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CHAPTER 25
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Novel Percutaneous Tricuspid
Repair Techniques
Abdallah El Sabbagh Mackram F. Eleid
Introduction
The tricuspid valve apparatus is a complex and dynamic structure that interacts intricately with
surrounding anatomy. The vast majority of patients with tricuspid valve disease have tricuspid
valve regurgitation (TR), whereas a minority present with tricuspid stenosis (TS). TR represents a significant epidemiologic burden, with an estimated 1.6 million Americans affected
by this condition and only 8000 tricuspid valve surgeries performed nationwide on a yearly
1,2
basis.
Untreated severe TR is associated with poor outcomes from long-standing volume
overload on the right ventricle (RV), with up to 36% 1-year mortality rate.
going tricuspid valve surgery, 60% of patients received tricuspid valve replacement, while 40%
underwent tricuspid valve repair. Despite the increase in surgical volumes, mortality remains
high and unchanged, at 8% to 9%.
is thought to be attributed to delayed referral for intervention, whereby irreversible RV dysfunction and end-organ damage have already ensued, increasing surgical risk. In patients who
undergo tricuspid bioprosthetic valve replacement, over half require reintervention at 15 years
due to prosthetic valve degeneration. Recently, percutaneous transcatheter tricuspid valve interventions have evolved as an option for patients who are at high risk for surgery and are the
focus of this chapter.
4
The high mortality associated with tricuspid valve surgery
3
In patients under-
5
Tricuspid Valve Anatomy and Pathophysiology
The tricuspid valve is composed of an annulus, three leaflets, and supporting structures (chordae
and papillary muscles). The tricuspid valve annulus is a saddle-shaped structure angled inferiorly
toward the RV apex posteromedially and superiorly toward the right atrium anteroseptally. At
the septum, the tricuspid annulus is a thin fibrous structure, whereas anteriorly and posteriorly
it becomes more muscular, underpinning the mechanism of annular dilatation in the anteroposterior direction that is frequently observed in functional TR. Surrounding the annulus, important structures pertinent to any tricuspid intervention include the bundle of His and the right
coronary artery. The tricuspid valve typically has three leaflets: anterior, which is the largest;
posterior; and septal. The anterior and posterior leaflets are characterized by multiple scallops
and are thinner than the mitral valve leaflets. The three leaflets are anchored by two main papillary muscles, the anterior and posterior, and sometimes a third rudimentary muscle on the
interventricular septum. The anterior papillary muscle is fused with the moderator band and has
chordal attachments to the anterior and posterior leaflets, whereas the posterior papillary muscle
is attached to the inferior RV free wall and sends chordae to the septal and anterior leaflets. The
septal leaflet has unique direct chordal attachments to the interventricular septum without a
papillary muscle.
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TR may occur as a result of primary leaflet abnormalities (e.g., pacemaker lead–induced injury,
prolapse/flail leaflet, congenital abnormalities (such as Ebstein anomaly), rheumatic disease, and
carcinoid disease) but more frequently occurs secondarily due to tricuspid annular dilatation and/
or RV enlargement. In pulmonary hypertension or untreated left-sided valvular heart disease,
progressive RV pressure overload eventually results in RV failure and secondary TR due to tethering of tricuspid leaflets and annular dilatation. More commonly, severe TR is observed as a
consequence of chronic atrial fibrillation, where progressive atrial enlargement causes tricuspid
annular dilatation, and severe TR that occurs in isolation from other valvular heart disease. The
degree of annular dilatation and severity of TR can vary widely. Recent recommendations have
included an expansion of TR grading beyond severe to also include massive and torrential grades,
to more accurately reflect severity of disease.
6
Transcatheter therapies in the native tricuspid valve remain challenging because of the following
anatomic features:
1. The tricuspid valve (average 10 cm2) is larger than the mitral valve (average 7 cm2) and is
subject to a very wide range of dilatation in severe TR.
2. The tricuspid valve annulus is not a rigid structure.
3. The tricuspid valve leaflets and chordae are thin, risking injury during interventions.
4. The angulation from the inferior vena cava (IVC) to the tricuspid valve is variable and can
pose a challenge to device delivery from the femoral route.
