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SAN FRANCISCO – Transcatheter aortic valve replacements seem to be holding up without feared increases in rates of stroke or regurgitation beyond what’s seen soon after the procedure, 3-year data from the PARTNER trial of 699 elderly, high-risk patients showed.
Rates of death from any cause were similar between patients randomized to transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) at each yearly follow-up so far. Those rates (the primary endpoint of the trial) were 24.3% in the TAVR group and 26.8% in SAVR group at 1 year, 33.7% and 34.6% at 2 years, and 442% and 44.8% at 3 years, respectively, according to ongoing follow-up of the PARTNER (Transcatheter vs. Surgical Aortic-Valve Replacement in High-Risk Patients) study.
Previously data had shown a higher stroke rate within 30 days of TAVR (5%), compared with SAVR (2%), though the difference did not reach statistical significance. By 3 years, the stroke rate in the surgery group caught up and even surpassed that in the TAVR group. After TAVR, stroke rates were 6% at 1 year, 8% at 2 years and 8% at 3 years, compared with rates of 3%, 5% and 9%, respectively, in the SAVR group, Dr. Vinod H. Thourani and his associates reported at the annual meeting of the American College of Cardiology. None of the stroke differences reached statistical significance.
Paravalvular leaks were common and more likely with TAVR at all follow-up time points. Even mild leakage after either procedure was associated with an unexpected, significantly increased risk of death, said Dr. Thourani, codirector of the Structural Heart and Valve Center and associate professor of cardiology at Emory University, Atlanta. Death rates in patients with mild aortic regurgitation of any kind (paravalvular or central) after TAVR were 26% at year 1, 32% at year 2, and 47% at year 3. For moderate to severe aortic regurgitation after TAVR, death rates increased to 38% at 1 year, 54% at 2 years, and 61% at 3 years.
The increased death risk with mild regurgitation has not shown up in European patient registries and caught investigators by surprise. The reason for this association in the study is a mystery, he said.
Echocardiographic analysis showed that hemodynamic performance after TAVR was maintained at 3 years, with similar valve areas and gradients, compared with SAVR. Both groups had significant improvements in left ventricular ejection fractions and left ventricular mass.
The PARTNER study included elderly patients with severe aortic stenosis who had a Society of Thoracic Surgeons (STS) score of at least 10%, suggesting they would be at high risk from surgery. Patients were randomized to undergo TAVR or SAVR at 1 of 25 sites in three countries and those in the TAVR group were further randomized to either transfemoral or transapical approach to placement of the balloon-expandable bovine pericardial valve, the first-generation Edwards SAPIEN transcatheter heart valve system (N. Engl. J. Med. 2011;364:2187-98).
Combining all-cause mortality or strokes, rates for TAVR and SAVR at 1 year were 27% and 29%, respectively, at 2 years were 37% and 36%, and at 3 years were 47% and 46%, respectively, he said.
Among clinical outcomes, rates of major vascular complications were significantly higher in the TAVR group, compared with SAVR: 12% vs. 4% at year 1, rates that held steady in years 2 and 3. Major bleeding was significantly less likely in the TAVR group each year, compared with SAVR: 16% vs. 27% in year 1, 19% vs. 30% in year 2, and 21% vs. 32% in year 3. Rates of endocarditis were similar between groups each year. No patients in either group developed structural valve deterioration requiring aortic valve replacement. Roughly 80% in each group had relief of symptoms.
Future efforts should aim to reduce procedure-related complications from TAVR, including strokes, vascular events, and paravalvular regurgitation, Dr. Thourani said.
"With a 44% mortality at 3 years, what we have to learn is how to select better patients," Dr. Bernard J. Gersh commented during a panel discussion of the findings. Dr. Gersh is professor of medicine at the Mayo Clinic, Rochester, Minn.
Experts in Europe have begun a series of meetings to try to define a transcatheter-specific risk score that might be a better gauge than the STS score in selecting patients for TAVR, Dr. Thourani said.
