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132 2—AORTIC VALVE INTERVENTIONS
STENTLESS
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Perimount
(Edwards Lifescinces)
Epic
(St. Jude Medical)
Hancock II
(Medtronic)
A
STENTED
Mitroflow
(Sorin)
C
STENTED, EXTERNALLY
MOUNTED LEAFLETS
Fig. 12.2 Bioprosthetic surgical valves. Examples of several commonly used surgical valves are shown in
this figure. (A) Stented prostheses, (B) supra annular stented prostheses, (C) stented valves with externally
mounted leaflets. These are at increased risk of coronary obstruction during valve-in-valve procedures.
(D) Stentless valves. (© 2018 Mayo.)
Tr ifecta
(St. Jude Medical)
Freedom
(Sorin)
D
Magna
(Edwards Lifesciences)
B
STENTED, SUPRA ANULAR POSITION
To ronto SPV
(St. Jude Medical)
Mosaic
(Medtronic)
Freestyle
(Medtronic)
Operators should strongly consider a supra-annular valve for smaller surgical valves: among
small surgical valves with an ID ,20 mm, elevated gradients are more common with SAPIEN
vs. CoreValve valves (59% vs. 20%, respectively). In cases where the need for repositioning is
likely due to unclear landmarks or need for assessment of coronary arteries, a device that can be
repositioned and retrieved, such as CoreValve Evolut R, may be preferred.
When selecting valve size, 1 to 2 mm of oversizing is usually sufficient, but if there is evidence
of marked pannus of calcification, a smaller valve should be considered to avoid valve underex-
cluded in the VIV app.
BIOPROSTHETIC VALVE FRACTURE
Bioprosthetic valve fracture (BVF) is an emerging novel technique for patients with small
surgical bioprostheses who are undergoing a VIV procedure. Only isolated cases and small
case series were reported, and the safety and efficacy of this approach need to be determined.
The technique includes positioning of a noncompliant valvuloplasty balloon within the surgical bioprosthesis, followed by a high-pressure balloon inflation to fracture the surgical sewing
ring of the surgical valve. Successful fracture is associated with a sudden release of the balloon
waist, sudden drop in inflation pressure, and an audible snap. This allows for further expansion
of the bioprosthesis and the implanted THV, thus increasing the maximum effective orifice
area that can be achieved after the VIV procedure. In a case series of 20 patients who underwent BVF, this technique was associated with improved hemodynamics with no procedural
complications.
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Procedural Considerations
ACCESS
The retrograde transfemoral approach remains the preferred option in the vast majority of cases.
Similar to standard TAVR procedures, an alternative route is used in a small minority of cases
where severe calcification, tortuosity, or smaller vessel diameter is present. Alternative access sites
include transapical, transaortic, and transaxillary. These are covered in Chapter 11. The transapi-
cal approach allows for better coaxial positioning of the transcatheter valve, but it is not feasible
with self-expandable valves. For more details on access site management, see Chapter 2.
BALLOON AORTIC VALVULOPLASTY
Balloon aortic valvuloplasty (BAV ) should be considered only in rare cases with major concerns of
inability to cross the prosthetic valve, as it carries risks of leaflet as well as possible myocardial injury.
Leaflet tear might cause acute severe regurgitation, and myocardial injury might lead to slow recov-
ery of the left ventricle (LV ) and hemodynamic instability. If performed, it is recommended to use
an undersized balloon to decrease the risk for leaflet injury. Predilatation may also be considered in
cases at high risk for coronary obstruction. In such cases, aortic angiography during maximal bal-
loon inflation may indicate whether coronaries are at risk for obstruction after THV implantation.
VALVE POSITIONING AND DEPLOYMENT
The transcatheter valve needs to overlap the surgical valve annular sewing ring to secure deploy-
ment without valve embolization. To achieve this, it is strongly recommended that the operators
be familiar with the fluoroscopic appearance and the characteristics of the exact type of aortic
bioprosthesis. Important characteristics include whether it is stented or stentless, dimensions, and
radiologic appearance of the basal portion of the valve. Operators should be aware that although
in some surgical valves the radiopaque markers are close to the anatomic sewing ring, in others
the markers may be close to the tip of the stent.
