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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3590_Библиотеки_им_академика_М_И_Перельмана
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17—MITRAL PARAVALVULAR LEAK CLOSURE 207
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Fig. 17.21 Transapical puncture can be performed in patients with double mechanical valves if extra support
provided by the rail system is required for successful closure. Transapical puncture can be performed with
combination of TTE/TEE and fluoroscopy guidance using a 19-gauge, 20-cm angio-needle over which a
Teflon catheter is advanced into the left ventricle. A 4F sheath can then be advanced over a short 0.0350
short guidewire carefully (see Fig. 17.7). The extra-support angled hydrophilic wire can be externalized and
used as a rail for antegrade delivery of sheaths and plugs through the transseptal approach, as previously
described.
Conclusions
n
Mitral PVL closure is associated with high success rates and low risk of complications if
performed by experienced operators.
n
Preprocedural imaging and detailed procedural planning are essential to execute the proce-
dure successfully and safely.
n
Complete resolution of mitral PVL is important for treatment of hemolytic anemia, and
residual #11 regurgitation is usually acceptable for treating heart failure.
References
1. Hammermeister K, Sethi GK, Henderson WG, Grover FL, Oprian C, Rahimtoola SH. Outcomes 15
years after valve replacement with a mechanical versus a bioprosthetic valve: final report of the Veterans
Affairs randomized trial. J Am Coll Cardiol. 2000;36:1152-1158.
2. Alkhouli M, Rihal CS, Zack CJ, et al. Transcatheter and surgical management of mitral paravalvular leak:
long-term outcomes. JACC Cardiovasc Interv. 2017;10:1946-1956.
3. Calvert PA, Northridge DB, Malik IS, et al. Percutaneous device closure of paravalvular leak: combined
experience from the United Kingdom and Ireland. Circulation. 2016;134:934-944.
4. Ionescu A, Fraser AG, Butchart EG. Prevalence and clinical significance of incidental paraprosthetic valvar
regurgitation: a prospective study using transoesophageal echocardiography. Heart. 2003;89:1316-1321.
5. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients
with valvular heart disease: executive summary: a report of the American College of Cardiology/American
Heart Association Task Force on Practice Guidelines. Circulation. 2014;129:2440-2492.
208 3—MITRAL VALVE INTERVENTIONS
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6. Eleid MF, Cabalka AK, Malouf JF, Sanon S, Hagler DJ, Rihal CS. Techniques and outcomes for the
treatment of paravalvular leak. Circ Cardiovasc Interv. 2015;8:e001945.
7. Spoon DB, Malouf JF, Spoon JN, et al. Mitral paravalvular leak: description and assessment of a novel
anatomical method of localization. JACC Cardiovasc Imaging. 2013;6:1212-1214.
8. Sorajja P, Cabalka AK, Hagler DJ, Rihal CS. Long-term follow-up of percutaneous repair of paravalvular
prosthetic regurgitation. J Am Coll Cardiol. 2011;58:2218-2224.
9. Sorajja P, Cabalka AK, Hagler DJ, Rihal CS. Percutaneous repair of paravalvular prosthetic regurgitation:
acute and 30-day outcomes in 115 patients. Circ Cardiovasc Interv. 2011;4:314-321.
10. Sorajja P, Cabalka AK, Hagler DJ, Rihal CS. The learning curve in percutaneous repair of paravalvular
prosthetic regurgitation: an analysis of 200 cases. JACC Cardiovasc Interv. 2014;7:521-529.
11. Maor E, Raphael CE, Panaich SS, et al. Left atrial pressure and predictors of survival after percutaneous
mitral paravalvular leak closure. Catheter Cardiovasc Interv. 2017;90:861-869.
e1
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Abstract: Paravalvular prosthetic leak (PVL) is a serious condition that can occur in 6% to 15%
of surgical prosthetic valves or annuloplasty rings secondary to degeneration and loss of integrity
of the annular tissue. Moderate-to-severe PVL is associated with increased morbidity and mortality if left untreated. Patients with chronic mitral PVL usually present with clinical heart
failure and/or hemolytic anemia. PVL can be treated with surgical repair or replacement or with
percutaneous closure. This chapter will focus on mitral PVL closure and the different techniques
involved in the procedure.
