefit of catheter ablation in heart failure patients, but I don’t think our findings lessen the utility of ablation in patients without heart failure,” he stressed. Even patients without heart failure showed reduction in AFib burden and improvement in quality of life that were similar to what was seen in the heart failure patients.
The new report from CABANA of benefit from AFib catheter ablation in patients with heart failure “absolutely advances the evidence,” commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago. “A number of us were quite circumspect about this based on the CASTLE-AF data, but the new CABANA analyses have addressed our anxiety that the CASTLE-AF results were just by chance.” The new CABANA analyses “may not confirm CASTLE-AF, but it enriches the conversation and makes it possible that we are seeing benefit in some patients with heart failure who get ablated.”
Dr. Yancy, who chaired the most recent update to the U.S. heart failure management guideline (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803) stopped short of saying that the cumulative evidence now supports a guideline change, but he acknowledged in an interview that the evidence could legitimately influence practice. Catheter ablation should now be “strongly considered” in patients with heart failure and AFib, he said, although he also had three qualifications for opting for this approach: Patients must already be on guideline-directed medical therapy for their heart failure, the catheter ablation needs to be performed by an experienced and skilled operator, and follow-up surveillance must focus on both the patient’s AFib and heart failure. “It’s absolutely appropriate to consider catheter ablation” for heart failure patients, but the evidence is not yet there for guideline change, Dr. Yancy concluded.
It remains uncertain why catheter ablation of AFib should be more effective in patients with heart failure than in those without. Dr. Packer speculated that one reason may be the heart rate reduction that AFib ablation produces may especially benefit heart failure patients. An additional helpful effect of ablation in heart failure patients may be reducing heart rate variability. Another notable finding of the new analysis was that 79% of patients with heart failure in CABANA had heart failure with preserved ejection fraction, with a left ventricular ejection fraction of at least 50%. “Getting rid of AFib in patients with heart failure with preserved ejection fraction will be more important than we have thought,” Dr. Packer said.
Other new CABANA analyses presented for the first time in separate talks at the meeting also showed that, while catheter ablation had no meaningful difference in effect on outcomes based on the sex of patients, both age and minority ethnic and racial status appeared to make a substantial difference. For CABANA’s primary endpoint, catheter ablation was especially effective for improving outcomes in patients 64 years old or younger, and the analysis showed a signal of possibly worse outcomes in patients who were at least 75 years old. The “substantially” better outcomes in minority-group patients represented the largest between-group difference among subgroups seen in CABANA and is a “big deal,” said Dr. Packer, who predicted that future catheter ablation use will likely rise in patients with heart failure, in younger patients, and in minority patients.
Dr. Piccini noted that, “it’s possible that CABANA identified some patient subgroups that do really well after ablation, but the problem is that, in the United States, we now often don’t treat” minority patients or those with reduced left ventricular ejection fractions with ablation, according to recent registry findings.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Dr. Piccini has ties Boston Scientific, Medtronic, and numerous other drug and device companies, and disclosed an unspecified relationship with GlaxoSmithKline. Dr. Yancy disclosed an unspecified relationship with Abbott Laboratories.
SOURCE: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
REPORTING FROM HEART RHYTHM 2019
Key clinical point: Catheter ablation for atrial fibrillation is especially effective in patients with heart failure.
Major finding: Heart failure patients treated with catheter ablation had a 36% relative cut in the primary endpoint, compared with control patients.
Study details: CABANA, a multicenter, randomized trial with 2,204 patients, including 778 patients with heart failure.
Disclosures: CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Source: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
Ultrasound’s arrhythmia localization surpassed ECG’s accuracy
SAN FRANCISCO – A new type of echocardiography that uses a high frame rate to track tissue motion allowed researchers to noninvasively map the source of cardiac arrhythmias in patients with significantly more precision than did standard 12-lead ECG recordings in a pilot, single-center study with 55 patients.
