Edge-to-Edge Transcatheter Mitral Valve Repair Versus Optimal Medical Treatment in Nonresponders to Cardiac Resynchronization Therapy: The MITRA-CRT Trial.

HomeCirculation: Heart FailureVol. 15, No. 12Edge-to-Edge Transcatheter Mitral Valve Repair Versus Optimal Medical Treatment in Nonresponders to Cardiac Resynchronization Therapy: The MITRA-CRT Trial Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBEdge-to-Edge Transcatheter Mitral Valve Repair Versus Optimal Medical Treatment in Nonresponders to Cardiac Resynchronization Therapy: The MITRA-CRT Trial Xavier Freixa, Jose María Tolosana, Pedro L. Cepas-Guillen, Marco Hernández-Enríquez, Laura Sanchis, Eduardo Flores-Umanzor, Marta Farrero, Rut Andrea, Mercè Roqué, Maria José Carretero, Ander Regueiro, Salvatore Brugaletta, Josep Rodés-Cabau, Lluís Mont, Marta Sitges, Manel Sabaté and M. Ángeles Castel Xavier FreixaXavier Freixa Correspondence to: Xavier Freixa, PhD, or Jose María Tolosana, PhD, Hospital Clinic, Cardiology Department, C/Villarroel, 170, 08036 Barcelona, Spain. Email E-mail Address: [email protected] or E-mail Address: [email protected] https://orcid.org/0000-0002-3203-9060 Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. *X. Freixa and J.M. Tolosana contributed equally. Search for more papers by this author , Jose María TolosanaJose María Tolosana Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. *X. Freixa and J.M. Tolosana contributed equally. Search for more papers by this author , Pedro L. Cepas-GuillenPedro L. Cepas-Guillen https://orcid.org/0000-0001-8814-7039 Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Search for more papers by this author , Marco Hernández-EnríquezMarco Hernández-Enríquez Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Search for more papers by this author , Laura SanchisLaura Sanchis https://orcid.org/0000-0003-2516-8953 Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Search for more papers by this author , Eduardo Flores-UmanzorEduardo Flores-Umanzor https://orcid.org/0000-0002-6428-241X Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Search for more papers by this author , Marta FarreroMarta Farrero https://orcid.org/0000-0002-2404-8821 Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Search for more papers by this author , Rut AndreaRut Andrea https://orcid.org/0000-0002-8409-5013 Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Search for more papers by this author , Mercè RoquéMercè Roqué https://orcid.org/0000-0001-9036-4825 Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Search for more papers by this author , Maria José CarreteroMaria José Carretero https://orcid.org/0000-0002-5887-6326 Anesthesiology Department (M.J.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Search for more papers by this author , Ander RegueiroAnder Regueiro Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Search for more papers by this author , Salvatore BrugalettaSalvatore Brugaletta https://orcid.org/0000-0001-5845-1435 Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Search for more papers by this author , Josep Rodés-CabauJosep Rodés-Cabau https://orcid.org/0000-0001-8237-7095 Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Quebec Heart and Lung Institute, Quebec City, Canada (J.R.-C.). Search for more papers by this author , Lluís MontLluís Mont https://orcid.org/0000-0002-8115-5906 Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Search for more papers by this author , Marta SitgesMarta Sitges Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Search for more papers by this author , Manel SabatéManel Sabaté https://orcid.org/0000-0002-2316-3705 Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Search for more papers by this author and M. Ángeles CastelM. Ángeles Castel Cardiology Department, Cardiovascular Institute (ICCV) (X.F., J.M.T., P.L.C.-G., M.H.-E., L.S., E.F.-U., M.F., R.A., M.R., A.R., S.B., J.R.-C., L.M., M. Sitges, M. Sabaté, M.Á.C.), Hospital Clinic, IDIBAPS, University of Barcelona, Spain. Search for more papers by this author Originally published20 Sep 2022https://doi.org/10.1161/CIRCHEARTFAILURE.121.009501Circulation: Heart Failure. 