For stented surgical valves, there is no need for contrast injections. Simple alignment of the
fluoroscopic markers will ensure that the deployment angle is correct. In cases of invisible bioprosthesis, a pigtail at the bottom of the aortic root can be used to identify the neo-annulus,
similar to what was described for standard TAVR procedures.
Ideally, and in order to achieve both firm fixation and optimal hemodynamic result, the valve should
be positioned as high as possible (Fig. 12.3). When using a self-expandable THV, a supra-annular
position can be achieved in most cases due to the repositioning option of this self-expandable valve.
When using the balloon-expandable valve, slow and careful deployment is critical, as it cannot be repositioned after deployment.
RAPID VENTRICULAR PACING
Performance of a VIV procedure using self-expandable valves typically does not require pacing.
In fact, in most cases, the risk for new conduction disturbance and the need for new permanent
pacemaker implantation is so low that there is no need to position a temporary pacemaker during
these procedures. However, in certain cases when the self-expandable THV is significantly oversized, accurate supra-annular positioning may be challenging, and operators may experience the
THV “diving” into the LV or “popping out” to the aorta. In such cases, moderate rapid pacing
(160 beats per minute) may lower the cardiac output and facilitate accurate valve positioning. Of
note, balloon-expandable valves always require rapid ventricular pacing; thus rapid pacing is required in all such VIV cases.
134 2—AORTIC VALVE INTERVENTIONS
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Fig. 12.3 High versus low implant. The figure shows two cases of a CoreValve 26-mm valve implanted
inside a Mitroflow 21-mm bioprosthesis. The left figure shows a low implantation resulting in high postprocedural residual gradients. The right figure shows a high implantation resulting in minimal residual gradients
across the valve.
POSTDILATATION
Postdilatation of the THV should be performed only in highly selected cases. Postdilatation
carries the risk of THV dislodgement from the original deployment position and thus should
not be routinely performed. It is advisable to perform postdilatation only in cases where there
is clear angiographic evidence for valve under expansion due to issues such as the presence of
pannus.
RISK OF CORONARY OBSTRUCTION
Coronary obstruction by bioprosthesis leaflets is a life-threatening complication, especially
when the left main coronary artery is involved. Contemporary VIV registries report very low
rate of coronary obstruction in only 1% to 2% of cases with predominance of the left coronary
2,3
ostia.
Meticulous preprocedural assessment of computed tomography of the bioprosthetic
valve and aortic root should be performed. Several approaches for preprocedural planning
have been reported. One possible workflow includes assessment of the double oblique view
and “short-axis” simulation of the THV position inside the bioprosthetic valve to predict
potential coronary obstruction. Contrary to the typical TAVR procedure in which it is important to examine the distance from the annulus to the coronary ostia, this dimension is less
relevant in the VIV procedure. The major factor in the VIV procedure is the proximity of the
coronary artery ostia to the bioprosthetic posts and to the anticipated final position of the
bioprosthetic leaflets.
9
The most important risk factors for coronary obstruction are surgical valve design and a
short distance from the transcatheter valve to coronary ostium.
leaflet tissue mounted internal to the stent frame, a design that prevents surgical valve tissue
from being displaced external to the valve posts. When bioprosthetic tissue is mounted external
to the valve frame or there is no stent frame, tissue can be displaced external to the valve posts
and obstruct the coronary ostia. Examples of surgical valves with pericardium sutured outside
10
Stented bioprostheses have
12—AORTIC VALVE-IN-VALVE TAVR 135
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Fig. 12.4 Coronary protection during valve-in-valve. Examples of left main (left) and right coronary (right)
protection during deployment of self-expandable valve. Both cases include cannulation and wiring of the
coronary vessel before valve deployment. Note the very low distance between the ostium of the right coro-
nary artery and the surgical valve.
the stent frame include Mitroflow (Sorin, Italy) and Trifecta (St. Jude Medical). The risk of
coronary obstruction is especially high with these valves when an oversized transcatheter valve
is being used and when the aortic sinuses are shallow. Composite aortic root and aortic valve
replacement with reimplantation of the left and right coronary ostia are another case with in-
creased risk of coronary obstruction, as there are no prosthetic valve posts to prevent the THV
from obstructing the coronaries in certain anatomic subsets. In high-risk cases, operators
should reconsider open heart surgery. If the heart team decision is to proceed with the trans-
catheter approach, precautions include placing a coronary wire with or without a coronary stent
at the ostium (Fig. 12.4), to allow immediate percutaneous coronary intervention (PCI) if
coronary obstruction occurs. Clinical presentation of coronary obstruction includes persistent
severe hypotension and ST-segment changes. Attempted PCI is challenging due to difficulties
with either guide catheter engagement of the coronary ostium or wire crossing. Reported mor-
tality rates are as high as 50% in 30 days.
