TBD Meeting (3154-22)

In patients with severe mitral regurgitation (MR) and cardiogenic shock, successful transcatheter edge-to-edge repair (TEER) is associated with a substantial reduction in all-cause mortality and lower morbidity at 1 year, according to an analysis of registry data.

The data from this analysis also confirm that “successful reduction of MR is achievable with TEER in most patients with cardiogenic shock,” reported Mohamad A. Alkhouli, MD, an interventional cardiologist and professor of medicine at the Mayo Clinic, Rochester, Minn.

STS/ACC TCT registry data queried

Drawn from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, 3,797 patients with cardiogenic shock underwent MR repair between November 2013 and December 2021. Outcomes at 1 year were evaluable in 2,773 of these patients. For inclusion, all had to meet at least one of the definitions of cardiogenic shock, such as inotrope use or mechanical circulatory support.

At baseline, 94.5% had a MR severity of at least 3+, and most of these had 4+. Thirty days after treatment, 88.8% had MR severity of 2+ or less, the majority of which had a severity of 1+.

These data address an important question not previously well studied, according to Dr. Alkhouli. In MR patients, cardiogenic shock is associated with a high risk of death, but there has been little evidence that valve repair does not exacerbate, let alone modify, this risk.

These data support the value of intervention, which was performed in almost all patients with MitraClipä (Abbott), the only device available for most of the period in which the registry was queried. However, Dr. Alkhouli cautioned that his data are best considered “hypothesis generating.”

“We need a randomized trial,” he said at the meeting sponsored by the Cardiovascular Research Foundation. He pointed out that this is a complex population for which multiple variables might have skewed results when data are analyzed retrospectively. Not least, those MR patients with cardiogenic shock in the database considered for TEER might well have been relatively healthy and not representative of an unselected population with both MR and cardiogenic shock.

The question might be better answered by the multicenter Canadian trial CAPITAL MINOS, which has just started. Described in an article in the American Heart Journal, it has a planned enrollment of about 150 MR patients with cardiogenic shock randomized to TEER or medical therapy. Results are expected in about 1 year, according to Dr. Alkhouli.

But regarding the present analysis, Dr. Alkhouli did note that sensitivity analyses conducted within his data across risk factors, such as degenerative versus nondegenerative MR, low (< 30%) versus higher left ventricular ejection fraction (LVEF), and presence or absence of an acute coronary syndrome (ACS), consistently supported a benefit from intervention.

Also, cardiogenic shock did not appear to be a factor in device failure, according to Dr. Alkhouli, addressing a potential criticism that cardiogenic shock was an underlying reason for device failure.
 

More than 90% in NYHA class III or IV heart failure

In this study, the mean age was 73 years. More than 90% were in class III or IV heart failure in the 2 weeks prior to TEER. More than half had established coronary artery disease. Other concomitant cardiovascular morbidities, including atrial fibrillation or flutter (65%), prior MI (39%), and prior stroke or transient ischemic attach (> 10%) were well represented.

When those with device success were compared with those with device failure, the risk profile was comparable. The predicted STS (Society of Thoracic Surgeons) mortality for mitral valve repair among these two groups was 14.8% versus 15% (P = 0.97), respectively.

However, those with device failure did have a lower baseline left ventricular ejection fraction (40.7% vs. 42.9%; P = .009) and a greater prevalence of moderate-to-severe or severe MR (96.1% vs. 84.9%; P < 0.001).

The growing experience with TEER means that benefit has now been shown in several complicated MR groups, such as those with severe ventricular dysfunction, renal insufficiency, and obstructive lung disease. This was a rationale for looking at the impact or repairing MR in patients with cardiogenic shock.

It is a pressing question, according to Dr. Alkhouli. He cited studies suggesting that up to 20% of patients hospitalized for cardiogenic shock have at least moderate-to-severe MR. Conversely, cardiogenic shock is not an uncommon finding in patients with MR.

