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SAN DIEGO – Findings were reported in a session and press conference at the Transcatheter Cardiovascular Therapeutics annual meeting.
Research on the tricuspid valve, “the so-called forgotten valve,” is limited, commented lead investigator Jörg Hausleiter, MD, of the Medizinische Klinik und Poliklinik I at the Klinikum der Universität München and the Munich Heart Alliance. But there is unmet need for transcatheter treatment of high-risk patients having symptomatic tricuspid regurgitation (TR).
“The MitraClip has been used in several sites in off-label and compassionate-use programs to treat these patients,” he noted. “But the data which are available so far are really just looking at the early outcome, like 30 days.”
Dr. Hausleiter and his colleagues undertook a retrospective cohort study of a subgroup of 249 patients undergoing edge-to-edge valve repair for symptomatic TR from the international, multidevice TriValve Registry. All received conventional MitraClips (Abbott Vascular) through off-label or compassionate-use programs.
The procedure was successful, reducing regurgitation to mild or moderate levels in nearly four-fifths of patients by discharge. And procedural success was associated with lower risk of rehospitalization and death.
At 1 year, more than two-thirds of all patients had achieved a New York Heart Association (NYHA) functional class of I or II. In addition, prevalence of peripheral edema had fallen dramatically.
“We were able to demonstrate that the TR reduction is durable and that this also improves the clinical outcome at 1 year,” Dr. Hausleiter concluded.
Uptake and applicability
This procedure will likely be increasingly used in Europe and will find its way into U.S. practice in the not-so-distant future, Dr. Hausleiter predicted. “The MitraClip actually is being used now in a modified version in trials, so that this edge-to-edge therapy is applied for TR. And the TRILUMINATE trial has just finished its enrollment in Europe. I guess that we are going to see EU Mark approval for this therapy also next year. At the same time, a U.S. study is currently being planned and will start very soon with this device, so you are going to see this type of therapy at least being investigated within the next few months.”
The procedure is applicable to a large proportion of patients with TR, including the sizable share having comorbid mitral regurgitation (MR), according to Dr. Hausleiter. In fact, more than half of the study patients had treatment of MR during the same procedure for their tricuspid valve.
“How were outcomes compared, mitral clip plus tricuspid clip, versus tricuspid clip alone? Could some of this benefit be attributed to the mitral clip procedure?” asked press conference panelist Mayra Guerrero, MD, a senior associate consultant in interventional cardiology in the department of cardiovascular medicine at the Mayo Clinic Hospital, Rochester, Minn.
The two groups had essentially the same mortality rates and improvements in NYHA class, Dr. Hausleiter said. “So we did not observe any difference between those patients who were just treated on the tricuspid side and those patients who had combined treatment. Of course the patients differed a bit in their baseline characteristics, but the outcome was very much the same.”
“With the new data we have, operators and teams may be encouraged to start treating functional MR. I personally think that, if we do that, we should probably evaluate the response and reevaluate the severity of TR after all therapies to the mitral valve have been provided, before we intervene on the tricuspid valve, until we have more data,” Dr. Guerrero further commented. “Do you agree?”
“The tricuspid regurgitation can also improve after treatment of the mitral side. However, when we look at least at the published data, in at least 50% of patients who have severe TR, this TR is not improving,” Dr. Hausleiter replied. In addition, registry data suggest that these patients with severe TR have higher in-hospital, 30-day, and 1-year mortality, compared with patients whose TR is not severe. “Since these are frail patients and you don’t want to bring them too often back to the hospital, if the procedure can be performed very easily, I think there might be a good rationale to combine this.”
Study details
The patients Dr. Hausleiter and his coinvestigators studied had symptomatic TR, predominantly of grade 3+ or 4+, despite receiving adequate medical therapy, as well as a high operative risk, with an average EuroSCORE II of 11.2%. On average, two MitraClips were placed in their tricuspid valve during the procedure.
“We were able to demonstrate that this procedure can be performed very safely. There was a mortality of only 2% in the first 30 days, and one conversion to surgery,” Dr. Hausleiter reported at the meeting, which is sponsored by the Cardiovascular Research Foundation. “We were able to reduce the TR by at least one grade in 89% of patients, and concomitant treatment for mitral regurgitation was also performed in the same procedure in 52%.”
