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15—PERCUTANEOUS EDGE-TO-EDGE MITRAL VALVE REPAIR USING THE MITRACLIP® 169
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BA
Fig. 15.9 (A) Transesophageal view of the Amplatzer plug lateral to the MitraClip®. (B) Fluoroscopic view of
the Amplatzer plug lateral to the MitraClip®.
in the gripper material in the MitraClip® NT system from Elgiloy to nitinol, allowing the grippers to drop to the level of the clip arms at 120 degrees, which allows for superior and secure
leaflet grasp (see Fig. 15.3). This was further improved in the XTR version, with longer clip
arms, and the NTR version, with better device maneuverability. Further improvements remain
desirable in this device, including simplified control knobs, individual control of the two arms,
and even different-sized clips that can be individualized according to patient morphology (longer
flail gaps, etc.).
PROCEDURAL COMPLICATIONS
MitraClip® is a transvenous procedure with relatively lower procedural risks compared with arterial procedures such as transcatheter aortic valve replacement. As such, procedure-related major
bleeding (requiring transfusion) was reported to be 13.4% in the EVEREST high-risk registries
Fig. 15.10 Transjugular approach for MitraClip®.
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and in only 3.9% of the patients in the ACCESS EU registry.11 The rates of stroke/transient
ischemic attack and myocardial infarction are again low—reported in only 0.7% of the patients.
Other procedural complications include chordal rupture (0.8%), pericardial tamponade (0.7%),
and myocardial infarction (0.4%). Single-leaflet device attachment (SLDA) (Video 15.4) was
reported in 8/351 (2.2%) patients in the EVEREST high-risk registries and in 27/567 (4.7%)
patients in the ACCESS EU registry, most of them in the early postprocedural period. Device
embolization is a rare complication and has not been reported in most recent registries and in
only 2/563 patients in the postapproval report from the STS/TVT registry.
cedural complications has declined with improving operator and institutional experience,
16
The rate of pro-
22
but
the overall 30-day mortality is higher, reported at 5.2% in the TVT registry, due to multiple
comorbidities in this population.
Chordal entrapment is an important procedural complication, which can result in worsening
of MR or even cardiac injury and require surgical intervention. It can be avoided by an appropriate height of the transseptal procedure, avoiding clip rotation or excessive manipulations inside
the LV. If chordal entrapment is suspected, avoid any rotation of the system and inspect the clip
carefully with TEE and fluoroscopy. Invert the clip, raise and lower the grippers, and try to carefully retract the system into the LA. If these maneuvers fail and surgery is not an option, the clip
can be deployed within the chordal apparatus as a last resort to free the CDS.
Pre- and Intraprocedural Imaging
Echocardiography is perhaps the most important component of assessment of candidacy for
the MitraClip®. Preprocedural TTE and TEE are essential in not only identifying the etiology
of MR and its quantification but also delineating the inclusive parameters for a successful
MitraClip® procedure. The primary anatomic eligibility criteria in the initial randomized trials
included a coaptation length of 2 mm, a coaptation depth of ,11 mm, and, in the case of
primary MR, a flail gap of ,10 mm and a flail width of ,15 mm.
of 4 cm
2
has been recommended to avoid mitral stenosis postprocedure. Imaging evaluation
should also exclude excessive leaflet calcification in the grasping zone and an adequate posterior
leaflet length (ideally 10 mm but at least 7 mm). Additionally, leaflet perforation or cleft,
restriction (Carpentier IIIB), or rheumatic thickening with restriction (Carpentier IIIA) and
Barlow disease are highly challenging and possibly unsuitable anatomies for MitraClip®. More
data are needed on detailed pathoanatomic factors that translate to optimal outcomes with
TMVR. Intraprocedural TEE is vital to guide the entire procedure, starting with a careful
transseptal puncture at the correct location (posterior and midsuperior height noted earlier).