While Dr. Alkhouli acknowledged that the many variables influencing outcome in patients with MR and cardiogenic shock will make a randomized trial “challenging,” many experts echoed this concern and even expressed some skepticism about the potential for an unbiased trial.
 

Data confirm MR repair is safe during shock

“These data do show that repair of MR is safe in patients safe in patients with cardiogenic shock,” said Anita W. Asgar, MD, an interventional cardiologist associated with the Montreal Heart Institute. She noted that there was a 5- to 6-day delay among the cardiogenic shock patients prior to undergoing MR repair in this analysis, potentially reflecting an elimination of those at very high risk. Similarly, she suggested that many interventionalists are likely to consider multiple variables before proceeding.

As a result, MR repair may not be amenable to randomization in a cardiogenic shock population, given that this decision is not typically undertaken out of the context of multiple variables.

“I am not sure that a clinical trial is ethical,” she said. She would expect that clinicians enrolling patients would only do so on a selective basis.

Alexandra J. Lansky, MD, Director of the Yale Heart and Vascular Research Program, Yale University, New Haven, Conn., also emphasized the difficulty of controlling for variables, such as the duration of cardiogenic shock, that influence decision-making.

Nevertheless, she called the data “very important” in that they at least lend some objective data for deciding whether to intervene a group of “challenging” patients not uncommonly faced in clinical practice.

Dr. Alkhouli reports financial relationships with Abbott Vascular, Boston Scientific, Johnson & Johnson, and Phillips. Dr. Asgar reports financial relationships with Abbott Vascular, Edwards Lifesciences, W.L. Gore & Associates, and Medtronic. Dr. Lasky reports no potential conflicts of interest.

A version of this article first appeared on Medscape.com.

In patients with severe mitral regurgitation (MR) and cardiogenic shock, successful transcatheter edge-to-edge repair (TEER) is associated with a substantial reduction in all-cause mortality and lower morbidity at 1 year, according to an analysis of registry data.

The data from this analysis also confirm that “successful reduction of MR is achievable with TEER in most patients with cardiogenic shock,” reported Mohamad A. Alkhouli, MD, an interventional cardiologist and professor of medicine at the Mayo Clinic, Rochester, Minn.

STS/ACC TCT registry data queried

Drawn from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, 3,797 patients with cardiogenic shock underwent MR repair between November 2013 and December 2021. Outcomes at 1 year were evaluable in 2,773 of these patients. For inclusion, all had to meet at least one of the definitions of cardiogenic shock, such as inotrope use or mechanical circulatory support.

At baseline, 94.5% had a MR severity of at least 3+, and most of these had 4+. Thirty days after treatment, 88.8% had MR severity of 2+ or less, the majority of which had a severity of 1+.

These data address an important question not previously well studied, according to Dr. Alkhouli. In MR patients, cardiogenic shock is associated with a high risk of death, but there has been little evidence that valve repair does not exacerbate, let alone modify, this risk.

These data support the value of intervention, which was performed in almost all patients with MitraClipä (Abbott), the only device available for most of the period in which the registry was queried. However, Dr. Alkhouli cautioned that his data are best considered “hypothesis generating.”

“We need a randomized trial,” he said at the meeting sponsored by the Cardiovascular Research Foundation. He pointed out that this is a complex population for which multiple variables might have skewed results when data are analyzed retrospectively. Not least, those MR patients with cardiogenic shock in the database considered for TEER might well have been relatively healthy and not representative of an unselected population with both MR and cardiogenic shock.

The question might be better answered by the multicenter Canadian trial CAPITAL MINOS, which has just started. Described in an article in the American Heart Journal, it has a planned enrollment of about 150 MR patients with cardiogenic shock randomized to TEER or medical therapy. Results are expected in about 1 year, according to Dr. Alkhouli.

