- Email: [email protected]
Plugging Paravalvular Leaks After Transcatheter Aortic Valve Replacement
JACC: CARDIOVASCULAR INTERVENTIONS
VOL. 8, NO. 5, 2015
ª 2015 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
ISSN 1936-8798/$36.00
PUBLISHED BY ELSEVIER INC.
http://dx.doi.org/10.1016/j.jcin.2015.01.018
EDITORIAL COMMENT
Plugging Paravalvular Leaks After Transcatheter Aortic Valve Replacement Why and How?* John D. Carroll, MD
P
aravalvular leaks or paravalvular regurgitation
central
(PVR) occur after most transcatheter aortic
uncommon.
aortic
regurgitation
following
TAVR
is
valve replacements (TAVRs) utilizing the first-
With that background, in this issue of JACC:
and second-generation devices. They are generally
Cardiovascular Interventions, we have a publication
mild and are seemingly of no clinical significance,
from a multicenter experience on performing trans-
although controversy exists on this point (1,2).
catheter plugging of PVR (6). Previous reports have
When PVR is moderate or greater, it is clinically
been useful in defining potential technical ap-
significant, blunting clinical improvement and left
proaches (7,8). The current publication from 4 expe-
ventricular chamber remodeling, and the optimal
rienced TAVR centers has a total of 24 patients. It is
management has not been defined (3,4). The emp-
unclear what the denominator is of the total TAVR
hasis has been on preventing PVR by better sizing
volume, but 24 patients represent a small fraction.
and placement of the valve (3).
They demonstrate procedure success in 88.9%, but
Is significant PVR a common issue for TAVR centers? Even a low estimate of 5% of patients having moderate to severe PVR would yield 1,250 cases in the United States initial experience, with the current number of patients receiving TAVR entered in the Society
of
Thoracic
Surgeons/American
the long-term mortality remains high and consists of significant noncardiac causes in many. SEE PAGE 681
An important and useful aspect of this paper is its
College
description of the process of determining the cause
of Cardiology TVT (Transcatheter Valve Therapy)
for the PVR. There is a variety of causes, and some,
Registry exceeding 25,000. A recent meta-analysis of
when identified at the time of the index TAVR, may
12,926 patients showed a pooled estimate of 11.7%
result in immediate action such as valve-in-valve.
with moderate to severe PVR post-TAVR (5). It thus
Therefore, it is important to understand that the
seems odd that there are so few reports of attempts to
patients reported here are those who had the index
treat these patients by PVR closure.
TAVR completed, often remotely, and subsequently
Does the burden of aortic regurgitation from a
had come to clinical attention. They all had symp-
paravalvular mechanism carry the same risk propor-
toms in the setting of a demonstrated PVR that was at
tionate to severity as all other forms of TAVR-AI (i.e.,
least moderate. Patient selection and technical details
TAVR-associated aortic insufficiency that is central
were decided by the center, and no standardized
rather than paravalvular)? Presently, we do not have
approach was used. Likewise, there are challenges in
enough data to answer this question, in part because
quantifying PVR and then linking the PVR to the symptoms of these complex patients post-TAVR who often have other reasons to have symptoms and a
*Editorials published in JACC: Cardiovascular Interventions reflect the views of the authors and do not necessarily represent the views of JACC: Cardiovascular Interventions or the American College of Cardiology. From the University of Colorado School of Medicine, Aurora, Colorado.
reduced functional state (4). The finding that mortality remained high despite PVR closure is surprising, because the therapeutic
Dr. Carroll has served as a consultant to and received research support
intervention of closing PVR was usually successful
from Philips Healthcare.
and the Society of Thoracic Surgeons score was only
690
Carroll
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 8, NO. 5, 2015 APRIL 27, 2015:689–91
Plugging Paravalvular Leaks After TAVR
moderately elevated. This, too, points to the fact that
visualize, quantify, and cross with equipment. The
these were highly-selected patients. In the absence of
size and shape of PVR following TAVR is difficult
a control group, it is impossible to make conclusions
to characterize by CTA, angiography, and trans-
about the effect of PVR closure on outcomes. It would
esophageal echocardiography due to the imaging
appear to be the correct management, when carried
artifacts and blind spots produced by the cage. In
out in centers experienced with PVR closure, but this
addition, the heavily-calcified valve remains and
study needs to be classified as observational, thought
further affects imaging, the creation of a complex
provoking, and hypothesis generating.