Manipulation of the SGC in the LA is facilitated by high-quality TEE images. This includes
positioning the clip above the largest mitral regurgitant jet (in the intercommissural/long-axis
view) and ensuring the clip arms are perpendicular to the MV coaptation line (preferably in
real-time 3D en face “surgeon’s view” of the MV from the LA). In a correct clip-arm orientation, the clip should be seen as a bar in the intercommissural view, whereas both clip arms
should be visible and of equal length in the LVOT view. Once the MitraClip® is advanced into
the LV, the leaflets are grasped in the LVOT view. The assessment of residual MR after clip
deployment is essential to evaluate the need for a second clip, which should ideally be deployed
in the area of largest flow convergence and vena contracta. The stability of the deployed clip is
confirmed in multiple views, ensuring an adequate tissue bridge in the 3D en face “surgeon’s
view.” Additionally, MV gradients should be assessed to avoid significant mitral stenosis. Recently, a case of TTE-guided implantation using apical views for both transseptal puncture
(parasternal short axis for relation to aorta) and steering the clip was published.
an alternative imaging modality in some select patients without the option of TEE (e.g.,
esophagectomy).
6
A baseline mitral valve area
23
This provides
15—PERCUTANEOUS EDGE-TO-EDGE MITRAL VALVE REPAIR USING THE MITRACLIP® 171
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Hemodynamic Considerations
The severity of MR can be variable due to varying loading conditions and thus misleading at
times during the procedure. Furthermore, the challenges associated with imaging and grading
MR after a double-orifice repair make residual MR grade a relatively weak end point to measure
the efficacy of the procedure. Hemodynamics can potentially guide us intraprocedurally regarding
the effectiveness of the procedure and potentially long-term outcomes. In a subset of patients in
the ACCESS EU registry, the authors reported an improvement in cardiac output by 0.7 L/min
and a reduction in pulmonary capillary wedge pressure (PCWP) v-wave by 3.5 mmHg. No longterm outcomes were reported in this subset of patients. Continuous left atrial pressure monitoring
during TMVR can be a useful adjunct to TEE for real-time assessment of intraprocedural re-
24
sults.
Some evidence suggests that the use of left atrial pressure monitoring (Fig. 15.11) may be
associated with improved procedural outcomes,
has been shown to predict improvement of 6-minute walk distance at 30 days postprocedure (see
Fig. 15.1).
26
Acute afterload mismatch and transient LV dysfunction have been described after surgical
MV repair for severe MR. Although less commonly seen in patients after TMVR, it is possible,
especially in patients with secondary MR and acute cardiogenic shock. Such acute hemodynamic
deterioration after MitraClip® is important to recognize and promptly treat with inotropic and
mechanical support.
27
Persistent desaturation postprocedure could result from a persistent atrial
septal defect (ASD) (transseptal procedure with a large sheath) and right-to-left shunting.
These ASDs are believed to be mostly inconsequential and are even beneficial due to acute LA
pressure relief. However, a persistent ASD could result in desaturation and even worsening of
right heart failure
29
due to right-to-left atrial shunting in patients with severe pulmonary hypertension/right ventricular failure and high right atrial pressures. Prompt recognition and closure
of the ASD might be necessary to relieve symptoms in such situations.
25
and the degree of left atrial v-wave reduction
28
120
RV RV
80
40
Baseline Post MitraClip
Fig. 15.11 Hemodynamic assessment during a MitraClip® procedure showing significant reduction in left
atrial pressure v-wave postprocedure. (© 2018 Mayo.)
Left Atrial Pressure
120
80
40
RARA
®
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Double-orifice repair using MitraClip® results in some degree of mitral stenosis, which is
largely influenced by the baseline MV area especially when #4 cm
2
and the number and location
of devices used. The trade-off between residual MR and transmitral pressure gradient must be
balanced when considering the location and number of devices used. A recent retrospective study
of 268 patients provided some insight by demonstrating poor outcomes, including increased allcause mortality in patients with MV gradients of .5 mmHg postprocedure in the presence of
MR grades #11.
30
This likely suggests that leaving some residual MR without compromising
the MV gradient might be a reasonable strategy in patients at higher risk of iatrogenic mitral
stenosis.