But regarding the present analysis, Dr. Alkhouli did note that sensitivity analyses conducted within his data across risk factors, such as degenerative versus nondegenerative MR, low (< 30%) versus higher left ventricular ejection fraction (LVEF), and presence or absence of an acute coronary syndrome (ACS), consistently supported a benefit from intervention.

Also, cardiogenic shock did not appear to be a factor in device failure, according to Dr. Alkhouli, addressing a potential criticism that cardiogenic shock was an underlying reason for device failure.
 

More than 90% in NYHA class III or IV heart failure

In this study, the mean age was 73 years. More than 90% were in class III or IV heart failure in the 2 weeks prior to TEER. More than half had established coronary artery disease. Other concomitant cardiovascular morbidities, including atrial fibrillation or flutter (65%), prior MI (39%), and prior stroke or transient ischemic attach (> 10%) were well represented.

When those with device success were compared with those with device failure, the risk profile was comparable. The predicted STS (Society of Thoracic Surgeons) mortality for mitral valve repair among these two groups was 14.8% versus 15% (P = 0.97), respectively.

However, those with device failure did have a lower baseline left ventricular ejection fraction (40.7% vs. 42.9%; P = .009) and a greater prevalence of moderate-to-severe or severe MR (96.1% vs. 84.9%; P < 0.001).

The growing experience with TEER means that benefit has now been shown in several complicated MR groups, such as those with severe ventricular dysfunction, renal insufficiency, and obstructive lung disease. This was a rationale for looking at the impact or repairing MR in patients with cardiogenic shock.

It is a pressing question, according to Dr. Alkhouli. He cited studies suggesting that up to 20% of patients hospitalized for cardiogenic shock have at least moderate-to-severe MR. Conversely, cardiogenic shock is not an uncommon finding in patients with MR.

While Dr. Alkhouli acknowledged that the many variables influencing outcome in patients with MR and cardiogenic shock will make a randomized trial “challenging,” many experts echoed this concern and even expressed some skepticism about the potential for an unbiased trial.
 

Data confirm MR repair is safe during shock

“These data do show that repair of MR is safe in patients safe in patients with cardiogenic shock,” said Anita W. Asgar, MD, an interventional cardiologist associated with the Montreal Heart Institute. She noted that there was a 5- to 6-day delay among the cardiogenic shock patients prior to undergoing MR repair in this analysis, potentially reflecting an elimination of those at very high risk. Similarly, she suggested that many interventionalists are likely to consider multiple variables before proceeding.

As a result, MR repair may not be amenable to randomization in a cardiogenic shock population, given that this decision is not typically undertaken out of the context of multiple variables.

“I am not sure that a clinical trial is ethical,” she said. She would expect that clinicians enrolling patients would only do so on a selective basis.

Alexandra J. Lansky, MD, Director of the Yale Heart and Vascular Research Program, Yale University, New Haven, Conn., also emphasized the difficulty of controlling for variables, such as the duration of cardiogenic shock, that influence decision-making.

Nevertheless, she called the data “very important” in that they at least lend some objective data for deciding whether to intervene a group of “challenging” patients not uncommonly faced in clinical practice.

Dr. Alkhouli reports financial relationships with Abbott Vascular, Boston Scientific, Johnson & Johnson, and Phillips. Dr. Asgar reports financial relationships with Abbott Vascular, Edwards Lifesciences, W.L. Gore & Associates, and Medtronic. Dr. Lasky reports no potential conflicts of interest.

A version of this article first appeared on Medscape.com.

In patients with severe mitral regurgitation (MR) and cardiogenic shock, successful transcatheter edge-to-edge repair (TEER) is associated with a substantial reduction in all-cause mortality and lower morbidity at 1 year, according to an analysis of registry data.

The data from this analysis also confirm that “successful reduction of MR is achievable with TEER in most patients with cardiogenic shock,” reported Mohamad A. Alkhouli, MD, an interventional cardiologist and professor of medicine at the Mayo Clinic, Rochester, Minn.

