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188 3—MITRAL VALVE INTERVENTIONS
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while warfarin is recommenced and should be continued on aspirin therapy indefinitely. If a
patient has indications for Plavix over aspirin, this can be substituted. At this time, warfarin
therapy is recommended indefinitely with an international normalization ratio (INR) goal of 2
to 3, though there remains no consensus on this issue in the literature.
In the absence of complications, patients can often be discharged on day 2 with close follow-
up as an outpatient. TTE is repeated at 1 to 3 months postprocedure and then often yearly, as
the expected long-term durability remains unknown.
Clinical Outcomes
Current data using SAPIEN valves rely on single-center series as well as registry data in patients
with prohibitively high surgical risk. Although the apical approach is still the most widely utilized, the gap is narrowing, with most recent estimates that 25% to 33% of procedures are now
done via the transseptal route.
10
The transseptal approach is more technically challenging, yet is
less invasive and is associated with improved left ventricular ejection fraction, cardiac output, and
3-year survival.
16,17
The largest single-center series reported a 97% success rate, with 30-day
mortality of 5%. Patients undergoing valve-in-ring had an increased rate of LVOT obstruction
(20% compared with 5%) and higher need for repeat procedure due to migration or instability.
15
Summary and Take-Home Points
n
Percutaneous mitral valve-in-valve is a low-risk and effective treatment for patients with
severe bioprosthetic mitral regurgitation or stenosis.
n
Mitral valve-in-ring is also an effective treatment option for selected patients with suitable
anatomy, but is associated with lower success rates and increased procedural risk.
n
Careful procedural planning with the use of multimodality imaging and technical skill in
transseptal structural heart interventions is required for optimal outcomes.
References
1. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular
heart diseases: A population-based study. Lancet. 2006;368:1005-1011.
2. Nishimura RA, Otto CM, Bonow RO, et al. 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 Practice Guidelines. J Thorac Cardiovasc Surg. 2014;148:e1-e132.
3. Ruel M, Chan V, Bédard P, et al. Very long-term survival implications of heart valve replacement with
tissue versus mechanical prostheses in adults ,60 years of age. Circulation. 2007;116:I-294–I-300.
4. Balsam LB, Grossi EA, Greenhouse DG, et al. Reoperative valve surgery in the elderly: Predictors of risk
and long-term survival. Ann Thorac Surg. 2010;90:1195-1201.
5. Maganti M, Rao V, Armstrong S, Feindel CM, Scully HE, David TE. Redo valvular surgery in elderly
patients. Ann Thorac Surg. 2009;87:521-525.
6. Eleid MF, Cabalka AK, Williams MR, et al. Percutaneous transvenous transseptal transcatheter valve
implantation in failed bioprosthetic mitral valves, ring annuloplasty, and severe mitral annular calcification.
JACC. 2016;9:1161-1174.
7. Cheung A, Webb JG, Barbanti M, et al. 5-year experience with transcatheter transapical mitral valve-in-
valve implantation for bioprosthetic valve dysfunction. JACC. 2013;61:1759-1766.
8. Bouleti C, Fassa A-A, Himbert D, et al. transfemoral implantation of transcatheter heart valves after
deterioration of mitral bioprosthesis or previous ring annuloplasty. JACC. 2015;8:83-91.
9. Dvir D, Webb JG. Mitral valve-in-valve and valve-in-ring: Technical aspects and procedural outcomes.
EuroIntervention. 2016;12:Y93-Y96.
16—PERCUTANEOUS MITRAL VALVE-IN-VALVE AND VALVE-IN-RING 189
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10. Yoon S-H, Whisenant BK, Bleiziffer S, et al. Transcatheter mitral valve replacement for degenerated
bioprosthetic valves and failed annuloplasty rings. JACC. 2017;70:1121-1131.
11. Bapat V. Valve-in-valve apps: Why and how they were developed and how to use them. EuroIntervention.
2014;10(Suppl U):U44-U51.
12. Wang DD, Eng MH, Greenbaum AB, et al. Validating a prediction modeling tool for left ventricular
outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR). Catheter
Cardiovasc Interv. 2018;92(2):379-387.
