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13—AORTIC PARAVALVULAR LEAK CLOSURE 141
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Fig. 13.2 Illustration of the differences between the Amplatzer Vascular Plug II and the Occlutech
paravalvular leak occluder. (A) The AVP-II commonly used in PVL closure. (B) AVP-II plug retrieved from a
patient with a prior percutaneous mitral PVL closure. Note the discrepancy between the circular shape in
vitro of the device and elliptical conformation in vivo. (C and D) The Occlutech PVL occluder is available in
square-shaped and rectangular-shaped designs and with two types of connections between the disks: waist
or twist.
are of small-to-medium sizes, and therefore 8- to 14-mm AVP-II are the most commonly
utilized occluders.
Amplatzer Vascular Plugs IV have a markedly lower profile compared with AVP-II, and thus
can be easily delivered via any catheter that can accommodate an 0.035-inch wire. However,
AVP-IV are only available in 4- to 8-mm diameters, and hence their utility is limited to smaller
PVLs. We oversize our occluder device by at least 50% relative to the largest diameter of the leak
to ensure an adequate seal of the leak and minimize the risk of device embolization.
LEAK CLOSURE TECHNIQUES
Once the leak is crossed, three common techniques are utilized to deliver the closure device(s).
Although switching between techniques during the procedure is possible, selecting the appropriate technique at the outset increases the efficiency and the safety of the procedure.
Catheter-only technique (Fig. 13.3A): With this method, after the delivery sheath/catheter is
advanced in the LV, the extra-stiff wire is removed and the occluder is directly deployed across
the leak. We utilize this technique when crossing of the defect is smooth and the leak is circular
in shape and likely to seal with one device. However, a disadvantage of this technique is the loss
of guidewire position across the leak at the time of device deployment.
Anchor wire technique (Fig. 13.3B): This technique preserves access across the defect, allowing sequential deployment of multiple devices if necessary. After the delivery sheath is advanced
into the LV, the 0.0350 extra-stiff curved wire is maintained in the LV (anchor wire). The device
is then delivered via the sheath alongside the anchor wire and deployed across the defect. The
device remains attached to the delivery cable and the delivery sheath/catheter is then removed
outside of the body and placed back on the anchor wire, leaving the device cable outside the
delivery catheter. The anchor wire can be used to recross the defect if additional devices are
needed. Knowledge of sheath-sizing requirements for each occluder with and without an anchor
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Fig. 13.3 Illustration of commonly applied techniques in aortic paravalvular leak closure. (A) Catheter-
only technique; (B) anchor wire technique; (C) arterio-arterial rail technique. AO, Aorta; LA, left atrium; LV, left
ventricle. (Reprinted with permission from Alkhouli M, Sarraf M, Maor E, et al. Techniques and outcomes of
percutaneous aortic paravalvular leak closure. JACC Cardiovasc Interv. 2016:12;9[23]:2416-2426. © 2016
Mayo.)
TABLE 13.1 n Compatibility Table for Catheter, Wire, and Device Combinations
7F Coronary Guide Yes Yes Yes No
8F Coronary Guide Yes Yes Yes Yes
4F Shuttle Sheath Yes No No No
6F Shuttle Sheath Yes Ye s Ye s Ye s
7F Shuttle Sheath Yes Ye s Ye s Ye s
8F Shuttle Sheath Yes Ye s Ye s Ye s
AVP II, Amplatzer Vascular Plug II. Yes/No 5 AVP II does/does not fit into delivery catheter (coronary guide or
shuttle sheath).
wire is key to a efficacious and cost-effective procedure. Table 13.1 summarizes the compatibility
of AVP-II devices with various sheaths/catheters.
Arterio-arterial (A-A) rail technique (Fig. 13.3C): In serpiginous, heavily calcified, or large
leaks, a more stable rail is often needed for device(s) deployment. In these cases, an A-A rail technique can be employed. After crossing the leak with the Glidewire, the wire is advanced through
Catheter-Only Technique
AVP-II 6 or
8 mm
AVP-II 10 or
12 mm
Anchor Technique with 0.032
or 0.035 Wire
AVP II 6 or
8 mm
AVP II 10 or
12 mm
13—AORTIC PARAVALVULAR LEAK CLOSURE 143
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the aortic valve into the descending aorta, snared (e.g., with an EnSnare [Merit Medical, South
Jordan, UT]), and exteriorized to the contralateral femoral artery establishing the A-A rail. The
reminder of the procedure is completed in a similar fashion to the anchor wire technique steps.
