- Email: [email protected]
A Good Reminder for Common Sense Approaches∗
JACC: CARDIOVASCULAR INTERVENTIONS
VOL. 10, NO. 5, 2017
ª 2017 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
ISSN 1936-8798/$36.00
PUBLISHED BY ELSEVIER
http://dx.doi.org/10.1016/j.jcin.2017.02.002
EDITORIAL COMMENT
A Good Reminder for Common Sense Approaches* D. Scott Lim, MDa,b
S
ince the introduction of transcatheter pulmo-
The article by Hascoet et al. (9) this issue of JACC:
nary valve replacement by Bonhoeffer et al.
Cardiovascular Interventions looks specifically at the
(1) in 2000, there has been a veritable rush in
risk of infective endocarditis following transcatheter
the pediatric and congenital cardiology community
pulmonary valve implantation with either the Melody
to switch from surgical pulmonary valved conduit
or Sapien valves, evaluating 79 patients having un-
replacement to the transcatheter approach, but
dergone transcatheter pulmonary valve replacement
without the benefit of a randomized clinical trial
at their center between 2008 and the present. It is
comparing transcatheter approaches with the surgical
notable that their follow-up period is longer than
standard of care. Therefore, we are left to infer com-
previous publications, in the intermediate range
parisons using data from case series on procedural
(median follow-up, 1.8 years), but that with that time
outcomes and complications, which generally have
frame there already is an incidence of 10.1% of
been favorable for the transcatheter approaches (2–5).
endocarditis using the established diagnostic criteria.
Based on the nonrandomized data available, in the
SEE PAGE 510
United States, 2 transcatheter pulmonary valves are approved for clinical care: the Melody valve (Med-
It is even more striking that although the mix of
tronic, Minneapolis, Minnesota) and the Sapien XT
implanted valves was nearly evenly split, the endo-
valve (Edwards Lifesciences, Irvine, California) (6,7).
carditis events occurred exclusively in those patients
Previous publications have demonstrated, albeit in
treated with the Melody valves. The cumulative
the short term, relatively low rates of endocarditis of
incidence of endocarditis was 24% at 4 years for
the Melody valve (3.2% at a median follow-up of 5
Melody valves versus 0% for Sapien valves. This is the
months) with common culprit organisms, such as
highest incidence noted for Melody valves yet pub-
Staphylococcus aureus and Streptococcus species (3).
lished, and immediately brings us to the next ques-
The Sapien and Sapien XT valves have not been in use
tion, which is why that incidence is so high.
for pulmonic applications long enough to previously
The authors looked for aggravating factors for
understand the risks of endocarditis until this present
endocarditis using a case-control analysis, yet found
publication, although applications in the aortic posi-
that other than the occurrence of noncardiac surgery,
tion have shown an even lower incidence than ex-
any risk factors related to implantation of the Melody
pected (8).
instead of a Sapien valve. The authors speculated that the use of bovine jugular vein tissue in the Melody valve may be related to the increased
*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 aDivision of Cardiovascular Medicine, University of Virginia b
Health System, Charlottesville, Virginia; and the Division of Pediatric
occurrence of endocarditis, because that has also been seen following surgical usage of bovine jugular valve implantation in the pulmonic position (10). It is probable that there are some tissue factors related to
Cardiology, University of Virginia Health System, Charlottesville, Vir-
bovine jugular tissue that would predispose to tissue
ginia. Dr. Lim is the national primary investigator of the COMPASSION-S3
seeing
Trial, sponsored by Edwards Lifesciences, and his institution, the Uni-
bacteremia.
versity of Virginia, receives funding to support that trial, although there is no direct payment to him; and has received a research grant from Edwards Lifesciences and Medtronic.
of
infectious
organisms
from
transient
Additionally, a potential difference between the 2 transcatheter pulmonary valves is that the stent
Lim
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 10, NO. 5, 2017 MARCH 13, 2017:518–9
A Good Reminder for Common Sense Approaches
frame of the Melody valve is less robust, and there-
(9) ought to give clinicians a thoughtful pause in their
fore requires pre-stenting with a rigid bare metal
selection of which pulmonary valve to implant, it still
stent first, to resist the external compressive forces
is a call for longer-term and rigorously adjudicated
from the beating aorta posteriorly. Significant degrees
clinical trial data to more adequately assess the risk/
of deformation of the bioprosthetic pulmonary valve
benefit ratio to our patients in terms of valve choice.
may lead to turbulent flow, which in turn increases
More than that, it also is a good reminder for the
the risk for bacterial seeding during bacteremia. The
inexpensive, low-intensity, and common-sense rec-
Sapien valve stent frame is more robust, and there-
ommendations to reduce the risk of endocarditis:
fore possibly more likely to be able to withstand the
regular
external compressive forces without deformation.
therapies, and reminders for vigilance for the subtle
This in turn means the Sapien valve may be more
signs of endocarditis.
dental
hygiene,
appropriate
antiplatelet
likely to retain its optimal configuration with laminar blood flow, reducing the risk of endocarditis. However, it is important to note, that any bio-
ADDRESS FOR CORRESPONDENCE: Dr. D. Scott Lim,
University of Virginia, Medicine, 1215 Lee Street,
prosthetic valve is subject to a lifetime risk of endo-
Hospital
carditis. Although the present study by Hascoet et al.
