European Heart Journal (2024) 45, 876–894 STATE OF THE ART REVIEW

https://doi.org/10.1093/eurheartj/ehae082 Valvular heart disease

Transcatheter treatment of the tricuspid valve:

current status and perspectives

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1 2
Francesco Maisano *, Rebecca Hahn , Paul Sorajja3, Fabien Praz 4
,
and Philipp Lurz5
1
Division of Cardiac Surgery and Valve Center, IRCCS Ospedale San Raffaele, Università Vita Salute, Via Olgettina 60, 20132 Milano, Italy; 2Department of Medicine, Columbia University
Irving Medical Center, New York, 161 Fort Washington Avenue, 10032 New York, NY, USA; 3Minneapolis Heart Institute at Abbott Northwestern Hospital, 920 East 28th Street, Suite 100,
55407 Minneapolis, MN, USA; 4Bern University Hospital, University of Bern, Anna-Seiler-Haus Freiburgstrasse 20, 3010 Bern, Switzerland; and 5Department of Cardiology,
Universitätsmedizin Johannes Gutenberg-University, Langenbeckstraße 1, 55131 Mainz, Germany

Received 2 August 2023; revised 13 January 2024; accepted 29 January 2024; online publish-ahead-of-print 1 March 2024

Graphical Abstract

Treatment of tricuspid valve regurgitation

CAVI
Right heart remodeling and dysfunction
Severe RV and
RA remodeling

Progressive resistance
to drugs TTV replacement

Medical therapy TTV repair

Less than severe TR, Surgical repair and Progressive organ

minimal RV, or replacement failure and symptoms
RA remodeling

Preclinical RHF, organ failure

Symptoms and clinical status

Disease stage and therapeutic strategies for tricuspid regurgitation. Tricuspid regurgitation evolves from undetectable early forms to advanced stages
characterized by escalating symptoms, right heart failure, and organ impairment. While medical therapy is utilized throughout the disease course, its
effectiveness wanes with progression. Surgery can play a role in the earlier stages, while transcatheter therapies are available for patients at high risk
and in the more advanced stages of disease. Significant overlap between treatment options underscores the urgent need for precise, evidence-based

* Corresponding author. Email: [email protected]

© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: [email protected]
Transcatheter tricuspid interventions 877

protocols. Overall, early intervention is crucial to prevent organ damage and avoid futility of late treatments (smileys becoming sad). CAVI, caval valve
implantation; RHF, right heart failure; TR, tricuspid regurgitation; RA, right atrial; RV, right ventricular; TTV, transcatheter tricuspid valve.

Abstract

Transcatheter tricuspid valve interventions (TTVI) are emerging as alternatives to surgery in high-risk patients with isolated or concomitant tricuspid

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regurgitation. The development of new minimally invasive solutions potentially more adapted to this largely undertreated population of patients, has
fuelled the interest for the tricuspid valve. Growing evidence and new concepts have contributed to revise obsolete and misleading perceptions
around the right side of the heart. New definitions, classifications, and a better understanding of the disease pathophysiology and phenotypes, as
well as their associated patient journeys have profoundly and durably changed the landscape of tricuspid disease. A number of registries and a recent
randomized controlled pivotal trial provide preliminary guidance for decision-making. TTVI seem to be very safe and effective in selected patients,
although clinical benefits beyond improved quality of life remain to be demonstrated. Even if more efforts are needed, increased disease awareness is
gaining momentum in the community and supports the establishment of dedicated expert valve centres. This review is summarizing the achieve­
ments in the field and provides perspectives for a less invasive management of a no-more-forgotten disease.
.............................................................................................................................................................................................
Keywords Tricuspid regurgitation • Right heart • Heart failure • TTVI • Transcatheter interventions • Percutaneous • Repair •
Replacement

Incipit: ‘In the delicate chambers of the heart, where life's symphony possibly related to the late referral but also influencing referral rates
finds its rhythm, a silent trouble lingers. A tricuspid valve, once a for this procedure.
guardian of harmony, now whispers a discordant tune, signaling Recent evidence challenges the belief that TV disease and, overall,
the presence of a hidden disease…’ right heart (RH) failure are of ‘secondary’ importance. In addition, re­
Anonimous Chatbot cent advances in valvular interventions have broadened the spectrum
of treatable patients to high risk or inoperable patients. The broad
The recent introduction of transcatheter tricuspid valve interventions
range of transcatheter treatment eligible patients, as well as less invasive
(TTVI) has dramatically influenced the perception of the relevance of tri­
nature of the procedures, will allow us to study the effect of TR reduc­
cuspid valve (TV) disease. As more evidence becomes available, concepts
tion on prognosis and quality of life (QoL), but also, and probably more
and strategies are evolving (Graphical Abstract) and new challenges emerge
importantly, advance our understanding of the interaction between TV
in the quest to uncover the secrets of the right side of the heart. This
function and RH physiology, improving our detection of adaptive and
state-of-the-art review is revisiting TV disease through the most
maladaptive processes.
up-to-date knowledge of its mechanisms, diagnostics, and treatment op­
tions, bringing to light the valve that is anything but forgotten.
The burden of a misleading disease:
from marker to culprit
Tricuspid valve regurgitation: a The role of TR as a marker of disease severity is unquestioned. The de­
no-more-forgotten entity velopment of TR as a consequence of left heart disease or pulmonary
hypertension (PH) is associated with worsening prognosis in congestive
The TV has long been disregarded and as a result remained relatively
heart failure,6 primary PH,7 and in patients undergoing aortic8,9or mitral
under-studied, leading to under-recognition, and under-treatment.
valve interventions.10–12 However, the absolute impact of isolated TR on
For more than 50 years, tricuspid regurgitation (TR) has been classi­
prognosis has been long questioned. In addition, symptoms of isolated se­
fied as a signal rather than a causative prognostic factor, believed to
vere TR can be highly misleading and underestimated during its early
be easily reversible with treatment of left heart disease, or surrogate
stages or confounded with other conditions, particularly in the elderly.
of end-stage disease indicating an inoperable condition. Nina In a recent study, asthenia, ankle swelling, abdominal pain or distention,
Braunwald, in a publication considered the manifesto of the ‘forgotten and/or anorexia have been found to be predictive of clinical outcomes
valve’, described TR as a secondary issue, ‘seldom requiring an inter­ in patients with TR.13 With an aging population and improved left heart
vention’.1 Several factors supported the theory that the right circula­ failure management, the prevalence of TR is increasing and these uncon­
tion is less impactful on survival than the left. As an example, children ventional symptoms are red flags motivating further investigations.
with surgically corrected congenital heart disease have survived with The Framingham study reported a prevalence of 1.5% in men and
univentricular physiology. TV endocarditis has been treated with val­ 5.6% in women of at least moderate TR in the elderly (above 70 years)
vectomy with acceptable short-term results.2 In addition, diuretics population.14 A more recent community-based prospective study
can efficiently control symptoms of venous congestion and reduce showed that 16% of patients ≥65 years old had previously undiagnosed
the degree of TR.3 In the setting of nonspecific signs and symptoms moderate or severe valvular heart disease, with TR having the highest
as well as early diuretic responsiveness, there has been a tendency prevalence at 7.2%,15 confirming the Framingham study. According to
to delay interventions. Surgery for isolated TR has been associated the Eurostat census, in 2001 there were 54 million elderly inhabitants
with debatable prognostic impact4 and high in-hospital mortality,5 in Europe, of which 21 million were male and 34 were million female
878 Maisano et al.

