Predictors for procedural success and all-cause mortality in patients undergoing transcatheter mitral valve edge-to-edge repair for mitral regurgitation

Abstract

A growing body of evidence shows that transcatheter mitral valve edge-to-edge repair (TMVr) for mitral regurgitation (MR) improves symptoms and prognosis of patients with heart failure. Still, as recently shown by two large randomized controlled trials (COAPT and MITRA-FR), there is differing information on which patients have the largest benefit. We aimed to summarize the current knowledge of clinical and anatomic predictors for acute procedural failure and long-term all-cause mortality after TMVr. TMVr is an effective treatment option for patients with symptomatic MR fulfilling certain echocardiographic and clinical criteria or being ineligible for surgery despite optimal medical therapy. Acute procedural failure is influenced by anatomic features of the mitral valve, among those are increased tenting and mitral valve leaflet configuration, leaflet-to-annulus index, as well as the mitral valve opening area. In contrast, anatomy of the mitral valve plays a minor role in predicting all-cause mortality after TMVr. This endpoint is associated with patient comorbidities (e.g., renal failure and chronic lung disease), severe heart failure as expressed by New York Hear Association functional class (NYHA) IV, left and right heart dysfunction, laboratory parameters (NT-proBNP), clinical scoring systems (STS and EuroScore), and procedural MR reduction. In patients undergoing TMVr for severe MR, careful preprocedural evaluation of relevant comorbidities, mitral valve anatomy, as well as left and right heart function can provide detailed prognostic value regarding acute procedural success and long-term survival.

Keywords

MitraClip / transcatheter mitral valve edge-to-edge repair / predictors for mortality / secondary mitral regurgitation / primary mitral regurgitation / heart failure / percutaneous mitral valve repair

References

[1] Asgar AW,Stone GW.Secondary mitral regurgitation in heart failure: pathophysiology, prognosis, and therapeutic considerations..J Am Coll Cardiol2015;65:1231-48

[2] Boudoulas KD,Pitsis AA,Abraham WT.The use of MitraClip in secondary mitral regurgitation and heart failure. Cardiovascular revascularization medicine: including molecular interventions..Cardiovasc Revasc Med2020;S1553-8389(20)30262-1

[3] Goel K,Lindenfeld J.Contemporary management of secondary mitral regurgitation..Eur Cardiol2020;15:e22 PMCID:PMC7236019

[4] Zoghbi WA,Bonow RO.Recommendations for noninvasive evaluation of native valvular regurgitation: a report from the American society of echocardiography developed in collaboration with the society for cardiovascular magnetic resonance..J Am Soc Echocardiogr2017;30:303-71

[5] Chehab O,Ng Yin Ling C.Secondary mitral regurgitation: pathophysiology, proportionality and prognosis..Heart2020;106:716-23

[6] Feldman T,Elmariah S.Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVEREST II..J Am Coll Cardiol2015;66:2844-54

[7] Glower DD,Trento A.Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study..J Am Coll Cardiol2014;64:172-81

[8] Bonow RO,Adams DH.2020 Focused Update of the 2017 ACC Expert Consensus Decision Pathway on the Management of Mitral Regurgitation: A Report of the American College of Cardiology Solution Set Oversight Committee..J Am Coll Cardiol2020;75:2236-70

[9] Baumgartner H,Bax JJ.2017 ESC/EACTS Guidelines for the management of valvular heart disease..Eur Heart J2017;38:2739-91

[10] Marmagkiolis K,Ebersole DG.Clinical outcomes of percutaneous mitral valve repair with MitraClip for the management of functional mitral regurgitation..Catheter Cardiovasc Interv2019;94:820-6

[11] Praz F,Unterhuber M.Edge-to-edge mitral valve repair with extended clip arms: early experience from a multicenter observational study..JACC Cardiovasc Interv2019;12:1356-65

[12] Obadia JF,Leurent G.Percutaneous repair or medical treatment for secondary mitral regurgitation..N Engl J Med2018;379:2297-306