5. The lack of chord-free zones on the leaflets, the presence of muscle bands, and the presence
of pacemaker leads,
7
as well as the thin RV wall, especially at the apex, can add complexity
and risk to tricuspid procedures.
Currently clinical percutaneous interventions in the tricuspid valve are limited to off-label use
of aortic balloon-expandable valves in failed bioprosthetic valves,
8
as described in the previous
chapter, and off-label use of the MitraClip device in the tricuspid position. However, there are
several novel dedicated tricuspid transcatheter devices under active investigation, a few of which
will be described briefly in this chapter.
Percutaneous Repair for Native Tricuspid
Regurgitation (Spacer Therapy, Edge-to-Edge
Plication, Percutaneous Annuloplasty)
Several percutaneous repair devices are currently being investigated for use in secondary TR due to
annular dilatation and work by different mechanisms (Fig. 25.1).
tigational devices is limited to early feasibility trials and case series. Spacer therapy, mainly the
Forma device (Edwards LifeSciences, Irvine, CA), is a foam-filled balloon that is delivered via a left
subclavian approach and positioned across the tricuspid valve and secured to the interventricular
group right ventricle with a fixation anchor. This device occupies the space created by tricuspid valve
malcoaptation and serves as a surface of contact for leaflet coaptation (Fig. 25.2).
The Forma early feasibility study evaluated the 30-day outcome in patients who had severe secondary tricuspid valve regurgitation and underwent placement of a Forma device. The 30 who were
enrolled in this study had significant comorbidities, with an average age of 76 years, most of which
had New York Heart Association (NYHA) class III or IV symptoms and atrial fibrillation. Twentyseven patients had the devices successfully implanted, with improvement in the effective regurgitant
orifice area, NYHA class, 6-minute walk test, and Kansas City Cardiopathy Questionnaire (KCCQ)
score. Two patients died, two patients had right ventricular perforation, three had device dislodgements, one had device infection, and three had device-related cardiac surgery.
Edge-to-edge plication therapy devices are also being used in the tricuspid position. The MitraClip device (Abbott, Santa Clara, CA) has been used off-label in the tricuspid position (Fig. 25.3),
with a dedicated tricuspid clip device anticipated in the near future. Several series have now been
9
Current evidence for these inves-
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RA
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30
RA
0
30
0
Fig. 25.1 Right ventricular inflow view, four-chamber view, and right atrial pressure tracing consistent
with severe tricuspid valve regurgitation (TR). After Forma device insertion, TR severity decreased, as
seen on echocardiography and right atrial tracing.
Fig. 25.2 Successful placement of a MitraClip device in the tricuspid position resulting in reduction in
the severity of the tricuspid valve regurgitation (TR).
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Isolated severe TR
Symptoms despite medical therapy
Failed surgical tricuspid bioprosthesis?
Tr icuspid valve-in-valve
Severe leaflet malcoaptation
• Pacemaker lead-induced TR
• Severe leaflet tethering
Eligible for investigational device?
Spacer therapy
Transcatheter tricuspid valve replacement
Fig. 25.3 Current algorithm of percutaneous tricuspid valve interventions.
+
High surgical risk
Native TR?
Mild/moderate malcoaptation
• Appropriate anatomy for repair
Edge to edge repair
Percutaneous annuloplasty
published showing the feasibility of this therapy with reduction of the severity of the TR.
In the largest series, 64 patients with severe TR underwent edge-to-edge repair in the tricuspid position using the MitraClip device. The MitraClip was successfully deployed in 97% of the cases, and
91% had a reduction in the severity of the tricuspid valve regurgitation. There were three in-hospital
deaths but no other procedural complication such as tamponade emergency surgery or major vascular bleeding. Thirty-day follow-up revealed improvement in the NYHA class and 6-minute walk
11
test.
A second tricuspid edge-to-edge repair device, Pascal (Edwards Lifesciences, Irvine, CA) has
shown safety and feasibility with reduction of TR of 2 or more grades in 85% of treated patients in
the initial experience.
13
Percutaneous tricuspid annuloplasty devices are also under investigation. These include
the Trialign device (MitraAlign, Inc., Tewksbury, MA), which deploys pledgeted sutures
into the tricuspid valve annulus near the commissures and locks the commissures together,
reducing the annular circumference. A recent early feasibility study using this device
enrolling 15 patients demonstrated a technical success rate of 80% with no mortality,
stroke, bleeding, or tamponade or need for valve reintervention on a 30-day follow-up.