The use of this method should be limited to patients with bioprosthetic valves, because a wire
across a mechanical prosthesis can cause mechanical leaflet immobility and result in rapid hemodynamic compromise. Even in patients with bioprosthetic valves, continuous monitoring of the
aortic and pulse pressures is paramount, as significant aortic regurgitation can develop with
tightly tethered A-A rails. In these cases, loosening tension of one end of the rail instantly reduces
the valvular regurgitation and its associated hemodynamic effects.
In rare occasions, veno-arterial or arterio-apical rails can also be utilized to allow successful
closure of challenging leaks (Fig. 13.4).
8
However, these more complex techniques should be used
with caution because of their additive risk of complications (hemothorax, iatrogenic atrial septal
defect, etc.).
3,8
LEAK CLOSURE TECHNIQUES IN PATIENTS WITH
TRANSCATHETER VALVES
The general principles of aortic PVL closure apply to both surgical and transcatheter valves. However, a few issues specific to PVL closure in transcatheter aortic valves are worth highlighting.
Fig. 13.4 Veno-arterial rail utilization for complex closure of a large aortic paravalvular leak in a patient
with a 23-mm Sapien XT transcatheter valve. Antegrade delivery of Amplatzer vascular plugs. (A) Creation
of arteriovenous rail; establishing an arterial limb—straight Glidewire across the leak (yellow arrows) and a
venous limb—0.0350 wire advanced through the septal defect to the left ventricle (white arrows). Asterisk,
Intracardiac echocardiography. (B) Snaring the glide wire with an EnSnare in the left ventricle. (C) Advancing
a Raabe sheath antegrade over the rail (yellow arrows indicate the arterial and white arrows indicate the venous portions of the sheath). The yellow circle indicates the location of the atrial septal defect. (D) Deploying
the second Amplatzer plug via an antegrade access while maintaining the arteriovenous rail (white arrows).
Asterisk, Intracardiac echocardiography. (E) Four plugs deployed across the leak before release (perpendicu-
lar view shown in the insert). (F) Amplatzer plugs after release. (Reprinted with permission from Alkhouli M,
Busu T, Hijaz M, Alqahtani F, Rihal CS. Antegrade transcatheter closure of a large aortic paravalvular leak.
Structural Heart. 2018;2:3, 250-251. doi: 10.1080/24748706.2018.1444830).
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The etiology of the PVL is a key determinant of the most appropriate first step in their per-
cutaneous treatment. After TAVR, paraprosthetic leaks can develop because of (1) gross undersizing of the transcatheter prosthesis, (2) suboptimal final position of the valve (too aortic or too
ventricular), or (3) partial incomplete apposition of the stent frame to the annulus. In cases of
valve undersizing, the leak is usually large and circumferential. Thus balloon dilation of the valve
can be attempted first. However, the success of balloon dilation is determined by the length of
time since the TAVR procedure and the specific valve type used. Sapien S3 (Edwards Lifesciences, Irvine, CA) and the CoreValve family of valves (Medtronic, Minneapolis, MN) are more
responsive to postdilation than the older-generation Sapien XT valve. In patients with suboptimal valve position, a second valve implantation may be necessary to resolve the leak. When an
incomplete valve annular apposition in an appropriately sized valve exists, the leaks are usually a
result of discrete calcified nodules. In these patients, balloon postdilation is unlikely to eliminate
the leak and carries the risk of annular injury, and hence percutaneous PVL closure is the firstline strategy.
Balloon-expandable valves have short stent frames, and therefore cannulation of the leak ex-
ternal to the stent frame is feasible in the majority of cases. However, for self-expandable valves
(CoreValve, CoreValve Evolut R), a higher crossing point in the stent lattice may be preferred to
facilitate smooth navigation of the defects with the delivery sheath/catheter (Fig. 13.5).
