83. Tanscatheter Mitral and Tricuspid Valve Interventions- Indications and Guidelines

Jessica G.Y. Luc MD LLM, Busra Cangut MD MS, David Barry MD, Paul M. Coady MD, Eric Gnall DO, William A. Gray MD, Sandra V. Abramson MD, Katie M. Hawthorne MD, Harish Jarrett MD, Khalid Ridwan MD, Roberto Rodriguez MD MSc, Scott M. Goldman MD, Basel Ramlawi MD MSc
Lankenau Medical Center, Main Line Health

Icahn School of Medicine

October 2024

Abbreviations & Definitions

ACC/AHA – American College of Cardiology and the American Heart Association
ASE – American Society of Echocardiography
CABG – Coronary artery bypass grafting
ERO – Effective regurgitant orifice
ESC/EACTS – European Society of Cardiology and the European Association for Cardio-Thoracic Surgery
FDA – U.S. Food and Drug Administration
GDMT – Guideline-directed medical therapy
LVEF – Left ventricular ejection fraction
LVESD – Left ventricular end systolic diameter
MAC – Mitral annular calcification
MG – Mean gradient
MR – Mitral regurgitation
MS – Mitral stenosis
MVA – Mitral valve area
NYHA – New York Heart Association
PAH – Pulmonary arterial hypertension
PASP – Pulmonary artery systolic pressure
PAWP – Pulmonary artery wedge pressure
PHT – Pressure half time
PMBC – Percutaneous mitral balloon commissurotomy
RWMA – Regional wall motion abnormality
TAVI – Transcatheter aortic valve implantation
TEER – Transcatheter edge-to-edge repair
TR – Tricuspid regurgitation
TS – Tricuspid stenosis
VAD – Ventricular assist device
VARC – Valve Academic Research Consortium
VTI – Velocity time integral

Indications & Guidelines for Management by Grade/Stage of Disease

The indications and guidelines for the management of mitral valve disease are provided by the 2020 ACC/AHA guidelines for the management of patients with valvular heart disease.1 The following chapter will focus on the 2020 ACC/AHA valve guidelines with a discussion on mitral stenosis (MS) and regurgitation (MR), as well as valve-in-valve interventions. In addition, a comparison of the 2020 ACC/AHA valve guidelines with the 2021 ESC/EACTS valve guidelines2 will be offered as a supplement.

A. Mitral Stenosis

Management of MS in the 2020 ACC/AHA valve guidelines1 is based on the stages and quantitative classification of severity grade (Table 1), which are supplemented by the ASE guidelines.3 The indications for intervention for MS are shown in Table 2, notably, these are indications for intervention (either mitral valve surgery or percutaneous mitral balloon commissurotomy [PMBC]).

Surgical mitral valve replacement is recommended if the patient has a Wilkins score >8 (range 4-16), nonpliable mitral valve, left atrial thrombus, presence of ≥mild MR, severe or bicommissural calcification, absence of commissural fusion, mitral valve area >1.5 cm2, or concomitant cardiac lesions requiring intervention.

Table 1: Components of the Wilkins score that are used in determining the likelihood of success of PMBC in the 2020 ACC/AHA valve guideline.

Grade Leaflet Mobility Valve Thickening Calcification Subvalvular Thickening
1 Highly mobile (except leaflet tip) Near normal (4-5 mm) Single area of brightness Minimal chordal thickening
2 Reduced mobility (leaflet and base move) Thickened tips (5-8 mm) Scattered areas at leaflet margins Chordal thickening up to 1/3
3 Basal leaflet motion only Entire leaflet thickened (5-8 mm) Brightness extends to mid leaflets Up to distal 2/3 of chordae thickening
4 Minimal motion  Marked leaflet thickening (>8 mm) Extensive leaflet brightness Extensive thickening to papillary muscle 

Table 2: Comparison of the 2020 ACC/AHA and the 2021 ESC/EACTS valve guidelines in the management of rheumatic and nonrheumatic MS.