Emerging Percutaneous Mitral Valve Repair
Technologies
There are many emerging technologies to address mitral regurgitation, none of which yet have
FDA approval or clinical use outside of clinical trials. The PASCAL is an edge-to- edge percutaneous mitral valve repair device designed with a central spacer that sits in the regurgitant orifice
of the mitral valve, with two paddles and clasps that attach it to the mitral valve leaflets. Each
clasp can be opened and closed separately, which aids successful leaflet grasp. Similar to MitraClip®, the PASCAL is inserted via a 22F guide sheath and a steerable catheter via the femoral
vein. The CLASP trial is an ongoing multicenter, multinational, prospective, single-arm study
that will assess the PASCAL for safety and clinical outcomes.
Summary and Take-Home Points
MitraClip® provides a valuable percutaneous alternative for repair of MR in a variety of conditions. Although currently approved for primary (degenerative) MR, observational data suggest its
utility in other etiologies. Recently published results of the COAPT trial have also demonstrated
significant benefit of this technology in patients with secondary MR. Iterative device improvements allowing for application to more diverse anatomies are expected to further improve the
utility and outcomes of this novel therapy.
Additional videos for this topic are available online at https://expertconsult.inkling.com/.
References
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doi: 10.1016/S0140-6736(09)60692-9.
2. 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(9540):1005-1111. doi: 10.1016/S0140-
6736(06)69208-8
3. Nishimura RA, Vahanian A, Eleid MF, Mack MJ. Mitral valve disease—current management and future
challenges. Lancet. 2016;387(10025):1324-1334. doi: 10.1016/S0140-6736(16)00558-4
4. Mirabel M, Iung B, Baron G, et al. What are the characteristics of patients with severe, symptomatic, mitral
regurgitation who are denied surgery? Eur Heart J. 2007;28(11):1358-1365. doi: 10.1093/eurheartj/ehm001
5. Goel SS, Bajaj N, Aggarwal B, et al. Prevalence and outcomes of unoperated patients with severe symp-
tomatic mitral regurgitation and heart failure: Comprehensive analysis to determine the potential role of
MitraClip for this unmet need. J Am Coll Cardiol. 2014;63(2):185-186. doi: 10.1016/j.jacc.2013.08.723
6. Feldman T, Foster E, Glower DD, et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J
Med. 2011;364(15):1395-1406. doi: 10.1056/NEJMoa1009355
7. Feldman T, Kar S, Elmariah S, et al. Randomized comparison of percutaneous repair and surgery for
mitral regurgitation: 5-year results of EVEREST II. J Am Coll Cardiol. 2015;66(25):284428-284454.
doi: 10.1016/j.jacc.2015.10.018
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8. 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 Am Coll Cardiol. 2014;63(22):e57-e185. doi: 10.1016/j.
jacc.2014.02.536
9. Mauri L, Foster E, Glower DD, et al. 4-year results of a randomized controlled trial of percutaneous
repair versus surgery for mitral regurgitation. J Am Coll Cardiol. 2013;62(4):317-328. doi: 10.1016/j.
jacc.2013.04.030
10. Grasso C, Capodanno D, Scandura S, et al. One- and twelve-month safety and efficacy outcomes of
patients undergoing edge-to-edge percutaneous mitral valve repair (from the GRASP Registry). Am J
Cardiol. 2013;111(10):1482-1487. doi: 10.1016/j.amjcard.2013.01.300
11. Maisano F, Franzen O, Baldus S, et al. Percutaneous mitral valve interventions in the real world: Early
and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval
study of the MitraClip therapy in Europe. J Am Coll Cardiol. 2013;62(12):1052-1061. doi: 10.1016/j.
jacc.2013.02.094
12. Nickenig G, Estevez-Loureiro R, Franzen O, et al. Percutaneous mitral valve edge-to-edge repair: Inhospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry.