9
Contrary to surgically placed prostheses, transcatheter valves are implanted without resection
of the native calcified aortic valve leaflets. Thus, although post-TAVR PVLs can be wired with
high success in the majority of patients, advancing large guiding catheters or delivery sheaths
Fig. 13.5 Closure of a moderate anterior paravalvular leak after CoreValve implantation. (A and B)
Crossing high in the lattice allows for cannulation of the defect. (C and D) The AVP-4 device is deliverable
through any catheter that can accommodate a 0.035-inch guidewire, making it an attractive option for small
posttranscatheter aortic valve replacement paravalvular leaks. An AVP-4 occluder was used to close this
defect with mild residual regurgitation (E) A picture of an AVP-IV Plug.
13—AORTIC PARAVALVULAR LEAK CLOSURE 145
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across the PVL can be challenging due to the calcified, irregular, and crowded perivalvular space.
However, these leaks are often small in size and can be successfully closed with the lower-profile
AVP-IV devices, which can be delivered via 5 to 6F diagnostic catheters.
9
The risk of valve embolization during PVL closure is small. However, we take extra care not
to apply excessive force in passing catheters or sheaths through the defect. In patients with no or
little annular calcifications (e.g., patients with aortic regurgitation or rheumatic aortic stenosis),
patients with gross undersizing of the transcatheter valve, and those with too aortic/too ventricular valves, the risk of embolization is higher. Thus in these patients we usually prefer balloon
postdilation or valve-in-valve over PVL closure. However, when PVL closure is performed in
cases with a higher risk of embolization, we institute a contingency plan by advancing a precurved
wire via a separate femoral access into the LV via the valve.
Outcomes of Aortic PVL Closure
SAFETY OF AORTIC PVL CLOSURE
Outcome data specific to aortic PVL closure are scarce, as the majority of studies reported combined
outcomes of aortic and mitral PVL closure. Potential immediate risks of aortic PVL closure include
(1) minor and major vascular complications, (2) device embolization, (3) leaflet impingement in
patients with mechanical prostheses, (4) coronary dissection due to inadvertent cannulation of
a coronary artery with the Glidewire, (5) coronary obstruction in patients with low coronary ostia,
(6) ventricular arrhythmia, (7) hemothorax related to transapical access, (8) acute kidney injury,
(9) stroke, and (10) cardiac tamponade or left ventricular pseudoaneurysm formation due to wire/
sheath ventricular interaction or transapical access.
However, data from single and multi-institutional registries suggest that percutaneous aortic
PVL closure can be carried out with low risk of major adverse events. In the largest dedicated
series of percutaneous aortic PVL closure (n 5 80), in-hospital major adverse events occurred in
six patients (7.6%).
access), one nonprocedural death (persistent cardiogenic shock despite successful PVL closure),
one tamponade, one vascular complication, one stroke, and one coronary dissection. In another
combined registry of aortic and mitral PVL closure from the UK and Ireland, the overall incidence of major adverse events was 24.8%, but was 80% lower after aortic versus mitral PVL
4
closure.
Other smaller series of PVL closure in patients with transcatheter valves reported low
rates of major adverse events, ranging between 0% and 6%.
3
These included one procedural-related death (hemothorax due to transapical
EFFICACY OF AORTIC PVL CLOSURE
Assessment of the efficacy of aortic PVL closure in the literature is hampered by the variable
definitions used for success in different studies: In the Mayo Clinic experience with aortic PVL
(n 5 80), success was defined as deployment of a closure device across the leak and reduction
in PVL grade to mild or less, and this was achieved in 62% of patients.
HOLE Spanish registry, which included 140 patients with aortic PVL, the reported success
rate was 74.2%. However, in this registry, a more lenient definition of success was used (closure
device deployment and the reduction of PVL by one grade at least).
to the Mayo Clinic reported experience will increase the success rate from 62% to 82%. To resolve those ongoing challenges, a standardized definition of success has recently been proposed
in a consensus document by the PVL Academic Research Consortium.
mediate success was termed “technical success” and was defined as deployment of the closure
device(s); reduction of the PVL grade to mild or less; and freedom from procedural mortality,
stroke, urgent surgery, or occluder-related hemolysis on exit from the procedure laboratory.
3
In the multicenter
5
Applying this definition
10
In this document, im-
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The document also provided guidance for standardized reporting of other short- and longterm safety and efficacy end points.