Keywords: Mitral regurgitation; Paravalvular leak; Mitral prosthesis
CHAPTER 18
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Mitral Valve-in-MAC
Mayra Guerrero* Mackram F. Eleid Charanjit Rihal
Introduction
Patients with symptomatic severe mitral valve disease due to severe mitral annular calcification
(MAC) are often elderly with multiple comorbidities and have a high risk of cardiovascular death.
Their surgical risk for standard mitral valve surgery is high due to comorbidities and technical
challenges secondary to severe calcification.
replacement due to their high surgical risk. Transcatheter mitral valve replacement (TMVR) with
the compassionate use of aortic transcatheter heart valves (THV ) is emerging as an alternative to
surgery. Most of the experience has been with the Edwards family of THVs (Edwards Lifesciences, Irvine, CA). The implantation technique has evolved. The first case reports used an open
transatrial
proach.
(Boston Scientific Corporation, Marlborough, MA)
Santa Rosa, CA),
System (Tendyne Holdings, Roseville, MN, a subsidiary of Abbott, Chicago, IL),
procedures have been done using balloon-expandable aortic THV technology. This chapter will
describe contemporary mitral valve-in-MAC (ViMAC) techniques using the SAPIEN 3 valve.
3
or transapical valve delivery access.4 Subsequent reports used a transseptal delivery ap-
5
Although there have been a few case reports using other aortic THVs, including Lotus
7
or a dedicated transcatheter mitral valve such as the Tendyne Mitral Valve
2
Many patients are not offered standard mitral valve
6
and Direct Flow (Direct Flow Medical, Inc.,
8
most of the
1
Indications
Transcatheter mitral ViMAC is a new technology that is currently performed off-label. Eligible
patients have severe MAC resulting in either severe symptomatic mitral stenosis or regurgitation
and are at prohibitive risk for conventional mitral valve surgery. Anatomic suitability is required
and is described next.
Preprocedural Planning, Sizing, and Other Anatomic
Considerations
Adequate sizing of the mitral annulus is challenging due to its complex oval saddle shape and irregular patterns of calcification. The experience with this procedure remains in the early phase, and
there is no consensus of the best sizing methodology defined at this time. Selecting a valve size
based on diameter or perimeter may not be the best method due to the oval saddle shape. We recommend use of the mitral annular area (Fig. 18.1A) and size the THV as we do for transcatheter
aortic valve replacement (TAVR). Oversizing is important to achieve proper anchoring. The SAPIEN
*Disclosure
**Dr. Guerrero has served as a proctor and consultant and has received research grant support from Edwards
Lifesciences.
209
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AB
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Fig. 18.1 Mitral annulus measurements. (A) Circumferential mitral annular calcification noted on cardiac
computed tomography–based measurements using 3Mensio Structural Heart Mitral Workflow version 8.1
(Pie Medical Imaging, Maastricht, the Netherlands). (B) Noncircumferential MAC with calcium predominantly
involving the posterior annulus and covering less than 270 degrees of the annular circumference.
3 valve was designed to treat calcific aortic stenosis, not mitral valve disease. It does not have an
anchoring mechanism, and therefore adequate oversizing becomes extremely important in ViMAC
to achieve proper anchoring. The percentage of oversizing that is safe to achieve anchoring without
increasing the risk of annular rupture has yet to be fully defined. In general, approximately 15% to
20% oversizing may be adequate, but this is a relative number, as we generally use additional contrast
volume during initial valve deployment to flare the ventricular edge of the THV to decrease the risk
of embolization into the left atrium. This additional contrast volume may result in more oversizing
than initially estimated. In addition to facilitating anchoring, oversizing aids in decreasing the
amount of paravalvular leak (PVL). Because the SAPIEN 3 valve is round, there is a risk of residual
perivalvular gaps that may result in significant PVL when implanted in the mitral position, which
has an oval shape. PVL risk may be lower with the use of dedicated transcatheter mitral valves that
are designed with a D-shape to respect the geometry of the mitral annulus.