The rate of procedural success, defined as achievement of TR grade of 1+ or 2+ at discharge, was 77%. Independent predictors of procedural failure were noncentral/nonanteroseptal TR jet location and larger TR effective regurgitant orifice area, tenting area, and leaflet gap.
With a mean follow-up of about 10 months, compared with peers in whom the procedure failed, patients in whom it was successful had a higher 1-year rate of freedom from unplanned rehospitalization or death (70.1% vs. 49.7%; P less than .0001).
The 77% rate of procedural success at discharge was largely maintained at 1 year, when it was 72%. There was also a significant improvement in NYHA class distribution in the entire cohort (P less than .001), with 69% of patients attaining class I or II at this time point, compared with virtually none at baseline. Prevalence of peripheral edema fell from 84% to 26% (P less than .001).
Dr. Hausleiter reported that he receives research support and speaker honoraria from Abbott Vascular and Edwards Lifesciences. The registry is sponsored by the University of Zürich.
SAN DIEGO – Findings were reported in a session and press conference at the Transcatheter Cardiovascular Therapeutics annual meeting.
Research on the tricuspid valve, “the so-called forgotten valve,” is limited, commented lead investigator Jörg Hausleiter, MD, of the Medizinische Klinik und Poliklinik I at the Klinikum der Universität München and the Munich Heart Alliance. But there is unmet need for transcatheter treatment of high-risk patients having symptomatic tricuspid regurgitation (TR).
“The MitraClip has been used in several sites in off-label and compassionate-use programs to treat these patients,” he noted. “But the data which are available so far are really just looking at the early outcome, like 30 days.”
Dr. Hausleiter and his colleagues undertook a retrospective cohort study of a subgroup of 249 patients undergoing edge-to-edge valve repair for symptomatic TR from the international, multidevice TriValve Registry. All received conventional MitraClips (Abbott Vascular) through off-label or compassionate-use programs.
The procedure was successful, reducing regurgitation to mild or moderate levels in nearly four-fifths of patients by discharge. And procedural success was associated with lower risk of rehospitalization and death.
At 1 year, more than two-thirds of all patients had achieved a New York Heart Association (NYHA) functional class of I or II. In addition, prevalence of peripheral edema had fallen dramatically.
“We were able to demonstrate that the TR reduction is durable and that this also improves the clinical outcome at 1 year,” Dr. Hausleiter concluded.
Uptake and applicability
This procedure will likely be increasingly used in Europe and will find its way into U.S. practice in the not-so-distant future, Dr. Hausleiter predicted. “The MitraClip actually is being used now in a modified version in trials, so that this edge-to-edge therapy is applied for TR. And the TRILUMINATE trial has just finished its enrollment in Europe. I guess that we are going to see EU Mark approval for this therapy also next year. At the same time, a U.S. study is currently being planned and will start very soon with this device, so you are going to see this type of therapy at least being investigated within the next few months.”
The procedure is applicable to a large proportion of patients with TR, including the sizable share having comorbid mitral regurgitation (MR), according to Dr. Hausleiter. In fact, more than half of the study patients had treatment of MR during the same procedure for their tricuspid valve.
“How were outcomes compared, mitral clip plus tricuspid clip, versus tricuspid clip alone? Could some of this benefit be attributed to the mitral clip procedure?” asked press conference panelist Mayra Guerrero, MD, a senior associate consultant in interventional cardiology in the department of cardiovascular medicine at the Mayo Clinic Hospital, Rochester, Minn.
The two groups had essentially the same mortality rates and improvements in NYHA class, Dr. Hausleiter said. “So we did not observe any difference between those patients who were just treated on the tricuspid side and those patients who had combined treatment. Of course the patients differed a bit in their baseline characteristics, but the outcome was very much the same.”