STS/ACC TCT registry data queried

Drawn from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, 3,797 patients with cardiogenic shock underwent MR repair between November 2013 and December 2021. Outcomes at 1 year were evaluable in 2,773 of these patients. For inclusion, all had to meet at least one of the definitions of cardiogenic shock, such as inotrope use or mechanical circulatory support.

At baseline, 94.5% had a MR severity of at least 3+, and most of these had 4+. Thirty days after treatment, 88.8% had MR severity of 2+ or less, the majority of which had a severity of 1+.

These data address an important question not previously well studied, according to Dr. Alkhouli. In MR patients, cardiogenic shock is associated with a high risk of death, but there has been little evidence that valve repair does not exacerbate, let alone modify, this risk.

These data support the value of intervention, which was performed in almost all patients with MitraClipä (Abbott), the only device available for most of the period in which the registry was queried. However, Dr. Alkhouli cautioned that his data are best considered “hypothesis generating.”

“We need a randomized trial,” he said at the meeting sponsored by the Cardiovascular Research Foundation. He pointed out that this is a complex population for which multiple variables might have skewed results when data are analyzed retrospectively. Not least, those MR patients with cardiogenic shock in the database considered for TEER might well have been relatively healthy and not representative of an unselected population with both MR and cardiogenic shock.

The question might be better answered by the multicenter Canadian trial CAPITAL MINOS, which has just started. Described in an article in the American Heart Journal, it has a planned enrollment of about 150 MR patients with cardiogenic shock randomized to TEER or medical therapy. Results are expected in about 1 year, according to Dr. Alkhouli.

But regarding the present analysis, Dr. Alkhouli did note that sensitivity analyses conducted within his data across risk factors, such as degenerative versus nondegenerative MR, low (< 30%) versus higher left ventricular ejection fraction (LVEF), and presence or absence of an acute coronary syndrome (ACS), consistently supported a benefit from intervention.

Also, cardiogenic shock did not appear to be a factor in device failure, according to Dr. Alkhouli, addressing a potential criticism that cardiogenic shock was an underlying reason for device failure.
 

More than 90% in NYHA class III or IV heart failure

In this study, the mean age was 73 years. More than 90% were in class III or IV heart failure in the 2 weeks prior to TEER. More than half had established coronary artery disease. Other concomitant cardiovascular morbidities, including atrial fibrillation or flutter (65%), prior MI (39%), and prior stroke or transient ischemic attach (> 10%) were well represented.

When those with device success were compared with those with device failure, the risk profile was comparable. The predicted STS (Society of Thoracic Surgeons) mortality for mitral valve repair among these two groups was 14.8% versus 15% (P = 0.97), respectively.

However, those with device failure did have a lower baseline left ventricular ejection fraction (40.7% vs. 42.9%; P = .009) and a greater prevalence of moderate-to-severe or severe MR (96.1% vs. 84.9%; P < 0.001).

The growing experience with TEER means that benefit has now been shown in several complicated MR groups, such as those with severe ventricular dysfunction, renal insufficiency, and obstructive lung disease. This was a rationale for looking at the impact or repairing MR in patients with cardiogenic shock.

It is a pressing question, according to Dr. Alkhouli. He cited studies suggesting that up to 20% of patients hospitalized for cardiogenic shock have at least moderate-to-severe MR. Conversely, cardiogenic shock is not an uncommon finding in patients with MR.

While Dr. Alkhouli acknowledged that the many variables influencing outcome in patients with MR and cardiogenic shock will make a randomized trial “challenging,” many experts echoed this concern and even expressed some skepticism about the potential for an unbiased trial.
 

Data confirm MR repair is safe during shock

“These data do show that repair of MR is safe in patients safe in patients with cardiogenic shock,” said Anita W. Asgar, MD, an interventional cardiologist associated with the Montreal Heart Institute. She noted that there was a 5- to 6-day delay among the cardiogenic shock patients prior to undergoing MR repair in this analysis, potentially reflecting an elimination of those at very high risk. Similarly, she suggested that many interventionalists are likely to consider multiple variables before proceeding.