PVR shape, and the challenging technical issues of
Fortunately, as pointed out by the authors, the
crossing and delivering a plug. Therefore, in general,
prevalence of PVR is expected to soon significantly
PVR closure following TAVR is often more difficult
drop as third-generation devices enter clinical prac-
than PVR closure following surgical AVR.
tice. These devices and delivery systems have cuffs to
Centers that are considering performing PVR
better seal the annular region and can be reposi-
closure need to make a major commitment to the time
tioned. The rapidly-evolving TAVR technology thus
needed, special inventory, the learning curve, and the
makes it difficult to organize and conduct a prospec-
team needed to perform this unique structural heart
tive study with a control group in a timely fashion.
intervention. Of the approximately 350 TAVR centers
The area of PVR closure has evaded industrysponsored device trials due to the small market
in the United States, it is unknown what percent are performing PVL closure and their results.
and the perception of major regulatory hurdles. The
In selecting patients for PVR closure after TAVR,
TVT Registry captures reintervention after TAVR,
what are reasonable indications? First, there must be
but it is unclear how many centers classify PVR
an unremitting clinical problem, such as persistent
closure as reintervention, and granular data are not
symptoms, left ventricular chamber dilation, or
gathered to better understand the outcomes of PVR
recurrent heart failure. Clinically-important hemoly-
closure. It is likely that the effect of more than trivial
sis is rare in the setting of TAVR. Second, there must
PVR on 1-year TAVR outcomes may be better un-
be evidence of at least a moderate degree of PVR.
derstood with registry data, although the lack of
Third, the leaks must be technically approachable.
standardized approaches to quantification of PVR
Finally, the benefit and risk balance must be clearly
will be a problem.
articulated and individualized for the patient and
The treatment of PVR following TAVR is important
family. This paper would suggest that experienced
to put in the context of the growing use of trans-
centers have a relatively high threshold for offering
catheter therapies for all types of PVR. The last
PVR closure.
5 years have been significant in improving our ability to successfully treat PVR including the following: 1. The availability of new closure devices, particularly vascular plugs, that are used “off-label;” 2. The ability to use smaller delivery catheters and special wires needed to cross the lesion, advance the delivery catheter, and deliver a plug; 3. The increasing sophistication of image guidance, particularly 3-dimensional transesophageal echocardiography registered with fluoroscopy; and 4. The growing experience of select centers in performing PVR closure.
This important report by Saia et al. (6) shows that this procedure can be time consuming, is not predictable in its outcome, can have major complications, and may not clearly provide the major improvement in prognosis that might be expected. We should be appreciative of these authors for making the effort to combine their experience so we might all learn from them. We need reports from more than only 24 patients to better understand the optimal management of this vexing clinical problem for all TAVR programs. REPRINT REQUESTS AND CORRESPONDENCE: Dr.
PVR closure following TAVR is quite different
John D. Carroll, University of Colorado School of
than PVR closure for surgically-implanted valves.
Medicine, 12401 East 17th Place, Aurora, Colorado
The stent that is part of TAVR makes PVR harder to
80045. E-mail: [email protected].
REFERENCES 1. Genereux P, Head SJ, Hahn R, et al. Paravalvular leak after transcatheter aortic valve replacement: the new Achilles’ heel? A comprehensive review of the literature. J Am Coll Cardiol 2013;61:1125–36.
2. Lerakis S, Hayek SS, Douglas PS. Paravalvular aortic leak after transcatheter aortic valve replacement: current knowledge. Circulation 2013; 127:397–407.
3. Kodali S, Pibarot P, Douglas PS, et al. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards Sapien valve in the PARTNER trial: characterizing patients
Carroll
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 8, NO. 5, 2015 APRIL 27, 2015:689–91
Plugging Paravalvular Leaks After TAVR
and impact on outcomes. Eur Heart J 2015;36: 449–56.
replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol 2013;61:1585–95.
Edwards Sapien valve. Catheter Cardiovasc Interv 2012;81:901–5.
4. Bax JJ, Delgado V, Bapat V, et al. Open issues in transcatheter aortic valve implantation. Part 2: procedural issues and outcomes after transcatheter aortic valve implantation. Eur Heart J 2014;35: 2639–54.
6. Saia F, Martinez C, Gafoor S, et al. Long-term outcomes of percutaneous paravalvular regurgitation closure after transcatheter aortic valve replacement: a multicenter experience. J Am Coll Cardiol Intv 2015;8:681–8.
8. Feldman T, Salinger MH, Levisay JP, Smart S. Low profile vascular plugs for paravalvular leaks after TAVR. Catheter Cardiovasc Interv 2014;83: 280–8.