Electromechanical wave imaging (EWI) correctly identified the arrhythmia source in 53 of 55 (96%) patients scheduled to undergo arrhythmia ablation, whereas only 39 of the same 55 patients (71%) were correctly mapped using recordings from a standard 12-lead ECG read by several trained electrophysiologists. The findings from this pilot study suggested that EWI performed with noninvasive ultrasound can provide useful, added information to 12-lead ECG tracings to localize cardiac arrhythmias of various types prior to invasive procedures, Elaine Y. Wan, MD, said at the annual scientific sessions of the Heart Rhythm Society.
She cautioned, however, that future studies must still establish that adding EWI to standard preprocedural assessment can benefit patients by, for example, reducing their radiation dosages or shortening their procedure times.
Patients at Columbia University Medical Center in New York scheduled to undergo ablation for a cardiac arrhythmia first had noninvasive assessment with EWI and 12-lead ECG. Patients averaged 56 years old; 45% had an atrial flutter, 22% had Wolff-Parkinson-White syndrome accessory pathways, 20% had premature ventricular complexes, and 13% had an atrial tachycardia. The researchers used 3D electroanatomic arrhythmia mapping performed during ablation as the arrhythmia-localization standard against which they compared both the EWI and ECG results.
EWI can map cardiac electromechanical activity in all four heart chambers by tracking, with high temporal and spatial resolution, transient tissue deformations that occur in response to local electrical activation of cardiac myocytes, the depolarizations in cardiac muscle that produce tissue movement. The technique captures 2,000 image frames per second, creating a “video of tissue movement that lets us see where the movement started,” explained Dr. Wan, a cardiac electrophysiologist at Columbia.
Dr. Wan and associates previously reported use of EWI to successfully map accessory pathways in all 14 children with Wolff-Parkinson-White syndrome they tested versus success in 11 of these 14 patients (79%) when using expert interpretation of 12-lead ECG recordings (JACC Clin Electrophysiol. 2019 Apr;5[4]:427-37).
The new study is the first report on using EWI in adults, Dr. Wan noted. Advantages of EWI over 12-lead ECG include its lack of dependence on correct lead placement, and EWI does not share the inherent limitation of 12-lead ECG for localizing arrhythmias on the heart’s posterior wall, she said in a video interview.
SOURCE: Wan EY et al. Heart Rhythm 2019, Abstract S-LCT04-03.
SAN FRANCISCO – A new type of echocardiography that uses a high frame rate to track tissue motion allowed researchers to noninvasively map the source of cardiac arrhythmias in patients with significantly more precision than did standard 12-lead ECG recordings in a pilot, single-center study with 55 patients.
Electromechanical wave imaging (EWI) correctly identified the arrhythmia source in 53 of 55 (96%) patients scheduled to undergo arrhythmia ablation, whereas only 39 of the same 55 patients (71%) were correctly mapped using recordings from a standard 12-lead ECG read by several trained electrophysiologists. The findings from this pilot study suggested that EWI performed with noninvasive ultrasound can provide useful, added information to 12-lead ECG tracings to localize cardiac arrhythmias of various types prior to invasive procedures, Elaine Y. Wan, MD, said at the annual scientific sessions of the Heart Rhythm Society.
She cautioned, however, that future studies must still establish that adding EWI to standard preprocedural assessment can benefit patients by, for example, reducing their radiation dosages or shortening their procedure times.
Patients at Columbia University Medical Center in New York scheduled to undergo ablation for a cardiac arrhythmia first had noninvasive assessment with EWI and 12-lead ECG. Patients averaged 56 years old; 45% had an atrial flutter, 22% had Wolff-Parkinson-White syndrome accessory pathways, 20% had premature ventricular complexes, and 13% had an atrial tachycardia. The researchers used 3D electroanatomic arrhythmia mapping performed during ablation as the arrhythmia-localization standard against which they compared both the EWI and ECG results.
EWI can map cardiac electromechanical activity in all four heart chambers by tracking, with high temporal and spatial resolution, transient tissue deformations that occur in response to local electrical activation of cardiac myocytes, the depolarizations in cardiac muscle that produce tissue movement. The technique captures 2,000 image frames per second, creating a “video of tissue movement that lets us see where the movement started,” explained Dr. Wan, a cardiac electrophysiologist at Columbia.
