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SAN DIEGO – Early benefits of valve-in-valve transcatheter aortic valve replacement (TAVR) for patients with failing surgical aortic bioprosthetic valves are sustained for at least 3 years, based on results presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
Previously published data for the 365 patients from the PARTNER Valve-in-Valve study showed dramatic improvements at 30 days and 1 year in hemodynamic measures, mitral and tricuspid regurgitation, and quality of life (J Am Coll Cardiol. 2017;69:2253-62).
At the 3-year mark, about one-third of patients had died, reported lead investigator John G. Webb, MD, a professor at the University of British Columbia, Vancouver. “I think we can say that this reflects multiple comorbidities in this high-risk patient population with an STS [Society of Thoracic Surgery] risk score of 1.9%. Patients were selected for being at extreme risk,” he commented. “This is not unexpected. ... This is very comparable to what we saw in the early PARTNER trials as well.”
For survivors, however, the early benefits were still present and largely unattenuated at 3 years. For example, about half of patients were New York Heart Association (NYHA) class I at 30 days, at 1 year, and at 3 years. And Kansas City Cardiomyopathy Questionnaire (KCCQ) score, reflecting heart failure–related quality of life, averaged 70-77 at all three time points.
The proportion of patients needing yet another valve replacement (surgical or transcatheter), possibly signaling structural valve deterioration or degeneration, was less than 2% at 3 years, and hemodynamic parameters remained good.
Practical matters
Valve-in-valve TAVR need not be restricted to academic high-volume centers, according to Dr. Webb. “I run a regional program, and my regional program had a hub-and-spoke model where this was restricted to one institution, and four other institutions just did routine transfemoral TAVR. We had to give up that because these are some of the easiest TAVR procedures that we do. You have a radio-opaque valve, you know the angle, you know the size, it seals well, you don’t get annular rupture, you don’t need pacemakers very often.”
In addition, recent TCT registry data suggest that outcomes with valve-in-valve TAVR are better than those with native-valve TAVR, Dr. Webb noted. “There’s a knowledge base that’s required that routine TAVR operators may not have. But it can be taught, it can be learned, and it’s not a difficult procedure when you know how to do it.”
“This study is very, very useful for all of us,” commented press conference panelist Jeffrey J. Popma, MD, an interventional cardiologist at the Beth Israel Deaconess Medical Center in Boston. “But should we be reconsidering anticoagulation therapy in some of the valve-in-valve procedures? We have learned from the leaflet thrombosis data that one of the risk factors for that is a valve-in-valve procedure. Clinically, we have seen a few cases where thrombus does form in the nidus of all the material that’s there.”
“There was no sign of leaflet thrombosis playing a role in reintervention,” Dr. Webb replied. “[Reintervention] was performed for various reasons, including leaks and valves that were too small. So it wasn’t clear that leaflet thrombosis was a factor in this study. That being said, we weren’t looking for it; we didn’t have sensitive means [to detect it], we weren’t doing transesophageal echoes, we weren’t doing CTs.
“Personally, I suspect that maybe we should be routinely anticoagulating all of our valve implants,” he added. “We certainly do it for our mitral valves routinely, and although I can’t recommend it, I have to admit that we do do this for aortic valves in my particular center. But I have no data from this study to support that either way.”
Study details
The 365 patients studied came from both an initial registry and a continued access registry, but were largely similar on baseline characteristics. All underwent valve-in-valve TAVR with SAPIEN XT transcatheter heart valves.
Mortality in the cohort was 12.1% at 1 year, 22.2% at 2 years, and 32.7% at 3 years, according to results reported at the meeting, which is sponsored by the Cardiovascular Research Foundation. In contrast, the rate of stroke was stable over time, at 5.1%, 5.1%, and 6.2%, respectively.
Repeat valve replacement (either surgical or transcatheter) had been performed in 0.6% of patients at 1 year, 0.6% at 2 years, and 1.9% at 3 years. “I think this is comparable to [what is seen in] surgical series,” Dr. Webb commented.
Between 30 days and 3 years, there were insignificant decreases in total aortic regurgitation that was moderate or worse in severity (from 2.9% to 2.5%) and paravalvular aortic regurgitation of these severities (from 2.6% to 1.4%). Although the valve used was older, “still, we had excellent sealing and aortic insufficiency was not a problem with these patients,” he noted.
In “interesting” findings, prevalence of mitral regurgitation that was moderate or worse continued falling, from 17.2% at 30 days to 8.6% at 3 years, and prevalence of tricuspid regurgitation that was moderate or worse did as well, from 21.8% to 18.8%.