13. Babaliaros VC, Greenbaum AB, Khan JM, et al. Intentional percutaneous laceration of the anterior
mitral leaflet to prevent outflow obstruction during transcatheter mitral valve replacement: First-inhuman experience. JACC. 2017;10:798-809.
14. Guerrero M, Wang DD, O’Neill W. Percutaneous alcohol septal ablation to acutely reduce left ventricular outflow tract obstruction induced by transcatheter mitral valve replacement. Catheter Cardiovasc
Interv. 2016;88(6):E191-E197.
15. Eleid MF, Whisenant BK, Cabalka AK, et al. Early outcomes of percutaneous transvenous transseptal
transcatheter valve implantation in failed bioprosthetic mitral valves, ring annuloplasty, and severe mitral
annular calcification. JACC. 2017;10:1932-1942.
16. Frerker C, Schmidt T, Schluter M, et al. Transcatheter implantation of aortic valve prostheses into degenerated mitral valve bioprostheses and failed annuloplasty rings: Outcomes according to access route and
Mitral Valve Academic Research Consortium (MVARC) criteria. EuroIntervention. 2016;12:1520-1526.
17. Dvir D. Transseptal instead of transapical valve implantation: Making mitral great again? JACC.
2016;9:1175-1177.
Further Suggested Reading
1. Eleid MF, Foley TA, Said SM, Pislaru SV, Rihal CS. Severe mitral annular calcification: multimodality
imaging for therapeutic strategies and interventions. JACC. 2016;9:1318-1337.
2. Nishimura RA, Vahanian A, Eleid MF, Mack MJ. Mitral valve disease—current management and future
challenges. Lancet. 2016;387:1324-1334.
3. Zoghbi WA, Chambers JB, Dumesnil JG, et al. Recommendations for evaluation of prosthetic valves with
echocardiography and doppler ultrasound: A report from the American Society of Echocardiography’s
Guidelines and Standards Committee and the Task Force on Prosthetic Valves, developed in conjunction
with the American College of Cardiology Cardiovascular Imaging Committee, Cardiac Imaging Committee
of the American Heart Association, the European Association of Echocardiography, a registered branch of
the European Society of Cardiology, the Japanese Society of Echocardiography and the Canadian
Society of Echocardiography, endorsed by the American College of Cardiology Foundation, American
Heart Association, European Association of Echocardiography, a registered branch of the European Society
of Cardiology, the Japanese Society of Echocardiography, and Canadian Society of Echocardiography. J Am
Soc Echocardiogr. 2009;22:975-1014.
e1
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Abstract: Mitral valve disease is the most prevalent cardiac valvular disorder, with many patients requiring repeat procedures for failing prosthetic valves or severe dysfunction after the
surgical annuloplasty ring. Traditional surgical approaches are associated with increased morbidity and mortality in this aging and increasingly frail population. Recent advances in percutaneous techniques have allowed for minimally invasive valve-in-valve and valve-in-ring
procedures to avoid major cardiac surgery with repeat sternotomy. In this chapter we discuss
the advances and current role of these percutaneous procedures and review the current literature regarding clinical outcomes. This chapter also highlights the importance of multimodality
imaging in procedural planning, describes techniques for transcatheter valve implantation, and
discusses the technical aspects of these procedures. There are many similarities between the
valve-in-valve and valve-in-ring procedures; however, some important differences exist, and
these will be reviewed.
Keywords: Mitral valve-in-valve, mitral valve-in-ring, prosthetic valve failure, mitral regurgitation,
mitral stenosis.
CHAPTER 17
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Mitral Paravalvular Leak Closure
Mohammed Al-Hijji Mackram F. Eleid
Introduction
Paravalvular prosthetic leak (PVL) occurs in 6% to 15% of surgical prosthetic valves or annuloplasty rings
secondary to degeneration and loss of integrity of the annular tissue.
ated with increased morbidity and mortality if left untreated.
prostheses and use of continuous sutures or sutures without pledgets.
usually present with clinical heart failure related to increased volume in the noncompliant left atrium
(LA) and left ventricle (LV) over time. Right-sided heart failure can develop due to an increase in pulmonary artery pressure. Hemolytic anemia is also frequently seen in mitral PVL due to turbulent flow
and increased shear stress on the red blood cells leading to fragmentation as they cross the paravalvular
defects. Patients with coexisting iron- or folate-deficiency anemia are more prone to hemolysis due to red
blood cell fragility and more turbulent flow through the defect in the setting of high cardiac output.