Patients in the current analysis have a minimum of 3 years of follow-up, so the findings really give a hint of 3- to 5-year results, Dr. Thourani said. "I think we can say something about the durability of these valves."
Dr. Patrick T. O’Gara cautioned against generalizing results from the PARTNER cohort, which averaged 84 years in age. "We have durability information in the octogenarian group over 3 years of time. When we think about deploying this kind of technology in younger and healthier individuals, there remain concerns about durability and about paravalvular leaks," he said at a press briefing.
Concerns about some findings, such as the 44% mortality rate at 3 years, may amount to unnecessarily "throwing darts" at the TAVR results, he suggested. "Let’s remember that we’re dealing with a group of patients who are 84 years of age on average. Our expectations for their outcomes need to be tempered by the context in which these procedures are offered," said Dr. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.
Each TAVR costs approximately $70,000-$75,000, Dr. Thourani estimated.
Edwards Lifesciences, which makes the transcatheter valve replacement systems, funded the PARTNER trial, and Dr. Thourani and some of his coinvestigators disclosed financial relationships with the company. He also disclosed relationships with St. Jude Medical, Marquet Medical, Sorin Medical, and Medtronic. Dr. O’Gara had nothing to disclose. Dr. Gersh disclosed financial relationships with St. Jude Medical and Boston Scientific.
Twitter @sherryboschert
There’s no question that TAVR is here to stay. In PARTNER and in registries from Europe, the valves have been shown to be durable. The 3-year outcomes are superb, compared with conventional AVR. We don’t know about years, 5, 6, 7, or 8; we still have to follow.
One of the questions here, as the valve gets better moving forward, is to define who is the best target for this. We’ve all seen the bar coming down from use in extremely high-risk patients, and now there are more and more trials in lower-risk patients.
On the other side of the fence, in very-high-risk patients, there is a time when people may be so high risk that we would be doing something futile. With such an expensive surgery, we have to "tune up" that a little bit. I hope that we refine those criteria in the future.
Aortic valve replacements frequently leak, and leaks can be mild, moderate, or severe. In the PARTNER trial, even a mild leak was associated with a higher risk of events over the follow-up period, which in the European registries doesn’t show up. That still remains a mystery. It may be a marker of something else that is going on with these patients.
Dr. Miguel A. Quiñones is a professor of medicine at Cornell University, New York, and chair of cardiology in the Methodist Hospital System, Houston, Tex. These were some of his comments at a press briefing after Dr. Thourani’s presentation. He had no disclosures.
There’s no question that TAVR is here to stay. In PARTNER and in registries from Europe, the valves have been shown to be durable. The 3-year outcomes are superb, compared with conventional AVR. We don’t know about years, 5, 6, 7, or 8; we still have to follow.
One of the questions here, as the valve gets better moving forward, is to define who is the best target for this. We’ve all seen the bar coming down from use in extremely high-risk patients, and now there are more and more trials in lower-risk patients.
On the other side of the fence, in very-high-risk patients, there is a time when people may be so high risk that we would be doing something futile. With such an expensive surgery, we have to "tune up" that a little bit. I hope that we refine those criteria in the future.
Aortic valve replacements frequently leak, and leaks can be mild, moderate, or severe. In the PARTNER trial, even a mild leak was associated with a higher risk of events over the follow-up period, which in the European registries doesn’t show up. That still remains a mystery. It may be a marker of something else that is going on with these patients.
Dr. Miguel A. Quiñones is a professor of medicine at Cornell University, New York, and chair of cardiology in the Methodist Hospital System, Houston, Tex. These were some of his comments at a press briefing after Dr. Thourani’s presentation. He had no disclosures.
There’s no question that TAVR is here to stay. In PARTNER and in registries from Europe, the valves have been shown to be durable. The 3-year outcomes are superb, compared with conventional AVR. We don’t know about years, 5, 6, 7, or 8; we still have to follow.
One of the questions here, as the valve gets better moving forward, is to define who is the best target for this. We’ve all seen the bar coming down from use in extremely high-risk patients, and now there are more and more trials in lower-risk patients.