ACC / AHA 2020 Valve ESC / EACTS 2021 Valve Recommendation Class
Indications for PMBC / mitral valve surgery for mitral stenosis
Rheumatic mitral stenosis
Symptomatic (Stage D) -> PMBC Same Class I
Severely Symptomatic (NYHA III/IV) (Stage D) who
1) not candidates for PMBC
2) failed a previous PMBC
3) require other cardiac procedures, or
4) do not have access to PMBC
-> mitral valve surgery (repair, commissurotomy, or valve replacement)		 Same Class I
Severely Symptomatic (NYHA class III/IV) (Stage D) + suboptimal valve anatomy + high risk for surgery -> PMBC Symptomatic, suboptimal anatomy, but no unfavourable clinical characteristics -> PMBC ACC: Class IIb; ESC: Class IIa
Asymptomatic (Stage C) + PASP >50 mmHg -> PMBC Asymptomatic + high risk of hemodynamic decompensation with 1 of
1. PASP >50mmHg at rest
2. Need for major non cardiac surgery
3. Desire for pregnancy
-> PMBC		 Class IIa
Asymptomatic (Stage C) + new onset of atrial fibrillation -> PMBC Asymptomatic + high thromboembolic risk with 1 of
1. Systemic embolism
2. Dense spontaneous contrast in left atrium
3. New onset or paroxysmal atrial fibrillation
-> PMBC		 ACC: Class IIb; ESC: Class IIa
Exertional symptoms (MVA>1.5cm2) (Stage B), + stress test hemodynamically significant with 1 of PAWP >25mmHg, PASP ≥60mmHg, or MG >15mmHg during exercise
-> PMBC		 Class IIb
Nonrheumatic mitral stenosis
Severely symptomatic (NYHA class III/IV) (Stage D) with extensive MAC -> valve intervention Class IIb
Note: PMBC needs Wilkins ≤8, pliable valve, <2+ mitral regurgitation, no clot
*Suboptimal anatomical characteristics = Wilkins &gt;8, small MVA, severe tricuspid regurgitation
*Suboptimal clinical characteristics = old age, history of commissurotomy, NYHA 4, permanent atrial fibrillation, severe pulmonary hypertension

B. Mitral Regurgitation

Management of MR in the 2020 ACC/AHA valve guidelines1 is based on the stages, then subclassified based on etiology as primary versus secondary. Management indications are further stratified by quantitative classification of severity grade (supplemented by the ASE3). The indications for intervention (either mitral valve surgery or transcatheter edge-to-edge repair [TEER]) are detailed for primary (Table 3) and secondary MR (Table 4).

Note that there are also anatomic leaflet criteria for TEER,4 where the ideal patient with secondary MR would have adequate coaptation length (>2 mm) and not be severely tethered (coaptation depth <11 mm). The ideal patient with primary MR for TEER would not have excessive flail width (>15 mm) and/or flail gap (>10 mm), with single-segment pathology and normal leaflet thickness. Primary and secondary MR also share “generic” criteria including adequate mobile posterior leaflet length (>10 mm), mitral valve area >4 cm2 (since TEER will typically reduce baseline MV area by at least 40-50%), lack of significant leaflet calcification in grasping area, and lack of cleft(s), which may either be the source of residual MR post-TEER or be made worse once grasp/tension is exerted on the adjacent leaflet. The presence of adequate primary and secondary chordal support, no commissural prolapse, and limited leaflet calcification or severe MAC, especially when contributing to reduced MV area, are also desirable characteristics; however, TEER may still be appropriate (with the understanding that the outcome may be suboptimal) if a surgical option is prohibitively risky. Contraindications to TEER include patients who are unable to tolerate procedural anticoagulation or post-procedural antiplatelet regimen, active endocarditis of the mitral valve, rheumatic mitral valve disease, or those with evidence of intracardiac, inferior vena cava, or femoral venous thrombus.

Table 3: Comparison of the 2020 ACC/AHA and the 2021 ESC/EACTS valve guidelines in the management of symptomatic and asymptomatic primary MR.

ACC / AHA 2020 Valve ESC / EACTS 2021 Valve Recommendation Class
Symptomatic Severe Primary Mitral Regurgitation
Stage D -> mitral valve intervention Same Class I
Severely Symptomatic (NYHA class III/IV) with high or prohibitive surgical risk -> TEER if life expectancy is >1 year Inoperable -> TEER ACC: Class IIa; ESC: Class IIb
Rheumatic, mitral valve repair may be considered Class IIb
Asymptomatic Severe Primary Mitral Regurgitation
Left ventricular systolic dysfunction (LVEF ≤60%, LVESD ≥40 mm) (Stage C2), mitral valve surgery Same Class I
LVEF >60%, LVESD <40 mm (Stage C1), mitral valve repair if likelihood of successful and durable repair without residual mitral regurgitation >95% with expected mortality rate of <1% LVEF ≥60%, LVESD ≤40mm, atrial fibrillation secondary to mitral regurgitation or pulmonary hypertension (PASP at rest >50mmHg) ACC: Class IIa; ESC: Class IIa
Low risk, normal LVEF, left atrial dilation (volume index ≥60mL/m2 or diameter ≥55mm) -> mitral valve repair if durable repair likely Class IIa
LVEF >60%, LVESD <40mm (Stage C1), progressive increase in left ventricular size or decrease in LVEF on ≥3 serial imaging studies, mitral valve surgery Class IIb
General
Mitral valve repair preferred over mitral valve replacement when mitral regurgitation is degenerative (expectation is that surgeons should have a success rate of ≥95% for posterior leaflet repair) Same Class I
Leaflet pathology <50% posterior leaflet, mitral valve replacement should not be performed unless mitral valve repair has been attempted (Note: This is in contrast to anterior or bileaflet primary mitral valve disease which requires a complex/extensive repair with less certain durability) Class III