As a result, MR repair may not be amenable to randomization in a cardiogenic shock population, given that this decision is not typically undertaken out of the context of multiple variables.

“I am not sure that a clinical trial is ethical,” she said. She would expect that clinicians enrolling patients would only do so on a selective basis.

Alexandra J. Lansky, MD, Director of the Yale Heart and Vascular Research Program, Yale University, New Haven, Conn., also emphasized the difficulty of controlling for variables, such as the duration of cardiogenic shock, that influence decision-making.

Nevertheless, she called the data “very important” in that they at least lend some objective data for deciding whether to intervene a group of “challenging” patients not uncommonly faced in clinical practice.

Dr. Alkhouli reports financial relationships with Abbott Vascular, Boston Scientific, Johnson & Johnson, and Phillips. Dr. Asgar reports financial relationships with Abbott Vascular, Edwards Lifesciences, W.L. Gore & Associates, and Medtronic. Dr. Lasky reports no potential conflicts of interest.

A version of this article first appeared on Medscape.com.

The design improvements introduced in the fourth-generation device for transcatheter mitral valve repair, called the MitraClip G4 (Abbott), appears to yield better outcomes than previous iterations, according to a multinational postapproval study with more than 1,000 patients.

Not least, the 1.3% all-cause mortality at 30 days in this series, called EXPAND G4, “is the lowest that has been reported to date,” reported Ralph Stephan von Bardeleben, MD, at the Transcatheter Cardiovascular Therapeutics annual meeting, sponsored by the Cardiovascular Research Foundation.

Ted Bosworth/MDedge News

The evidence of relative advantages was based on comparisons with historical data and a similar study of the previous-generation device. That previous study, called EXPAND, evaluated the MitraClip NTR and ETR systems.

Device times shorter with new device

“There were shorter device times with MitraClip G4,” said Dr. von Bardeleben, referring to a more than 10-minute advantage over the previous generation device (35 minutes in EXPAND G4 vs. 46 min in EXPAND). Although the reduction in overall median procedure time was more modest (77 vs. 80 minutes), Dr. von Bardeleben said these are “the shortest device and procedural times reported to date.”

He also reported what appeared to be incremental advantages across multiple other endpoints, such as procedural success (96.2% vs. 95.8%) and a reduction in the mean clip rate (1.4 vs. 1.5).

Compared with historical outcomes with other devices employed in transcatheter edge-to-edge repair (TEER) of mitral valves, Dr. von Bardeleben contended that the results support the premise that the MitraClip G4 system is a meaningful advance by incorporating such features as an expanded choice of clip sizes, a greater coaptation area, and a more advanced gripper actuation for leaflet grasping.
 

Over 90% achieve MR 1+

Not least, it appears to increase the proportion of patients who achieve a mitral regurgitation grade of 1+ (MR1+) or lower, which is increasingly recognized as the goal of TEER, said Dr. von Bardeleben, head of the Centre of Structure Heart Disease Interventions, Heart Valve Centre, Mainz, Germany.

He said the rates of 91% achieving MR1+ or less and 98% achieved 2+ or lower compare favorably with most other series and exceeds levels achieved with surgery.

Dr. von Bardeleben also contended that, because of its design features, the MitraClip G4 “expands the spectrum of TEER-suitable patients.” He noted that 5% of the patients in this real-world series had a high risk of stenosis owing to such issues as severe annular or leaflet calcification and another 5% had factors that would predict inadequate MR reduction, such as Barlow’s disease, bi-leaflet prolapse, and severe leaflet degeneration.

The 1,164 patients in EXPAND G4 were enrolled from sites in the United States, Europe, Canada, and Japan. For the key outcome measure of procedural success, echocardiograms were assessed by an independent core laboratory. Of the 1,164 patients enrolled, 1,044 (91%) had complete follow-up data at 30 days.