However, there were three cases of pledget detachment. There was a reduction in the tricuspid
annulus diameter, as well as the effective regurgitant orifice, with an increase in the left
ventricular stroke volume coupled with improvement in NYHA class as well as 6-minute
walk test. A second annuloplasty device, Cardioband (Edwards Lifesciences, Irvine, CA),
10–12
294 7—TRICUSPID VALVE
FORMA Tr iClip TriAlign TriCinch
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consists of corkscrew anchors that are inserted into the tricuspid annulus from the anteroseptal commissure around the lateral border of the annulus to the coronary sinus. Following insertion under echocardiographic and fluoroscopic guidance, the band is contracted,
thereby reducing annular dimensions. The initial experience in 30 patients demonstrated
successful device implantation in all patients, 50% reduction in tricuspid regurgitation
severity, and functional improvements in 3 out of 4 patients at 6 months.
14
Another device, the Tricinch (4Tech Cardio, Galway, Ireland), consists of a midsternal stent
deployed in the IVC, which is connected via a band to a corkscrew anchor that connects the stent
to the tricuspid annulus. This anchor is then retracted toward the IVC, thereby changing the
geometry of the valve and lessening the regurgitation. Transcatheter tricuspid valve replacement
devices are also under active investigation.
Summary and Take-Home Points
n
Severe TR is a major health care burden with limited treatment options.
n
The tricuspid valve anatomy presents a challenge for percutaneous therapies.
n
Transcatheter valve-in-valve implantation has a high success and safety rate for the treatment
of failed bioprosthetic valves.
n
The future of transcatheter tricuspid interventions is promising, with several investigational
devices that work by different mechanisms currently being evaluated (Fig. 25.4).
Fig. 25.4 Investigational transcatheter tricuspid valve devices. (Modified from Al-Hijji M, Fender EA, El
Sabbagh A, Holmes DR. Current treatment strategies for tricuspid regurgitation. Curr Cardiol Rep.
2017;19(11):106).
References
1. Singh JP, Evans JC, Levy D, et al. Prevalence and clinical determinants of mitral, tricuspid, and aortic
regurgitation (the Framingham Heart Study). Am J Cardiol. 1999;83(6):897-902.
2. Stuge O, Liddicoat J. Emerging opportunities for cardiac surgeons within structural heart disease.
J Thorac Cardiovasc Surg. 2006;132(6):1258-1261.
3. Nath J, Foster E, Heidenreich PA. Impact of tricuspid regurgitation on long-term survival. J Am Coll
Cardiol. 2004;43(3):405-409.
4. Zack CJ, Fender EA, Chandrashekar P, et al. National trends and outcomes in isolated tricuspid valve
surgery. J Am Coll Cardiol. 2017;70(24):2953-2960.
25—NOVEL PERCUTANEOUS TRICUSPID REPAIR TECHNIQUES 295
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5. Chang BC, Lim SH, Yi G, et al. Long-term clinical results of tricuspid valve replacement. Ann Thorac
Surg. 2006;81(4):1317-1323; discussion 1323-1324.
6. Hahn RT, Zamorano JL. The need for a new tricuspid regurgitation grading scheme. Eur Heart J
Cardiovasc Imaging. 2017;18(12):1342-1343.
7. Eleid MF, Asirvatham SJ, Cabalka AK, et al. Transcatheter tricuspid valve-in-valve in patients with
transvalvular device leads. Catheter Cardiovasc Interv. 2016;87(4):E160-E165.
8. McElhinney DB, Cabalka AK, Aboulhosn JA, et al. Transcatheter tricuspid valve-in-valve implantation
for the treatment of dysfunctional surgical bioprosthetic valves: an international, multicenter registry
study. Circulation. 2016;133(16):1582-1593.
9. Al-Hijji M, Fender EA, El Sabbagh A, Holmes DR. Current treatment strategies for tricuspid regurgitation.
Curr Cardiol Rep. 2017;19(11):106.
10. Lurz P, Besler C, Noack T, et al. Transcatheter treatment of tricuspid regurgitation using edge-to-edge
repair: procedural results, clinical implications and predictors of success. EuroIntervention. 2018;14(3):
e290-e297.