Table 1 New classification of TR according to mechanism and aetiology

Mechanism of regurgitation aetiology Main imaging and staging Typical patient

journey (referral
clinics)
......................................................................................................................................................................................
Secondary (functional) tricuspid regurgitation
Valve structures are anatomically normal, valve dysfunction is secondary to atrial or ventricular remodelling and dysfunction

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Ventricular TR due to a combination of annular Pulmonary hypertension 2D/3D echocardiography for TR grading, Heart Failure clinic
TR dilatation and leaflet tethering Left heart valvular disease quantification of valve and ventricular Cardiovascular surgery
caused by RV remodelling and/or HFrEF, HFpEF remodelling, RV systolic function Pneumology
dysfunction Right ventricular infarction RH catheterization GUCH
Right ventricular Biomarkers
cardiomyopathy
Congenital anomalies
Atriogenic TR is mainly driven by annular dilatation Atrial fibrillation 2D/3D echocardiography for TR grading, Electrophysiology
TR and dysfunction. Normal RV HFpEF quantification of valve and ventricular General cardiologist
function and shape (conical shape Aging remodelling, RV systolic function Family physician
preserved) RH catheterization Internal Medicine
Biomarkers Heart Failure clinic
Primary or mixed tricuspid regurgitation
Valve structures are abnormal
Primary Chordal elongation/rupture Endocarditis 2D/3D echocardiography for TR grading, Internal medicine
Papillary muscle rupture (trauma) Myxomatous disease quantification of valve and ventricular Infectivology
Excessive leaflet motion (myxomatous Rheumatic disease remodelling, RV systolic function Traumatology
disease) Trauma General Cardiologist
Leaflet perforation (endocarditis) NET tumours Gastroenterology
Leaflet retraction (rheumatic,
inflammatory diseases)
CIED-related
TR is caused by the interaction with intracavitary leads
CIED-related Leaflet impingement, chordal Implant of an intracardiac EP evaluation Electrophysiology
entanglement or rupture, leaflet electrical device crossing 2D/3D echocardiography for TR grading, Heart failure clinic
adherence, perforation, laceration the tricuspid valve. quantification of valve and ventricular
(post-extraction) Implant of a leadless remodelling, RV systolic function
pacemaker Assessment of lead influence:
Lead extraction CIED-related vs. CIED-associated TR)

The existence of multiple tricuspid regurgitation phenotypes, each with distinct regurgitation mechanisms and patient trajectories, indicates the necessity for personalized care strategies.
This encompasses everything from diagnostic and therapeutic approaches to ongoing lifetime management.
RV, right ventricular; HFrEF, heart failure with reduced ejection fraction; HFpEF, heart failure with preserved ejection fraction; NET, neuroendocrine tumours; RH, right heart; EP,
electrophysiology; CIED, cardiac implantable electronic device; GUCH, grown-up congenital heart disease; TR, tricuspid regurgitation.

(https://ec.europa.eu/eurostat/databrowser/view/CENS_HNMGA__ Data from the UK Biobank showed that, compared to patients with
custom_6714995/default/table? lang=en). This would predict a poten­ no valvular heart disease, the risk of all-cause death is more than 2.5
tial population of 2.2 million individuals with at least moderate TR in times higher for TR.18 This is supported by a large population study
Europe. Topilsky et al., in a population-based registry, found a 0.55% of the National Echocardiography Database of Australia on 439 558
prevalence of at least moderate TR in the overall population, which in­ patients referred to echocardiographic examination19 that revealed a
creased with age and in women.16 The most common cause of TR was prevalence of moderate and severe TR of 5.9% and 1.8%, respectively.
left heart disease (valve disease or left ventricular dysfunction) and PH, Following adjustment for RV systolic pressure, atrial fibrillation, and left
while isolated, non-primary, TR was found in 8% of the population. The heart disease, severe TR was associated with 2.65 increased risk of
overall survival under medical management in patients with isolated TR mortality. Interestingly, increased risk was observed also in patients
was inferior to that of matched individuals with trivial TR (hazard ratio with mild (HR 1.24), or moderate TR (HR 1.72). Wang et al.20
-HR-15 1.17; P = .01). Nath et al. reported an increased mortality risk [ad­ performed a systematic review and meta-analysis suggesting that TR
justed for age, left ventricular ejection fraction, inferior vena cava (IVC) size, is associated with increased mortality independently of pulmonary
and right ventricular (RV)16 size and function] with moderate (HR 1.17) pressures and RH failure. The risk of mortality at a mean follow-up
and severe TR (HR 1.31) in a retrospective analysis of 5223 patients.17 of 3.2 ± 2.1 years increased from 1.25 to 1.61 and 3.44-fold in patients
Transcatheter tricuspid interventions 879