Indications for Paravalvular Leak Closure
AHA Recommendations
1
Moderate-to-severe PVL is associ-
2,3
PVL is more common with mitral
1,4
Patients with chronic mitral PVL
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
American College of Cardiology/American Heart Association (ACC/AHA) valve guidelines call for percutaneous PVL closure in patients with intractable hemolysis and severe heart
failure symptoms who are at high risk for surgical intervention, if they have suitable anatomy
for a catheter-based approach.
undergone a previous sternotomy and usually have a moderate to high risk for surgical intervention;
therefore the vast majority of these patients are offered percutaneous repair at our institution if their
anatomy is suitable before consideration of redo surgery (Fig. 17.1).
Contraindications for Paravalvular Leak Closure
Important contraindications include (1) active endocarditis, (2) intracardiac thrombus or vegetation,
(3) a defect involving more than one-third of annular tissue, and (4) a rocking/unstable prosthesis.
PVL closure can be performed in patients with a history of endocarditis who have negative
confirmatory blood cultures after completion of an intravenous antibiotic course. Similarly, patients
with a history of intracardiac thrombus can be treated with anticoagulation, and percutaneous PVL
closure can be attempted after ensuring full resolution of the thrombus by cardiac imaging.
190
5
Patients with clinically significant mitral PVL have already
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Mitral PVL
Hemodynamically significant mitral
PVL by echocardiography*
Medical
management
Fig. 17.1 Algorithm for screening and treatment of patients with mitral paravalvular leak (PVL). Defining hemo-
dynamically significant mitral PVL by echocardiography is hard due to the small orifice of defects, presence of
multiple eccentric jets, and presence of shadow artifact from prosthesis interfering with Doppler measure-
ments. Transesophageal echocardiogram (TEE) is usually required to define the location and degree of mitral
PVL. Potential parameters of significant mitral PVL include (1) left ventricular enlargement; (2) increased mitral
valve inflow (peak velocity 1.9 m/s or mitral velocity time integral/left ventricular outflow velocity time integral
ratio 2.5 m/s); (3) flow convergence in the left ventricle; and (4) pulmonary vein flow reversal.
Intractable
hemolysis?
Surgical repair
NoNo NoYe s
Contraindications
to PVL closure?
Ye s
Heart failure
and/or hemolysis?
Ye sYe s
No
Suitable anatomy?
Ye sNo
PVL closure Surgical repair
Medical
management
Preprocedural Planning
Transthoracic echocardiogram (TTE) is usually inadequate for assessment of mitral PVL due to
the presence of a shadowing artifact from the prosthesis that interferes with localizing the
defect(s) and assessing Doppler flow across it. Transesophageal echocardiography (TEE) is es-
sential for preprocedural planning, as it provides in-depth information about the atrial septum
and helps rule out intracardiac thrombus or vegetations. Using TEE, the mitral annulus can be
divided into eight sectors (Fig. 17.2) to enhance communication between the echocardiographer
and operator.
provide the location of the defect and assess the degree of PVL. Three-dimensional TEE can
further delineate the accurate location, size, shape, and circumferential extent of the defect, as
well as identify the number of defects present.