The procedural success rates were reflected in improvements in New York Heart Association (NYHA) functional classes and in the Kansas City Cardiomyopathy Questionnaire (KCCQ), a quality of life instrument. Prior to treatment, 69% were in NYHA class III or greater. Following treatment, the proportion was 17% (P < .0001). The 18-point improvement in the KCCQ was characterized by Dr. von Bardeleben as “both clinically and statistically significant [P < .0001].”

There were no strokes in this series, and the 30-day incidence of myocardial infarction was 0.2%. The proportion requiring cardiovascular surgery within 30 days was less than 1%. The rate of bleeding episodes, all of which were nonserious, was 7%.

The “EXPAND G4 study confirms the safety and effectiveness of the next generation MitraClip G4 system,” according to Dr. von Bardeleben, and it did so “in a contemporary real-world setting.”
 

Outcome data characterized as ‘excellent’

Several invited panelists participating in a discussion following the presentation agreed.

“These results are excellent,” said Raj Makkar, MD, associate director of interventional technologies at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles. While he was impressed with the fact that only 2% missed the primary endpoint of MR 2+ or lower, he indicated that the 91% achieving MR 1+ or lower might be an even more apt signal that newer-generation devices are improving.

This was echoed by other panelists who appeared to form a general consensus over the premise that the target in TEER should no longer be MR 2+ for most patients.

“We should now be aiming for MR grade of 0-1,” stated panelist Stephan Windecker, MD, chairman, department of cardiology, University of Bern (Switzerland). He indicated that this goal is increasingly reasonable given the advances in device design and greater operator experience.

Dr. von Bardeleben reported financial relationships with Abbott Vascular, Edwards Lifesciences, Medtronic, and Neochord. Dr. Makkar reported financial relationships with Abbott Vascular, Cordis, Edwards Lifesciences, and Medtronic. Dr. Windecker reported financial relationships with more than 30 pharmaceutical companies, including Abbott Vascular, which manufactures MitraClip G4.
 

The design improvements introduced in the fourth-generation device for transcatheter mitral valve repair, called the MitraClip G4 (Abbott), appears to yield better outcomes than previous iterations, according to a multinational postapproval study with more than 1,000 patients.

Not least, the 1.3% all-cause mortality at 30 days in this series, called EXPAND G4, “is the lowest that has been reported to date,” reported Ralph Stephan von Bardeleben, MD, at the Transcatheter Cardiovascular Therapeutics annual meeting, sponsored by the Cardiovascular Research Foundation.

Ted Bosworth/MDedge News

The evidence of relative advantages was based on comparisons with historical data and a similar study of the previous-generation device. That previous study, called EXPAND, evaluated the MitraClip NTR and ETR systems.

Device times shorter with new device

“There were shorter device times with MitraClip G4,” said Dr. von Bardeleben, referring to a more than 10-minute advantage over the previous generation device (35 minutes in EXPAND G4 vs. 46 min in EXPAND). Although the reduction in overall median procedure time was more modest (77 vs. 80 minutes), Dr. von Bardeleben said these are “the shortest device and procedural times reported to date.”

He also reported what appeared to be incremental advantages across multiple other endpoints, such as procedural success (96.2% vs. 95.8%) and a reduction in the mean clip rate (1.4 vs. 1.5).

Compared with historical outcomes with other devices employed in transcatheter edge-to-edge repair (TEER) of mitral valves, Dr. von Bardeleben contended that the results support the premise that the MitraClip G4 system is a meaningful advance by incorporating such features as an expanded choice of clip sizes, a greater coaptation area, and a more advanced gripper actuation for leaflet grasping.
 