J Am Coll Cardiol. 2014;64(9):875-884. doi: 10.1016/j.jacc.2014.06.1166
13. Joint Task Force on the Management of Valvular Heart Disease of the European Society of C, European Association for Cardio-Thoracic S, Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on
the management of valvular heart disease (version 2012). Eur Heart J. 2012;33(19):2451-2496. doi:
10.1093/eurheartj/ehs109
14. Sorajja P, Kanda B, Bae R, Pedersen WA, Gossl M. Maneuvers for technical success with transcatheter
mitral valve repair. Catheter Cardiovasc Interv. 2018;92(3):617-626. doi: 10.1002/ccd.26899
15. Franzen O, Baldus S, Rudolph V, et al. Acute outcomes of MitraClip therapy for mitral regurgitation in
high-surgical-risk patients: Emphasis on adverse valve morphology and severe left ventricular dysfunction.
Eur Heart J. 2010;31(11):1373-1381. doi: 10.1093/eurheartj/ehq050
16. Sorajja P, Mack M, Vemulapalli S, et al. Initial experience with commercial transcatheter mitral valve
repair in the United States. J Am Coll Cardiol. 2016;67(10):1129-1140. doi: 10.1016/j.jacc.2015.12.054
17. Alkhouli M, El Sabbagh A, Villarraga HR, Hagler DJ, Rihal CS, Eleid MF. Novel treatment of residual
peri-MitraClip regurgitation with an Amplatzer Vascular Plug II. JACC Cardiovasc Interv.
2016;9(17):e171-e175. doi: 10.1016/j.jcin.2016.06.016
18. Taramasso M, Alessandrini H, Kuwata S, et al. Multicenter experience with treatment of residual mitral
regurgitation after MitraClip implantation using Amplatzer closure device: Mid-term results. JACC
Cardiovasc Interv. 2017;10(9):966-970. doi: 10.1016/j.jcin.2017.02.011
19. Frerker C, Meincke F, Seibert HP, et al. MitraClip(R) via direct right atrial access in case of a missing
inferior vena cava. EuroIntervention. 2013;9(5):643-647. doi: 10.4244/EIJV9I5A102
20. Tiroch K, Brinkmann H, Koudonas D, Vorpahl M, Seyfarth M, Vetter HO. “First-in-man” MitraClip
via pulmonary vein access through a right mini-thoracotomy in a patient with agenesis of the inferior
vena cava. EuroIntervention. 2015;10(10):1204-7120. doi: 10.4244/EIJY14M05_04
21. Fam NP, Ho EC, Ahmed N, Edwards J. First transjugular edge-to-edge mitral valve repair with the
MitraClip system. EuroIntervention. 2017;13(3):284-285. doi: 10.4244/EIJ-D-17-00164
22. Eleid MF, Reeder GS, Malouf JF, et al. The learning curve for transcatheter mitral valve repair with
MitraClip. J Interv Cardiol. 2016;29(5):539-545. doi: 10.1111/joic.12326
23. Hart EA, Teske AJ, Voskuil M, Stella PR, Chamuleau SA, Kraaijeveld AO. Transthoracic echocardiography guided MitraClip placement under conscious sedation. JACC Cardiovasc Interv.
2017;10(3):e27-e29. doi: 10.1016/j.jcin.2016.11.050
24. Eleid MF, Sanon S, Reeder GS, Suri RM, Rihal CS. Continuous left atrial pressure monitoring during
MitraClip: Assessing the immediate hemodynamic response. JACC Cardiovasc Interv. 2015;8(7):e117-e119.
doi: 10.1016/j.jcin.2015.02.010
25. Horstkotte J, Kloeser C, Beucher H, Schwarzlaender E, von Bardeleben RS, Boekstegers P. Intraprocedural assessment of mitral regurgitation during the mitraclip procedure: Impact of continuous left atrial
pressure monitoring. Catheter Cardiovasc Interv. 2016;88(7):1134-1143. doi: 10.1002/ccd.26504
26. Maor E, Raphael CE, Panaich SS, et al. Acute changes in left atrial pressure after MitraClip are associated with improvement in 6-minute walk distance. Circ Cardiovasc Interv. 2017;10(4). doi: 10.1161/
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27. Tang GH, Cohen M, Dutta T, Undemir C. Afterload mismatch after transcatheter mitral valve repair
with MitraClip for degenerative mitral regurgitation in acute cardiogenic shock. Catheter Cardiovasc
Interv. 2018;92(3):E168-E171. doi: 10.1002/ccd.27019.