The magnitude of clinical benefit from aortic PVL closure corresponds to the amount of PVL
reduction achieved. In the Mayo Clinic registry, patients who had successful reduction in PVL to
mild or less experienced more improvement in NYHA functional class (from 2.9 6 0.6 to 1.7 6
0.7) compared with those with more than mild residual leak (from 3.0 6 0.6 to 2.5 6 0.7)
(P ,0.001), and these patients also had higher rates of event-free survival from death or repeat
3
surgery.
associated with significant morality reduction during long-term follow up.
In the combined British/Irish registry, adequate PVL reduction to mild or less was
4
Conclusions and Take-Home Points
n
Percutaneous closure is the preferred method of aortic PVL closure in contemporary prac-
tice in experienced centers.
n
This procedure can be performed with a low complication rate and high technical success.
n
Detailed preprocedural assessment; knowledge of the available devices, their strengths, and
limitations; and experience with basic and advanced PVL closure techniques are key to
achieve optimal outcomes.
References
1. Goel K, Eleid MF. Paravalvular leak in structural heart disease. Curr Cardiol Rep. 2018:6;20(3):18.
2. Busu T, Alqahtani F, Badhwar V, Cook CC, Rihal CS, Alkhouli M. Meta-analysis comparing transcatheter and surgical treatments of paravalvular leaks. Am J Cardiol. 2018. pii: S0002-9149(18)30848-8. doi:
10.1016/j.amjcard.2018.03.360. [Epub ahead of print].
3. Alkhouli M, Sarraf M, Maor E, et al. Techniques and outcomes of percutaneous aortic paravalvular leak
closure. JACC Cardiovasc Interv. 2016:12;9(23):2416-2426.
4. Calvert PA, Northridge DB, Malik IS, et al. Percutaneous device closure of paravalvular leak: Combined
experience from the United Kingdom and Ireland. Circulation. 2016:27;134(13):934-944.
5. García E, Arzamendi D, Jimenez-Quevedo P, et al. Outcomes and predictors of success and complications for paravalvular leak closure: An analysis of the SpanisH real-wOrld paravalvular LEaks closure
(HOLE) registry. EuroIntervention. 2017:20;12(16):1962-1968.
6. Takagi H, Umemoto T; ALICE (All-Literature Investigation of Cardiovascular Evidence) Group. Impact of paravalvular aortic regurgitation after transcatheter aortic valve implantation on survival. Int J
Cardiol. 2016:15;221:46-51.
7. Dahou A, Ribeiro HB, Rodés-Cabau J, Pibarot P. Impact and management of paravalvular regurgitation
after transcatheter aortic valve replacement. Interv Cardiol Clin. 2015;4(1):67-82.
8. Alkhouli M, Busu T, Hijaz M, Alqahtani F, Rihal CS. Antegrade transcatheter closure of a large aortic
paravalvular leak. Structural Heart. 2018;2:3, 250-251. doi: 10.1080/24748706.2018.1444830
9. Waterbury TM, Reeder GS, Pislaru SV, Cabalka AK, Rihal CS, Eleid MF. Techniques and outcomes of
paravalvular leak repair after transcatheter aortic valve replacement. Catheter Cardiovasc Interv.
2017:1;90(5):870-877.
10. Ruiz CE, Hahn RT, Berrebi A, et al. Clinical trial principles and endpoint definitions for paravalvular
leaks in surgical prosthesis: An expert statement. J Am Coll Cardiol. 2017:25;69(16):2067-2087.
e1
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Abstract: Paravalvular leak (PVL) closure has emerged as a safe and effective alternative to repeat
surgery in selected patients. Aortic PVLs have distinctive characteristics compared with PVLs of
mitral prostheses. This chapter focuses on the contemporary techniques and outcomes of percutaneous closure of aortic PVL.
Keywords: aortic paravalvular leak, percutaneous closure, aortic valve replacement.
SECTION 3
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Mitral Valve Interventions
147
CHAPTER 14
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Percutaneous Balloon Mitral
Valvuloplasty
Mohamad Alkhouli Mohammad Sarraf
Introduction
Mitral stenosis (MS) is the most common sequelae of rheumatic heart disease and is characterized by diffuse fibrous thickening of the margins of the mitral valve (MV) leaflets and
fusion of the commissures. Untreated, severe MS can lead to significant derangement of the
functional status of patients and reduced long-term survival. Since its introduction in the
1980s, percutaneous balloon mitral valvuloplasty (PBMV) has proven to be an effective and
durable treatment option for selected patients with rheumatic MS.
challenging, PBMV has also been utilized in patients with nonrheumatic MS (e.g., calcific
2
MS).