Dr. Wan and associates previously reported use of EWI to successfully map accessory pathways in all 14 children with Wolff-Parkinson-White syndrome they tested versus success in 11 of these 14 patients (79%) when using expert interpretation of 12-lead ECG recordings (JACC Clin Electrophysiol. 2019 Apr;5[4]:427-37).
The new study is the first report on using EWI in adults, Dr. Wan noted. Advantages of EWI over 12-lead ECG include its lack of dependence on correct lead placement, and EWI does not share the inherent limitation of 12-lead ECG for localizing arrhythmias on the heart’s posterior wall, she said in a video interview.
SOURCE: Wan EY et al. Heart Rhythm 2019, Abstract S-LCT04-03.
SAN FRANCISCO – A new type of echocardiography that uses a high frame rate to track tissue motion allowed researchers to noninvasively map the source of cardiac arrhythmias in patients with significantly more precision than did standard 12-lead ECG recordings in a pilot, single-center study with 55 patients.
Electromechanical wave imaging (EWI) correctly identified the arrhythmia source in 53 of 55 (96%) patients scheduled to undergo arrhythmia ablation, whereas only 39 of the same 55 patients (71%) were correctly mapped using recordings from a standard 12-lead ECG read by several trained electrophysiologists. The findings from this pilot study suggested that EWI performed with noninvasive ultrasound can provide useful, added information to 12-lead ECG tracings to localize cardiac arrhythmias of various types prior to invasive procedures, Elaine Y. Wan, MD, said at the annual scientific sessions of the Heart Rhythm Society.
She cautioned, however, that future studies must still establish that adding EWI to standard preprocedural assessment can benefit patients by, for example, reducing their radiation dosages or shortening their procedure times.
Patients at Columbia University Medical Center in New York scheduled to undergo ablation for a cardiac arrhythmia first had noninvasive assessment with EWI and 12-lead ECG. Patients averaged 56 years old; 45% had an atrial flutter, 22% had Wolff-Parkinson-White syndrome accessory pathways, 20% had premature ventricular complexes, and 13% had an atrial tachycardia. The researchers used 3D electroanatomic arrhythmia mapping performed during ablation as the arrhythmia-localization standard against which they compared both the EWI and ECG results.
EWI can map cardiac electromechanical activity in all four heart chambers by tracking, with high temporal and spatial resolution, transient tissue deformations that occur in response to local electrical activation of cardiac myocytes, the depolarizations in cardiac muscle that produce tissue movement. The technique captures 2,000 image frames per second, creating a “video of tissue movement that lets us see where the movement started,” explained Dr. Wan, a cardiac electrophysiologist at Columbia.
Dr. Wan and associates previously reported use of EWI to successfully map accessory pathways in all 14 children with Wolff-Parkinson-White syndrome they tested versus success in 11 of these 14 patients (79%) when using expert interpretation of 12-lead ECG recordings (JACC Clin Electrophysiol. 2019 Apr;5[4]:427-37).
The new study is the first report on using EWI in adults, Dr. Wan noted. Advantages of EWI over 12-lead ECG include its lack of dependence on correct lead placement, and EWI does not share the inherent limitation of 12-lead ECG for localizing arrhythmias on the heart’s posterior wall, she said in a video interview.
SOURCE: Wan EY et al. Heart Rhythm 2019, Abstract S-LCT04-03.
REPORTING FROM HEART RHYTHM 2019
New risk score predicts cardiac-device infection
SAN FRANCISCO – Researchers have devised a five-item scoring formula to quantify the risk for infection in patients undergoing placement, revision, or removal of a cardiac-rhythm device based on data from nearly 20,000 patients enrolled in a recent infection-prophylaxis trial.