11. Nickenig G, Kowalki M, Hausleiter J, et al. Transcatheter treatment of severe tricuspid regurgitation with
the edge-to-edge MitraClip technique. Circulation. 2017;135(19):1802-1814.
12. Orban M, Besler C, Braun D, et al. Six-month outcome after transcatheter edge-to-edge repair of severe
tricuspid regurgitation in patients with heart failure. Eur J Heart Fail. 2018;20(6):1055-1062.
13. Fam NP, Braun D, von Bardeleben RS et al. Compassionate use of the PASCAL transcatheter valve
repair system for severe tricuspid regurgitation: a multicenter, observational, first-in-human experience.
JACC Cardiovasc Interv 2019;12(24):2488-2495.
14. Nickenig G, Weber M, Schueler R et al. 6-month outcomes of tricuspid valve reconstruction for patients
with severe tricuspid regurgitation. J Am Coll Cardiol. 2019;73(15):1905-1915.
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e1
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Abstract: Severe tricuspid regurgitation is a major health care burden with limited treatment options. The tricuspid valve anatomy presents a challenge for percutaneous therapies. Transcatheter
valve-in-valve implantation has a high success and safety rate for treatment of failed bioprosthetic
valves. The future of transcatheter tricuspid interventions is promising, with several investigational
devices that work by different mechanisms currently being evaluated.
Keywords: Tricuspid valve, transcatheter valve interventions
SECTION 8
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ACHD Interventions
297
CHAPTER 26
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Coarctation and PDA Closure
Donald J. Hagler
Coarctation of the aorta can most simply be characterized as a discrete stenosis of the upper
descending thoracic aorta. Since in many cases coarctation occurs at or near the origin of the
ductus arteriosus, these can be described as juxtaductal coarctation. However, longer segment
stenosis and aortic arch hypoplasia may also be recognized in some patients.
Clinical Presentation
The clinical presentation may vary from severe congestive heart failure in the neonate to hypertension and stroke in adolescents and adults. Coarctation represents approximate 6-8% of patients
with congenital heart disease. It may be associated with other congenital heart disease such as
bicuspid aortic valve and most complex forms of congenital heart disease such as Shone syndrome
with multiple sites of left ventricular inflow and outflow tract obstruction. There is a recognized
male predominance, with male-to-female ratio between 1.3 and 1.7. A clear genetic influence has
been recognized in patients with Turner Syndrome (45X) with about 35% of Turner patients affected and notably 5% of girls with coarctation having Turner Syndrome. NOTCH 1 and MCTP2
genetic mutations have been reported in left ventricular obstructive lesions such as bicuspid aortic
valve, coarctation of the aorta, and hypoplastic left heart syndrome.
The histology of juxtaductal coarctation often consists of a thick intimal and medial ridge
projecting posteriorly and circumferentially into the aorta. Intimal thickening, hyperplasia, and
calcification can be observed in older patients. Cystic medial necrosis with disarray of the media
elastic tissue may provide the substrate for aortic dilation, aneurysm formation, and dissection.
Noninvasive Imaging Assessment
The initial imaging assessment of coarctation of the aorta should include transthoracic echocardiography, and magnetic resonance imaging or CT angiography. The primary purpose of the
echocardiographic study will be to define any associated lesions such as bicuspid aortic valve, mitral
valve abnormalities, and severity of ventricular hypertrophy. Transthoracic echocardiography will
allow some visualization of the aortic arch and upper descending aorta. Some assessment of severity and site of obstruction is evident with additional color-flow and continuous wave Doppler
echocardiography (Fig. 26.1). However, the ideal method of coarctation imaging, particularly beyond infancy, is magnetic resonance imaging, since excellent three-dimensional reconstructions of
the aortic arch and descending aorta can be obtained. In addition the two-dimensional images can
be incorporated into the x-ray imaging obtained at catheterization to assist in catheter, balloon,
and stent placement.
During infancy, if satisfactory arch and coarctation images cannot be obtained with echocardiography, CT images provide the most rapid and high-resolution images to define the severity
or arch hypoplasia and the anatomy of the coarctation site (Fig. 26.2). Both MRI and CT imaging can provide 3D reconstruction images that can be viewed in a rotation cine format or with a
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