5. Athappan G, Patvardhan E, Tuzcu EM, et al. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve
7. Whisenant B, Jones K, Horton KD, Horton S. Device closure of paravalvular defects following transcatheter aortic valve replacement with the
KEY WORDS aortic regurgitation, paravalvular, transcatheter aortic valve replacement, transcatheter closure
691
VOL. 8, NO. 5, 2015
ª 2015 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
ISSN 1936-8798/$36.00
PUBLISHED BY ELSEVIER INC.
http://dx.doi.org/10.1016/j.jcin.2015.01.018
EDITORIAL COMMENT
Plugging Paravalvular Leaks After Transcatheter Aortic Valve Replacement Why and How?* John D. Carroll, MD
P
aravalvular leaks or paravalvular regurgitation
central
(PVR) occur after most transcatheter aortic
uncommon.
aortic
regurgitation
following
TAVR
is
valve replacements (TAVRs) utilizing the first-
With that background, in this issue of JACC:
and second-generation devices. They are generally
Cardiovascular Interventions, we have a publication
mild and are seemingly of no clinical significance,
from a multicenter experience on performing trans-
although controversy exists on this point (1,2).
catheter plugging of PVR (6). Previous reports have
When PVR is moderate or greater, it is clinically
been useful in defining potential technical ap-
significant, blunting clinical improvement and left
proaches (7,8). The current publication from 4 expe-
ventricular chamber remodeling, and the optimal
rienced TAVR centers has a total of 24 patients. It is
management has not been defined (3,4). The emp-
unclear what the denominator is of the total TAVR
hasis has been on preventing PVR by better sizing
volume, but 24 patients represent a small fraction.
and placement of the valve (3).
They demonstrate procedure success in 88.9%, but
Is significant PVR a common issue for TAVR centers? Even a low estimate of 5% of patients having moderate to severe PVR would yield 1,250 cases in the United States initial experience, with the current number of patients receiving TAVR entered in the Society
of
Thoracic
Surgeons/American
the long-term mortality remains high and consists of significant noncardiac causes in many. SEE PAGE 681
An important and useful aspect of this paper is its
College
description of the process of determining the cause
of Cardiology TVT (Transcatheter Valve Therapy)
for the PVR. There is a variety of causes, and some,
Registry exceeding 25,000. A recent meta-analysis of
when identified at the time of the index TAVR, may
12,926 patients showed a pooled estimate of 11.7%
result in immediate action such as valve-in-valve.
with moderate to severe PVR post-TAVR (5). It thus
Therefore, it is important to understand that the
seems odd that there are so few reports of attempts to
patients reported here are those who had the index
treat these patients by PVR closure.
TAVR completed, often remotely, and subsequently
Does the burden of aortic regurgitation from a
had come to clinical attention. They all had symp-
paravalvular mechanism carry the same risk propor-
toms in the setting of a demonstrated PVR that was at
tionate to severity as all other forms of TAVR-AI (i.e.,
least moderate. Patient selection and technical details
TAVR-associated aortic insufficiency that is central
were decided by the center, and no standardized
rather than paravalvular)? Presently, we do not have
approach was used. Likewise, there are challenges in
enough data to answer this question, in part because
quantifying PVR and then linking the PVR to the symptoms of these complex patients post-TAVR who often have other reasons to have symptoms and a
*Editorials published in JACC: Cardiovascular Interventions reflect the views of the authors and do not necessarily represent the views of JACC: Cardiovascular Interventions or the American College of Cardiology. From the University of Colorado School of Medicine, Aurora, Colorado.
reduced functional state (4). The finding that mortality remained high despite PVR closure is surprising, because the therapeutic
Dr. Carroll has served as a consultant to and received research support
intervention of closing PVR was usually successful
from Philips Healthcare.
and the Society of Thoracic Surgeons score was only
690
Carroll
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 8, NO. 5, 2015 APRIL 27, 2015:689–91
Plugging Paravalvular Leaks After TAVR
moderately elevated. This, too, points to the fact that
visualize, quantify, and cross with equipment. The
these were highly-selected patients. In the absence of
size and shape of PVR following TAVR is difficult
a control group, it is impossible to make conclusions
to characterize by CTA, angiography, and trans-
about the effect of PVR closure on outcomes. It would
esophageal echocardiography due to the imaging
appear to be the correct management, when carried
artifacts and blind spots produced by the cage. In
out in centers experienced with PVR closure, but this
addition, the heavily-calcified valve remains and
study needs to be classified as observational, thought
further affects imaging, the creation of a complex
provoking, and hypothesis generating.