28. Schueler R, Ozturk C, Wedekind JA, et al. Persistence of iatrogenic atrial septal defect after interventional mitral valve repair with the MitraClip system: A note of caution. JACC Cardiovasc Interv.
2015;8(3):450-459. doi: 10.1016/j.jcin.2014.10.024
29. Huntgeburth M, Muller-Ehmsen J, Baldus S, Rudolph V. Postinterventional iatrogenic atrial septal defect with hemodynamically relevant left-to-right and right-to-left shunt as a complication of successful
percutaneous mitral valve repair with the MitraClip. Int J Cardiol. 2013;168(1):e3-e5. doi: 10.1016/
j.ijcard.2013.05.018
30. Neuss M, Schau T, Isotani A, Pilz M, Schopp M, Butter C. Elevated mitral valve pressure gradient after
MitraClip implantation deteriorates long-term outcome in patients with severe mitral regurgitation and
severe heart failure. JACC Cardiovasc Interv. 2017;10(9):931-939. doi: 10.1016/j.jcin.2016.12.280
e1
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Abstract: Mitral valve regurgitation (MR) is the most common valvular regurgitant abnormality,
increasing in prevalence with age and affecting approximately 4 million people in the United States
alone. Percutaneous edge-to-edge transcatheter mitral valve repair (TMVR) (also known as the
MitraClip® system) provides a durable alternative in severe (≥ 3+ MR) MR and was approved by
the Food and Drug Administration (FDA) in October 2013 for prohibitive-risk patients with
primary MR. Recently published results of the Cardiovascular Outcomes Assessment of the
MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation
(COAPT) trial demonstrated the benefit of this technology in secondary MR in terms of lower
hospitalization rates and all-cause mortality within 24 months of follow-up. This chapter will review the indications, pre-procedural imaging and planning, procedural details, troubleshooting,
and post-procedural follow-up for MitraClip®.
Keywords: Mitral valve regurgitation, transcatheter mitral valve repair, edge-to-edge mitral valve
repair, MitraClip®
CHAPTER 16
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Percutaneous Mitral Valve-in-Valve
and Valve-in-Ring
Timothy A. Joseph Mackram F. Eleid
Introduction
Mitral valve disease is the most common cardiac valve condition, with the prevalence of significant regurgitation or stenosis increasing with age and estimated to be 9.5% in the general population above the age of 75.
surgical mitral valve repair (usually including an annuloplasty ring) or replacement with either a
tissue or mechanical prosthesis.
compared with those receiving mechanical valves due to age and comorbidities that make lifelong
anticoagulation unattractive. However, with the estimated bioprosthetic median life span of as
little as 12 years in one cohort,
prosthesis failure may include degeneration of leaflet tissue, thrombosis, pannus formation, and
endocarditis. Repeat mitral valve replacement is associated with increased morbidity and mortality, with initial mortality ranging from 5.4% to 15.1%,
having multiple repeat replacements.
Because of the risks in this population, percutaneous mitral valve-in-valve implantation has
become an attractive option for patients at prohibitive surgical risk with prosthetic valve or annuloplasty dysfunction. Initial case reports and case series have shown the early feasibility,
international registries have been created for further assessment.
have been evaluated in the mitral position, including the Melody valve (Medtronic, Minneapolis,
MN) designed for percutaneous implantation in the pulmonary position (Fig. 16.1). However,
given the design of this valve and the high hemodynamic stresses placed on the mitral valve
position, there have been concerns over the long-term durability of the valve in the mitral position.
The balloon-expandable SAPIEN valves (Edwards Lifesciences, Irvine, CA) are the transcatheter
prosthesis of choice, with improved ease of deployment and expectations of improved durability
(Fig. 16.2). Large case series of mitral valve-in-valve with the SAPIEN valve have shown early
feasibility and safety,
valve for treatment of bioprosthetic mitral valve failure in 2017. Mitral valve-in-ring remains a
more investigational procedure involving off-label use of transcatheter valves and will be included
in this chapter due to similar procedural techniques.