The risk score can help identify patients who might benefit from intensified antibiotic prophylaxis, and it can also help during shared decision making with patients to better understand the risk a patient faces from infection, compared with their predicted device benefit, David H. Birnie, MD, said at the annual scientific sessions of the Heart Rhythm Society.
The new risk score produced a concordance statistic, the area under the receiver-operator characteristic curve, of 0.704. It showed that, although it could use further validation, the score as it currently stands has substantial predictive value, said Dr. Birnie, professor of medicine at the University of Ottawa and deputy chief of cardiology at the University of Ottawa Heart Institute. “It’s certainly better than anything we have now,” he said in a video interview.
Dr. Birnie and his associates used data they collected on baseline characteristics and infection outcomes of the 19,603 patients enrolled in PADIT (Prevention of Arrhythmia Device Infection Trial) who underwent a rhythm-device procedure at 1 of 28 participating Canadian centers. The primary aim of PADIT was to assess the safety and efficacy of an intensified antibiotic-prophylaxis regimen, compared with a standard regimen of a cefazolin infusion just before the procedure. The study’s primary endpoint was the incidence of hospitalization for device infection during 1-year follow-up, and while the intensified prophylactic regimen linked with a 23% relative reduction in the hospitalization rate, compared with standard treatment, the difference was not statistically significant (J Am Coll Cardiol. 2018 Dec 18;72[24]:3098-109).
The researchers analyzed the baseline patient data and the blindly adjudicated infection outcomes and identified five factors that were independently associated with an increased infection rate. They organized the five factors and produced a formula they call the PADIT score (see chart). Those five factors are: prior procedures (the greater the number the greater the risk), age (which unexpectedly had an inverse relationship with infection incidence), depressed renal function, immuno-compromised status, and type of procedure. A patient can potentially score 0-15 points.
Among the PADIT patients a score of 0 correlated with about a 0.3% rate of hospitalization for a device-related infection during 1 year of follow-up, a score of 5 with about a 1.1% rate, a score of 6 with about a 1.8% rate, and a score of seven or more with a 3.4% infection rate over the following year. About 5% of patients had a score of 7 or more, and roughly another 5% had a score of 5 or 6, Dr. Birnie said. At his center, clinicians have begun routinely calculating scores for patients scheduled for an arrhythmia-device procedure, and they are considering routinely administering added antibiotic prophylaxis to patients with a preprocedural score of 6 or higher. They may also use the score to determine whether to use the antibacterial envelope recently reported to prevent cardiac-device infections (N Engl J Med. 2019 May 16;380[20]:1895-905).
“It’s very easy for patients to get to a PADIT score of 7 or higher,” Dr. Birnie noted. As an example, he cited a common patient, an 85-year-old with renal dysfunction who is under consideration for a second replacement of an implantable cardioverter defibrillator. The patient would score 1 point for renal insufficiency, 2 points for the type of device, and 4 points for having a prior history of two devices, and the consequent 3.4% risk for infection might counterbalance the potential benefit this elderly patient could expect from the new device. The score will be very important for targeting treatment, shared decision making, and selection of patients for future intervention trials, he concluded.
“I think this risk score will change practice by giving clinicians a better idea of a patient’s risk for infection,” commented Fred M. Kusumoto, MD, professor of medicine at the Mayo Medical School, Rochester, Minn., and director of heart rhythm services at the Mayo Clinic in Jacksonville, Fla. The PADIT score will help identify patients for whom leaving a device in place is a better option than taking it out because of their infection risk. The risk score could also help improve the cost effectiveness of preventive treatments, such as antibiotic-eluting envelopes, by targeting treatment to higher-risk patients, Dr. Kusumoto said during a press briefing.
SOURCE: Birnie DH. Heart Rhythm 2019, Absract S-LCT02-01.
I like this new infection risk score. It addresses a very clinically relevant issue. It’s important for the electrophysiology community to better understand how to best manage infections related to cardiac rhythm devices and ideally prevent them from happening.
I’m not a big fan of risk scores in general because they can sometimes detract from independent thinking about how to manage a patient. However, it is also helpful to have this type of risk-assessment information when discussing management options with a patient.