Virginia 22908. E-mail: [email protected].
Expansion
Room
4033,
Charlottesville,
REFERENCES 1. Bonhoeffer P, Boudjemline Y, Saliba Z, et al. Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction. Lancet 2000;356: 1403–5. 2. Bonhoeffer P, Boudjemline Y, Qureshi SA, et al. Percutaneous insertion of the pulmonary valve. J Am Coll Cardiol 2002;39:1664–9. 3. Lurz P, Coats L, Khambadkone S, et al. Percutaneous pulmonary valve implantation impact of evolving technology and learning curve on clinical outcomes. Circulation 2008; 117:1964–72. 4. Kenny D, Hijazi ZM, Kar S, et al. Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: early phase 1 results from an
international multicenter clinical trial. J Am Coll Cardiol 2011;58:2248–56.
and subsequent infective endocarditis and inhospital death. JAMA 2016;316:1083–92.
5. Boone RH, Webb JG, Horlick E, et al. Trans-
9. Hascoet S, Mauri L, Claude C, et al. Infective endocarditis risk after percutaneous pulmonary valve implantation with the melody and sapien valves. J Am Coll Cardiol Intv 2017;
catheter pulmonary valve implantation using the Edwards SAPIEN transcatheter heart valve. Catheter Cardiovasc Interv 2010;75:286–94.
10:510–7. 6. US Food and Drug Administration, Products & Medical Procedures. Available at: http://www. accessdata.fda.gov/cdrh_docs/pdf14/p140017a.pdf. Accessed January 3, 2017. 7. US Food and Drug Administration, Products & Medical Procedures. Available at: http://www.acc
10. Malekzadeh-Milani S, Ladouceur M, Iserin L, et al. Incidence and outcomes of right-sided endocarditis in patients with congenital heart disease after surgical or transcatheter pulmonary valve implantation. J Thorac Cardiovasc Surg 2014;148:2253–9.
essdata.fda.gov/cdrh_docs/pdf13/p130009s037a.pdf. Accessed January 3, 2017. 8. Regueiro A, Linke A, Latib A, et al. Association between transcatheter aortic valve replacement
KEY WORDS bioprosthetic heart valve, endocarditis, pulmonary valve replacement
519
VOL. 10, NO. 5, 2017
ª 2017 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
ISSN 1936-8798/$36.00
PUBLISHED BY ELSEVIER
http://dx.doi.org/10.1016/j.jcin.2017.02.002
EDITORIAL COMMENT
A Good Reminder for Common Sense Approaches* D. Scott Lim, MDa,b
S
ince the introduction of transcatheter pulmo-
The article by Hascoet et al. (9) this issue of JACC:
nary valve replacement by Bonhoeffer et al.
Cardiovascular Interventions looks specifically at the
(1) in 2000, there has been a veritable rush in
risk of infective endocarditis following transcatheter
the pediatric and congenital cardiology community
pulmonary valve implantation with either the Melody
to switch from surgical pulmonary valved conduit
or Sapien valves, evaluating 79 patients having un-
replacement to the transcatheter approach, but
dergone transcatheter pulmonary valve replacement
without the benefit of a randomized clinical trial
at their center between 2008 and the present. It is
comparing transcatheter approaches with the surgical
notable that their follow-up period is longer than
standard of care. Therefore, we are left to infer com-
previous publications, in the intermediate range
parisons using data from case series on procedural
(median follow-up, 1.8 years), but that with that time
outcomes and complications, which generally have
frame there already is an incidence of 10.1% of
been favorable for the transcatheter approaches (2–5).
endocarditis using the established diagnostic criteria.
Based on the nonrandomized data available, in the
SEE PAGE 510
United States, 2 transcatheter pulmonary valves are approved for clinical care: the Melody valve (Med-
It is even more striking that although the mix of
tronic, Minneapolis, Minnesota) and the Sapien XT
implanted valves was nearly evenly split, the endo-
valve (Edwards Lifesciences, Irvine, California) (6,7).
carditis events occurred exclusively in those patients
Previous publications have demonstrated, albeit in
treated with the Melody valves. The cumulative
the short term, relatively low rates of endocarditis of
incidence of endocarditis was 24% at 4 years for
the Melody valve (3.2% at a median follow-up of 5
Melody valves versus 0% for Sapien valves. This is the
months) with common culprit organisms, such as
highest incidence noted for Melody valves yet pub-
Staphylococcus aureus and Streptococcus species (3).
lished, and immediately brings us to the next ques-
The Sapien and Sapien XT valves have not been in use
tion, which is why that incidence is so high.