Another factor that plays an important role in anchoring is the pattern of calcification. The
amount, distribution, and type of calcification (i.e., caseating calcification vs. noncaseating) play a
role in providing support to anchor a SAPIEN 3 valve. A larger amount and distribution of calcium
help provide more anchoring capacity. A nearly circumferential calcification would most likely result
in adequate anchoring, provided that the THV size chosen is correct and the ventricular edge of the
stent is flared in transseptal cases, or anchoring sutures are placed in transatrial cases. Less than 270
degrees of calcified circumference or calcium limited to the posterior aspect of the annulus, which
is frequently the case, may not provide adequate anchoring (see Fig. 18.1). However, the exact
percentage of circumferential involvement required for procedural success is not well understood. In
addition, other factors may help facilitate anchoring in the absence of complete circumferential
calcium, such as trigone calcification or the presence of a prosthetic valve in the aortic position,
which may provide additional anterior support for anchoring. A CT-based MAC score has been
created to help categorize MAC severity and predict valve embolization. A MAC score of 7 or
greater is associated with lower embolization risk than MAC score of 6 or less.
20
Other anatomic features to consider in the preprocedural planning include the subvalvular apparatus and surrounding structures, in particular the left ventricular outflow tract (LVOT), which can
be affected by interactions with the SAPIEN 3 valve in the mitral position. Permanent anterior
displacement of the anterior mitral leaflet toward the LVOT space occurs after ViMAC. If the
LVOT space is not large enough, this interaction may result in severe LVOT obstruction, which can
be fatal. Patients with severe MAC often have concomitant calcific aortic stenosis or history of a prior
aortic valve replacement.
9–11
The importance of concomitant or prior aortic stenosis is that those
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patients often have left ventricular hypertrophy with associated small left ventricular cavity size,
which is in turn associated with a small LVOT that puts them at higher risk of LVOT obstruction.
Role of Cardiac Computed Tomography
Detailed analysis of the patient’s mitral valve anatomy using multi-imaging modality is key for
technical success. Transthoracic and transesophageal echocardiography (TEE) are useful tools
to evaluate the severity of mitral valve disease, the function of cardiac structures, and to rule
out the presence of thrombus. Cardiac computed tomography (CT) has become an essential
tool for mitral annular sizing, assessment of LVOT obstruction risk, access route, and overall
procedural planning. Acquisition protocols are similar to TAVR protocols, with some varia-
12
tions.
It is important to include all cardiac phases to allow measurement of the annular area
in diastole, when is usually larger, and assess the risk of LVOT obstruction in systole, when it
is usually worse. Cardiac CT is also helpful to determine the landing zone of the THV stent
frame in the left ventricle. During transseptal cases, it is useful to identify a radiopaque structure in the ventricle at the desired location of the ventricular edge of the stent frame. During
valve deployment, the stent frame will foreshorten from the left atrium, and the radio-opaque
marker in the balloon moves. Because the ventricular edge of the stent frame does not move
during deployment, it is helpful to identify the landing zone in the left ventricle before the
procedure when possible (Fig. 18.2). This is not needed during open transatrial access. Once
the THV size and the landing zone are identified, the neo-LVOT area is determined through
placing a virtual valve in that position (Fig. 18.3). Detailed techniques to measure the neoLVOT area on cardiac CT have been published.
Cardiac CT analysis also aids in planning the access route, particularly to determine the best
transseptal or transapical access location (Fig. 18.4) and to determine the valve deployment angle
before the procedure (see Fig. 18.2).
13,14
Delivery Access Types
The transseptal route is the least invasive option and our preferred method when anatomy is favorable. However, not all patients are good candidates due to anatomy that puts them at high risk
of embolization, LVOT obstruction, or both. In these situations, the open transatrial delivery can
AB
Fig. 18.2 Landing zone. Fluoroscopy simulation of valve deployment angle using 3Mensio Structural Heart
Mitral Workflow version 8.1. (A) A virtual transcatheter heart valves (THV) is placed in the desired position. A radiopaque marker is identified at the ventricular edge of the stent frame to be used as a landing zone during valve
deployment (blue arrow). (B) The virtual valve is removed to simulate the expected fluoroscopy image before
deployment. The blue arrow indicates the landing zone where the ventricular edge of the THV should be placed.
212 3—MITRAL VALVE INTERVENTIONS
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AB
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Fig. 18.3 LVOT assessment. (A) Measurement of the left ventricular outflow tract (LVOT) area in short-axis
(white circle) view using 3Mensio Structural Heart Mitral Workflow version 8.1. (B) Measurement of the remaining LVOT area in short-axis view after placement of a virtual transcatheter heart valve (pink). The remaining
space in the LVOT is the neo-LVOT (white).