Over 90% achieve MR 1+

Not least, it appears to increase the proportion of patients who achieve a mitral regurgitation grade of 1+ (MR1+) or lower, which is increasingly recognized as the goal of TEER, said Dr. von Bardeleben, head of the Centre of Structure Heart Disease Interventions, Heart Valve Centre, Mainz, Germany.

He said the rates of 91% achieving MR1+ or less and 98% achieved 2+ or lower compare favorably with most other series and exceeds levels achieved with surgery.

Dr. von Bardeleben also contended that, because of its design features, the MitraClip G4 “expands the spectrum of TEER-suitable patients.” He noted that 5% of the patients in this real-world series had a high risk of stenosis owing to such issues as severe annular or leaflet calcification and another 5% had factors that would predict inadequate MR reduction, such as Barlow’s disease, bi-leaflet prolapse, and severe leaflet degeneration.

The 1,164 patients in EXPAND G4 were enrolled from sites in the United States, Europe, Canada, and Japan. For the key outcome measure of procedural success, echocardiograms were assessed by an independent core laboratory. Of the 1,164 patients enrolled, 1,044 (91%) had complete follow-up data at 30 days.

The procedural success rates were reflected in improvements in New York Heart Association (NYHA) functional classes and in the Kansas City Cardiomyopathy Questionnaire (KCCQ), a quality of life instrument. Prior to treatment, 69% were in NYHA class III or greater. Following treatment, the proportion was 17% (P < .0001). The 18-point improvement in the KCCQ was characterized by Dr. von Bardeleben as “both clinically and statistically significant [P < .0001].”

There were no strokes in this series, and the 30-day incidence of myocardial infarction was 0.2%. The proportion requiring cardiovascular surgery within 30 days was less than 1%. The rate of bleeding episodes, all of which were nonserious, was 7%.

The “EXPAND G4 study confirms the safety and effectiveness of the next generation MitraClip G4 system,” according to Dr. von Bardeleben, and it did so “in a contemporary real-world setting.”
 

Outcome data characterized as ‘excellent’

Several invited panelists participating in a discussion following the presentation agreed.

“These results are excellent,” said Raj Makkar, MD, associate director of interventional technologies at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles. While he was impressed with the fact that only 2% missed the primary endpoint of MR 2+ or lower, he indicated that the 91% achieving MR 1+ or lower might be an even more apt signal that newer-generation devices are improving.

This was echoed by other panelists who appeared to form a general consensus over the premise that the target in TEER should no longer be MR 2+ for most patients.

“We should now be aiming for MR grade of 0-1,” stated panelist Stephan Windecker, MD, chairman, department of cardiology, University of Bern (Switzerland). He indicated that this goal is increasingly reasonable given the advances in device design and greater operator experience.

Dr. von Bardeleben reported financial relationships with Abbott Vascular, Edwards Lifesciences, Medtronic, and Neochord. Dr. Makkar reported financial relationships with Abbott Vascular, Cordis, Edwards Lifesciences, and Medtronic. Dr. Windecker reported financial relationships with more than 30 pharmaceutical companies, including Abbott Vascular, which manufactures MitraClip G4.
 

The design improvements introduced in the fourth-generation device for transcatheter mitral valve repair, called the MitraClip G4 (Abbott), appears to yield better outcomes than previous iterations, according to a multinational postapproval study with more than 1,000 patients.

Not least, the 1.3% all-cause mortality at 30 days in this series, called EXPAND G4, “is the lowest that has been reported to date,” reported Ralph Stephan von Bardeleben, MD, at the Transcatheter Cardiovascular Therapeutics annual meeting, sponsored by the Cardiovascular Research Foundation.

Ted Bosworth/MDedge News

The evidence of relative advantages was based on comparisons with historical data and a similar study of the previous-generation device. That previous study, called EXPAND, evaluated the MitraClip NTR and ETR systems.