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Figure 1 Patient journeys across different tricuspid regurgitation phenotypes. Patients with significant tricuspid regurgitation come from diverse dis­
ease journeys and may be referred to the Valve Team by different specialists. Following screening and risk stratification, if tricuspid regurgitation is
deemed suitable for treatment, comprehensive multimodal imaging is essential for choosing the appropriate device, planning the procedure, and guiding
the intervention. Post-intervention, patients enter a lifelong care program within a network that emphasizes seamless continuity of care and ongoing
evaluation of their health outcomes. Abbreviations: A-STR, atrial secondary tricuspid regurgitation; V-STR, ventricular secondary tricuspid regurgitation;
PH, pulmonary hypertension; RV, right ventricular; MR, mitral regurgitation; TR, tricuspid regurgitation; TAVR, transcatheter aortic valve replacement;
CIED, cardiac implantable electronic device; AFib, atrial fibrillation; HFpEF, heart failure with preserved ejection fraction; PA, pulmonary artery; IVC,
inferior vena cava; SVC, superior vena cava; HTA, health technology assessment

with mild, moderate, or severe TR, respectively. Patients with at least prognosis of A-STR treated conservatively23 or following an interven­
moderate TR had an overall 2.56-fold increased cardiac mortality and tion24 is more favourable as compared to patients with V-STR, while
a 1.73-fold increased heart failure hospitalization rate. the impact of TR treatment in patients with fixed pre-capillary PH is de­
These data challenge the misconception that TR is a benign condition batable. Such variability deserves further investigation and targeted
and suggests us to refer patients presenting with at least moderate TR therapies for a tailored approach. Recently, a comprehensive risk strati­
to a valve centre with dedicated expertise for further risk stratification fication based on pheno-clusters including aetiology and clinical presen­
and management. tation has been proposed.25 RH function plays a major role in risk
assessment with signs of RV failure indicating later stages of disease
progression.26,27
Risk scores for assessing short-term mortality both for medically
Revised definitions unveiling treated28 and surgically treated29 patients have included both RV func­
different phenotypes and patient tion and RH failure symptoms, in addition to a number of other clinical
and laboratory parameters (Figure 2).
journeys Function follows morphology, and in the spectrum of TR subsets, the
TR disease can develop under diverse circumstances, leading to a wide anatomo-functional presentation of the valve and of the RH is highly
spectrum of phenotypes with different mechanisms and aetiology. The variable.30 Different mechanisms of regurgitation and disease progres­
PCR Focus group (https://www.pcronline.com/Network/Tricuspid- sion imply the need for different types of interventions. Recent ad­
Focus-Group) revised the TR classification21,22 (Table 1) subdividing vances in three-dimensional (3D) echocardiography and the use of
the formerly called functional TR into atrial secondary TR (A-STR) or tomographic imaging modalities allow a comprehensive investigation
ventricular secondary TR (V-STR), while primary TR encompasses a of the morphology of the valve apparatus and guide device selection
variety of subsets ranging from congenital malformation, traumatic for valve repair and replacement.
lesions to endocarditis. Cardiac implantable electronic device (CIED)- All the components of the valve apparatus play a role: leaflet and sub­
related TR is considered a separate entity with distinctive disease valvar apparatus distribution, annular shape and function, as well as right
mechanisms and management. In addition to the variability of valve atrial31 and ventricular32 function and morphology. To challenge the
morphology, mechanisms of regurgitation, and hemodynamics, clinical current nomenclature, TV has rarely three leaflets. Almost half of the
presentation seems to have prognostic relevance. This suggests differ­ valves with TR have more than three leaflets. This finding is highly rele­
ent patient journeys and referral pathways (Figure 1). As an example, vant for leaflet devices, such as Triclip (Abbott Vascular, Menlo Park, CA,
880 Maisano et al.

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Figure 2 Risk models for all-cause mortality for conservative and surgical treatment. (A) Risk model for 1-year all-cause mortality in isolated secondary
tricuspid regurgitation (adapted from Wang et al.28). (B) Surgical risk model for in-hospital mortality after isolated tricuspid regurgitation surgery
(adapted from Dreyfus et al.29)

USA) and Pascal (Edwards lifesciences, Irvine, CA, USA). A recent leaflet dimensional (2D) and 3D echocardiography is instrumental in defining
distribution classification33 has been proposed as a guide for patient the morphologic characteristics that differentiate the TR subpheno­
selection.34 types.31,39 State-of-the-art multi-modality imaging is required to appre­
Less invasive technologies to manage TR have ignited the need for a ciate the complexity of TV leaflet morphology,33 provide a nuanced
dedicated quantification model. Compared to mitral regurgitation quantitation of TR severity40 and to assess RH size and function.41
(MR), the TR regurgitant volumes are larger, requiring a grading scheme Because transcatheter devices can anchor at the leaflets, annulus, at­
taking into account more than severe TR.35 The new grading scheme, rium, ventricle, and vena cavae, pre-procedural imaging is key for the
which includes two more grades (massive and torrential TR) beyond se­ assessment of device suitability, prediction of efficacy, and guarantee
vere is reliable for risk stratification in patients treated conservatively,36 of technical success.21 A comprehensive evaluation of the TV should
as well as for patient selection and to assess postprocedural outcomes.37 be performed by transthoracic echocardiography to quantify the sever­
ity and aetiology of TR, assess left ventricular and RV size and function,
and the presence of concomitant disease of other valves or PH.
Imaging: a fundamental partner for Transoesophageal echocardiography (TEE) should be performed in
all patients considered for TTVI to further assess leaflet morphology
valvular interventions and function (i.e. mobility, tethering, and coaptation gaps), TR jet num­
The fundamental role of imaging and dedicated imagers for structural ber, size and location, annular morphology and size, and subvalvular
heart interventions is well established.38 Advanced imaging using two- anatomy (i.e. location and density of chordae, location/height of
Transcatheter tricuspid interventions 881