“I was a little suspicious this was just a survival issue, that patients with severe mitral or tricuspid regurgitation died and, consequently, the average patient was less likely to have [these findings]. But the analysis that’s being done is linear mixed-effects analysis, which accounts for the survival bias,” Dr. Webb said.
The reasons for these trends are unknown, but possibly improved left ventricular function led to functional (rather than structural) improvements in mitral and tricuspid regurgitation.
At 3 years, proportions of patients with various NYHA classes were much the same as they had been at 30 days: class I (51.4% vs. 53.9%), class II (34.6% vs. 35.7%), and class III (13.0% vs. 9.2%). Similarly, the mean KCCQ overall summary score at 30 days (70.8) was sustained at 3 years (73.1).
Risk of death did not differ significantly according to the surgical valve size as labeled, the surgical valve true internal dimensions, the mode of valve failure, the approach used (transfemoral vs. transthoracic), or the residual gradient after valve implantation.
Analysis of the registry data is ongoing. For example, the investigators will be looking more closely at determinants of outcomes, such as additional characteristics of the surgical valve alone and in combination with those of the new valve. “We are all very aware that a lot of the outcomes have to do with what surgical valves you had to begin with. I think that is really critical – what surgical valve is in there,” he said.
Dr. Webb reported that he receives grant/research support and honoraria from, and is on the steering committee for, Edwards Lifesciences. The registry is sponsored by Edwards Lifesciences.
SAN DIEGO – Early benefits of valve-in-valve transcatheter aortic valve replacement (TAVR) for patients with failing surgical aortic bioprosthetic valves are sustained for at least 3 years, based on results presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
Previously published data for the 365 patients from the PARTNER Valve-in-Valve study showed dramatic improvements at 30 days and 1 year in hemodynamic measures, mitral and tricuspid regurgitation, and quality of life (J Am Coll Cardiol. 2017;69:2253-62).
At the 3-year mark, about one-third of patients had died, reported lead investigator John G. Webb, MD, a professor at the University of British Columbia, Vancouver. “I think we can say that this reflects multiple comorbidities in this high-risk patient population with an STS [Society of Thoracic Surgery] risk score of 1.9%. Patients were selected for being at extreme risk,” he commented. “This is not unexpected. ... This is very comparable to what we saw in the early PARTNER trials as well.”
For survivors, however, the early benefits were still present and largely unattenuated at 3 years. For example, about half of patients were New York Heart Association (NYHA) class I at 30 days, at 1 year, and at 3 years. And Kansas City Cardiomyopathy Questionnaire (KCCQ) score, reflecting heart failure–related quality of life, averaged 70-77 at all three time points.
The proportion of patients needing yet another valve replacement (surgical or transcatheter), possibly signaling structural valve deterioration or degeneration, was less than 2% at 3 years, and hemodynamic parameters remained good.
Practical matters
Valve-in-valve TAVR need not be restricted to academic high-volume centers, according to Dr. Webb. “I run a regional program, and my regional program had a hub-and-spoke model where this was restricted to one institution, and four other institutions just did routine transfemoral TAVR. We had to give up that because these are some of the easiest TAVR procedures that we do. You have a radio-opaque valve, you know the angle, you know the size, it seals well, you don’t get annular rupture, you don’t need pacemakers very often.”
In addition, recent TCT registry data suggest that outcomes with valve-in-valve TAVR are better than those with native-valve TAVR, Dr. Webb noted. “There’s a knowledge base that’s required that routine TAVR operators may not have. But it can be taught, it can be learned, and it’s not a difficult procedure when you know how to do it.”
“This study is very, very useful for all of us,” commented press conference panelist Jeffrey J. Popma, MD, an interventional cardiologist at the Beth Israel Deaconess Medical Center in Boston. “But should we be reconsidering anticoagulation therapy in some of the valve-in-valve procedures? We have learned from the leaflet thrombosis data that one of the risk factors for that is a valve-in-valve procedure. Clinically, we have seen a few cases where thrombus does form in the nidus of all the material that’s there.”
“There was no sign of leaflet thrombosis playing a role in reintervention,” Dr. Webb replied. “[Reintervention] was performed for various reasons, including leaks and valves that were too small. So it wasn’t clear that leaflet thrombosis was a factor in this study. That being said, we weren’t looking for it; we didn’t have sensitive means [to detect it], we weren’t doing transesophageal echoes, we weren’t doing CTs.
“Personally, I suspect that maybe we should be routinely anticoagulating all of our valve implants,” he added. “We certainly do it for our mitral valves routinely, and although I can’t recommend it, I have to admit that we do do this for aortic valves in my particular center. But I have no data from this study to support that either way.”
Study details
The 365 patients studied came from both an initial registry and a continued access registry, but were largely similar on baseline characteristics. All underwent valve-in-valve TAVR with SAPIEN XT transcatheter heart valves.