PVR shape, and the challenging technical issues of
Fortunately, as pointed out by the authors, the
crossing and delivering a plug. Therefore, in general,
prevalence of PVR is expected to soon significantly
PVR closure following TAVR is often more difficult
drop as third-generation devices enter clinical prac-
than PVR closure following surgical AVR.
tice. These devices and delivery systems have cuffs to
Centers that are considering performing PVR
better seal the annular region and can be reposi-
closure need to make a major commitment to the time
tioned. The rapidly-evolving TAVR technology thus
needed, special inventory, the learning curve, and the
makes it difficult to organize and conduct a prospec-
team needed to perform this unique structural heart
tive study with a control group in a timely fashion.
intervention. Of the approximately 350 TAVR centers
The area of PVR closure has evaded industrysponsored device trials due to the small market
in the United States, it is unknown what percent are performing PVL closure and their results.
and the perception of major regulatory hurdles. The
In selecting patients for PVR closure after TAVR,
TVT Registry captures reintervention after TAVR,
what are reasonable indications? First, there must be
but it is unclear how many centers classify PVR
an unremitting clinical problem, such as persistent
closure as reintervention, and granular data are not
symptoms, left ventricular chamber dilation, or
gathered to better understand the outcomes of PVR
recurrent heart failure. Clinically-important hemoly-
closure. It is likely that the effect of more than trivial
sis is rare in the setting of TAVR. Second, there must
PVR on 1-year TAVR outcomes may be better un-
be evidence of at least a moderate degree of PVR.
derstood with registry data, although the lack of
Third, the leaks must be technically approachable.
standardized approaches to quantification of PVR
Finally, the benefit and risk balance must be clearly
will be a problem.
articulated and individualized for the patient and
The treatment of PVR following TAVR is important
family. This paper would suggest that experienced
to put in the context of the growing use of trans-
centers have a relatively high threshold for offering
catheter therapies for all types of PVR. The last
PVR closure.
5 years have been significant in improving our ability to successfully treat PVR including the following: 1. The availability of new closure devices, particularly vascular plugs, that are used “off-label;” 2. The ability to use smaller delivery catheters and special wires needed to cross the lesion, advance the delivery catheter, and deliver a plug; 3. The increasing sophistication of image guidance, particularly 3-dimensional transesophageal echocardiography registered with fluoroscopy; and 4. The growing experience of select centers in performing PVR closure.
This important report by Saia et al. (6) shows that this procedure can be time consuming, is not predictable in its outcome, can have major complications, and may not clearly provide the major improvement in prognosis that might be expected. We should be appreciative of these authors for making the effort to combine their experience so we might all learn from them. We need reports from more than only 24 patients to better understand the optimal management of this vexing clinical problem for all TAVR programs. REPRINT REQUESTS AND CORRESPONDENCE: Dr.
PVR closure following TAVR is quite different
John D. Carroll, University of Colorado School of
than PVR closure for surgically-implanted valves.
Medicine, 12401 East 17th Place, Aurora, Colorado
The stent that is part of TAVR makes PVR harder to
80045. E-mail: [email protected].
REFERENCES 1. Genereux P, Head SJ, Hahn R, et al. Paravalvular leak after transcatheter aortic valve replacement: the new Achilles’ heel? A comprehensive review of the literature. J Am Coll Cardiol 2013;61:1125–36.
2. Lerakis S, Hayek SS, Douglas PS. Paravalvular aortic leak after transcatheter aortic valve replacement: current knowledge. Circulation 2013; 127:397–407.
3. Kodali S, Pibarot P, Douglas PS, et al. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards Sapien valve in the PARTNER trial: characterizing patients
Carroll
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 8, NO. 5, 2015 APRIL 27, 2015:689–91
Plugging Paravalvular Leaks After TAVR
and impact on outcomes. Eur Heart J 2015;36: 449–56.
replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol 2013;61:1585–95.
Edwards Sapien valve. Catheter Cardiovasc Interv 2012;81:901–5.
4. Bax JJ, Delgado V, Bapat V, et al. Open issues in transcatheter aortic valve implantation. Part 2: procedural issues and outcomes after transcatheter aortic valve implantation. Eur Heart J 2014;35: 2639–54.
6. Saia F, Martinez C, Gafoor S, et al. Long-term outcomes of percutaneous paravalvular regurgitation closure after transcatheter aortic valve replacement: a multicenter experience. J Am Coll Cardiol Intv 2015;8:681–8.
8. Feldman T, Salinger MH, Levisay JP, Smart S. Low profile vascular plugs for paravalvular leaks after TAVR. Catheter Cardiovasc Interv 2014;83: 280–8.
5. Athappan G, Patvardhan E, Tuzcu EM, et al. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve
7. Whisenant B, Jones K, Horton KD, Horton S. Device closure of paravalvular defects following transcatheter aortic valve replacement with the
KEY WORDS aortic regurgitation, paravalvular, transcatheter aortic valve replacement, transcatheter closure
691