Cardiac computed tomography (CT) angiography imaging can also help determine the
location, size, and extent of PVL but is typically not necessary for mitral PVL, given the excellent visualization provided by TEE (in contrast to aortic PVL, where CT can provide important incremental data to TEE). CT can also help predefine the best working fluoroscopic angles
during the procedure. Careful discussion between the imaging cardiologist, radiologist, and
6,7
Comprehensive evaluation of the prosthesis annulus with 2D TEE can help
192 3—MITRAL VALVE INTERVENTIONS
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C
Fig. 17.2 Transesophageal echocardiogram (TEE) is an essential imaging modality for preprocedural planning. (A) 2D TEE image of the mitral valve bioprosthesis reveals posterolateral gap (red arrow) between the
prosthesis and atrioventricular junction. (B) 2D TEE with color Doppler confirms the presence of a significant
paravalvular leak (PVL). (C) 3D TEE image further defines the crescent shape and the extent of the defect (red
arrows) from posteromedial to the posterolateral sectors. The mitral valve plane can be divided into eight
sectors to help localize the defect and improve communication between the interventional and imaging cardiologist. (D) 3D TEE with color Doppler further assists to define the extent and degree of PVL. AV, Aortic
valve; LAA, left atrial appendage.
D
interventional cardiologist is essential in preprocedural planning to help understand the anatomy and aid in deciding the best approach and equipment needed for PVL closure.
The Procedure
Mitral PVL closure is a complex procedure that requires multiple skills for successful execution,
including transseptal access, catheter navigation in the LA, plug delivery and deployment, and
wire snaring for creation of a wire rail. LV puncture may be necessary to create a rail system in
cases with double mechanical prostheses. Table 17.1 includes some of the common equipment
utilized for mitral PVL closure.
It is important to note that no specific devices are approved by the Food and Drug Adminis-
tration (FDA) for PVL closure. The devices preferred for this procedure are the Amplatzer
Vascular Plugs (AVP) (St. Jude Medical; St. Paul, MN) made of low-profile fine nitinol mesh,
allowing easy deliverability through guiding catheters and sheaths. The AVP II and AVP IV are
available in the United States, and the AVP III is available in Europe.
Mitral PVL closure is usually performed under general anesthesia for patient safety and
comfort due to the length of the procedure and the need for intraprocedure TEE guidance.
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TABLE 17.1 n Common Equipment Used for Mitral PVL Closure
Step Common Equipment
Imaging 2D to 3D transesophageal echocardiography
Access 14F to 20F venous sheath
Transseptal Access 7F to 8F Mullin or SL1 dilators and sheaths
Steerable Telescoping
System
Double-Wire Technique Multiple 0.0320 to 0.0350 extra-stiff, exchange length Amplatz guidewire
Anchor Wire Technique 0.0320 to 0.0350 extra-stiff, long exchange Amplatz guidewire
Rail System Two access sites
Plugs AVP II plugs (4-16 mm)
AV, Arteriovenous; AVP II, Amplatz Vascular Plug II; AVP IV, Amplatz Vascular Plug IV; LV , left ventricle.
Biplane fluoroscopy
6F femoral artery sheath (AV rail or retrograde approach)
LV puncture needle and 4F to 6F sheath (transapical rail or retrograde approach)
Proglide preclose system or figure-of-8 stich
Brockenbrough needle
Inoue dilator and wire
SafeSept or electrocautery in difficult anatomy
8.5 Agilis steerable sheath
6F to 7F 100-cm coronary guides
5F 125-cm multipurpose catheter
Exchange-length, extra-support 0.0350 hydrophilic angled Glidewire
Flexor Shuttle Sheath
Flexor Shuttle Sheath
Exchange-length, extra-support 0.0350 hydrophilic angled Glidewire
Two Hemostats
6F Ensnare catheter
AVP IV plugs (4-8 mm)
Biplane fluoroscopy is highly useful tool to facilitate 3D navigation along the mitral prosthesis annulus. The fluoroscopic views are set up at right anterior oblique and left anterior
oblique-caudal angulation to provide simultaneous on side and en face views of the mitral
prosthesis, respectively (Fig. 17.3). To minimize radiation exposure, low-resolution biplane
fluoroscopy at 7.5 frames/second is recommended. The average procedure duration is 2 to
3 hours.
Mitral PVL closure can be performed using multiple methods: (1) antegrade transseptal
approach, (2) retrograde transaortic approach, and (3) retrograde transapical approach. The
antegrade transseptal approach is the most commonly used technique.
Antegrade Transseptal Approach
Most cases of mitral PVL require ultrasound-guided 14F sheath femoral venous access to provide
room to alternate between different techniques during the procedure. The access site is usually
managed with the preclose technique described in Chapter 2 or with a figure-of-8 stich using an
Ethibond Excel polyester suture.