On the other side of the fence, in very-high-risk patients, there is a time when people may be so high risk that we would be doing something futile. With such an expensive surgery, we have to "tune up" that a little bit. I hope that we refine those criteria in the future.
Aortic valve replacements frequently leak, and leaks can be mild, moderate, or severe. In the PARTNER trial, even a mild leak was associated with a higher risk of events over the follow-up period, which in the European registries doesn’t show up. That still remains a mystery. It may be a marker of something else that is going on with these patients.
Dr. Miguel A. Quiñones is a professor of medicine at Cornell University, New York, and chair of cardiology in the Methodist Hospital System, Houston, Tex. These were some of his comments at a press briefing after Dr. Thourani’s presentation. He had no disclosures.
SAN FRANCISCO – Transcatheter aortic valve replacements seem to be holding up without feared increases in rates of stroke or regurgitation beyond what’s seen soon after the procedure, 3-year data from the PARTNER trial of 699 elderly, high-risk patients showed.
Rates of death from any cause were similar between patients randomized to transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) at each yearly follow-up so far. Those rates (the primary endpoint of the trial) were 24.3% in the TAVR group and 26.8% in SAVR group at 1 year, 33.7% and 34.6% at 2 years, and 442% and 44.8% at 3 years, respectively, according to ongoing follow-up of the PARTNER (Transcatheter vs. Surgical Aortic-Valve Replacement in High-Risk Patients) study.
Previously data had shown a higher stroke rate within 30 days of TAVR (5%), compared with SAVR (2%), though the difference did not reach statistical significance. By 3 years, the stroke rate in the surgery group caught up and even surpassed that in the TAVR group. After TAVR, stroke rates were 6% at 1 year, 8% at 2 years and 8% at 3 years, compared with rates of 3%, 5% and 9%, respectively, in the SAVR group, Dr. Vinod H. Thourani and his associates reported at the annual meeting of the American College of Cardiology. None of the stroke differences reached statistical significance.
Paravalvular leaks were common and more likely with TAVR at all follow-up time points. Even mild leakage after either procedure was associated with an unexpected, significantly increased risk of death, said Dr. Thourani, codirector of the Structural Heart and Valve Center and associate professor of cardiology at Emory University, Atlanta. Death rates in patients with mild aortic regurgitation of any kind (paravalvular or central) after TAVR were 26% at year 1, 32% at year 2, and 47% at year 3. For moderate to severe aortic regurgitation after TAVR, death rates increased to 38% at 1 year, 54% at 2 years, and 61% at 3 years.
The increased death risk with mild regurgitation has not shown up in European patient registries and caught investigators by surprise. The reason for this association in the study is a mystery, he said.
Echocardiographic analysis showed that hemodynamic performance after TAVR was maintained at 3 years, with similar valve areas and gradients, compared with SAVR. Both groups had significant improvements in left ventricular ejection fractions and left ventricular mass.
The PARTNER study included elderly patients with severe aortic stenosis who had a Society of Thoracic Surgeons (STS) score of at least 10%, suggesting they would be at high risk from surgery. Patients were randomized to undergo TAVR or SAVR at 1 of 25 sites in three countries and those in the TAVR group were further randomized to either transfemoral or transapical approach to placement of the balloon-expandable bovine pericardial valve, the first-generation Edwards SAPIEN transcatheter heart valve system (N. Engl. J. Med. 2011;364:2187-98).
Combining all-cause mortality or strokes, rates for TAVR and SAVR at 1 year were 27% and 29%, respectively, at 2 years were 37% and 36%, and at 3 years were 47% and 46%, respectively, he said.
Among clinical outcomes, rates of major vascular complications were significantly higher in the TAVR group, compared with SAVR: 12% vs. 4% at year 1, rates that held steady in years 2 and 3. Major bleeding was significantly less likely in the TAVR group each year, compared with SAVR: 16% vs. 27% in year 1, 19% vs. 30% in year 2, and 21% vs. 32% in year 3. Rates of endocarditis were similar between groups each year. No patients in either group developed structural valve deterioration requiring aortic valve replacement. Roughly 80% in each group had relief of symptoms.