Mortality in the cohort was 12.1% at 1 year, 22.2% at 2 years, and 32.7% at 3 years, according to results reported at the meeting, which is sponsored by the Cardiovascular Research Foundation. In contrast, the rate of stroke was stable over time, at 5.1%, 5.1%, and 6.2%, respectively.
Repeat valve replacement (either surgical or transcatheter) had been performed in 0.6% of patients at 1 year, 0.6% at 2 years, and 1.9% at 3 years. “I think this is comparable to [what is seen in] surgical series,” Dr. Webb commented.
Between 30 days and 3 years, there were insignificant decreases in total aortic regurgitation that was moderate or worse in severity (from 2.9% to 2.5%) and paravalvular aortic regurgitation of these severities (from 2.6% to 1.4%). Although the valve used was older, “still, we had excellent sealing and aortic insufficiency was not a problem with these patients,” he noted.
In “interesting” findings, prevalence of mitral regurgitation that was moderate or worse continued falling, from 17.2% at 30 days to 8.6% at 3 years, and prevalence of tricuspid regurgitation that was moderate or worse did as well, from 21.8% to 18.8%.
“I was a little suspicious this was just a survival issue, that patients with severe mitral or tricuspid regurgitation died and, consequently, the average patient was less likely to have [these findings]. But the analysis that’s being done is linear mixed-effects analysis, which accounts for the survival bias,” Dr. Webb said.
The reasons for these trends are unknown, but possibly improved left ventricular function led to functional (rather than structural) improvements in mitral and tricuspid regurgitation.
At 3 years, proportions of patients with various NYHA classes were much the same as they had been at 30 days: class I (51.4% vs. 53.9%), class II (34.6% vs. 35.7%), and class III (13.0% vs. 9.2%). Similarly, the mean KCCQ overall summary score at 30 days (70.8) was sustained at 3 years (73.1).
Risk of death did not differ significantly according to the surgical valve size as labeled, the surgical valve true internal dimensions, the mode of valve failure, the approach used (transfemoral vs. transthoracic), or the residual gradient after valve implantation.
Analysis of the registry data is ongoing. For example, the investigators will be looking more closely at determinants of outcomes, such as additional characteristics of the surgical valve alone and in combination with those of the new valve. “We are all very aware that a lot of the outcomes have to do with what surgical valves you had to begin with. I think that is really critical – what surgical valve is in there,” he said.
Dr. Webb reported that he receives grant/research support and honoraria from, and is on the steering committee for, Edwards Lifesciences. The registry is sponsored by Edwards Lifesciences.
SAN DIEGO – Early benefits of valve-in-valve transcatheter aortic valve replacement (TAVR) for patients with failing surgical aortic bioprosthetic valves are sustained for at least 3 years, based on results presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
Previously published data for the 365 patients from the PARTNER Valve-in-Valve study showed dramatic improvements at 30 days and 1 year in hemodynamic measures, mitral and tricuspid regurgitation, and quality of life (J Am Coll Cardiol. 2017;69:2253-62).
At the 3-year mark, about one-third of patients had died, reported lead investigator John G. Webb, MD, a professor at the University of British Columbia, Vancouver. “I think we can say that this reflects multiple comorbidities in this high-risk patient population with an STS [Society of Thoracic Surgery] risk score of 1.9%. Patients were selected for being at extreme risk,” he commented. “This is not unexpected. ... This is very comparable to what we saw in the early PARTNER trials as well.”
For survivors, however, the early benefits were still present and largely unattenuated at 3 years. For example, about half of patients were New York Heart Association (NYHA) class I at 30 days, at 1 year, and at 3 years. And Kansas City Cardiomyopathy Questionnaire (KCCQ) score, reflecting heart failure–related quality of life, averaged 70-77 at all three time points.
The proportion of patients needing yet another valve replacement (surgical or transcatheter), possibly signaling structural valve deterioration or degeneration, was less than 2% at 3 years, and hemodynamic parameters remained good.
Practical matters
Valve-in-valve TAVR need not be restricted to academic high-volume centers, according to Dr. Webb. “I run a regional program, and my regional program had a hub-and-spoke model where this was restricted to one institution, and four other institutions just did routine transfemoral TAVR. We had to give up that because these are some of the easiest TAVR procedures that we do. You have a radio-opaque valve, you know the angle, you know the size, it seals well, you don’t get annular rupture, you don’t need pacemakers very often.”
In addition, recent TCT registry data suggest that outcomes with valve-in-valve TAVR are better than those with native-valve TAVR, Dr. Webb noted. “There’s a knowledge base that’s required that routine TAVR operators may not have. But it can be taught, it can be learned, and it’s not a difficult procedure when you know how to do it.”
