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PARIS – Follow-up data from a randomized trial of transcatheter versus surgical aortic valve replacement in low-surgical-risk patients with symptomatic severe aortic stenosis showed sustained superior hemodynamic valve performance and less structural valve deterioration in the transcatheter group through 6 years, Lars Sondergaard, MD, reported at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
Moreover, the rate of bioprosthetic valve failure as formally defined in a recent European consensus statement (Eur Heart J. 2017 Dec 1;38[45]:3382-90) was similarly low in the transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) arms at about 7%, in the randomized study known as NOTION (Nordic Aortic Valve Intervention), added Dr. Sondergaard, professor of cardiology at the University of Copenhagen, who was a coauthor of the consensus statement.
“As we look to expand TAVR to younger patients with longer life expectancy, durability, of course, becomes much more important,” the cardiologist observed.
NOTION was a pioneering prospective, multicenter, nonblinded, randomized trial of first-generation TAVR technology. The 280 participants, average age 79 years, were truly a low-surgical-risk population, with a mean Society of Thoracic Surgeons risk score of 3%.
NOTION is a small trial, but the results at 6 years of a planned 10-year follow-up augur well for TAVR success in the large, ongoing, definitive, randomized trials of TAVR versus SAVR in low-risk patients. That’s because NOTION participants were treated in 2009-2013, when the self-expanding TAVR CoreValve was implanted on the basis of aortic annulus measurements obtained via echocardiography, which is considerably less accurate than CT, the standard practice today. For this reason, it’s highly unlikely that the larger, ongoing trials, including PARTNER 3 and the Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients trial, will experience moderate paravalvular leak rates anything like the 20.9% rate seen in the TAVR group in NOTION, where the SAVR group’s rate was just 1.5%.
“I’m sure quite a few of the NOTION patients would have a larger TAVR valve prosthesis if they were treated today,” according to Dr. Sondergaard.
Valve function
The rate of moderate hemodynamic structural valve deterioration through 6 years of follow-up was 3.6% in the TAVR arm, compared with 23.7% in the SAVR group. The rate of nonstructural valve deterioration was 54.0% with TAVR and 57.8% with SAVR, and there were no cases of moderate or severe aortic regurgitation in either group.
The mean aortic valve gradient in the TAVR group went from 44.9 mm Hg at baseline to 12.2 mm Hg at 3 months and to 14.7 mm Hg at 6 years. In the SAVR group, the figures were 44.9 mm Hg, 8.3 mm Hg, and 9.9 mm Hg, respectively.
The effective orifice area in the TAVR group improved from 0.74 cm2 at baseline to 1.37 cm2 at 3 months and to 1.16 cm2 at 6 years. With SAVR, the effective orifice area was 0.74 cm2 at baseline, 1.66 cm2 at 3 months, and 1.53 cm2 at 6 years.
Clinical outcomes
Through 6 years of follow-up, there were no cases of thrombosis in either study arm, and the rate of endocarditis was just under 6% in each group through 6 years. All-cause mortality through 6 years was 42.5% in the TAVR group, not significantly different from the 37.7% rate in the SAVR arm.
The valve-related death rate was 5.0% in the TAVR arm and similar at 3.7% with SAVR. Reintervention occurred in 2.2% of TAVR patients and in 0.7% of SAVR patients. Severe hemodynamic structural valve deterioration was documented in 0.7% of TAVR patients and 3.0% of SAVR patients. The overall rate of bioprosthetic valve failure – a composite of these three endpoints – was 7.5% with TAVR and similar at 6.7% with SAVR.
Session cochair Alain G. Cribier, MD, a TAVR pioneer who is professor of medicine and director of cardiology at Charles Nicolle Hospital, University of Rouen (France), declared, “This is extremely encouraging.”
However, discussant Corrado Tamburino, MD, was more circumspect.
“If you look, there’s a trend for increased all-cause mortality in the TAVR versus SAVR group at 6 years. This could be related to the big difference in paravalvular leak. Do you think paravalvular leak could have a real impact on mortality?” asked Dr. Tamburino, professor of cardiology at the University of Catania, Italy.
Not in the NOTION study, where they looked for but didn’t find any such association, according to Dr. Sondergaard.
“If you look at the survival curves from the beginning out to 6 years, you’ll see that the lines cross each other several times, so this small difference right now could just be random. I don’t think we can say there’s a higher mortality rate with TAVR for the time being,” he added.
The NOTION trial was funded by the Danish Heart Foundation. Dr. Sondergaard reported receiving research grants from and/or serving as a consultant to Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis.