Future efforts should aim to reduce procedure-related complications from TAVR, including strokes, vascular events, and paravalvular regurgitation, Dr. Thourani said.
"With a 44% mortality at 3 years, what we have to learn is how to select better patients," Dr. Bernard J. Gersh commented during a panel discussion of the findings. Dr. Gersh is professor of medicine at the Mayo Clinic, Rochester, Minn.
Experts in Europe have begun a series of meetings to try to define a transcatheter-specific risk score that might be a better gauge than the STS score in selecting patients for TAVR, Dr. Thourani said.
Patients in the current analysis have a minimum of 3 years of follow-up, so the findings really give a hint of 3- to 5-year results, Dr. Thourani said. "I think we can say something about the durability of these valves."
Dr. Patrick T. O’Gara cautioned against generalizing results from the PARTNER cohort, which averaged 84 years in age. "We have durability information in the octogenarian group over 3 years of time. When we think about deploying this kind of technology in younger and healthier individuals, there remain concerns about durability and about paravalvular leaks," he said at a press briefing.
Concerns about some findings, such as the 44% mortality rate at 3 years, may amount to unnecessarily "throwing darts" at the TAVR results, he suggested. "Let’s remember that we’re dealing with a group of patients who are 84 years of age on average. Our expectations for their outcomes need to be tempered by the context in which these procedures are offered," said Dr. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.
Each TAVR costs approximately $70,000-$75,000, Dr. Thourani estimated.
Edwards Lifesciences, which makes the transcatheter valve replacement systems, funded the PARTNER trial, and Dr. Thourani and some of his coinvestigators disclosed financial relationships with the company. He also disclosed relationships with St. Jude Medical, Marquet Medical, Sorin Medical, and Medtronic. Dr. O’Gara had nothing to disclose. Dr. Gersh disclosed financial relationships with St. Jude Medical and Boston Scientific.
Twitter @sherryboschert
SAN FRANCISCO – Transcatheter aortic valve replacements seem to be holding up without feared increases in rates of stroke or regurgitation beyond what’s seen soon after the procedure, 3-year data from the PARTNER trial of 699 elderly, high-risk patients showed.
Rates of death from any cause were similar between patients randomized to transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) at each yearly follow-up so far. Those rates (the primary endpoint of the trial) were 24.3% in the TAVR group and 26.8% in SAVR group at 1 year, 33.7% and 34.6% at 2 years, and 442% and 44.8% at 3 years, respectively, according to ongoing follow-up of the PARTNER (Transcatheter vs. Surgical Aortic-Valve Replacement in High-Risk Patients) study.
Previously data had shown a higher stroke rate within 30 days of TAVR (5%), compared with SAVR (2%), though the difference did not reach statistical significance. By 3 years, the stroke rate in the surgery group caught up and even surpassed that in the TAVR group. After TAVR, stroke rates were 6% at 1 year, 8% at 2 years and 8% at 3 years, compared with rates of 3%, 5% and 9%, respectively, in the SAVR group, Dr. Vinod H. Thourani and his associates reported at the annual meeting of the American College of Cardiology. None of the stroke differences reached statistical significance.
Paravalvular leaks were common and more likely with TAVR at all follow-up time points. Even mild leakage after either procedure was associated with an unexpected, significantly increased risk of death, said Dr. Thourani, codirector of the Structural Heart and Valve Center and associate professor of cardiology at Emory University, Atlanta. Death rates in patients with mild aortic regurgitation of any kind (paravalvular or central) after TAVR were 26% at year 1, 32% at year 2, and 47% at year 3. For moderate to severe aortic regurgitation after TAVR, death rates increased to 38% at 1 year, 54% at 2 years, and 61% at 3 years.
The increased death risk with mild regurgitation has not shown up in European patient registries and caught investigators by surprise. The reason for this association in the study is a mystery, he said.