Summary and Take-Home Messages
n
VIV therapy for failed aortic bioprostheses is an emerging technique for patients at high
risk for redo aortic valve replacement (AVR).
n
Registry data have been encouraging to date with high procedural success and low compli-
cation rates.
n
For selected patients, such as very-low-risk patients and patients with small-diameter
bioprosthesis, a heart team discussion should consider the option of redoing the surgical
AVR.
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Fig. 12.5 Examples of different valve-in-valve positions. Each figure (A) to (F) has six panels: (a) and
(b) show the side profile of the implanted CoreValve in an ideal position; (c) and (d) show the SAPIEN XT in
an ideal position; (e) shows the end-on fluoroscopic view of the SAPIEN XT after implantation; and (f) shows
the end-on fluoroscopic view of the CoreValve after implantation to assess their circularity. (A) Perimount
2725; (B) Perimount 2700; (C) Magna; (D) CE;
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Fig. 12.5 cont’d
et al. Fluoroscopic guide to an ideal implant position for Sapien XT and CoreValve during a valve-in-valve
procedure. JACC-Cardiovasc Interv. 2013;6[11]:1186-1194.)
(E) CE SAV Porcine; (F) Trifecta (St. Jude Medical). (From Bapat VN, Attia RQ, Condemi F,
References
1. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC
guideline for the management of patients with valvular heart disease: A report of the American College
of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation.
2017;CIR.0000000000000503.
2. Dvir D, Webb JG, Bleiziffer S, et al. Transcatheter aortic valve implantation in failed bioprosthetic surgical valves. JAMA. 2014;312(2):162-170.
3. Webb JG, Mack MJ, White JM, et al. Transcatheter aortic valve implantation within degenerated aortic
surgical bioprostheses: PARTNER 2 Valve-in-Valve Registry. J Am Coll Cardiol. 2017;69(18):2253-2262.
4. Makkar RR, Fontana G, Jilaihawi H, et al. Possible subclinical leaflet thrombosis in bioprosthetic aortic
valves. N Engl J Med. 2015;373(21):2015-2024.
5. Rahimtoola SH. The problem of valve prosthesis-patient mismatch. Circulation. 1978;58(1):20-24.
6. Mohty-Echahidi D, Malouf JF, Girard SE, et al. Impact of prosthesis-patient mismatch on long-term
survival in patients with small St Jude medical mechanical prostheses in the aortic position. Circulation.
2006;113(3):420-426.
7. Bapat V. Valve-in-valve apps: Why and how they were developed and how to use them. Eurointervention
J. 2014;10:U44-U51. DOI: 10.4244/EIJV10SUA7.
8. Chhatriwalla AK, Allen KB, Saxon JT, et al. Bioprosthetic valve fracture improves the hemodynamic
results of valve-in-valve transcatheter aortic valve replacement. Circ Cardiovasc Interv. 2017;10(7):e005216.
9. Blanke P, Soon J, Dvir D, et al. Computed tomography assessment for transcatheter aortic valve in valve
implantation: The Vancouver approach to predict anatomical risk for coronary obstruction and other
considerations. J Cardiovasc Comput Tomogr. 2016;10(6):491-499.
10. Ribeiro HB, Rodés-Cabau J, Blanke P, et al. Incidence, predictors, and clinical outcomes of coronary
obstruction following transcatheter aortic valve replacement for degenerative bioprosthetic surgical
valves: Insights from the VIVID registry. Eur Heart J. 2018;39(8):687-695.
e1
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Abstract: Transcatheter aortic valve-in-valve (VIV ) is established treatment of degenerative
surgical bioprostheses in patients at high operative risk and was approved by the US Food and
Drug Administration in 2015. The AHA/ACC guidelines for the management of patients with
valvular heart disease give it class IIa indication based on nonrandomized data including registries
and case series only. When planning an aortic VIV procedure, therapy of small surgical valves
should be approached with caution, as patient prosthesis mismatch (PPM) and significant residual gradients remain a major challenge. In addition, when the indication for the procedure is
valve regurgitation, every effort should be taken to rule out aortic para-valvular leak, since VIV
implantation is not expected to improve hemodynamics in this case. In addition to careful patient
selection and procedural planning, the VIV procedure itself has particular operator-associated
aspects that will be discussed in this chapter. Despite growing experience with this procedure, for
selected patients, such as very-low-risk patients and patients with small diameter bioprosthesis, a
heart team discussion should still consider the option of redo surgical aortic valve replacement.