Transseptal access can be performed under fluoroscopy and TEE guidance. Full heparinization is recommended as soon as transseptal access is achieved, with target activated clotting time
(ACT) .300 seconds to reduce the risk of thrombus formation. Presence of a septal patch or
scarred/fibrotic septal tissue is not uncommon in this patient population; therefore the use of a
SafeSept transseptal guidewire (Pressure Products Medical Supplies Inc., San Pedro, CA) or
electrocautery system might be helpful to increase safety during transseptal puncture. Balloon
194 3—MITRAL VALVE INTERVENTIONS
Anterior Anterior
Lateral
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Medial
Posterior
Posterior
DC
Fig. 17.3 Combining biplane fluoroscopy and intraprocedural transesophageal echocardiogram (TEE) helps
facilitate navigation of the delivery catheter to cross the mitral PVL defect. (A) Fluoroscopic still image with
right anterior oblique angulation helps define the anterior and posterior axis of the mitral valve plane. In this
case, an antegrade transseptal approach was used to cross an anterior defect with a 0.0350 exchangelength, extra-support angled Glidewire (white arrow) and coaxial telescoping system with a 125-cm, 5F
multipurpose diagnostic catheter (blue arrow) and 100-cm, 6Fr multipurpose guide (red arrow) inserted inside
the 8.5F Agilis steerable sheath. (B) Fluoroscopic still image with left anterior oblique and caudal angulation
demonstrates the quadrants of the mitral prosthesis plane. Here, we can see the anterior location of the
defect with the Glidewire and delivery catheter across it. (C) Intraprocedural 3D TEE helps guide the interventional cardiologist to navigate the transseptal steerable sheath (blue arrow) close to the anterior defect. It also
helps to visualize the wire and delivery catheter crossing the defect before deploying the plug through it (red
arrow). (D) Right anterior oblique fluoroscopic still image demonstrates deployment of a 12-mm AVP II (red
arrow) plug across the defect. The device is still attached to its cable to ensure stable position and no inter-
ference with the mechanical leaflet before final release of the plug.
dilatation of the atrial septum over a stiff coronary wire is also occasionally required to facilitate
transseptal puncture.
Once transseptal puncture is achieved, access to the LA is secured with an Inoue wire (Toray
Group, USA) or 0.0350 Amplatz exchange-length extra-stiff guidewire (Cook Medical; Bloomington, IN) parked in one of the pulmonary veins. After the septum is dilated with an Inoue
dilator, a steerable and flexible sheath such as the 8.5F Agilis Steerable NxT Introducer (St. Jude
Medical, St. Paul, MN) is advanced in the LA. Through the steerable introducer, a coaxial telescoping system consisting of 100-cm 6F to 7F multipurpose or JR4 coronary guide and 125-cm
5F multipurpose diagnostic catheter is advanced into the LA. Larger French-size guiding catheters provide more room to deliver the larger AVP plugs needed for larger defects, but might
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TABLE 17.2 n Compatibility of Catheter, Wire, and Device Combinations
Catheter-Only Technique
AVP II 6-8 mm AVP II 10-12 mm AVP II 6-8 mm AVP II 10-12 mm
6F Coronary Guide Yes Ye s No No
7F Coronary Guide Yes Ye s Ye s No
8F Coronary Guide Yes Ye s Ye s Ye s
4F Shuttle Sheath Yes No No No
5F Shuttle Sheath Yes Ye s Yes No
6F Shuttle Sheath Yes Ye s Yes Yes
7F Shuttle Sheath Yes Ye s Yes Yes
8F Shuttle Sheath Yes Ye s Yes Yes
AVP II, Amplatz Vascular Plug II.
Yes/No: AVP II does/does not fit into catheter.
Modified from 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.