[13] Stone GW,Abraham WT.Transcatheter mitral-valve repair in patients with heart failure..N Engl J Med2018;379:2307-18

[14] Grayburn PA,Packer M.Proportionate and disproportionate functional mitral regurgitation: a new conceptual framework that reconciles the results of the MITRA-FR and COAPT trials..JACC Cardiovasc Imaging2019;12:353-62

[15] Mauricio R.MitraClip: how do we reconcile the inconsistent findings of MITRA-FR and COAPT?.Curr Cardiol Rep2019;21:150

[16] Luc JGY,Cheung AW.The MITRA-FR trial vs the COAPT trial: more complementary than contradictory?.Ann Thorac Surg2019;108:965-8

[17] Gaasch WH,Meyer TE.An appraisal of the association of clinical outcomes with the severity of regurgitant volume relative to end-diastolic volume in patients with secondary mitral regurgitation..JAMA Cardiol2020;5:476-81

[18] Adamo M,Gavazzoni M.Impact of disproportionate secondary mitral regurgitation in patients undergoing edge-to-edge percutaneous mitral valve repair..EuroIntervention2020;16:413-20

[19] Orban M,Lubos E.Impact of proportionality of secondary mitral regurgitation on outcome after transcatheter mitral valve repair..JACC Cardiovasc Imaging2020;S1936-878X(20)30620-3

[20] Ben-Shoshan J,Buithieu J.Predictors of outcomes following transcatheter edge-to-edge mitral valve repair..JACC Cardiovasc Interv2020;13:1733-48

[21] Zanolla L.Selection of endpoints for heart failure clinical trials..Eur J Heart Fail2003;5:717-23

[22] Anker SD,Atar D.Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency..Eur J Heart Fail2016;18:482-9

[23] Fiuzat M,Stockbridge N.Endpoints in heart failure drug development: history and future..JACC Heart Fail2020;8:429-40

[24] Stone GW,Abraham WT.Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions a consensus document from the mitral valve academic research consortium..J Am Coll Cardiol2015;66:308-21

[25] Orban M,Lesevic H.Predictors for long-term survival after transcatheter edge-to-edge mitral valve repair..J Interv Cardiol2017;30:226-33

[26] Braun D,Orban M.Percutaneous edge-to-edge repair of the mitral valve in patients with degenerative versus functional mitral regurgitation..Catheter Cardiovasc Interv2014;84:137-46

[27] Öztürk C,Werner N.Single-center five-year outcomes after interventional edge-to-edge repair of the mitral valve..Cardiol J2019;

[28] Sürder D,Corti R.Impact of mitral regurgitation aetiology on MitraClip outcomes: the MitraSwiss registry..EuroIntervention2020;16:e112-20

[29] Dörr O,Liebetrau C.Galectin-3 and ST2 as predictors of therapeutic success in high-risk patients undergoing percutaneous mitral valve repair (MitraClip)..Clin Cardiol2018;41:1164-9 PMCID:PMC6489771

[30] Thaden JJ,Nkomo VT.Mitral valve anatomic predictors of hemodynamic success with transcatheter mitral valve repair..J Am Heart Assoc2018;7:e007315 PMCID:PMC5850157

[31] Oguz D,Dhesi S.Quantitative three-dimensional echocardiographic correlates of optimal mitral regurgitation reduction during transcatheter mitral valve repair..J Am Soc Echocardiogr2019;32:1426-35.e1

[32] Tabata N,Sugiura A.Impact of the leaflet-to-annulus index on residual mitral regurgitation in patients undergoing edge-to-edge mitral repair..JACC Cardiovasc Interv2019;12:2462-72

[33] Reichart D,Rübsamen N.The impact of residual mitral regurgitation after MitraClip therapy in functional mitral regurgitation..Eur J Heart Fail2020;

[34] Bozdag-Turan I,Birkemeyer R.Percutaneous mitral repair with the MitraClip system in patients with mild-to-moderate and severe heart failure: a single-centre experience..Cardiovasc Ther2014;32:66-73