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Figure 3 Transesophageal echocardiography imaging levels. Recent screening guidelines recommend a standardized imaging protocol for evaluating
tricuspid valve structure and functionality. Three-dimensional imaging has become integral to the detailed assessment of the tricuspid valve, providing
critical insights into its morphology and function. Abbreviations: ME, mid-esophageal; RV, right ventricular; DE, deep esophageal; TG, transgastric; DT,
deep transgastric; SAX, short axis; A, anterior; P, posterior; S, septal; TEER, transcatheter edge-to-edge repair

papillary muscles). These anatomic parameters support optimal 3D intracardiac echocardiography (ICE) catheters already had a signifi­
patient-specific device selection. Multi-modality imaging has also be­ cant impact on TTVI technical success when TEE is suboptimal.49–52
come the standard for the assessment of procedural eligibility.34 Both TEE and ICE catheters have biplane imaging with both lateral
Computed tomography (CT) allows comprehensive anatomical evalu­ and elevational tilt, and live 3D multi-planar reconstruction (MPR)
ation of the TV complex, right ventricle, and right coronary artery. In which allows simultaneous visualization of three different (often or­
addition, CT is essential for pre-procedural planning of device delivery. thogonal) 2D images, in addition to the 3D volume. Because of the in­
Device-specific evaluation may include assessment of femoral or jugular numerable ways in which the images can be manipulated, a dedicated,
vein diameters, cavo-atrial angulation, or detailed evaluation of caval trained interventional imager is required for both TEE and ICE imaging
anatomy.42,43 Although currently underutilized for TR, cardiac magnet­ during TTVI.38
ic resonance (CMR) imaging is helpful to quantify TR in case of discrep­
ant echocardiographic findings44 and is the reference method to
quantify RV size and function.41,45 Current treatment options:
Intra-procedural imaging relies primarily on TEE and fluoros­
copy.34,46,47 New TEE screening guidelines have standardized TV im­
guidelines and real-world
aging48 and improved intra-procedural imaging protocols46 (Figure 3). The 2021 ESC/EACTS valvular heart disease guidelines recommend
The use of echo-fluoro fusion imaging may improve intra-procedural that interventional treatment of secondary TR may be considered in
communication between operators by the fusion of two modalities experienced Heart Valve Centers in symptomatic but inoperable pa­
from nearly orthogonal points of view.21 The recent introduction of tients, who are anatomically eligible and have the potential for a clinical
882 Maisano et al.

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Figure 4 Imaging protocols for in-hospital tricuspid regurgitation screening and treatment planning. For patients with severe symptomatic tricuspid
regurgitation, initial screening combines basic imaging techniques, predominantly transthoracic echocardiography, and right heart catheterization, with
clinical assessments to stage the disease. Intervention candidates, whether for transcatheter or surgical approaches, require further comprehensive
multimodal imaging to tailor the optimal treatment strategy and to support procedural and device selection
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Figure 5 Repair technologies approved for clinical use in Europe or actively under investigation. (A) Triclip (CE marked); (B) PASCAL (CE marked);
(C) Dragonfly; (D) Cardioband (CE marked); (E) MIA-T; (F) Cardiac Implants Tri-Ring; (G) Dragon Ring; (H ) F-clip; (I ) Coramaze; (J ) PivotTR; (K )
Mitrelix; (L) Croivalve Duo

benefit from the procedure.53 While the exact timing for the proced­ system optimized for T-TEER, while PASCAL can be used indifferently
ure in both symptomatic and asymptomatic with RH dilation is still mat­ for both atrio-ventricular valves. Both feature T-TEER devices of differ­
ter of debate, earlier referral is beneficial and supported by guidelines. ent sizes to accommodate for diverse leaflet anatomies and jet
As far as TTVI should be reserved for inoperable patients, surgical risk locations. The TriClip device features implants of four different sizes
should be assessed using specific risk scores. The common simplifica­ with an active closing mechanism. The most used device is the XTW,
tion that surgery is high risk, should be demystified. Overall surgical the longest and larger clip size, maximizing the amount of potential an­
risk in the Society of Thoracic Surgeons database is ∼7%. However, nular reduction.60 The fourth-generation device allows independent
hospital mortality is highly dependent on the disease stage and indica­ grasping and continuous pressure monitoring. The PASCAL system is
tion of treatment, being highest in patients with right-sided infective a nitinol-based device with a passive closing mechanism, incorporating
endocarditis.54 When surgery is performed at earlier stages, mortality two paddles and a spacer to fill the coaptation defect. The device has a
for isolated TR can be minimized.55 The TRI-SCORE registry developed unique elongation feature that minimize the risk of leaflet entangle­
an additive scoring method to predict hospital mortality in patients ment. Two sizes are available and continuous pressure monitoring is in­
undergoing surgery for isolated TR (Figure 2).29 Lacking a reliable meth­ tegrated in the steerable catheter. Additional devices are in early
od to avoid futility, data from real-world registries56–58 as well as local feasibility development and initial clinical trials. The Dragonfly61
experience within the Heart Team should guide decisions within the in- (Venus Medtec, Hangzhou, China) system is currently under
hospital pathway (Figure 4). first-in-man evaluation in China.
T-TEER addresses TR by a combination of leaflet approximation at
the site of regurgitation and indirect annular reduction. Initial efforts
Transcatheter valve repair have been challenged by anatomical complexity, lack of dedicated
devices, and intra-procedural imaging complexity. Initially, most im­
techniques plants were confined in the anteroseptal commissure, because of
Valve repair can be achieved with leaflet approximation devices, with the ease of approach and visualization by TEE. The anteroseptal co­
annuloplasty, or with other devices including ‘spacers’ (devices filling aptation line remains the main initial target, trying to approximate
the coaptation gap) and chordal approximation devices (Figure 5). leaflet in the centre of the valve. The clover technique requires an
The first transcatheter tricuspid valve repair (TTVr) has been per­ additional device in the postero-septal coaptation line62,63 to
formed with the MitraClip system (Abbott Vascular Inc, Santa Clara, maximize leaflet approximation and annular reduction.60 Safety and
CA, USA) in a corrected transposition patient with a morphologically efficacy of T-TEER have been shown in several single-arm
tricuspid left atrio-ventricular valve.59 Initially, tricuspid transcatheter registries64–67 and recently confirmed in pivotal trials.68 The improve­
edge-to-edge repair (T-TEER) with off-label MitraClip was broadly per­ ment of clinical outcomes follows TR reduction,57,68 while the ideal
formed in Europe, usually as an adjunct to mitral interventions. To-date, cut-off for residual gradients remains debated.69 Few non-randomized
T-TEER remains the most commonly performed TTVr procedure, with comparisons between devices show very comparable outcomes.70
two approved devices. The TriClip is a dedicated multi-steering delivery Several predictors of procedural success have been found. The
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Figure 6 Quality of life improvement (as assessed by Kansas City Cardiomyopathy Questionnaire) in various heart failure randomized controlled
trials. The quality of life improvements reported in the TRILUMINATE trial align with those seen in other structural heart disease studies and exceed
the enhancements typically noted in heart failure drug trials. In these trials, various interventions were evaluated: sacubitril/valsartan in
PARADIGM-HF;103 dapagliflozin in DEFINE-HF104 and DAPA-HF,105 intravenous ferric carboxymaltose in FAIR-HF;106 the MitraClip procedure for
secondary mitral regurgitation in COAPT,102 and transcatheter aortic valve implantation for intermediate-risk patients in PARTNER 2107

