MitraClip and Tertiary Mitral Regurgitation—Mitral Regurgitation Gets Curiouser and Curiouser

Carabello, Blasé A.

doi:10.1001/jamacardio.2019.0195

Cited by 22 publications

(17 citation statements)

References 11 publications

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“…Considering both trials together, one might postulate that MitraClip might benefit very selected in whom the functional MR is thought to be responsible for a worsening left ventricle function, and not solely the result of a progressive enlargement of the left ventricle and atrium. Some authors proposed the concept of "tertiary" MR to describe these patients, in whom MR severity is excessive with regard to a moderate left ventricle dysfunction and dilatation [19]. Consecutively, the upcoming international guidelines are likely to adopt a COAPT-like approach and propose criteria for MC aiming at patients with a "tertiary" functional MR rather than the currently recommended compassionate approach [11]: moderate or severe, LVEF 20-50% and left ventricle endsystolic diameter ≤ 70 mm with symptoms despite maximally tolerated medical therapy.…”

Section: Edge-to-edge Transcatheter Mitral Valve Plastymentioning

confidence: 99%

Advances in transcatheter mitral and tricuspid therapies

Overtchouk

Piazza

Granada

et al. 2020

BMC Cardiovasc Disord

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Background: While rheumatic mitral stenosis has been effectively treated percutaneously for more than 20 years, mitral and tricuspid regurgitation treatment appear as a contemporary unmet need. The advent of transcatheter therapies offer new treatment options to often elderly and frail patients at high risk for open surgery. We aimed at providing an updated review of fast-growing domain of transcatheter mitral and tricuspid technology. Main body: We reviewed the existing literature on mitral and tricuspid transcatheter therapies. Mitraclip is becoming an established therapy for secondary mitral regurgitation in selected patients with disproportionately severe regurgitation associated with moderate left ventricle dysfunction. Evidence is less convincing for primary mitral regurgitation. Transcatheter mitral valve replacement is a promising emerging alternative to transcatheter repair, for secondary as well as primary mitral regurgitation. But further development is needed to improve delivery. Transcatheter tricuspid intervention arrives late after similar technologies have been developed for aortic and mitral valves and is currently at its infancy. This is likely due in part to previously under-recognized impact of tricuspid regurgitation on patient outcomes. Edge-to-edge repair is the most advanced transcatheter solution in development. Data on tricuspid annuloplasty and replacement is limited, and more research is warranted. Conclusion: The future appears bright for transcatheter mitral therapies, albeit their place in clinical practice is yet to be clearly defined. Tricuspid transcatheter therapies might address the unmet need of tricuspid regurgitation treatment.

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Section: Edge-to-edge Transcatheter Mitral Valve Plastymentioning

confidence: 99%

Advances in transcatheter mitral and tricuspid therapies

Overtchouk

Piazza

Granada

et al. 2020

BMC Cardiovasc Disord

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“…The New England Journal of Medicine published articles detailing the results of these two trials with contradictory conclusions in the same 2018 issue. What followed were multiple viewpoints and reviews comparing and analyzing the trials apparent opposite results [7][8][9][10] . We intend to review several of these interpretations as well as assess the methodologic and study population differences between these two studies [ Table 1].…”

Section: Compare and Contrastmentioning

confidence: 99%

“…Underlying an informed analysis of MITRA-FR and COAPT trials is a new concept: "disproportionate" [8] or "tertiary" MR [7] . As explained by Packer et al [8] MR severity may or may not be proportional to left ventricular (LV) dilation, and also may or may not contribute to the disease process.…”

Section: Compare and Contrastmentioning

confidence: 99%

“…The authors agree with this observation emphasizing the value of preoperative advanced imaging and thus its use is representative of current medical practice and therefore should be included in the study protocol. Garbi et al [15] recognize that the "disproportionate" [8] or "tertiary" MR [7] along with reduced left atrial pressure observed in COAPT patients, both may have contributed to improved symptoms post-procedurally which the authors agree with as a possibility. Despite that the COAPT trial was company sponsored (Kalavrouziotis et al [16] ), the authors posit an independence of medical decision making.…”

Section: Specific Similarities and Differencesmentioning

confidence: 99%

“…Intensive analysis of these two trials have led most practitioners to agree that the trials are "complimentary rather than contradictory" (Tang et al [21] , Carabello et al [7] ). Whether the diagnosis is "disproportionate MR" (Packer et al [8] , Praz et al [9] ) or "tertiary MR" [7] , consensus appears to be that patients with the combination of severe secondary MR (EROA > 0.3 cm 2 ) with no more than moderate LV dilatation (LVEDVI < 96 mL/m 2 ) potentially will benefit from percutaneous edge-to-edge repair (MitraClip @ ) procedure after optimal medical therapy, as shown in COAPT trail.…”

Section: Specific Similarities and Differencesmentioning

confidence: 99%

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Percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation: perspectives on COAPT and MITRA-FR trials