[35] Adamo M,Capodanno D.Five-year clinical outcomes after percutaneous edge-to-edge mitral valve repair: Insights from the multicenter GRASP-IT registry..Am Heart J2019;217:32-41

[36] Paranskaya L,Bozdag-Turan I.Early and mid-term outcomes of percutaneous mitral valve repair with the MitraClip®: comparative analysis of different EuroSCORE strata..EuroIntervention2012;8:571-8

[37] Yzeiraj E,Tiburtius C.Tricuspid regurgitation is a predictor of mortality after percutaneous mitral valve edge-to-edge repair..EuroIntervention2017;12:e1817-24

[38] Itabashi Y,Kubo S.Different indicators for postprocedural mitral stenosis caused by single- or multiple-clip implantation after percutaneous mitral valve repair..J Cardiol2018;71:336-45

[39] Watanabe N,Yamaura Y.Mitral annulus flattens in ischemic mitral regurgitation: geometric differences between inferior and anterior myocardial infarction: a real-time 3-dimensional echocardiographic study..Circulation2005;112:I458-62

[40] El Sebaie MH,Zarea AA.Assessment of mitral valve geometric deformity in patients with ischemic heart disease using three-dimensional echocardiography..Egypt Heart J2017;69:13-20 PMCID:PMC5839364

[41] Stolfo D,Morea G.Predicting device failure after percutaneous repair of functional mitral regurgitation in advanced heart failure: Implications for patient selection..Int J Cardiol2018;257:182-7

[42] Kalbacher D,V Bardeleben RS.Long-term outcome, survival and predictors of mortality after MitraClip therapy: Results from the German Transcatheter Mitral Valve Interventions (TRAMI) registry..Int J Cardiol2019;277:35-41

[43] Bannehr M,Okamoto M.Post-procedural tricuspid regurgitation predicts long-term survival in patients undergoing percutaneous mitral valve repair..J Cardiol2019;74:524-31

[44] Buzzatti N,Denti P.What is a “good” result after transcatheter mitral repair? Impact of 2+ residual mitral regurgitation..J Thorac Cardiovasc Surg2016;151:88-96

[45] Rudolph V,Schlüter M.Aetiology of mitral regurgitation differentially affects 2-year adverse outcomes after MitraClip therapy in high-risk patients..Eur J Heart Fail2013;15:796-807

[46] Azzalini L,Khan R.Impact of left ventricular function on clinical outcomes of functional mitral regurgitation patients undergoing transcatheter mitral valve repair..Catheter Cardiovasc Interv2016;88:1124-33

[47] Baldi C,Silverio A.Predictors of outcome in heart failure patients with severe functional mitral regurgitation undergoing MitraClip treatment..Int J Cardiol2019;284:50-8

[48] Godino C,Taramasso M.Two-year cardiac mortality after MitraClip treatment of functional mitral regurgitation in ischemic and non-ischemic dilated cardiomyopathy..Int J Cardiol2018;269:33-9

[49] De Bonis M,Lapenna E.MitraClip therapy and surgical edge-to-edge repair in patients with severe left ventricular dysfunction and secondary mitral regurgitation: mid-term results of a single-centre experience..Eur J Cardiothorac Surg2016;49:255-62

[50] Bartko PE,Arfsten H.Disproportionate functional mitral regurgitation: advancing a conceptual framework to clinical practice..JACC Cardiovasc Imaging2019;12:2088-90

[51] Keßler M,Mammadova E.Atrial fibrillation predicts long-term outcome after transcatheter edge-to-edge mitral valve repair by MitraClip implantation..Biomolecules2018;8:152 PMCID:PMC6316291

[52] Iliadis C,Kalbacher D.Impact of left atrial diameter on outcome in patients undergoing edge-to-edge mitral valve repair: results from the German TRAnscatheter Mitral valve Interventions (TRAMI) registry..Eur J Heart Fail2020;22:1202-10