main anatomical determinants are the leaflet coaptation gap and the symptomatic functional TR.84 At 2 years, echocardiography showed
non-central or non-anteroseptal location of the jet.71,72 A threshold a 16% reduction in septolateral annular diameter, and ≤2+ TR in
for coaptation gap defining ineligibility for TEER is debatable, due 72% of patients. Six-minute walking distance and Kansas City
to its load dependency. Leaflet-to-annulus index72 is a promising al­ Cardiomyopathy Questionnaire (KCCQ) score improved by 73 m
ternative, derived from mitral interventions.73,74 Complex valve and 14 points, respectively. Despite its strong rationale, Cardioband
morphologies, with multiple leaflets, in isolation,33 or in combination is implanted only in very experienced centres, because of the com­
with larger gaps,75 are associated with residual TR. T-TEER is feasible plexity of the procedure, and the potential risk of coronary lesions.85
in selected patients with CIED leads with short-term clinical out­ For the same reasons, several other direct and indirect annuloplasty
comes comparable to patients without lead.76 devices have been discontinued or are in the early feasibility
Short and long-term outcomes are strongly affected by aetiology,77 stage,47,86–100 Second-generation devices are expected to simplify
clinical presentation,78 RH hemodynamics,79,80 comorbidities, organ re­ the procedure. The minimal effect on valve gradients, the minimal
serve, and stage of the disease.81 Recent registries show an overall im­ footprint of the implant, and the possibility of combining leaflet and
provement in safety and efficacy of T-TEER even in anatomically annular repair imitating surgery101 warrant further efforts in this field.
challenging scenarios. In the post-approval bRIGHT post-approval
study using the fourth-generation TriClip system, most patients were
highly symptomatic [New York Heart Association (NYHA) class III–
IV] and had more than severe TR. In this unselected population, hospital
Emerging randomized controlled
mortality and rate of adverse events were as low as 1% and 2.5%, re­ evidence: the impact of TR
spectively. Procedural success (reduction to ≤2+ TR) was obtained in
77% of patients, with early improvement of symptoms and QoL.
treatment
Predictors of success were smaller tethering distance and smaller right Although registries are key to explore the safety and feasibility of inter­
atrial volumes at baseline.58 Similarly, the CLASP TR trial reported a ventions, the fundamental question of whether TR treatment can influ­
3.1% 30 day-mortality, and sustained 1-year TR reduction (86% achiev­ ence survival remains to be answered. A propensity-matched analysis
ing ≤2+ TR),82 associated with improved QoL and symptoms and com­ comparing survival of patients undergoing TTVI to a historical series
parable results were reported in the PASTE post-market registry of medically treated patients suggested a potential survival benefit in pa­
including more than 230 patients.66 tients who received successful treatment.56
While T-TEER is the most performed intervention, annuloplasty The TRILUMINATE pivotal trial68 has a historical significance since it
replicates the most common surgical repair procedure, with the pe­ is the first randomized study investigating an isolated TR treatment
culiarity of leaving all alternative options open. Cardioband system strategy compared to medical therapy alone. The trial randomized
was the first TTVI device approved in Europe.83 Cardioband is im­ 350 symptomatic patients with severe TR with a hierarchical composite
planted under echocardiographic guidance with multiple anchoring primary endpoint at 1 year consisting of death or TV surgery, heart fail­
screws, followed by echo-guided annular reduction. The ure hospitalization, and improvement in QoL as measured with the
TRI-REPAIR observational study enrolled 30 patients with KCCQ. A minimal 15 KCCQ points improvement was considered
Transcatheter tricuspid interventions 885

Table 2 Comparison between the TRILUMINATE cohort and ‘real-world’ data from registries

TRILUMINATE RCT arm bRIGHT Study PASTE Registry TRISCEND I

(TriClip) n = 350 (TriClip) n = 511 (PASCAL) n = 603 (EVOQUE) n = 176
......................................................................................................................................................................................
Demographics
Age, years, mean ± SD 77.9 ± 7.3 78.9 ± 7.1 78 ± 9 78.7 ± 7.33