Keywords: Aortic valve, aortic stenosis, bioprosthesis, valve-in-valve, patient prosthesis mismatch
CHAPTER 13
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Aortic Paravalvular Leak Closure
Mohamad Alkhouli Saurabh Sanon Mohammed Al-Hijji Mackram F. Eleid
Paravalvular leak (PVL) occurs in 5% to 17% of patients after valve replacement surgery.1 Although the majority of PVLs are subclinical, some patients develop symptoms of heart failure,
hemolysis, or both, requiring intervention. Surgical repair or valve re-replacement is the historical
gold standard for the management of symptomatic PVL, but is associated with significant morbidity and mortality, even in modern practice.
feasible alternative to repeat surgery, with safety and efficacy demonstrated in several studies.
Techniques and outcomes of percutaneous PVL closure differ significantly according to the
prosthesis location (aortic vs. mitral).
techniques and outcomes of percutaneous aortic PVL closure.
3
This chapter focuses on summarizing the contemporary
Clinical Impact of Aortic PVL
2
Percutaneous PVL closure has proven to be a
1-5
The incidence of PVL is higher among patients with mitral prostheses than those with aortic
prostheses.
ment.
data from the transcatheter aortic valve replacement (TAVR) literature suggest that more than
mild aortic PVL is associated with worse long-term survival even in asymptomatic patients.
However, in current practice, the majority of patients considered for PVL closure are referred due
to heart failure, progressive ventricular dilatation, unexplained dyspnea, or hemolytic anemia.
Once the decision is made to offer percutaneous aortic PVL closure to the patient, detailed preand intraprocedural imaging assessment is necessary to understand the mechanism and anatomic
characteristics of the leak and to select the optimal closure technique.
1
It is also higher in patients undergoing transcatheter vs. surgical aortic valve replace-
1
Although symptomatic aortic PVL is known to negatively affect long-term outcomes,6
3-5
AHA Guidelines
IIa B Percutaneous repair of paravalvular regurgitation is reasonable in patients with prosthetic
heart valves and intractable hemolysis or New York Heart Association (NYHA) class
III/IV heart failure who are at high risk for surgery and have anatomic features suitable
for catheter-based therapy when performed in centers with expertise in the procedure.
Multimodality Assessment of the Paravalvular Leak
PREPROCEDURAL IMAGING
Procedural success relies on full understanding of the location, number, and severity of PVL(s).
Although aortic PVLs are often detected on transthoracic echocardiography (TTE), detailed
assessment of their characteristics often requires additional imaging. Transesophageal echocardiography (TEE) provides excellent delineation of the location and the severity of the leak.
8
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13—AORTIC PARAVALVULAR LEAK CLOSURE 139
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Fig. 13.1 Utility of cardiac computed tomography in the preprocedural planning of aortic paravalvular
leak closure. (A-C) Identification of the location and dimensions of an aortic paravalvular leak on cardiac
computed tomography. The paravalvular leak can be readily located in a modified four-chamber view (A), a
modified two-chamber view (B), and a modified short-axis view (C) (yellow arrows). The distance between the
neck of the paravalvular leak and the ostium of the adjacent coronary artery is shown in (D). The black star
indicates the ostium of the left main coronary artery. 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).
Cardiac computed tomography (CCT) offers incremental value in identifying the path of the
leak, measuring its dimensions, distances from the right and left coronary ostia, and predicting
the ideal fluoroscopic angles for the closure procedure (Fig. 13.1). Meticulous planning increases
the likelihood of successful closure and decreases the procedure duration, radiation exposure, and
contrast use.