The PADIT risk score may also help identify which patients could potentially benefit the most from an antibiotic-eluting envelope when receiving an implanted cardiac-rhythm device. Recently reported results from WRAP-IT showed that routinely using envelopes cut the incidence of major infections by a relative 40%, but in absolute terms, the number needed to treat with the envelop to prevent one major infection was about 200 patients, a big number given the high cost of the envelope (N Engl J Med. 2019 May 16;380[20]:1895-905). It is therefore very interesting to think about using the PADIT risk score to better target an effective but expensive preventive measure like an antibiotic-eluting envelop to patients at the highest risk for infection.
Ulrika Birgersdotter-Green, MD , professor of medicine and director of pacemaker and ICD services at the University of California, San Diego, made these comments as a designated discussant for the report. She has been a consultant to and received honoraria from Abbott, Boston Scientific, and Medtronic.
I like this new infection risk score. It addresses a very clinically relevant issue. It’s important for the electrophysiology community to better understand how to best manage infections related to cardiac rhythm devices and ideally prevent them from happening.
I’m not a big fan of risk scores in general because they can sometimes detract from independent thinking about how to manage a patient. However, it is also helpful to have this type of risk-assessment information when discussing management options with a patient.
The PADIT risk score may also help identify which patients could potentially benefit the most from an antibiotic-eluting envelope when receiving an implanted cardiac-rhythm device. Recently reported results from WRAP-IT showed that routinely using envelopes cut the incidence of major infections by a relative 40%, but in absolute terms, the number needed to treat with the envelop to prevent one major infection was about 200 patients, a big number given the high cost of the envelope (N Engl J Med. 2019 May 16;380[20]:1895-905). It is therefore very interesting to think about using the PADIT risk score to better target an effective but expensive preventive measure like an antibiotic-eluting envelop to patients at the highest risk for infection.
Ulrika Birgersdotter-Green, MD , professor of medicine and director of pacemaker and ICD services at the University of California, San Diego, made these comments as a designated discussant for the report. She has been a consultant to and received honoraria from Abbott, Boston Scientific, and Medtronic.
I like this new infection risk score. It addresses a very clinically relevant issue. It’s important for the electrophysiology community to better understand how to best manage infections related to cardiac rhythm devices and ideally prevent them from happening.
I’m not a big fan of risk scores in general because they can sometimes detract from independent thinking about how to manage a patient. However, it is also helpful to have this type of risk-assessment information when discussing management options with a patient.
The PADIT risk score may also help identify which patients could potentially benefit the most from an antibiotic-eluting envelope when receiving an implanted cardiac-rhythm device. Recently reported results from WRAP-IT showed that routinely using envelopes cut the incidence of major infections by a relative 40%, but in absolute terms, the number needed to treat with the envelop to prevent one major infection was about 200 patients, a big number given the high cost of the envelope (N Engl J Med. 2019 May 16;380[20]:1895-905). It is therefore very interesting to think about using the PADIT risk score to better target an effective but expensive preventive measure like an antibiotic-eluting envelop to patients at the highest risk for infection.
Ulrika Birgersdotter-Green, MD , professor of medicine and director of pacemaker and ICD services at the University of California, San Diego, made these comments as a designated discussant for the report. She has been a consultant to and received honoraria from Abbott, Boston Scientific, and Medtronic.
SAN FRANCISCO – Researchers have devised a five-item scoring formula to quantify the risk for infection in patients undergoing placement, revision, or removal of a cardiac-rhythm device based on data from nearly 20,000 patients enrolled in a recent infection-prophylaxis trial.
The risk score can help identify patients who might benefit from intensified antibiotic prophylaxis, and it can also help during shared decision making with patients to better understand the risk a patient faces from infection, compared with their predicted device benefit, David H. Birnie, MD, said at the annual scientific sessions of the Heart Rhythm Society.