for pulmonic applications long enough to previously
The authors looked for aggravating factors for
understand the risks of endocarditis until this present
endocarditis using a case-control analysis, yet found
publication, although applications in the aortic posi-
that other than the occurrence of noncardiac surgery,
tion have shown an even lower incidence than ex-
any risk factors related to implantation of the Melody
pected (8).
instead of a Sapien valve. The authors speculated that the use of bovine jugular vein tissue in the Melody valve may be related to the increased
*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 aDivision of Cardiovascular Medicine, University of Virginia b
Health System, Charlottesville, Virginia; and the Division of Pediatric
occurrence of endocarditis, because that has also been seen following surgical usage of bovine jugular valve implantation in the pulmonic position (10). It is probable that there are some tissue factors related to
Cardiology, University of Virginia Health System, Charlottesville, Vir-
bovine jugular tissue that would predispose to tissue
ginia. Dr. Lim is the national primary investigator of the COMPASSION-S3
seeing
Trial, sponsored by Edwards Lifesciences, and his institution, the Uni-
bacteremia.
versity of Virginia, receives funding to support that trial, although there is no direct payment to him; and has received a research grant from Edwards Lifesciences and Medtronic.
of
infectious
organisms
from
transient
Additionally, a potential difference between the 2 transcatheter pulmonary valves is that the stent
Lim
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 10, NO. 5, 2017 MARCH 13, 2017:518–9
A Good Reminder for Common Sense Approaches
frame of the Melody valve is less robust, and there-
(9) ought to give clinicians a thoughtful pause in their
fore requires pre-stenting with a rigid bare metal
selection of which pulmonary valve to implant, it still
stent first, to resist the external compressive forces
is a call for longer-term and rigorously adjudicated
from the beating aorta posteriorly. Significant degrees
clinical trial data to more adequately assess the risk/
of deformation of the bioprosthetic pulmonary valve
benefit ratio to our patients in terms of valve choice.
may lead to turbulent flow, which in turn increases
More than that, it also is a good reminder for the
the risk for bacterial seeding during bacteremia. The
inexpensive, low-intensity, and common-sense rec-
Sapien valve stent frame is more robust, and there-
ommendations to reduce the risk of endocarditis:
fore possibly more likely to be able to withstand the
regular
external compressive forces without deformation.
therapies, and reminders for vigilance for the subtle
This in turn means the Sapien valve may be more
signs of endocarditis.
dental
hygiene,
appropriate
antiplatelet
likely to retain its optimal configuration with laminar blood flow, reducing the risk of endocarditis. However, it is important to note, that any bio-
ADDRESS FOR CORRESPONDENCE: Dr. D. Scott Lim,
University of Virginia, Medicine, 1215 Lee Street,
prosthetic valve is subject to a lifetime risk of endo-
Hospital
carditis. Although the present study by Hascoet et al.
Virginia 22908. E-mail: [email protected].
Expansion
Room
4033,
Charlottesville,
REFERENCES 1. Bonhoeffer P, Boudjemline Y, Saliba Z, et al. Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction. Lancet 2000;356: 1403–5. 2. Bonhoeffer P, Boudjemline Y, Qureshi SA, et al. Percutaneous insertion of the pulmonary valve. J Am Coll Cardiol 2002;39:1664–9. 3. Lurz P, Coats L, Khambadkone S, et al. Percutaneous pulmonary valve implantation impact of evolving technology and learning curve on clinical outcomes. Circulation 2008; 117:1964–72. 4. Kenny D, Hijazi ZM, Kar S, et al. Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: early phase 1 results from an
international multicenter clinical trial. J Am Coll Cardiol 2011;58:2248–56.
and subsequent infective endocarditis and inhospital death. JAMA 2016;316:1083–92.
5. Boone RH, Webb JG, Horlick E, et al. Trans-
9. Hascoet S, Mauri L, Claude C, et al. Infective endocarditis risk after percutaneous pulmonary valve implantation with the melody and sapien valves. J Am Coll Cardiol Intv 2017;
catheter pulmonary valve implantation using the Edwards SAPIEN transcatheter heart valve. Catheter Cardiovasc Interv 2010;75:286–94.
10:510–7. 6. US Food and Drug Administration, Products & Medical Procedures. Available at: http://www. accessdata.fda.gov/cdrh_docs/pdf14/p140017a.pdf. Accessed January 3, 2017. 7. US Food and Drug Administration, Products & Medical Procedures. Available at: http://www.acc
10. Malekzadeh-Milani S, Ladouceur M, Iserin L, et al. Incidence and outcomes of right-sided endocarditis in patients with congenital heart disease after surgical or transcatheter pulmonary valve implantation. J Thorac Cardiovasc Surg 2014;148:2253–9.
essdata.fda.gov/cdrh_docs/pdf13/p130009s037a.pdf. Accessed January 3, 2017. 8. Regueiro A, Linke A, Latib A, et al. Association between transcatheter aortic valve replacement
KEY WORDS bioprosthetic heart valve, endocarditis, pulmonary valve replacement
519