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Male/female sex 45%/55% 44%/56% 47%/53% 39%/71%
Medical history
NYHA class III/IV at baseline 57.5% 80% 89% 75.4%
Prior permanent pacemaker implantation 14.9% 22.5% 28% 32.4%
KCCQ score at baseline, mean ± SD 55.1 ± 23.8 44.5 ± 22.6 46.0 ± 21.8
Prior heart failure hospitalization lasts 12 months 25.1% 40.3% 40.9%
Baseline TR grade
Moderate 1.8% 2.0% 6% 12.5%
Severe 27.5% 10.0% 38% 44.7%
Massive/torrential 70.7% 88% 56% 42.8%
Key procedural data
Coaptation gap, mm, mean ± SD 5.4 ± 1.8 6.5 ± 2.7 6.3 ± 3.4
TR ≤ moderate at 30 days 87% 77% 81% 100%
SLDA rate 7.0% 3.8% 3% NA

KCCQ, Kansas City Cardiomyopathy Questionnaire; NYHA, New York Heart Association; SLDA, Single leaflet device attachment; RCT, randomized controlled trial; TR, tricuspid
regurgitation; SD, standard deviation.

relevant. The patient population included elderly individuals (mean 78 sided heart disease (particularly previous cardiac surgery) (Table 2).
years, 55% women), with reduced baseline QoL (mean KCCQ at base­ While QoL represents a relevant endpoint for elderly patients with
line: 55.1 ± 23.8 points). However, only 25% of the patients were ad­ TR, longer-term follow-up data are awaited to verify whether
mitted for heart failure treatment in the year before enrolment, T-TEER can influence more objective outcomes. Unfortunately, the
suggesting that, despite poor QoL, most TR patients remain managed possibility to crossover without experiencing an event at one year by
in the ambulatory setting. At baseline, TR was severe or worse in al­ design has the potential to blunt this expectation.
most all patients in both groups, while severe TR was still present in Several additional randomized studies comparing different treatment
95% of the control patients against 13% in the therapy arm at 1-year strategies with conservative treatment are currently enrolling in differ­
follow-up. This outcome contrasts with the COAPT trial, where MR ent countries (e.g. TRISCEND II, CLASP TR, TRICI-HF in Germany and
was reduced significantly also in the medical arm at 2 years.102 This find­ TRI-FR in France, TRICAV for heterotopic valve replacement with the
ing confirms the efficacy of T-TEER and underlines the inefficacy of TricValve system) and will provide further insights into the clinical im­
medical therapy to control TR in symptomatic patients. The procedure pact of TR treatment.
was safe, with 0.6% all-cause mortality at 30 days and only a few adverse
events. At 1 year, there was no difference in mortality, surgery for TR,
or hospitalization rate between the two groups, while KCCQ improved
Valve replacement
by 12.3 ± 1.8 points in the TEER group, in contrast to only .6 ± 1.8 In the timeline of TR interventions, transcatheter tricuspid valve re­
points in the control group (P < .001). placement (TTVR), as valve-in-valve108 and valve-in-ring procedures,
The improvement in QoL is similar to that observed in the device came first. The off-label implant of balloon-expandable aortic or pul­
group of the COAPT trial and larger than most of the heart failure trials monary valves109 efficiently restores failed surgical repair and replace­
(Figure 6). There was a direct correlation between QoL improvement ments. The implanted prostheses function as fixation scaffold for the
and TR reduction, suggesting a dose-effect, although a placebo effect balloon-expandable valves. The VIVID (Valve-in-Valve International
cannot be completely excluded due to trial design (patient-reported Database) registry reported outcomes of 306 patients undergoing
outcome, open-label trial). The TRILUMINATE trial is a matter of in­ valve-in-ring and valve-in-valve procedures, with an incidence of 17%
tensive debate, with all its intrinsic limitations, being the randomized mortality, 12% reintervention, and an 8% risk of valve-related complica­
study of a widely undefined field of interest. While observational studies tions at 3-year follow-up.110 Valve-in-ring and valve-in-valve have been
were predicting a much higher treatment impact, the TRILUMINATE performed successfully also in patients with preexisting pacemaker
trial included patients with a lower burden of symptoms (NYHA class leads without the need for lead extraction.111 Valve-in-ring procedures
and KCCQ) and hospitalizations before entering the study, less ad­ have been sometimes unsuccessful due to device and patient selection,
vanced V-STR with smaller coaptation gaps and lower incidence of left- although few reports are available in the literature.112 Patient selection,
886 Maisano et al.

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Figure 7 Transcatheter tricuspid valve replacement devices. Orthotopic devices: (A) Evoque; (B) Cardiovalve; (C ) Gate; (D) Intrepid; (E) Lux valve;
(F) V-Dyne, (G) Trisol; (H ) Topaz Heterotopic devices; (I ) Tric Valve; (J ) Trillium; (K) Tricento