Anchor Technique With 0.0320
or 0.0350 Wire
increase the difficulty in crossing smaller defects (Table 17.2). The system can be navigated and
steered in 3D space to position the catheter tip in close proximity to the defect. Through the
telescoping system, an exchange-length extra-support angled hydrophilic 0.0350 wire (Glidewire,
Terumo Medical Corp., Somerset, NJ) is advanced and torqued to probe the defect until passage,
with confirmation by 3D TEE and biplane fluoroscopy. Once the wire is positioned in a safe place
(usually in the ascending aorta in the absence of a mechanical aortic prosthesis), the 5F diagnostic catheter and then the guide are advanced into the LV across the defect. The most commonly
used AVP II devices are #12 mm and can be advanced in a 6F coronary guide system without
difficulty. If larger devices or multiple devices are required in a nested fashion, the telescoping
system can be exchanged for a shuttle sheath (Cook Medical, Bloomington, IN) over 0.0320 or
0.0350 Amplatz exchange-length extra-stiff guidewire looped in the LV (see the anchor wire
technique section later). If crossing the defect with catheters is not possible due to a defect in
anatomy or lack of support, additional techniques such as the use of an arteriovenous rail may be
necessary after obtaining arterial access and snaring the exchange-length hydrophilic Glidewire.
The defect can be studied further with 3D TEE once the catheter is across the defect in the
LV. Mitral PVL defects usually have a crescent shape and require more than one AVP to be deployed to fully seal the defect. Cylindrical defects can be usually closed with one AVP device. For
very large defects, multiple AVP devices are usually deployed to seal the defect in a nested fashion.
AVP II placement can be performed by extruding the distal third of the plug in the LV while
carefully moving the entire system (catheter 1 plug) backward toward the annulus. Once the
distal portion of the plug is snug against the annulus, the rest of device is extruded slowly as the
delivery sheath is withdrawn into the LA. While the device is in position, careful evaluation for
mitral valve prosthetic leaflet impingement with fluoroscopy and 3D TEE should be performed.
If there are signs of leaflet impingement, the entire assembly should be readvanced into the LV
and a smaller device deployed, or the same device can be positioned in a more atrial position, with
reassessment of the mechanical leaflet before releasing the device. Further evaluation with
3D TEE will determine the need for additional plugs if significant reduction of the PVL is
not achieved. The device can be released from its cable if felt to be stable and snug in the mitral
annular plane and no leaflet impingement observed.
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TECHNIQUES FOR MULTIPLE DEVICE DEPLOYMENT
IN ONE DEFECT
Simultaneous Deployment (Double Wire)
In patients with very large defects in which more than one AVP device is needed, a double-wire
technique can be used. In this technique, a larger-access, ≈
20F venous sheath is needed. Once the
defect is crossed with the telescoping system, two to three 0.0320 Amplatz long-exchange extra-stiff
guidewires can be advanced and looped in the LV. Two to three separate telescoping systems of 6F
guides and 5F multipurpose catheter can be advanced, each over a separate Amplatz wire, into the
LV. After removal of the multipurpose catheter, multiple AVP II #12 mm can be positioned in the
defect and deployed, as previously described (Fig. 17.4).
Sequential Deployment (Anchor Wire)
The anchor wire technique is most commonly used for defects that require more than one plug
but are not large enough to accommodate multiple catheters over double wires. After crossing the
C
Fig. 17.4 Simultaneous double-wire deployment technique in a patient with double mechanical valves.
(A) Crossing the defect was performed with the antegrade transseptal approach with extra-support, exchange-length 0.0350 Glidewire and coaxial telescoping system through which a 100-cm, 6F guide (blue
arrow) is inserted into the left ventricle. Through the guide two 0.0350 exchange-length, extra-stiff Amplatz
wires (red arrow) are advanced and looped into the left ventricle. (B) Two separate coaxial telescoping
systems, each consisting of a 125-cm, 5Fr multipurpose diagnostic catheter and a 100-cm, 6F multipurpose
guide, were loaded on each Amplatz wire separately and advanced through the steerable sheath to cross
the paravalvular leak (PVL) defect. (C) Still-frame fluoroscopic image demonstrates simultaneous extrusion
by pulling the delivery catheter back to the left atrium and deployment of two 12-mm AVP II (blue arrows).
(D) Still-frame left anterior oblique angulation fluoroscopic image reveals two 12-mm AVP II plugs (blue arrow)
occupying the medial PVL defect after their release.
D
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