This chapter focuses on the contemporary indications, patient selection, and tech-
niques of PBMV.
1
Although it is more
Indications and Patient Selection
PBMV is recommended for symptomatic patients with severe MS (mitral valve area [MVA]
,1.5 cm
(Fig. 14.1).
valvular pathology by inducing an effective commissural split without a significant increase in
mitral regurgitation (MR). Hence, in symptomatic patients, the main determinants of patient
selection for PBMV are the anatomic features of the mitral apparatus. Other considerations include the patient’s age, functional status, and the presence or absence of atrial fibrillation or
pulmonary hypertension.
with transthoracic 6 transesophageal echocardiography (TEE). The MV and subvalvular apparatus need to be systematically evaluated for favorable and unfavorable features for PBMV.
Attempts have been made to incorporate certain individual characteristics into a holistic scoring system to predict optimal PBMV results. The Wilkins echocardiography score is the most
commonly used scoring system for PBMV.
characteristics of the mitral apparatus, including leaflet mobility, leaflet thickness, leaflet calcification, and subvalvular thickening (Table 14.1). Each component is given a 1- to 4-point
score. Patients with Wilkins scores #8 are, in general, suitable for PBMV.
score is .10, the risk of complications, including severe MR requiring urgent or emergent
MV replacement, is significantly higher. Patients with a Wilkins score between
8 and 10 may be considered for PBMV on an individual basis. A simpler scoring system is the
Lung and Cormier score, which divides the valvular anatomy into three groups, with patients
148
2
, stage D) and favorable valve morphology in the absence of contraindications
2
The goal of PBMV for patients with rheumatic MS is to directly affect the main
Patients who are being considered for PBMV should undergo a comprehensive assessment
3
This score incorporates four echocardiographic
3
When the Wilkins
14—PERCUTANEOUS BALLOON MITRAL VALVULOPLASTY 149
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Class I
Rheumatic MS
Class IIa
Class IIb
Very severe MS
MVA ≤1 cm
T ½ ≥220 ms
Asymptomatic
(stage C)
Favorable valve
morphology
No LA clot
No or mild MR
No Ye s
Periodic
monitoring
Fig. 14.1 Indications for intervention in patients with rheumatic mitral stenosis. AF, Atrial fibrillation; LA,
left atrium; MS, mitral stenosis; MR, mitral regurgitation; MVA, mitral valve area; NYHA, New York Heart
Association; PCWP, pulmonary capillary wedge pressure; T
PMBC
(IIa)
2
Symptomatic
(stage D)
Favorable valve
morphology
No LA clot
No or mild MR
Ye s
PMBC
(I)
Severe MS
MVA ≤1.5 cm
T ½ ≥150 ms
No
NYHA class III-IV
symptoms
with high
surgical risk
Ye s
MVR
(I)
PMBC
2
Asymptomatic
(stage C)
New onset AF
Favorable valve
morphology
No LA clot
No or mild MR
Ye s
(IIb)
, pressure half-time.
1/2
No
Ye s
NoNo
Periodic
monitoring
Progressive MS
MVA >1.5 cm
T ½ <150 ms
Symptomatic with no
other cause
PCWP >25 mm Hg
with exercise
Ye s
PMBC
(IIb)
2
Periodic
monitoring
2
No
in group 1, 2, and 3 considered optimal, intermediate, and borderline candidates for PBMV,
respectively (Table 14.2).
proposed.
5,6
These scores incorporate novel predictors of PBMV outcomes, such as commissural morphology, leaflet displacement, commissural calcium, and commissural fusion. These
scoring systems have weaknesses and strengths. One fundamental criticism applying to all
scoring systems is that they are mainly derived from single-center experience and with a limited number of operators. Furthermore, assessment of the subvalvular apparatus is difficult in
most patients, despite TEE. Most of the echocardiographic assessments are qualitative, which
makes the reproducibility of a specific scoring system more challenging. Nevertheless, using
any of these scoring systems might help the operator in predicting the outcome and potential
complications that should be discussed with the patient as part of the informed consent and
shared decision-making.
4
Newer scoring systems to predict PBMV outcomes have been
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