imaging screening, and device selection are key elements to perform a were observed in 18% and 30% of patients at 30 days and 1 year, re­
safe and simple procedure in most cases. spectively. New pacemaker implantation was needed in 13% of patients
Balloon-expandable aortic valves have also been used as caval im­ within 30 days (none thereafter). At 1 year, patients had significant im­
plants,113,114 although this approach has been overcome by the devel­ provement in NYHA class, QoL, and functional status. In addition, 2
opment of dedicated devices. years outcomes of patients implanted under compassionate use
Heterotopic or caval valve implantation (CAVI) has been attempted show superimposable outcomes121 and reported a 37% increase of
to protect organs from venous hypertension and reduce left ventricular forward stroke volume and improvement of hepatic
backflow-associated TR. CAVI (Figure 7) has been mainly used in pa­ function. The TRISCEND II (NCT04482062) pivotal trial comparing
tients who either had a failed or had anatomical contraindications for Evoque TTVR to medical therapy is recruiting.
a ‘conventional’ transcatheter intervention. However, CAVI can be per­ Cardiovalve (Cardiovalve Inc., Or Yehuda, Israel), with leaflet fixation,
formed under local anaesthesia, solely fluoro-guided and non- requiring minimal radial force, therefore applicable to valves with large
constrained by TV anatomy. Dedicated prostheses are available with annulus, features a sealing cuff to minimize perivalvular leaks. The
different fixation modalities, such as single bicaval implant,115 or sepa­ TARGET trial (NCT05486832) is collecting feasibility safety outcomes
rated valves.116 A recent registry reported significant improvements in an international registry. To date, more than 40 patients have been
in QoL and symptoms despite no haemodynamic improvements fol­ enrolled. Data from 30 compassionate-use patients report 6% mortal­
lowing CAVI.117 More recently, RH remodelling has been reported fol­ ity, 6% pacemaker implant rate, and 6% need for reintervention. At dis­
lowing CAVI, suggesting a potential prognostic value.118 The exact role charge, TR was less than moderate in 92% of patients (George Nickenig,
of CAVI in the field needs to be further developed, considering its sim­ PCR London Valves 2023, personal communication).
plicity and reproducibility, with the inherent limitation of an interven­ Other technologies are under investigation in an early phase, such as
tion that does not address the culprit lesion. the Intrepid (Medtronic Inc, Minneapolis, MN, USA),122 the
Several orthotopic valve devices (Figure 7) are under clinical investi­ LuX-Valve123 (Jenscare Biotechnology, Ningbo, China), the Vdyne
gation, most of them derived from a mitral valve design, while few are (VDyne, Minneapolis, MN, USA), the Topaz (TRiCares SAS, Paris,
natively for the TV. The first TTVR with a dedicated device was per­ France) and Trisol Valve (TriSol Medical Ltd., Inc., Yokneam, Israel).
formed using the Gate (NaviGate Cardiac Structures, Inc.) valve.119 The Duo Valve (Croivalve, Dublin, Ireland) is a hybrid device
The large device, specifically designed to fit the large TV annulus, fea­ implanted in the superior vena cava but acting as a coaptation device
tures a combination of leaflet and annular fixation. Limitations in the de­ (either a valve or a spacer) at the valve level.
livery system have confined this device to mainly direct transatrial
access and have resulted in cases of malposition requiring surgical
revision.
Spacers
The experience with the Evoque system (Edwards Lifesciences Inc, Several attempts to treat atrio-ventricular valve regurgitation with
Irvine, CA, USA), a self-expanding device using a mix of leaflet and an­ spacers have been until now discouraging. These devices fill the regur­
nular fixation, with a dedicated delivery system is the largest so far. The gitant orifice to reduce backflow. The main limitation is the stability of
safety-efficacy trial TRISCEND120 collected data on 172 patients. fixation and efficacy in a complex 3D-shaped regurgitant orifice. The
Cardiovascular mortality was 1.7% and 9.4%, and major adverse events FORMA spacer was fixated at the subclavian vein and the apex of the
Transcatheter tricuspid interventions 887

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Figure 8 Decision-making and device selection algorithm for primary isolated tricuspid regurgitation. Initial echocardiographic screening, often via
transoesophageal approach, is essential to evaluate the extent and cause of regurgitation and to examine right heart function and structure. If lesions
are unsuitable for tricuspid transcatheter edge-to-edge repair, a cardiac computed tomography scan becomes crucial to scrutinize the anatomical de­
tails, determining suitability for alternative interventions like transcatheter tricuspid valve replacement or caval valve implantation (TEE, transoesopha­
geal echocardiography; CT, computed tomography; TTVR, transcatheter tricuspid valve replacement; CAVI, caval valve implantation; T-TEER, tricuspid
transcatheter edge-to-edge repair)

right ventricle. A multicenter registry demonstrated some reduction of key for success. Currently, T-TEER accounts for more than 90% of the
regurgitation with improvement in QoL,124 however, its production indications. Future changes in this prevalence depend on ease of use, scal­
has been discontinued. A recent revival of spacers is observed,125 re­ ability, clinical outcomes, and availability of approved devices. Device se­
gaining interest due to their independence from valve anatomy and sim­ lection is made by the Heart Team in a step-wise process that involves
plicity of implant, but clinical outcomes are unavailable.124–126 careful clinical and anatomical assessment. Multi-modality imaging help
to assess the aetiology, mechanism of regurgitation, valve anatomy,
deliverability and device eligibility, and to evaluate RV function and RH,
physiology (to predict the tolerability of the procedure in end-stage
Device selection and screening patients).
process: tailoring the therapy to In case of primary (organic) TR, T-TEER is an option for localized le­
sions (Figure 8). In patients with ruptured papillary muscles (usually
patients post-traumatic), T-TEER may be considered but surgery is the most
Once indication for TTVI is given, based on a predicted clinical benefit in common solution.127 Patients with restricted leaflet motion or with a
high risk or inoperable patients, TTVI device and procedure selection is a lack of tissue (e.g. carcinoid disease) should be referred to TTVR
888 Maisano et al.

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Figure 9 Decision-making and device selection algorithm for cardiac implantable electronic device-tricuspid regurgitation. Echocardiography, occa­
sionally supplemented by CT imaging to better delineate the cardiac implantable electronic device pathway, is pivotal for evaluating how the cardiac
implantable electronic device affects tricuspid valve functionality. Should the cardiac implantable electronic device be implicated in tricuspid regurgita­
tion (cardiac implantable electronic device-related tricuspid regurgitation), interventions such as lead extraction, repositioning, or device replacement
may be initiated by an electrophysiologist. Additionally, advanced imaging is indispensable for elucidating the regurgitation dynamics and for tailoring
treatment to the patient’s specific anatomical considerations (CIED, cardiac implantable electronic device; TEE, transoesophageal echocardiography;
CT, computed tomography; EP, electrophysiology; T-TEER, tricuspid transcatheter edge-to-edge repair; TTVR, transcatheter tricuspid valve replace­
ment; CAVI, caval valve implantation)
Transcatheter tricuspid interventions 889

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Figure 10 Decision-making and device selection algorithm for secondary isolated tricuspid regurgitation. The algorithm for decision-making in iso­
lated secondary tricuspid regurgitation is intricate, requiring multiple steps. Initially, a distinction is made between atrial and ventricular tricuspid regur­
gitation based on clinical and echocardiographic data. Atrial secondary tricuspid regurgitation demands a collaborative approach with electrophysiology
experts to devise rhythm management strategies. For ventricular secondary tricuspid regurgitation, especially in advanced stages, right heart catheter­
ization is essential to gauge the severity and characteristics of pulmonary hypertension and to evaluate right heart function. The choice of intervention
and device is then guided by detailed valve anatomy and cardiac function assessments through multimodal imaging (CIED, cardiac implantable electronic
device; TEE, transoesophageal echocardiography; CT, computed tomography; EP, electrophysiology; T-TEER, tricuspid transcatheter edge-to-edge re­
pair; TTVA, transcatheter tricuspid annuloplasty; TTVR, transcatheter tricuspid valve replacement; CAVI, caval valve implantation)
890 Maisano et al.