“With the new data we have, operators and teams may be encouraged to start treating functional MR. I personally think that, if we do that, we should probably evaluate the response and reevaluate the severity of TR after all therapies to the mitral valve have been provided, before we intervene on the tricuspid valve, until we have more data,” Dr. Guerrero further commented. “Do you agree?”
“The tricuspid regurgitation can also improve after treatment of the mitral side. However, when we look at least at the published data, in at least 50% of patients who have severe TR, this TR is not improving,” Dr. Hausleiter replied. In addition, registry data suggest that these patients with severe TR have higher in-hospital, 30-day, and 1-year mortality, compared with patients whose TR is not severe. “Since these are frail patients and you don’t want to bring them too often back to the hospital, if the procedure can be performed very easily, I think there might be a good rationale to combine this.”
Study details
The patients Dr. Hausleiter and his coinvestigators studied had symptomatic TR, predominantly of grade 3+ or 4+, despite receiving adequate medical therapy, as well as a high operative risk, with an average EuroSCORE II of 11.2%. On average, two MitraClips were placed in their tricuspid valve during the procedure.
“We were able to demonstrate that this procedure can be performed very safely. There was a mortality of only 2% in the first 30 days, and one conversion to surgery,” Dr. Hausleiter reported at the meeting, which is sponsored by the Cardiovascular Research Foundation. “We were able to reduce the TR by at least one grade in 89% of patients, and concomitant treatment for mitral regurgitation was also performed in the same procedure in 52%.”
The rate of procedural success, defined as achievement of TR grade of 1+ or 2+ at discharge, was 77%. Independent predictors of procedural failure were noncentral/nonanteroseptal TR jet location and larger TR effective regurgitant orifice area, tenting area, and leaflet gap.
With a mean follow-up of about 10 months, compared with peers in whom the procedure failed, patients in whom it was successful had a higher 1-year rate of freedom from unplanned rehospitalization or death (70.1% vs. 49.7%; P less than .0001).
The 77% rate of procedural success at discharge was largely maintained at 1 year, when it was 72%. There was also a significant improvement in NYHA class distribution in the entire cohort (P less than .001), with 69% of patients attaining class I or II at this time point, compared with virtually none at baseline. Prevalence of peripheral edema fell from 84% to 26% (P less than .001).
Dr. Hausleiter reported that he receives research support and speaker honoraria from Abbott Vascular and Edwards Lifesciences. The registry is sponsored by the University of Zürich.
SAN DIEGO – Findings were reported in a session and press conference at the Transcatheter Cardiovascular Therapeutics annual meeting.
Research on the tricuspid valve, “the so-called forgotten valve,” is limited, commented lead investigator Jörg Hausleiter, MD, of the Medizinische Klinik und Poliklinik I at the Klinikum der Universität München and the Munich Heart Alliance. But there is unmet need for transcatheter treatment of high-risk patients having symptomatic tricuspid regurgitation (TR).
“The MitraClip has been used in several sites in off-label and compassionate-use programs to treat these patients,” he noted. “But the data which are available so far are really just looking at the early outcome, like 30 days.”
Dr. Hausleiter and his colleagues undertook a retrospective cohort study of a subgroup of 249 patients undergoing edge-to-edge valve repair for symptomatic TR from the international, multidevice TriValve Registry. All received conventional MitraClips (Abbott Vascular) through off-label or compassionate-use programs.
The procedure was successful, reducing regurgitation to mild or moderate levels in nearly four-fifths of patients by discharge. And procedural success was associated with lower risk of rehospitalization and death.
At 1 year, more than two-thirds of all patients had achieved a New York Heart Association (NYHA) functional class of I or II. In addition, prevalence of peripheral edema had fallen dramatically.
“We were able to demonstrate that the TR reduction is durable and that this also improves the clinical outcome at 1 year,” Dr. Hausleiter concluded.
Uptake and applicability
This procedure will likely be increasingly used in Europe and will find its way into U.S. practice in the not-so-distant future, Dr. Hausleiter predicted. “The MitraClip actually is being used now in a modified version in trials, so that this edge-to-edge therapy is applied for TR. And the TRILUMINATE trial has just finished its enrollment in Europe. I guess that we are going to see EU Mark approval for this therapy also next year. At the same time, a U.S. study is currently being planned and will start very soon with this device, so you are going to see this type of therapy at least being investigated within the next few months.”