[53] Ledwoch J,Fellner C.Prognostic impact of left atrial function following transcatheter mitral valve repair..J Am Heart Assoc2019;8:e011727 PMCID:PMC6512104

[54] Deferm S,Verbrugge FH.Atrial functional mitral regurgitation: JACC review topic of the week..J Am Coll Cardiol2019;73:2465-76

[55] Neuss M,Isotani A.Elevated mitral valve pressure gradient after MitraClip implantation deteriorates long-term outcome in patients with severe mitral regurgitation and severe heart failure..JACC Cardiovasc Interv2017;10:931-9

[56] Boerlage-vanDijk K,Araki M.Predictors of outcome in patients undergoing MitraClip implantation: an aid to improve patient selection..Int J Cardiol2015;189:238-43

[57] Puls M,Bleckmann A.Failure of acute procedural success predicts adverse outcome after percutaneous edge-to-edge mitral valve repair with MitraClip..EuroIntervention2014;9:1407-17

[58] Puls M,Bleckmann A.Failure of acute procedural success predicts adverse outcome after percutaneous edge-to-edge mitral valve repair with MitraClip..EuroIntervention2014;9:1407-17

[59] Sürder D,Gaemperli O.Predictors for efficacy of percutaneous mitral valve repair using the MitraClip system: the results of the MitraSwiss registry..Heart2013;99:1034-40

[60] Capodanno D,Barbanti M.Predictors of clinical outcomes after edge-to-edge percutaneous mitral valve repair..Am Heart J2015;170:187-95

[61] Patzelt J,Sauter R.Elevated mitral valve pressure gradient is predictive of long-term outcome after percutaneous edge-to-edge mitral valve repair in patients with degenerative mitral regurgitation (MR), but not in functional MR..J Am Heart Assoc2019;8:e011366 PMCID:PMC6662353

[62] Alessandrini H,Schlüter M.Prognostic implication of post-MitraClip vena contracta area in heart failure patients with functional mitral regurgitation..EuroIntervention2017;12:1946-53

[63] Taramasso M,Latib A.Clinical and anatomical predictors of MitraClip therapy failure for functional mitral regurgitation: single central clip strategy in asymmetric tethering..Int J Cardiol2015;186:286-8

[64] Kitamura M,Schlüter M.Predictors of mortality in ischaemic versus non-ischaemic functional mitral regurgitation after successful transcatheter mitral valve repair using MitraClip: results from two high-volume centres..Clin Res Cardiol2019;108:264-72

[65] Hoit BD.Atrial functional mitral regurgitation: the left atrium gets its due respect..J Am Coll Cardiol2011;58:1482-4

[66] Kagiyama N,Yoshida K,Cameli M.Subtypes of atrial functional mitral regurgitation: imaging insights into their mechanisms and therapeutic implications..JACC Cardiovasc Imaging2020;13:820-35

[67] Tigges E,von Bardeleben RS.Implication of pulmonary hypertension in patients undergoing MitraClip therapy: results from the German transcatheter mitral valve interventions (TRAMI) registry..Eur J Heart Fail2018;20:585-94

[68] Yucel E,Bertrand PB.Pulmonary hypertension in patients eligible for transcatheter mitral valve repair: prognostic impact and clinical implications..Curr Treat Options Cardiovasc Med2019;21:60

[69] Al-Bawardy R,Thourani VH.Association of pulmonary hypertension with clinical outcomes of transcatheter mitral valve repair..JAMA Cardiol2020;5:47-56 PMCID:PMC6902209

[70] Osteresch R,Kühl M.Impact of right heart function on outcome in patients with functional mitral regurgitation and chronic heart failure undergoing percutaneous edge-to-edge-repair..J Interv Cardiol2018;31:916-24

[71] Kaneko H,Weissenborn J.Prognostic significance of right ventricular dysfunction in patients with functional mitral regurgitation undergoing MitraClip..Am J Cardiol2016;118:1717-22