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Figure 11 Device selection: key constraints of various tricuspid regurgitation treatment technologies. This figure outlines the technical obstacles for
each tricuspid regurgitation treatment technology. Tricuspid transcatheter edge-to-edge repair effectiveness is constrained by factors such as the co­
aptation gap, leaflet number and distribution, transoesophageal echocardiography image quality, and the presence of transvalvular leads. Transcatheter
tricuspid valve annuloplasty applicability is limited by the extent of right ventricular remodelling, leaflet tethering, proximity of the right coronary artery
to the annulus, as well as device complexity and imaging requirements during the procedure. Transcatheter tricuspid valve replacement faces limitations
due to the annulus size and shape, right ventricular dimensions, subvalvular apparatus anatomy, and the venous system’s size and anatomy, with specific
devices presenting unique anatomical contraindications (T-TEER, tricuspid transcatheter edge-to-edge repair; TTVA, transcatheter tricuspid valve an­
nuloplasty; TTVR, transcatheter tricuspid valve replacement)

(when available) or CAVI. Obviously, surgery should be reconsidered in moderate tethering, as seen in patients with late forms of A-STR and
patients who are not eligible for any TTVI procedure, and is mandatory concomitant RV remodelling.
in most patients with active infective endocarditis. The main limitation of T-TEER (Figure 11) is the coaptation gap and
Patients with CIED-related TR (Figure 9) can be challenging.128 First, the leaflet anatomy, while annuloplasty is limited by leaflet tethering,
multi-modality imaging is required to determine whether TR is caused and the anatomy of the right coronary artery. In patients with V-STR,
by the CIED (CIED-related TR) or the lead has no direct impact on the while T-TEER remains the most common treatment, TTVR and
mechanism of regurgitation (CIED-associated TR). In very selected cases CAVI are a potential alternative, when the right ventricle is remodelled
of CIED-related TR, a lead management strategy can be attempted by re­ and the disease more advanced. CAVI is an option for end-stage un­
placing, relocating,129 or removing130 the lead and implanting a valve- treatable patients in whom a palliative approach is needed, while its
sparing pacemaker system (leadless pacemaker or coronary sinus lead). use in the earlier stages is still under evaluation.117 Orthotopic TTVR
However, lead extraction, particularly in patients with leads entangled in is a very promising alternative to repair due to the predictability of
the subvalvular apparatus, can worsen TR by generating additional le­ TR reduction and to the ease of use. However, several anatomical lim­
sions131 (even in leadless pacemakers.132) In case of CIED-associated itations are excluding a large number of potential candidates. The eligi­
TR, T-TEER, and annuloplasty are not contraindicated and the presence bility anatomical criteria are strictly related to the delivery system and
of a CIED seems to have no impact on outcomes.76 On the other hand, the mode of fixation of the different prostheses. They include the size
if the lead is actively involved and adherent to a valve structure, repair tech­ and shape of the annulus, the size of the right ventricle, the quality of the
niques should be used only in very experienced hands. leaflet tissue, and the deliverability (venous access and angle between
TTVR can be a good alternative, although the issue of lead manage­ the IVC and the valve). In addition, patients considered for TTVR
ment remains debated. Many patients have been treated by jailing the undergo a more comprehensive evaluation of RV function. A suitable
lead without acute effects,110,133 but there are some cases of damaged coupling between pulmonary resistance and RV function is considered
leads and other complex situations (e.g. need for infected lead extrac­ a reliable method to exclude the risk of afterload mismatch.80,135–137
tion following TTVR.134)
In the case of secondary TR (Figure 10), the treatment options are
wider.21 Patients with A-STR can be successfully treated with either
Future perspectives
T-TEER or annuloplasty. Annuloplasty (eventually followed by TEER) To optimize outcomes, awareness, and early disease detection and
can be very efficient in patients with larger coaptation gaps and minimal management have to be further encouraged. In the era of individualized
leaflet tethering, while T-TEER is more adequate for patients with precision medicine, TTVI offers the opportunity to apply innovative
Transcatheter tricuspid interventions 891

treatment approaches and gain systematic evidence in a largely under­ from Abbott Vascular, Edwards Lifesciences, Polares medical, Medira,
investigated field of modern cardiology. Given the high disease com­ and Siemens Healthineers. Philipp Lurz has received institutional grants
plexity of TR, with several clinical phenotypes and crossing patient from Abbott Structural, ReCor and Edwards Lifesciences, Honoraria
journeys, a one-size-fits-all approach is unlikely to succeed. Novel diag­ from ReCor and Innoventric and holds share options of Innoventric.
nostic and patient selection tools, including artificial intelligence, able to
integrate multiple variables, analyze large datasets, harmonize layers of
knowledge, and competence should be implemented to guide
Data Availability
decision-making. No data were generated or analysed for or in support of this paper.

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Combining multi-modality imaging with circulating biomarkers may
inform about the biological mechanisms that contribute to disease pro­ Funding
gression and allow for future pathway-specific therapies and persona­ Nothing to declare.
lized treatments.138 Moreover, they may help identifying early red
flags, as well as late signs of futility.139 Further basic and clinical research
is needed to identify novel biomarkers that indicate early disease of the References
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