The procedure is applicable to a large proportion of patients with TR, including the sizable share having comorbid mitral regurgitation (MR), according to Dr. Hausleiter. In fact, more than half of the study patients had treatment of MR during the same procedure for their tricuspid valve.
“How were outcomes compared, mitral clip plus tricuspid clip, versus tricuspid clip alone? Could some of this benefit be attributed to the mitral clip procedure?” asked press conference panelist Mayra Guerrero, MD, a senior associate consultant in interventional cardiology in the department of cardiovascular medicine at the Mayo Clinic Hospital, Rochester, Minn.
The two groups had essentially the same mortality rates and improvements in NYHA class, Dr. Hausleiter said. “So we did not observe any difference between those patients who were just treated on the tricuspid side and those patients who had combined treatment. Of course the patients differed a bit in their baseline characteristics, but the outcome was very much the same.”
“With the new data we have, operators and teams may be encouraged to start treating functional MR. I personally think that, if we do that, we should probably evaluate the response and reevaluate the severity of TR after all therapies to the mitral valve have been provided, before we intervene on the tricuspid valve, until we have more data,” Dr. Guerrero further commented. “Do you agree?”
“The tricuspid regurgitation can also improve after treatment of the mitral side. However, when we look at least at the published data, in at least 50% of patients who have severe TR, this TR is not improving,” Dr. Hausleiter replied. In addition, registry data suggest that these patients with severe TR have higher in-hospital, 30-day, and 1-year mortality, compared with patients whose TR is not severe. “Since these are frail patients and you don’t want to bring them too often back to the hospital, if the procedure can be performed very easily, I think there might be a good rationale to combine this.”
Study details
The patients Dr. Hausleiter and his coinvestigators studied had symptomatic TR, predominantly of grade 3+ or 4+, despite receiving adequate medical therapy, as well as a high operative risk, with an average EuroSCORE II of 11.2%. On average, two MitraClips were placed in their tricuspid valve during the procedure.
“We were able to demonstrate that this procedure can be performed very safely. There was a mortality of only 2% in the first 30 days, and one conversion to surgery,” Dr. Hausleiter reported at the meeting, which is sponsored by the Cardiovascular Research Foundation. “We were able to reduce the TR by at least one grade in 89% of patients, and concomitant treatment for mitral regurgitation was also performed in the same procedure in 52%.”
The rate of procedural success, defined as achievement of TR grade of 1+ or 2+ at discharge, was 77%. Independent predictors of procedural failure were noncentral/nonanteroseptal TR jet location and larger TR effective regurgitant orifice area, tenting area, and leaflet gap.
With a mean follow-up of about 10 months, compared with peers in whom the procedure failed, patients in whom it was successful had a higher 1-year rate of freedom from unplanned rehospitalization or death (70.1% vs. 49.7%; P less than .0001).
The 77% rate of procedural success at discharge was largely maintained at 1 year, when it was 72%. There was also a significant improvement in NYHA class distribution in the entire cohort (P less than .001), with 69% of patients attaining class I or II at this time point, compared with virtually none at baseline. Prevalence of peripheral edema fell from 84% to 26% (P less than .001).
Dr. Hausleiter reported that he receives research support and speaker honoraria from Abbott Vascular and Edwards Lifesciences. The registry is sponsored by the University of Zürich.
REPORTING FROM TCT 2018
Key clinical point: Transcatheter edge-to-edge valve repair for tricuspid regurgitation is safe and effective at 1 year.
Major finding: The procedure had a success rate of 77% and netted a 1-year improvement in New York Heart Association class (P less than .001), with 69% of patients achieving class I or II.
Study details: A retrospective cohort study of a subgroup of 249 patients undergoing edge-to-edge valve repair for symptomatic tricuspid regurgitation from the TriValve Registry.
Disclosures: Dr. Hausleiter reported that he receives research support and speaker honoraria from Abbott Vascular and Edwards Lifesciences. The registry is sponsored by the University of Zürich.