PARIS – Follow-up data from a randomized trial of transcatheter versus surgical aortic valve replacement in low-surgical-risk patients with symptomatic severe aortic stenosis showed sustained superior hemodynamic valve performance and less structural valve deterioration in the transcatheter group through 6 years, Lars Sondergaard, MD, reported at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
Moreover, the rate of bioprosthetic valve failure as formally defined in a recent European consensus statement (Eur Heart J. 2017 Dec 1;38[45]:3382-90) was similarly low in the transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) arms at about 7%, in the randomized study known as NOTION (Nordic Aortic Valve Intervention), added Dr. Sondergaard, professor of cardiology at the University of Copenhagen, who was a coauthor of the consensus statement.
“As we look to expand TAVR to younger patients with longer life expectancy, durability, of course, becomes much more important,” the cardiologist observed.
NOTION was a pioneering prospective, multicenter, nonblinded, randomized trial of first-generation TAVR technology. The 280 participants, average age 79 years, were truly a low-surgical-risk population, with a mean Society of Thoracic Surgeons risk score of 3%.
NOTION is a small trial, but the results at 6 years of a planned 10-year follow-up augur well for TAVR success in the large, ongoing, definitive, randomized trials of TAVR versus SAVR in low-risk patients. That’s because NOTION participants were treated in 2009-2013, when the self-expanding TAVR CoreValve was implanted on the basis of aortic annulus measurements obtained via echocardiography, which is considerably less accurate than CT, the standard practice today. For this reason, it’s highly unlikely that the larger, ongoing trials, including PARTNER 3 and the Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients trial, will experience moderate paravalvular leak rates anything like the 20.9% rate seen in the TAVR group in NOTION, where the SAVR group’s rate was just 1.5%.
“I’m sure quite a few of the NOTION patients would have a larger TAVR valve prosthesis if they were treated today,” according to Dr. Sondergaard.
Valve function
The rate of moderate hemodynamic structural valve deterioration through 6 years of follow-up was 3.6% in the TAVR arm, compared with 23.7% in the SAVR group. The rate of nonstructural valve deterioration was 54.0% with TAVR and 57.8% with SAVR, and there were no cases of moderate or severe aortic regurgitation in either group.
The mean aortic valve gradient in the TAVR group went from 44.9 mm Hg at baseline to 12.2 mm Hg at 3 months and to 14.7 mm Hg at 6 years. In the SAVR group, the figures were 44.9 mm Hg, 8.3 mm Hg, and 9.9 mm Hg, respectively.
The effective orifice area in the TAVR group improved from 0.74 cm2 at baseline to 1.37 cm2 at 3 months and to 1.16 cm2 at 6 years. With SAVR, the effective orifice area was 0.74 cm2 at baseline, 1.66 cm2 at 3 months, and 1.53 cm2 at 6 years.
Clinical outcomes
Through 6 years of follow-up, there were no cases of thrombosis in either study arm, and the rate of endocarditis was just under 6% in each group through 6 years. All-cause mortality through 6 years was 42.5% in the TAVR group, not significantly different from the 37.7% rate in the SAVR arm.
The valve-related death rate was 5.0% in the TAVR arm and similar at 3.7% with SAVR. Reintervention occurred in 2.2% of TAVR patients and in 0.7% of SAVR patients. Severe hemodynamic structural valve deterioration was documented in 0.7% of TAVR patients and 3.0% of SAVR patients. The overall rate of bioprosthetic valve failure – a composite of these three endpoints – was 7.5% with TAVR and similar at 6.7% with SAVR.
Session cochair Alain G. Cribier, MD, a TAVR pioneer who is professor of medicine and director of cardiology at Charles Nicolle Hospital, University of Rouen (France), declared, “This is extremely encouraging.”
However, discussant Corrado Tamburino, MD, was more circumspect.
“If you look, there’s a trend for increased all-cause mortality in the TAVR versus SAVR group at 6 years. This could be related to the big difference in paravalvular leak. Do you think paravalvular leak could have a real impact on mortality?” asked Dr. Tamburino, professor of cardiology at the University of Catania, Italy.
Not in the NOTION study, where they looked for but didn’t find any such association, according to Dr. Sondergaard.
“If you look at the survival curves from the beginning out to 6 years, you’ll see that the lines cross each other several times, so this small difference right now could just be random. I don’t think we can say there’s a higher mortality rate with TAVR for the time being,” he added.
The NOTION trial was funded by the Danish Heart Foundation. Dr. Sondergaard reported receiving research grants from and/or serving as a consultant to Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis.
PARIS – Follow-up data from a randomized trial of transcatheter versus surgical aortic valve replacement in low-surgical-risk patients with symptomatic severe aortic stenosis showed sustained superior hemodynamic valve performance and less structural valve deterioration in the transcatheter group through 6 years, Lars Sondergaard, MD, reported at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
Moreover, the rate of bioprosthetic valve failure as formally defined in a recent European consensus statement (Eur Heart J. 2017 Dec 1;38[45]:3382-90) was similarly low in the transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) arms at about 7%, in the randomized study known as NOTION (Nordic Aortic Valve Intervention), added Dr. Sondergaard, professor of cardiology at the University of Copenhagen, who was a coauthor of the consensus statement.