[72] Giannini C,Colombo A.Right ventricular evaluation to improve survival outcome in patients with severe functional mitral regurgitation and advanced heart failure undergoing MitraClip therapy..Int J Cardiol2016;223:574-80

[73] Godino C,Cera M.Impact and evolution of right ventricular dysfunction after successful MitraClip implantation in patients with functional mitral regurgitation..Int J Cardiol Heart Vasc2016;11:90-8 PMCID:PMC5441334

[74] Schueler R,Sinning JM.Impact of baseline tricuspid regurgitation on long-term clinical outcomes and survival after interventional edge-to-edge repair for mitral regurgitation..Clin Res Cardiol2017;106:350-8

[75] Al-Hindwan HSA,Curio J.The impact of moderate aortic valve disease in patients undergoing MitraClip for severe MR..Clin Hemorheol Microcirc2020;

[76] Geis NA,Lubos E.Safety and efficacy of MitraClip™ therapy in patients with severely impaired left ventricular ejection fraction: results from the German transcatheter mitral valve interventions (TRAMI) registry..Eur J Heart Fail2018;20:598-608

[77] Gyoten T,Schenk S.Impact of preinterventional tricuspid regurgitation on outcome of MitraClip therapy in patients with severely reduced ejection fraction..Open Heart2020;7:e001203 PMCID:PMC7076264

[78] Asch FM,Siegel RJ.Echocardiographic outcomes after transcatheter leaflet approximation in patients with secondary mitral regurgitation: the COAPT trial..J Am Coll Cardiol2019;74:2969-79

[79] Schueler R,May AE.Predictors for short-term outcomes of patients undergoing transcatheter mitral valve interventions: analysis of 778 prospective patients from the German TRAMI registry focusing on baseline renal function..EuroIntervention2016;12:508-14

[80] Triantafyllis AS,Bakker AL.Long-term survival and preprocedural predictors of mortality in high surgical risk patients undergoing percutaneous mitral valve repair..Catheter Cardiovasc Interv2016;87:467-75

[81] Kyhse-Andersen J,Nordin G.Serum cystatin C, determined by a rapid, automated particle-enhanced turbidimetric method, is a better marker than serum creatinine for glomerular filtration rate..Clin Chem1994;40:1921-6

[82] Devarajan P.Neutrophil gelatinase-associated lipocalin: a promising biomarker for human acute kidney injury..Biomark Med2010;4:265-80 PMCID:PMC2893148

[83] Sims JR,Guerrero M.Characteristics and outcomes of patients with normal left atrial pressure undergoing transcatheter mitral valve repair..Heart2020;106:898-903

[84] Gotzmann M,Ewers A,Bösche L.One-year outcome of percutaneous mitral valve repair in patients with severe symptomatic mitral valve regurgitation..World J Cardiol2017;9:39-46 PMCID:PMC5253193

[85] Buccheri S,Barbanti M.A risk model for prediction of 1-year mortality in patients undergoing MitraClip implantation..Am J Cardiol2017;119:1443-9

[86] Ailawadi G,Mack MJ.One-year outcomes after MitraClip for functional mitral regurgitation..Circulation2019;139:37-47

[87] Kalbacher D,von Bardeleben RS.Impact of tricuspid valve regurgitation in surgical high-risk patients undergoing MitraClip implantation: results from the TRAMI registry..EuroIntervention2017;12:e1809-16

[88] Matsumoto T,Yeow WL.Impact of pulmonary hypertension on outcomes in patients with functional mitral regurgitation undergoing percutaneous edge-to-edge repair..Am J Cardiol2014;114:1735-9

[89] Dörr O,Liebetrau C.Evaluation of cystatin C and neutrophil gelatinase-associated lipocalin as predictors of mortality in patients undergoing percutaneous mitral valve repair (MitraClip)..Clin Cardiol2018;41:1474-9 PMCID:PMC6489940

[90] Keßler M,Muche R.Predictors of rehospitalization after percutaneous edge-to-edge mitral valve repair by MitraClip implantation..Eur J Heart Fail2019;21:182-92