The new risk score produced a concordance statistic, the area under the receiver-operator characteristic curve, of 0.704. It showed that, although it could use further validation, the score as it currently stands has substantial predictive value, said Dr. Birnie, professor of medicine at the University of Ottawa and deputy chief of cardiology at the University of Ottawa Heart Institute. “It’s certainly better than anything we have now,” he said in a video interview.
Dr. Birnie and his associates used data they collected on baseline characteristics and infection outcomes of the 19,603 patients enrolled in PADIT (Prevention of Arrhythmia Device Infection Trial) who underwent a rhythm-device procedure at 1 of 28 participating Canadian centers. The primary aim of PADIT was to assess the safety and efficacy of an intensified antibiotic-prophylaxis regimen, compared with a standard regimen of a cefazolin infusion just before the procedure. The study’s primary endpoint was the incidence of hospitalization for device infection during 1-year follow-up, and while the intensified prophylactic regimen linked with a 23% relative reduction in the hospitalization rate, compared with standard treatment, the difference was not statistically significant (J Am Coll Cardiol. 2018 Dec 18;72[24]:3098-109).
The researchers analyzed the baseline patient data and the blindly adjudicated infection outcomes and identified five factors that were independently associated with an increased infection rate. They organized the five factors and produced a formula they call the PADIT score (see chart). Those five factors are: prior procedures (the greater the number the greater the risk), age (which unexpectedly had an inverse relationship with infection incidence), depressed renal function, immuno-compromised status, and type of procedure. A patient can potentially score 0-15 points.
Among the PADIT patients a score of 0 correlated with about a 0.3% rate of hospitalization for a device-related infection during 1 year of follow-up, a score of 5 with about a 1.1% rate, a score of 6 with about a 1.8% rate, and a score of seven or more with a 3.4% infection rate over the following year. About 5% of patients had a score of 7 or more, and roughly another 5% had a score of 5 or 6, Dr. Birnie said. At his center, clinicians have begun routinely calculating scores for patients scheduled for an arrhythmia-device procedure, and they are considering routinely administering added antibiotic prophylaxis to patients with a preprocedural score of 6 or higher. They may also use the score to determine whether to use the antibacterial envelope recently reported to prevent cardiac-device infections (N Engl J Med. 2019 May 16;380[20]:1895-905).
“It’s very easy for patients to get to a PADIT score of 7 or higher,” Dr. Birnie noted. As an example, he cited a common patient, an 85-year-old with renal dysfunction who is under consideration for a second replacement of an implantable cardioverter defibrillator. The patient would score 1 point for renal insufficiency, 2 points for the type of device, and 4 points for having a prior history of two devices, and the consequent 3.4% risk for infection might counterbalance the potential benefit this elderly patient could expect from the new device. The score will be very important for targeting treatment, shared decision making, and selection of patients for future intervention trials, he concluded.
“I think this risk score will change practice by giving clinicians a better idea of a patient’s risk for infection,” commented Fred M. Kusumoto, MD, professor of medicine at the Mayo Medical School, Rochester, Minn., and director of heart rhythm services at the Mayo Clinic in Jacksonville, Fla. The PADIT score will help identify patients for whom leaving a device in place is a better option than taking it out because of their infection risk. The risk score could also help improve the cost effectiveness of preventive treatments, such as antibiotic-eluting envelopes, by targeting treatment to higher-risk patients, Dr. Kusumoto said during a press briefing.
SOURCE: Birnie DH. Heart Rhythm 2019, Absract S-LCT02-01.
SAN FRANCISCO – Researchers have devised a five-item scoring formula to quantify the risk for infection in patients undergoing placement, revision, or removal of a cardiac-rhythm device based on data from nearly 20,000 patients enrolled in a recent infection-prophylaxis trial.
The risk score can help identify patients who might benefit from intensified antibiotic prophylaxis, and it can also help during shared decision making with patients to better understand the risk a patient faces from infection, compared with their predicted device benefit, David H. Birnie, MD, said at the annual scientific sessions of the Heart Rhythm Society.