Table 4: Comparison of the 2020 ACC/AHA and the 2021 ESC/EACTS valve guidelines in the management of secondary MR.

ACC / AHA 2020 Valve ESC / EACTS 2021 Valve Recommendation Class
Severe Secon

ACC / AHA 2020 Valve ESC / EACTS 2021 Valve Recommendation Class
Severe Secondary Mitral Regurgitation Indications for Intervention
TEER
Symptomatic LVEF 20-50%, LVESD ≤70mm, PASP ≤70mmHg (Stage D), favorable anatomy -> TEER Symptomatic, LVEF 20-50%, LVESD <70mm, not surgical candidate ± concomitant cardiac disease -> PCI (± TAVI) followed by TEER (in case of persisting severe secondary mitral regurgitation) Class IIa
Symptomatic, LVEF 20-50%, LVESD ≤70mm, high risk / inoperable / suboptimal TEER -> consider TEER, transcatheter valve therapy after evaluation for VAD or transplant ESC: Class IIb
Surgical Mitral Valve Intervention
(Stages C/D) undergoing other cardiac surgery Same ACC: Class IIa; ESC: Class I
Symptomatic, LVEF <50% (Stage D), NYHA 3/4, not suitable for TEER ACC: Class IIb
Symptomatic, LVEF ≥50% (Stage D) with atrial annular dilation Same Class IIb
For MVR
Symptomatic, coronary artery disease, LVEF <50% (Stage D) undergoing mitral valve surgery, chordal-sparing mitral valve replacement preferred over downsized annuloplasty repair Class IIa
Note: No recommendation for moderate ischemic mitral regurgitation (Stage B) undergoing CABG for mitral valve repair (previously 2b) but now gone in 2020 version of the guideline
TEER needs: LVEF 20-50%, LVESD and PASP &lt;70
Not favorable for TEER: vertical coaptation length &lt;2mm, calcium at the grasping area (A2/P2), lack of both primary and secondary chordal support

urgitation, patient prosthesis mismatch, or other factors such as pannus, inappropriate position, or embolization), thrombosis, and endocarditis.

Table 5: Comparison of the 2020 ACC/AHA and the 2021 ESC/EACTS valve guidelines in the choice between reoperative surgical mitral valve intervention vs. TEER or transcatheter valve-in-valve in the management of prosthetic valve MS or MR.

ACC / AHA 2020 Valve ESC / EACTS 2021 Valve Recommendation Class
Prosthetic Valve Stenosis
Surgical repair
Bioprosthetic or mechanical, symptomatic severe stenosis, repeat surgery Same Class I
Asymptomatic severe prosthetic dysfunction, low risk, repeat surgery Class IIa
Percutaneous repair
Bioprosthetic aortic valve stenosis, symptomatic, high or prohibitive surgical risk, TAVR valve in valve Same Class IIa
Bioprosthetic mitral or tricuspid stenosis, high risk, transcatheter valve in valve Class IIb
Prosthetic Valve Regurgitation
Surgical repair
Prosthetic transvalvular or paravalvular leak + (intractable hemolysis or heart failure), surgery Same, + related to endocarditis Class I
Asymptomatic, severe prosthetic regurgitation, low operative risk, surgery Class IIa
Percutaneous repair
Prosthetic paravalvular regurgitation w/
1) intractable hemolysis or NYHA class III/IV
2) high or prohibitive surgical risk
3) anatomic features suitable for catheter-based therapy,
percutaneous repair		 Same Class IIa
Bioprosthetic valve regurgitation, severe heart failure, high to prohibitive surgical risk, transcatheter valve in valve Class IIa

D. Tricuspid Valve Regurgitation and Stenosis

Management of tricuspid regurgitation (TR) and stenosis (TS) in the 2020 ACC/AHA valve guidelines1 is based on the stages, then subclassified based on etiology. Management indications are further stratified by quantitative classification of severity grade (supplemented by the ASE3). The indications for intervention (either tricuspid valve surgery or percutaneous intervention) are detailed for primary and secondary TR as well as TS (Table 6).