Pal¹,

Nelson²,

Butterworth³

2019

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How to cite this article: Pal N, Nelson M, Butterworth J. Percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation: perspectives on COAPT and MITRA-FR trials. Vessel Plus 2019;3:39. http://dx.Mitral valve regurgitation (MR) is classified as primary or secondary depending upon pathophysiology. Primary MR arises from degenerative disease of the valve leaflets whereas secondary MR is due to dilatation of left ventricle leading to distortion of valve architecture [1] . Therapy for primary MR is established: valve repair (surgery or percutaneous), or valve replacement when repair is not possible [2,3] . In contrast, therapy for secondary MR is still a matter of debate [4] . It is universally agreed that treatment for left ventricular dilatation is foremost by guideline directed medical therapy (GDMT) and cardiac resynchronization therapy [3] . Whether to treat the MR mechanically constitutes the dilemma. This intriguing conundrum becomes even more interesting with publication of two similar trials with opposite results [5,6] . If reproducibility is the foundation of settled new knowledge, then why did these two large randomized controlled trials have seemingly irreconcilable results?Investigators of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation, USA) [6] and the MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation, France) [5] trials hoped to seek whether secondary MR was simply a marker of a diseased and dilated left ventricle or separately contributed to patient mortality and therapy via edge-to-edge percutaneous repair of mitral valve (MV) (MitraClip @ ) would be efficacious. Incidentally, results of the MITRA-FR trial support the former assertion while those of COAPT trial seem to corroborate the later.

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Association of Effective Regurgitation Orifice Area to Left Ventricular End-Diastolic Volume Ratio With Transcatheter Mitral Valve Repair Outcomes

et al. 2021

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IMPORTANCETranscatheter mitral valve repair (TMVr) plus maximally tolerated guideline-directed medical therapy (GDMT) reduced heart failure (HF) hospitalizations (HFHs) and all-cause mortality (ACM) in symptomatic patients with HF and secondary mitral regurgitation (SMR) compared with GDMT alone in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) trial but not in a similar trial, Multicenter Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR), possibly because the degree of SMR relative to the left ventricular end-diastolic volume index (LVEDVi) was substantially lower.OBJECTIVE To explore contributions of the degree of SMR using the effective regurgitation orifice area (EROA), regurgitant volume (RV), and LVEDVi to the benefit of TMVr in the COAPT trial. DESIGN, SETTING, AND PARTICIPANTSThis post hoc secondary analysis of the COAPT randomized clinical trial performed December 27, 2012, to June 23, 2017, evaluated a subgroup of COAPT patients (group 1) with characteristics consistent with patients enrolled in MITRA-FR (n = 56) (HF with grade 3+ to 4+ SMR, left ventricular ejection fraction of 20%-50%, and New York Heart Association function class II-IV) compared with remaining (group 2) COAPT patients (n = 492) using the end point of ACM or HFH at 24 months, components of the primary end point, and quality of life (QOL) (per the Kansas City Cardiomyopathy Questionnaire overall summary score) and 6-minute walk distance (6MWD). The same end points were evaluated in 6 subgroups of COAPT by combinations of EROA and LVEDVi and of RV relative to LVEDVi. INTERVENTIONS Interventions were TMVr plus GDMT vs GDMT alone.RESULTS A total of 548 participants (mean [SD] age, 71.9 [11.2] years; 351 [64%] male) were included. In group 1, no significant difference was found in the composite rate of ACM or HFH between TMVr plus GDMT vs GDMT alone at 24 months (27.8% vs 33.1%, P = .83) compared with a significant difference at 24 months (31.5% vs 50.2%, P < .001) in group 2. However, patients randomized to receive TMVr vs those treated with GDMT alone had significantly greater improvement in QOL at 12 months (mean [SD] Kansas City Cardiomyopathy Questionnaire summary scores: group 1: 18.36 [5.38] vs 0.43 [4.00] points; P = .01; group 2: 16.54 [1.57] vs 5.78 [1.82] points; P < .001). Group 1 TMVr-randomized patients vs those treated with GDMT alone also had significantly greater improvement in 6MWD at 12 months (mean [SD] paired improvement: 39.0 [28.6] vs −48.0 [18.6] m; P = .02). Group 2 TMVr-randomized patients vs those treated with GDMT alone tended to have greater improvement in 6MWD at 12 months, but the difference did not reach statistical significance (mean [SD] paired improvement: 35.0 [7.7] vs 16.0 [9.1] m; P = .11). CONCLUSIONS AND RELEVANCEA small subgroup of COAPT-resembling patients enrolled in MITRA-FR did not achieve improvement in ACM or HFH at 24...

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MitraClip and Tertiary Mitral Regurgitation—Mitral Regurgitation Gets Curiouser and Curiouser

Cited by 22 publications

References 11 publications

Advances in transcatheter mitral and tricuspid therapies

Advances in transcatheter mitral and tricuspid therapies

Percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation: perspectives on COAPT and MITRA-FR trials

Association of Effective Regurgitation Orifice Area to Left Ventricular End-Diastolic Volume Ratio With Transcatheter Mitral Valve Repair Outcomes

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