The new risk score produced a concordance statistic, the area under the receiver-operator characteristic curve, of 0.704. It showed that, although it could use further validation, the score as it currently stands has substantial predictive value, said Dr. Birnie, professor of medicine at the University of Ottawa and deputy chief of cardiology at the University of Ottawa Heart Institute. “It’s certainly better than anything we have now,” he said in a video interview.
Dr. Birnie and his associates used data they collected on baseline characteristics and infection outcomes of the 19,603 patients enrolled in PADIT (Prevention of Arrhythmia Device Infection Trial) who underwent a rhythm-device procedure at 1 of 28 participating Canadian centers. The primary aim of PADIT was to assess the safety and efficacy of an intensified antibiotic-prophylaxis regimen, compared with a standard regimen of a cefazolin infusion just before the procedure. The study’s primary endpoint was the incidence of hospitalization for device infection during 1-year follow-up, and while the intensified prophylactic regimen linked with a 23% relative reduction in the hospitalization rate, compared with standard treatment, the difference was not statistically significant (J Am Coll Cardiol. 2018 Dec 18;72[24]:3098-109).
The researchers analyzed the baseline patient data and the blindly adjudicated infection outcomes and identified five factors that were independently associated with an increased infection rate. They organized the five factors and produced a formula they call the PADIT score (see chart). Those five factors are: prior procedures (the greater the number the greater the risk), age (which unexpectedly had an inverse relationship with infection incidence), depressed renal function, immuno-compromised status, and type of procedure. A patient can potentially score 0-15 points.
Among the PADIT patients a score of 0 correlated with about a 0.3% rate of hospitalization for a device-related infection during 1 year of follow-up, a score of 5 with about a 1.1% rate, a score of 6 with about a 1.8% rate, and a score of seven or more with a 3.4% infection rate over the following year. About 5% of patients had a score of 7 or more, and roughly another 5% had a score of 5 or 6, Dr. Birnie said. At his center, clinicians have begun routinely calculating scores for patients scheduled for an arrhythmia-device procedure, and they are considering routinely administering added antibiotic prophylaxis to patients with a preprocedural score of 6 or higher. They may also use the score to determine whether to use the antibacterial envelope recently reported to prevent cardiac-device infections (N Engl J Med. 2019 May 16;380[20]:1895-905).
“It’s very easy for patients to get to a PADIT score of 7 or higher,” Dr. Birnie noted. As an example, he cited a common patient, an 85-year-old with renal dysfunction who is under consideration for a second replacement of an implantable cardioverter defibrillator. The patient would score 1 point for renal insufficiency, 2 points for the type of device, and 4 points for having a prior history of two devices, and the consequent 3.4% risk for infection might counterbalance the potential benefit this elderly patient could expect from the new device. The score will be very important for targeting treatment, shared decision making, and selection of patients for future intervention trials, he concluded.
“I think this risk score will change practice by giving clinicians a better idea of a patient’s risk for infection,” commented Fred M. Kusumoto, MD, professor of medicine at the Mayo Medical School, Rochester, Minn., and director of heart rhythm services at the Mayo Clinic in Jacksonville, Fla. The PADIT score will help identify patients for whom leaving a device in place is a better option than taking it out because of their infection risk. The risk score could also help improve the cost effectiveness of preventive treatments, such as antibiotic-eluting envelopes, by targeting treatment to higher-risk patients, Dr. Kusumoto said during a press briefing.
SOURCE: Birnie DH. Heart Rhythm 2019, Absract S-LCT02-01.
REPORTING FROM HEART RHYTHM 2019
Key clinical point: Researchers have devised a five-item scoring formula to predict a patient’s risk for infection from an cardiac rhythm–device procedure.
Major finding: The risk score had an optimism-corrected concordance statistic of 0.704.
Study details: Investigators developed the risk score using data from PADIT, a multicenter, randomized trial with 19,603 patients.
Disclosures: PADIT received no commercial funding. Dr. Birnie had no relevant disclosures.
Source: Birnie DH. Heart Rhythm 2019, Absract S-LCT02-01.