Table 6: Comparison of the 2020 ACC/AHA and the 2021 ESC/EACTS valve guidelines in the management of symptomatic and asymptomatic primary and secondary TR and TS.

ACC / AHA 2020 Valve ESC / EACTS 2021 Valve Recommendation Class
Primary TR
(Stages C and D) Undergoing other cardiac surgery -> surgery Same Class I
(Stage B) undergoing other cardiac surgery -> surgery if 1 of
1. Tricuspid annular dilation (tricuspid annulus end diastolic diameter >40mm)
2. Right heart failure		 Moderate primary TR undergoing other cardiac surgery -> surgery Class IIa
Severe primary TR (Stage D) + right heart failure -> isolated tricuspid valve surgery to reduce symptoms and recurrent hospitalizations Symptomatic severe primary TR without severe right ventricular dysfunction -> surgery ESC: Class I
Asymptomatic severe primary TR (Stage C) + progressive right ventricular dilation or systolic dysfunction -> isolated tricuspid valve surgery Same ACC: Class IIb; ESC: Class IIa
(Stage D) + right heart failure who have undergone previous left-sided valve surgery -> reoperation with isolated tricuspid valve surgery in the absence of severe PAH or severe right ventricular systolic dysfunction Class IIb
Secondary TR
(Stages C and D) undergoing other cardiac surgery -> surgery Same Class I
(Stage B) undergoing other cardiac surgery -> surgery if 1 of
1. Tricuspid annular dilation (tricuspid annulus end diastolic diameter >40mm)
2. Right heart failure		 Mild or moderate secondary TR undergoing other cardiac surgery -> surgery if tricuspid annular dilation (≥40mm or >21mm/m2) Class IIa
Severe secondary TR (Stage D) + right heart failure due to annular dilation (in the absence of PAH or left-sided disease) -> isolated tricuspid valve surgery to reduce symptoms and recurrent hospitalizations Right ventricular dilation or symptoms, Severe secondary TR ± previous left sided surgery, absence of right or left ventricular dysfunction and severe PAH -> surgery ESC: Class IIa
(Stage D) + right heart failure who have undergone previous left-sided valve surgery -> reoperation with isolated tricuspid valve surgery in the absence of severe PAH or severe right ventricular systolic dysfunction Severe secondary TR with previous left sided surgery + symptoms or right ventricular dilation (in the absence of right or left ventricular dysfunction and severe PAH) -> surgery Class IIb
Symptomatic severe secondary TR, inoperable -> transcatheter tricuspid valve repair or replacement Class IIb
TS Indications for Intervention
Symptomatic severe TS -> Surgery or percutaneous balloon valvuloplasty Class I
Severe TS undergoing other cardiac surgery -> Surgery Class I

Supporting Evidence for Current Indications and Guidelines

Guideline-Directed Medical Therapy (GDMT) vs. TEER in Secondary MR

There have been three major multicenter randomized controlled trials evaluating the use of TEER with GDMT vs. GDMT alone in patients with symptomatic severe secondary MR. The main trials include the COAPT Trial,7 which found that among 614 patients with LVEF 20-50% and LVESD ≤70 mm, TEER significantly reduced hospitalizations for heart failure (36% vs. 68% for GDMT) and improved mortality (29.1% vs. 46.1%) at 24 months, with freedom from device-related complications of 97% at 12 months. In contrast, the MITRA-FR Trial8 demonstrated no significant differences in the primary outcome of death or hospitalization for heart failure for patients with severe MR who were unsuitable for mitral valve surgery in those treated with TEER vs. GDMT (55% vs. 51%).

Possible reasons for differences amongst the two landmark trials include enrollment of patients with more severe MR (EROA >30 in COAPT vs. >20 in MITRA-FR) and less dilated ventricles in the COAPT trial (LVEDV 101 vs. 135, respectively), as well as differences in the success rate of reduction of MR post-TEER, where more patients had >3+ MR in MITRA-FR (5% in COAPT vs. 9% in MITRA-FR).9

RESHAPE-HF210 was recently published, which demonstrated that TEER with GDMT was superior to GDMT alone for the primary endpoint, rate of heart failure hospitalization or cardiovascular death at 24 months (37.0 vs. 58.9 events per 100 patient-years [RR 0.64, 95% CI: 0.48-0.85, p=0.002]; number needed to treat = 5.1).