C
Fig. 18.4 Transseptal and transapical location planning. Fluoroscopy simulation view of transseptal and
transapical access location using 3Mensio Structural Heart Mitral Workflow version 8.1. (A) Anteroposterior
projection view of transseptal puncture location. (B) Transseptal puncture location seen from valve deployment angle. (C) Transapical access trajectory in anteroposterior projection of fluoroscopy view. (D) Transapical
access location and trajectory seen in anteroposterior projection of “heart and bone” view.
D
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be used to overcome those challenges. The transapical route is more invasive than the transseptal,
but may be an option in selected patients if the operators are not familiar with transseptal
techniques or when transseptal access cannot be obtained due to unfavorable anatomy.
Transatrial ViMAC Technique
The open transatrial TMVR technique is the most invasive. However, it may be the best option
in patients with lack of circumferential calcium because it allows the operators to place anchoring
sutures to decrease embolization risk. It may also be a better option for patients with high risk of
LVOT obstruction who are not candidates for alcohol ablation or percutaneous laceration of the
anterior mitral leaflet, as the open delivery approach allows surgical resection of the anterior
mitral leaflet to decrease LVOT obstruction risk. However, not all patients are good candidates
for this invasive approach. Although there were challenges in the early experience,
have improved with better patient selection and modification of the technique.
reported the contemporary transatrial technique step by step.
will be the fully percutaneous transseptal technique.
15
Therefore the focus of this chapter
11
outcomes
15
We recently
Transapical Technique
The transapical access and closure technique is similar to the technique used for TAVR.
Transapical access is obtained with an 18-gauge needle, a J wire, and a 7F sheath placed in the
left ventricle. A Brite Tip sheath facilitates visualization of the sheath tip. Crossing the mitral
valve in a retrograde fashion is more challenging, particularly when the pathology treated is mitral
stenosis. Once the valve is crossed with a J wire, the trajectory can be flossed with a balloon
catheter over the wire to ensure the wire is not through chordae. Then the wire is exchanged for
a supportive wire such as Amplatz extra-stiff wire (Cook Medical, LLC, Bloomington, IN)
placed in a pulmonary vein, with careful attention to avoid pulmonary vein perforation, or the use
of a preshaped wire in the left atrium such as Safari2 guidewire (Boston Scientific, Marlborough,
MA) or Confida Brecker guidewire (Medtronic, Inc., Minneapolis, MN). The sheath is then
upsized to the Edwards sheath over the supportive wire. The valve deployment technique is
similar to the one used in transseptal delivery described next.
Transseptal ViMAC Technique
The procedure is performed under general anesthesia with TEE guidance in a hybrid cath lab/
operating room suite. Absence of left atrial appendage thrombus should be confirmed with
intraprocedural TEE at the start of the case. A 35-cm-long, 6F Brite Tip sheath is placed in
the abdominal aorta via the left femoral artery. A long sheath is used to allow simultaneous left
ventricular and aortic pressure monitoring during the procedure through a 5F pigtail catheter
in the left ventricle and the side arm of the 6F long sheath in the descending aorta. A 35-cm-long,
7F Brite Tip sheath is placed in the inferior vena cava via the left femoral vein. A long venous
sheath facilitates pacemaker placement and manipulation, as sometimes this may be challenging
with a large-caliber THV delivery sheath in the inferior vena cava.
Right femoral venous access is obtained with a 6F or 7F sheath, and the site is preclosed with
one Proglide closure device (Abbott Vascular, Abbott Park, IL) and a 7F or 8F sheath is placed.
The baseline LVOT gradient is documented by measuring simultaneous left ventricular pressure
and aortic pressure. If desired, baseline left ventriculography may be performed, but this is not
always needed. Left ventriculography is particularly helpful to visualize the mitral valve annulus
and landing zone of the SAPIEN 3 valve when it is not obvious under plain fluoroscopy, but is
not always needed. A 5F transvenous pacemaker is placed in the right ventricle via the left
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femoral vein. The sheath in the right femoral vein is upsized to a 16F Edwards eSheath. Because
the sheath is the venous system and the risk of bleeding may be the same with a 14F or 16F
sheath in the vein, it is easier to use the same 16F sheath for all valve sizes to facilitate valve
delivery manipulation. Transseptal puncture is performed with a 7F or 8F Mullins transseptal and
BRK or BRK-1 extra-sharp needle (St. Jude Medical, St. Paul, MN) under TEE and fluoroscopic
guidance at the predetermined location by cardiac CT (see Fig. 18.4). We favor a transseptal
puncture in the inferoposterior portion of the fossa ovalis, similar to transseptal access for left
atrial appendage closure procedures. In the initial experience, we have performed TMVR with a
superior and posterior location of septostomy, similar to the transseptal puncture for MitraClip
procedures. However, it is usually more difficult to navigate across the septum and deliver the
SAPIEN 3 valve with superior punctures. If the operators have experience in transseptal access,
low-dose heparin (3000 units) may be given after venous and arterial access before transseptal
puncture to decrease the risk of thrombus formation in sheaths or on the transseptal needle. Fulldose heparin is given as soon as transseptal puncture is performed.