We utilize a multifaceted approach incorporating echocardiographic, invasive hemodynamic, and angiographic data to grade the leak to mild, mild to moderate, moderate, and severe. Common echocardiographic parameters used include (1) PVL jet width measured in the
short and long axis at the level of the sewing ring and in the left ventricular (LV ) outflow tract,
(2) diastolic flow reversal in the descending thoracic and abdominal aorta, (3) deceleration rate
by pressure half-time, and (4) regurgitant volume and regurgitant fraction. Invasive hemodynamics and aortic root angiography are often used to ascertain the severity of regurgitation in
equivocal cases.
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INTRAPROCEDURAL IMAGING
Closure of simple leaks can be guided by TTE, but complex leaks (multiple, serpiginous, posterior, etc.) require TEE or intracardiac echocardiography (ICE) guidance. Both TEE and ICE
offer high-resolution imaging, but TEE has the additional advantage of biplane (also referred to
as x-plane) and 3D imaging. TEE requires a dedicated echocardiographer and deeper sedation or
general anesthesia. When TEE is used to guide the closure procedure, a standardized nomenclature based on fixed anatomic reference points is necessary to ensure efficient communication
between the echocardiographer and interventionalist.
Whereas mitral PVLs are usually localized based on their location in the surgical 3D-TEE
view (anterior, posterior, medial, lateral), aortic PVLs are best localized relative to their position
to the aortic cusps (left, right, and noncoronary cusps).
When ICE is utilized, a dedicated venous access (8 to 10F) is obtained, and an ICE probe
(AcuNav, Siemens-Acuson, Mountain View, CA, or View-Flex, Abbott Vascular, St. Paul, MN)
is positioned in the right ventricular outflow tract. This view affords excellent imaging of the
aortic valve (AV) in the short and long axis.
Percutaneous Closure Techniques
VASCULAR ACCESS AND LEAK CROSSING
We place an 8F arterial sheath and a Perclose suture (Abbott Vascular, Santa Clara, CA) in the
common femoral artery. We then telescope a 125-cm, 5F, multipurpose coronary or vertebral
catheter through a 100-cm 6F guiding catheter (usually Amplatz Left-1) adjacent to the leak and
probe the leak with a 0.035-inch stiff-angled Glidewire (Terumo, Tokyo, Japan). After advancing
the wire into the LV, the 6F guide catheter is telescoped toward the apex over the wire and the
5F catheter, which acts as a dilator to the guiding catheter. The wire is then removed and exchanged with a manually curved Amplatzer extra-stiff wire or a precurved extra-stiff Safari wire
(Boston Scientific, Marlborough, MA). The extra-stiff wire serves as the platform to advance a 5
to 8F Flexor Ansel, Raabe, or Shuttle sheath (Cook Medical, Bloomington, IN) or Destination
sheath (Terumo, Tokyo, Japan) to the LV. Most of these sheaths are available in 90- to 100-cm
lengths, which is adequate to reach the LV in the majority of patients. Shuttle sheaths (4 to 6F)
are available in a 110-cm length and might be utilized in taller patients.
Radial access can be used in simple leaks when use of only one occluder device is anticipated,
but we generally prefer the femoral route because closure techniques for larger leaks often require
multiple catheter exchanges and large-bore access.
ensure an activated clotting time to be above 250 seconds during the procedure.
3
We administer intravenous heparin and
CHOICE OF CLOSURE DEVICE
The shape of the PVL may be complex and variable, but is often crescentic. Hence, an oblong
device, such as the Occlutech PLD device (Occlutech, Jena, Germany) or the Amplatzer
Vascular Plug 3 (AVP-3) (St. Jude Medical, St. Paul, MN), may conform better to the anatomy
of the leak (Fig. 13.2).
designed for percutaneous closure of PVL. The use of oblong devices has been associated with
a trend toward a more complete PVL reduction in the European experience. However, these
devices are not approved by the Food and Drug Administration (FDA) and thus are not available in the United States. We utilize the AVP-II in the majority of closures of parasurgical
prosthetic valve leaks and either the AVP-II or IV for the closure of paratranscatheter prosthetic valve leaks. Amplatzer Vascular Plugs II are available in a wide range of sizes (diameters
3 to 22 mm) and can be delivered via 4 to 7F sheaths or 5 to 9F guiding catheters. Most PVLs
4,5
The Occlutech PLD device is the only device that was specifically
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