“As we look to expand TAVR to younger patients with longer life expectancy, durability, of course, becomes much more important,” the cardiologist observed.
NOTION was a pioneering prospective, multicenter, nonblinded, randomized trial of first-generation TAVR technology. The 280 participants, average age 79 years, were truly a low-surgical-risk population, with a mean Society of Thoracic Surgeons risk score of 3%.
NOTION is a small trial, but the results at 6 years of a planned 10-year follow-up augur well for TAVR success in the large, ongoing, definitive, randomized trials of TAVR versus SAVR in low-risk patients. That’s because NOTION participants were treated in 2009-2013, when the self-expanding TAVR CoreValve was implanted on the basis of aortic annulus measurements obtained via echocardiography, which is considerably less accurate than CT, the standard practice today. For this reason, it’s highly unlikely that the larger, ongoing trials, including PARTNER 3 and the Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients trial, will experience moderate paravalvular leak rates anything like the 20.9% rate seen in the TAVR group in NOTION, where the SAVR group’s rate was just 1.5%.
“I’m sure quite a few of the NOTION patients would have a larger TAVR valve prosthesis if they were treated today,” according to Dr. Sondergaard.
Valve function
The rate of moderate hemodynamic structural valve deterioration through 6 years of follow-up was 3.6% in the TAVR arm, compared with 23.7% in the SAVR group. The rate of nonstructural valve deterioration was 54.0% with TAVR and 57.8% with SAVR, and there were no cases of moderate or severe aortic regurgitation in either group.
The mean aortic valve gradient in the TAVR group went from 44.9 mm Hg at baseline to 12.2 mm Hg at 3 months and to 14.7 mm Hg at 6 years. In the SAVR group, the figures were 44.9 mm Hg, 8.3 mm Hg, and 9.9 mm Hg, respectively.
The effective orifice area in the TAVR group improved from 0.74 cm2 at baseline to 1.37 cm2 at 3 months and to 1.16 cm2 at 6 years. With SAVR, the effective orifice area was 0.74 cm2 at baseline, 1.66 cm2 at 3 months, and 1.53 cm2 at 6 years.
Clinical outcomes
Through 6 years of follow-up, there were no cases of thrombosis in either study arm, and the rate of endocarditis was just under 6% in each group through 6 years. All-cause mortality through 6 years was 42.5% in the TAVR group, not significantly different from the 37.7% rate in the SAVR arm.
The valve-related death rate was 5.0% in the TAVR arm and similar at 3.7% with SAVR. Reintervention occurred in 2.2% of TAVR patients and in 0.7% of SAVR patients. Severe hemodynamic structural valve deterioration was documented in 0.7% of TAVR patients and 3.0% of SAVR patients. The overall rate of bioprosthetic valve failure – a composite of these three endpoints – was 7.5% with TAVR and similar at 6.7% with SAVR.
Session cochair Alain G. Cribier, MD, a TAVR pioneer who is professor of medicine and director of cardiology at Charles Nicolle Hospital, University of Rouen (France), declared, “This is extremely encouraging.”
However, discussant Corrado Tamburino, MD, was more circumspect.
“If you look, there’s a trend for increased all-cause mortality in the TAVR versus SAVR group at 6 years. This could be related to the big difference in paravalvular leak. Do you think paravalvular leak could have a real impact on mortality?” asked Dr. Tamburino, professor of cardiology at the University of Catania, Italy.
Not in the NOTION study, where they looked for but didn’t find any such association, according to Dr. Sondergaard.
“If you look at the survival curves from the beginning out to 6 years, you’ll see that the lines cross each other several times, so this small difference right now could just be random. I don’t think we can say there’s a higher mortality rate with TAVR for the time being,” he added.
The NOTION trial was funded by the Danish Heart Foundation. Dr. Sondergaard reported receiving research grants from and/or serving as a consultant to Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis.
REPORTING FROM EUROPCR 2018
Key clinical point: TAVR provided superior hemodynamic valve performance and less structural valve deterioration than SAVR in low-surgical-risk patients through 6 years of follow-up.
Major finding: The rate of moderate hemodynamic structural valve deterioration through 6 years was 3.6% with TAVR and 23.7% with SAVR.
Study details: An analysis of 6-year follow-up data from NOTION, a prospective, multicenter, randomized trial in 280 low-surgical-risk patients.
Disclosures: NOTION was funded by the Danish Heart Foundation. The presenter reported receiving research grants from and/or serving as a consultant to several medical device companies.