A 230-cm, 0.0250 Toray wire (Toray Industries, Inc., Tokyo, Japan) is then introduced in the
left atrium, the Mullens sheath is removed, a 14F Toray dilator may be used to dilate the interatrial septum, and a deflectable sheath is introduced such as the 8.5F Agilis steerable introducer
(St. Jude Medical, St. Paul, MN) or the 9.5F Dexterity deflectable sheath (Spirus Medical, LLC,
Bridgewater, MA). Simultaneous left atrial and left ventricular pressures may be recorded
through the Agilis sheath and the 5F pigtail catheter. The Agilis catheter is flexed to point toward
the mitral valve under fluoroscopic and TEE guidance, and the mitral valve is crossed in the
deployment fluoroscopy angle using a 6F pigtail catheter and a J guidewire (Fig. 18.5A). The J
wire is left inside the pigtail to provide support, but it is not used to cross the valve with wire
alone. The intention is to avoid wire entanglement through chordae—such risk is lower when
crossing the valve with the pigtail catheter itself. Once the pigtail is in the left ventricle, a 0.0350
small or extra-small Safari wire or Confida wire is introduced and positioned in the left ventricular apex (see Fig. 18.5B). Slow movements advancing and manipulating this wire may be needed,
as it often tends to displace the pigtail catheter and Agilis sheath to the left atrium. The pigtail
catheter is removed and a 10-mm or 12-mm balloon that is 4 cm long and has a 110- to 135-cm
AB
Fig. 18.5 Crossing the mitral valve. (A) An 8.5F Agilis sheath is in the left atrium and a pigtail catheter was
used to cross the mitral valve plane. (B) A 0.0350 preshaped small Safari wire was placed at the apex through
the pigtail catheter.
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shaft is introduced to perform a septostomy (Fig. 18.6). A 10-mm balloon is generally used for
the 23- and 26-mm SAPIEN 3 valves and a 12-mm balloon for the 29-mm valve when the
septum has not been instrumented during a prior surgery. In patients with prior cardiac surgery
where the septum was opened and closed, or in patients with thick or calcified septum, a 12-mm
balloon may be needed for the 23- and 26-mm valves and a 14-mm balloon for the 29-mm valve.
The balloon is introduced to the tip of the Agilis sheath in the left atrium, and then the Agilis is
retracted to expose the balloon and facilitate the positioning across the septum. Operators may
encounter difficulty advancing the septostomy balloon across the septum if this is attempted after
the Agilis sheath is pulled back. Operators should consider the length of the Agilis sheath when
selecting the shaft length of the septostomy balloon. Longer balloon shafts will be required (usually 110, 120, or 135 cm). It is important to adequately prepare the septum to avoid challenges
crossing with the valve delivery system—30-second inflations may be better than short inflations.
After the septostomy is completed, the partially inflated balloon is advanced across the mitral
valve to “floss”—to test the trajectory and confirm freedom from chordae in the subvalvular apparatus. The balloon is removed, and the SAPIEN 3 valve is introduced. The SAPIEN 3 valve must
be mounted with the sealing skirt toward the left atrium and the open cells toward the left ventricle,
in the opposite direction compared with transfemoral TAVR and similar to transapical TAVR procedures (Fig. 18.7). We prepare the valves with additional contrast to flare the ventricular edge of
Fig. 18.6 Atrial septostomy. Balloon atrial septostomy is illustrated (yellow arrow).
Fig. 18.7 Preparation of the SAPIEN 3 valve. The SAPIEN 3 valve is mounted with the sealing skirt (yellow
arrow) toward the left atrium and the open cells toward the left ventricle.
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