User login
WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.
Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.
These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).
The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.
“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.
Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.
Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.
According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.
Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.
“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.
Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
SOURCE: Dvir D. CRT 2018.
WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.
Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.
These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).
The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.
“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.
Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.
Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.
According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.
Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.
“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.
Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
SOURCE: Dvir D. CRT 2018.
WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.
Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.
These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).
The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.
“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.
Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.
Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.
According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.
Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.
“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.
Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
SOURCE: Dvir D. CRT 2018.
AT THE 2018 CRT MEETING
Key clinical point:
Major finding: With newer-generation THV, rates of incorrect positioning (9%), persistent regurgitation (4%), and 30-day mortality (8%) remain unacceptably high.
Data source: A registry data analysis.
Disclosures: Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
Source: Dvir D. CRT 2018.