Device times shorter with new device

“There were shorter device times with MitraClip G4,” said Dr. von Bardeleben, referring to a more than 10-minute advantage over the previous generation device (35 minutes in EXPAND G4 vs. 46 min in EXPAND). Although the reduction in overall median procedure time was more modest (77 vs. 80 minutes), Dr. von Bardeleben said these are “the shortest device and procedural times reported to date.”

He also reported what appeared to be incremental advantages across multiple other endpoints, such as procedural success (96.2% vs. 95.8%) and a reduction in the mean clip rate (1.4 vs. 1.5).

Compared with historical outcomes with other devices employed in transcatheter edge-to-edge repair (TEER) of mitral valves, Dr. von Bardeleben contended that the results support the premise that the MitraClip G4 system is a meaningful advance by incorporating such features as an expanded choice of clip sizes, a greater coaptation area, and a more advanced gripper actuation for leaflet grasping.
 

Over 90% achieve MR 1+

Not least, it appears to increase the proportion of patients who achieve a mitral regurgitation grade of 1+ (MR1+) or lower, which is increasingly recognized as the goal of TEER, said Dr. von Bardeleben, head of the Centre of Structure Heart Disease Interventions, Heart Valve Centre, Mainz, Germany.

He said the rates of 91% achieving MR1+ or less and 98% achieved 2+ or lower compare favorably with most other series and exceeds levels achieved with surgery.

Dr. von Bardeleben also contended that, because of its design features, the MitraClip G4 “expands the spectrum of TEER-suitable patients.” He noted that 5% of the patients in this real-world series had a high risk of stenosis owing to such issues as severe annular or leaflet calcification and another 5% had factors that would predict inadequate MR reduction, such as Barlow’s disease, bi-leaflet prolapse, and severe leaflet degeneration.

The 1,164 patients in EXPAND G4 were enrolled from sites in the United States, Europe, Canada, and Japan. For the key outcome measure of procedural success, echocardiograms were assessed by an independent core laboratory. Of the 1,164 patients enrolled, 1,044 (91%) had complete follow-up data at 30 days.

The procedural success rates were reflected in improvements in New York Heart Association (NYHA) functional classes and in the Kansas City Cardiomyopathy Questionnaire (KCCQ), a quality of life instrument. Prior to treatment, 69% were in NYHA class III or greater. Following treatment, the proportion was 17% (P < .0001). The 18-point improvement in the KCCQ was characterized by Dr. von Bardeleben as “both clinically and statistically significant [P < .0001].”

There were no strokes in this series, and the 30-day incidence of myocardial infarction was 0.2%. The proportion requiring cardiovascular surgery within 30 days was less than 1%. The rate of bleeding episodes, all of which were nonserious, was 7%.

The “EXPAND G4 study confirms the safety and effectiveness of the next generation MitraClip G4 system,” according to Dr. von Bardeleben, and it did so “in a contemporary real-world setting.”
 

Outcome data characterized as ‘excellent’

Several invited panelists participating in a discussion following the presentation agreed.

“These results are excellent,” said Raj Makkar, MD, associate director of interventional technologies at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles. While he was impressed with the fact that only 2% missed the primary endpoint of MR 2+ or lower, he indicated that the 91% achieving MR 1+ or lower might be an even more apt signal that newer-generation devices are improving.

This was echoed by other panelists who appeared to form a general consensus over the premise that the target in TEER should no longer be MR 2+ for most patients.

“We should now be aiming for MR grade of 0-1,” stated panelist Stephan Windecker, MD, chairman, department of cardiology, University of Bern (Switzerland). He indicated that this goal is increasingly reasonable given the advances in device design and greater operator experience.

Dr. von Bardeleben reported financial relationships with Abbott Vascular, Edwards Lifesciences, Medtronic, and Neochord. Dr. Makkar reported financial relationships with Abbott Vascular, Cordis, Edwards Lifesciences, and Medtronic. Dr. Windecker reported financial relationships with more than 30 pharmaceutical companies, including Abbott Vascular, which manufactures MitraClip G4.