These trials paved the way towards demonstrating the effectiveness of TEER in reducing heart failure symptoms in patients with severe symptomatic MR refractory to GDMT as compared to GDMT alone, leading to both an FDA device extension of indication and the aforementioned guideline inclusion criteria.

TEER vs. Mitral Valve Repair/Replacement for Primary MR

The EVEREST II trial11 was the first multicenter randomized trial comparing TEER to mitral valve repair/replacement in patients with moderate/severe MR and found that patients undergoing surgery had a significantly higher freedom from death, surgery for mitral valvular dysfunction, or residual MR ≥3+ or 4+. Notably, of this population of patients, approximately 70% were patients with primary MR and 30% were secondary, with 14% of the surgical arm receiving surgical mitral valve replacement rather than repair. The results demonstrated improved MR reduction in the surgical arm, greater safety in the TEER arm (largely related to differences in transfusion), and greater need for a secondary procedure in the TEER arm. Despite these observations, there were no differences between groups in heart failure classification through 5 years.

TEER vs. Mitral Valve Repair/Replacement for Secondary MR

The recent multicenter MATTERHORN12 trial demonstrated that TEER was noninferior to surgical mitral valve repair in patients with symptomatic severe secondary MR despite GDMT for the primary efficacy outcome of death, heart failure hospitalization, mitral reintervention, assist device implantation, or stroke (17% in the TEER group vs. 23% in the surgery group [p for noninferiority < 0.001]). Recurrence of grade ≥3+ or 4+ MR at 1 year was 8.9% in the TEER group vs. 1.5% in the surgery group (p for noninferiority = 0.02). Limitations of the MATTERHORN trial are a relatively small trial of 210 patients with a wide noninferiority margin of 17.5% and short follow-up of 1 year, among other limitations.

Ongoing studies evaluating TEER vs. mitral valve repair in the treatment of primary MR include the MITRA-HR13 evaluating outcomes in patients at high surgical risk, the REPAIR MR trial14 evaluating outcomes in moderate surgical risk patients, as well as the PRIMARY trial15 evaluating outcomes in patients across all surgical risk spectrums.

GDMT vs. TEER for TR

The TRILUMINATE trial16 demonstrated that TEER was effective in improving quality of life compared to GDMT in patients with severe symptomatic TR with intermediate or greater risk for mortality/morbidity with tricuspid valve surgery, with a reduction in TR severity to moderate or less in 87% of patients.

Furthermore, there are several studies that are ongoing evaluating transcatheter mitral and tricuspid valve replacement that will better inform options and outcomes for patients in the future.

Ongoing Trials

Significant efforts are underway to expand treatment options for mitral and tricuspid valve disease, particularly through minimally invasive, transcatheter approaches. Multiple ongoing clinical trials are currently recruiting patients with varying risk profiles. One such study, the APOLLO trial, is evaluating the Intrepid transcatheter mitral valve replacement system in patients with severe symptomatic MR who are at high or extreme risk for conventional surgery. In the tricuspid space, there is the TRISCEND II trial, which is evaluating the Evoque transcatheter tricuspid valve replacement system in patients with severe TR, among other trials. Similarly, the CLASP IID/IIF trial is investigating the Edwards PASCAL Transcatheter Valve Repair System to assess its safety and effectiveness in patients with degenerative MR who are considered at prohibitive surgical risk by the Heart Team. Another study (MitraClip Repair MR study) is examining the clinical outcomes of the MitraClip™ device compared to surgical repair in patients with severe primary MR.

These ongoing trials are crucial in advancing the treatment landscape for mitral valve disease, providing important data on the safety and efficacy of emerging transcatheter therapies. Collectively, these studies reflect a strong commitment to improving patient outcomes and broadening the spectrum of minimally invasive treatment options for mitral valve disease.

Expert Commentary

Mitral and tricuspid valve disease is a complex condition that demands a nuanced and multidisciplinary approach to management. The Heart Team model plays a critical role in ensuring optimal decision-making by bringing together diverse expertise. Key elements of successful treatment include careful patient selection, meticulous procedural planning, and the thoughtful integration of emerging transcatheter technologies into clinical practice. Over the past decade, there have been significant advancements in transcatheter mitral and tricuspid valve interventions, with several novel devices showing promising early results and the potential to transform the treatment landscape.

Sources

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