“This study is very, very useful for all of us,” commented press conference panelist Jeffrey J. Popma, MD, an interventional cardiologist at the Beth Israel Deaconess Medical Center in Boston. “But should we be reconsidering anticoagulation therapy in some of the valve-in-valve procedures? We have learned from the leaflet thrombosis data that one of the risk factors for that is a valve-in-valve procedure. Clinically, we have seen a few cases where thrombus does form in the nidus of all the material that’s there.”
“There was no sign of leaflet thrombosis playing a role in reintervention,” Dr. Webb replied. “[Reintervention] was performed for various reasons, including leaks and valves that were too small. So it wasn’t clear that leaflet thrombosis was a factor in this study. That being said, we weren’t looking for it; we didn’t have sensitive means [to detect it], we weren’t doing transesophageal echoes, we weren’t doing CTs.
“Personally, I suspect that maybe we should be routinely anticoagulating all of our valve implants,” he added. “We certainly do it for our mitral valves routinely, and although I can’t recommend it, I have to admit that we do do this for aortic valves in my particular center. But I have no data from this study to support that either way.”
Study details
The 365 patients studied came from both an initial registry and a continued access registry, but were largely similar on baseline characteristics. All underwent valve-in-valve TAVR with SAPIEN XT transcatheter heart valves.
Mortality in the cohort was 12.1% at 1 year, 22.2% at 2 years, and 32.7% at 3 years, according to results reported at the meeting, which is sponsored by the Cardiovascular Research Foundation. In contrast, the rate of stroke was stable over time, at 5.1%, 5.1%, and 6.2%, respectively.
Repeat valve replacement (either surgical or transcatheter) had been performed in 0.6% of patients at 1 year, 0.6% at 2 years, and 1.9% at 3 years. “I think this is comparable to [what is seen in] surgical series,” Dr. Webb commented.
Between 30 days and 3 years, there were insignificant decreases in total aortic regurgitation that was moderate or worse in severity (from 2.9% to 2.5%) and paravalvular aortic regurgitation of these severities (from 2.6% to 1.4%). Although the valve used was older, “still, we had excellent sealing and aortic insufficiency was not a problem with these patients,” he noted.
In “interesting” findings, prevalence of mitral regurgitation that was moderate or worse continued falling, from 17.2% at 30 days to 8.6% at 3 years, and prevalence of tricuspid regurgitation that was moderate or worse did as well, from 21.8% to 18.8%.
“I was a little suspicious this was just a survival issue, that patients with severe mitral or tricuspid regurgitation died and, consequently, the average patient was less likely to have [these findings]. But the analysis that’s being done is linear mixed-effects analysis, which accounts for the survival bias,” Dr. Webb said.
The reasons for these trends are unknown, but possibly improved left ventricular function led to functional (rather than structural) improvements in mitral and tricuspid regurgitation.
At 3 years, proportions of patients with various NYHA classes were much the same as they had been at 30 days: class I (51.4% vs. 53.9%), class II (34.6% vs. 35.7%), and class III (13.0% vs. 9.2%). Similarly, the mean KCCQ overall summary score at 30 days (70.8) was sustained at 3 years (73.1).
Risk of death did not differ significantly according to the surgical valve size as labeled, the surgical valve true internal dimensions, the mode of valve failure, the approach used (transfemoral vs. transthoracic), or the residual gradient after valve implantation.
Analysis of the registry data is ongoing. For example, the investigators will be looking more closely at determinants of outcomes, such as additional characteristics of the surgical valve alone and in combination with those of the new valve. “We are all very aware that a lot of the outcomes have to do with what surgical valves you had to begin with. I think that is really critical – what surgical valve is in there,” he said.
Dr. Webb reported that he receives grant/research support and honoraria from, and is on the steering committee for, Edwards Lifesciences. The registry is sponsored by Edwards Lifesciences.
REPORTING FROM TCT 2018
Key clinical point: Early improvements in functional status and quality of life measures with valve-in-valve transcatheter aortic valve replacement are maintained longer term.
Major finding: Improvements at 30 days post procedure were maintained at 3 years post procedure; patients had similar distributions of New York Heart Association classes (for example, class I in 53.9% and 51.4%, respectively) and similar heart failure–related quality of life scores (70.8 vs. 73.1, P = .29).
Study details: A multicenter, prospective cohort study of 365 patients who underwent valve-in-valve transcatheter aortic valve replacement because of a failing surgical aortic bioprosthetic valve.
Disclosures: Dr. Webb reported that he receives grant/research support and honoraria from, and is on the steering committee for Edwards Lifesciences. The registry is sponsored by Edwards Lifesciences.