Echocardiographic analysis showed that hemodynamic performance after TAVR was maintained at 3 years, with similar valve areas and gradients, compared with SAVR. Both groups had significant improvements in left ventricular ejection fractions and left ventricular mass.
The PARTNER study included elderly patients with severe aortic stenosis who had a Society of Thoracic Surgeons (STS) score of at least 10%, suggesting they would be at high risk from surgery. Patients were randomized to undergo TAVR or SAVR at 1 of 25 sites in three countries and those in the TAVR group were further randomized to either transfemoral or transapical approach to placement of the balloon-expandable bovine pericardial valve, the first-generation Edwards SAPIEN transcatheter heart valve system (N. Engl. J. Med. 2011;364:2187-98).
Combining all-cause mortality or strokes, rates for TAVR and SAVR at 1 year were 27% and 29%, respectively, at 2 years were 37% and 36%, and at 3 years were 47% and 46%, respectively, he said.
Among clinical outcomes, rates of major vascular complications were significantly higher in the TAVR group, compared with SAVR: 12% vs. 4% at year 1, rates that held steady in years 2 and 3. Major bleeding was significantly less likely in the TAVR group each year, compared with SAVR: 16% vs. 27% in year 1, 19% vs. 30% in year 2, and 21% vs. 32% in year 3. Rates of endocarditis were similar between groups each year. No patients in either group developed structural valve deterioration requiring aortic valve replacement. Roughly 80% in each group had relief of symptoms.
Future efforts should aim to reduce procedure-related complications from TAVR, including strokes, vascular events, and paravalvular regurgitation, Dr. Thourani said.
"With a 44% mortality at 3 years, what we have to learn is how to select better patients," Dr. Bernard J. Gersh commented during a panel discussion of the findings. Dr. Gersh is professor of medicine at the Mayo Clinic, Rochester, Minn.
Experts in Europe have begun a series of meetings to try to define a transcatheter-specific risk score that might be a better gauge than the STS score in selecting patients for TAVR, Dr. Thourani said.
Patients in the current analysis have a minimum of 3 years of follow-up, so the findings really give a hint of 3- to 5-year results, Dr. Thourani said. "I think we can say something about the durability of these valves."
Dr. Patrick T. O’Gara cautioned against generalizing results from the PARTNER cohort, which averaged 84 years in age. "We have durability information in the octogenarian group over 3 years of time. When we think about deploying this kind of technology in younger and healthier individuals, there remain concerns about durability and about paravalvular leaks," he said at a press briefing.
Concerns about some findings, such as the 44% mortality rate at 3 years, may amount to unnecessarily "throwing darts" at the TAVR results, he suggested. "Let’s remember that we’re dealing with a group of patients who are 84 years of age on average. Our expectations for their outcomes need to be tempered by the context in which these procedures are offered," said Dr. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.
Each TAVR costs approximately $70,000-$75,000, Dr. Thourani estimated.
Edwards Lifesciences, which makes the transcatheter valve replacement systems, funded the PARTNER trial, and Dr. Thourani and some of his coinvestigators disclosed financial relationships with the company. He also disclosed relationships with St. Jude Medical, Marquet Medical, Sorin Medical, and Medtronic. Dr. O’Gara had nothing to disclose. Dr. Gersh disclosed financial relationships with St. Jude Medical and Boston Scientific.
Twitter @sherryboschert
AT ACC 13
Major finding: All-cause mortality rates after 3 years were 44% following TAVR and 45% following SAVR, with higher rates of valve leakage after TAVR and similar 3-year stroke rates between groups.
Data source: Three-year follow-up data on 699 elderly patients with aortic stenosis at high risk for surgery in the randomized, controlled PARTNER trial.
Disclosures: Edwards Lifesciences, which makes the transcatheter valve replacement systems, funded the PARTNER trial, and Dr. Thourani and some of his coinvestigators disclosed financial relationships with the company. He also disclosed relationships with St. Jude Medical, Marquet Medical, Sorin Medical, and Medtronic.