1
The most common treatments for severe mitral valve disease include
2
Patients receiving mitral bioprosthetic valves are often older
3
this population may require repeat intervention. Mechanisms of
4
5
6–10
leading to Food and Drug Administration (FDA) approval of the SAPIEN
with highest risk in those over 75 or
9,10
Multiple transcatheter valves
6–8
and
Evaluation and Procedural Planning
Procedural planning is crucial to successful percutaneous mitral valve replacement. Evaluation by
a structural interventionalist with expertise in the procedure and a cardiac surgeon is recommended to ensure optimal patient selection. Previous surgical records for valve specifications of
the failing prosthesis or type and size of annuloplasty ring are vital for sizing of the new prosthetic
valve. Beyond this, the mainstay of planning relies on multimodality imaging consisting of
175
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First transseptal
melody mitral
v
First transseptal
balloons
CD
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alve in valve
2011
Fig. 16.1 Timeline of iterative improvements in transseptal mitral valve replacement.
SAPIEN mitral
valve in valve
2014
Elimination of
apical rail
Elimination of
lunderquist wire
2015
Use of smaller
septostomy
Septostomy
balloon flossing
2016
A
Fig. 16.2 Transvenous transseptal mitral valve-in-valve procedure. (A) Balloon septostomy dilation to allow valve
delivery. (B) Transcatheter heart valve and delivery catheter advanced to appropriate device position over left
ventricular anchor wire. (C) Valve deployment within the previous prosthetic valve. (D) Removal of equipment
with valve seated in the mitral position. (From Eleid MF, Cabalka AK, Williams MR, Whisenant BK, Alli OO, Fam
N, Pollak PM, Barrow F, Malouf JF, Nishimura RA, Joyce LD, Dearani JA, Rihal CS. Transseptal techniques for
emerging structural heart interventions. JACC Cardiovasc Interv 2016;9(11):1161–1174. © Mayo 2015.)
B
16—PERCUTANEOUS MITRAL VALVE-IN-VALVE AND VALVE-IN-RING 177
D
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transthoracic and transesophageal echocardiography (TEE) and, in selected cases, computed tomography (CT). In conjunction with prior surgical records, annular size and prosthesis internal
dimensions can be confirmed by TEE or computed tomography angiography (CTA). Once
known, the dimensions can be used in the Valve-in-Valve Mitral application
11
to select the new
prosthesis size. Occasionally measurements will be on the margin of two prosthesis sizes. In these
cases, it is usually preferred to use the smaller prosthesis size, with the use of additional volume
to ensure optimal prosthesis anchoring. Additional volume is added to the deployment balloon
to ensure adequate prosthesis flaring on the ventricular side and a “conical” deployment during
the procedure. Evidence of irregular or elliptical-shaped annuli (rigid annuloplasty ring or incomplete annuloplasty ring) can predispose to paravalvular leak (PVL) or can cause inadequate
anchoring in the case of the latter. In patients undergoing valve-in-valve, this risk is reduced due
to a complete and circular annulus on which to anchor.
Echocardiography
The initial evaluation of prosthetic valve dysfunction typically involves transthoracic echocardiography (TTE) (Fig. 16.3). TTE is often useful in identifying the etiology of the patient’s
symptoms, assessing right and left ventricular function, and measuring septal thickness and
A
C
Fig. 16.3 Transesophageal echocardiography (TEE) images pre- and postprocedure for surgical prosthetic
valve failure. A 78-year-old woman who developed congestive heart failure and paroxysmal nocturnal dyspnea
8 years after undergoing mitral valve replacement with a 29-mm bioprosthesis. Society of Thoracic Surgeons
(STS) risk score for redo mitral valve replacement 7.34%. (A) TEE showing severe prosthetic mitral valve regurgitation. (B) Measurement of previous prosthetic valve strut showing diameter of 1.67 cm resulting in left
ventricular outflow tract (LVOT) area of 218 mm2. (C) Minimal regurgitation postdeployment of transcatheter
mitral valve-in-valve. (D) 3D imaging showing good position and complete opening of prosthetic valve leaflets.
B
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