2022;15Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: September 20, 2022: Ahead of Print Transcatheter mitral valve repair (TMVr) with “edge-to-edge” systems have shown promising results in patients with dilated cardiomyopathy (DCM) and reduced left ventricular ejection fraction (LVEF).1 Recent randomized trials comparing optimal medical therapy (OMT) versus TMVr in patients with functional mitral regurgitation (FMR) >2 have shown divergent results. One of them, the COAPT trial (Cardiovascular Outcomes Assessment of the Mitraclip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), reported reduced mortality and heart failure (HF) admissions after 2 years in patients undergoing TMVr on top of OMT.1,2 In addition, a subgroup analysis of this latter study focusing on patients with and without cardiac resynchronization therapy (CRT) also revealed improved 2-year prognosis in the TMVr group.3 Auricchio et al4 analyzed a cohort of DCM patients with CRT and FMR >2, showing significant clinical improvement, LVEF recovery, and left ventricle volume reduction after TMVr. Nonetheless, the post hoc or retrospective nature of the aforementioned studies and the absence of stratification according to the CRT response represent major limitations. The hypothesis of our trial was that TMVr in nonresponder patients to CRT and significant FMR (grade ≥2, 100%) would be associated with improved functional class, LVEF recovery, and reduced left ventricle volumes. Thus, the objective of the present pilot study was to compare OMT versus OMT+TMVr in DCM patients who received CRT and remained with FMR >2 and advanced HF.The MITRA CRT trial (Transcatheter Mitral Valve Repair in non-Responders to Cardiac Resynchronization Therapy) was a pilot, single-center, randomized, controlled and open-label trial comparing OMT versus OMT+“edge-to-edge” TMVr with the Mitraclip device in DCM patients with CRT who were clinically symptomatic (nonresponders) and had FMR >2. Clinical candidates had DCM with LVEF between 15% and 40%, CRT implantation >6 months with effective therapy defined as biventricular stimulation in >95% of heart beats5 and moderate-to-severe3 or severe4 MR. Inclusion required advanced heart failure symptoms defined by the presence of a New York Heart Association class III or IV or II with a hospital admission for HF within the previous year despite the use of stable maximal doses of guideline-directed medical therapy. If mitral anatomy was suitable for TMVr with Mitraclip, the patient signed consent and was randomized 1:1 to control or TMVr. The study was approved by the Ethics Committee of Hospital Clinic Barcelona and consistent to the principles outlined in the Declaration of Helsinki. The data that support the findings of this study are available from the corresponding author upon reasonable request. All participants gave written informed consent. Clinical and echocardiographic follow-up was performed at 1, 3, and 12 months. Categorical data are reported as percentages (percentages) were compared with Fisher exact test. Continuous data are reported as means±SD or as a median (interquartile range) and were tested between groups using the Kruskal-Wallis test. The primary efficacy end point was defined as the combined of CV death, heart transplantation, or HF hospitalizations at 12 months. A secondary safety end point included the number of procedure- or device-related serious adverse events.From 2015 to 2019, a total of 53 patients were initially screened. Among them, 31 patients were finally included in the study: 15 in the control and 16 in the TMVr group. All patients but one received the allocated treatment (a patient randomized to TMVr refused the intervention). Baseline characteristics showed no differences among groups but a higher prevalence of COPD patients in the control group and a trend toward older age in the TMVr group (Table). Clinical status was relatively advanced as depicted by the small percentage of patients in New York Heart Association class II (13%) and the high percentage of admissions for HF within the previous year (60%). As shown in the Table, LVEF was very low in most of patients (median of 21%) and left ventricles exhibited significant enlargements in both groups (mean LVED volume of 136.8±40.6 mL/m2). Technical and procedural success was achieved in all patients. Transesophageal echocardiography after clip implantation showed residual MR≤2 in all patients, and no procedural- or device-related serious adverse events were registered.Table. Baseline Characteristics and Procedural and Follow-Up Outcomes at 1 YearTotal (n=31)TMVr group (n=16)Control group (n=15)Baseline clinical characteristics Age, y69.7±772.1±767.2±6 Male sex25 (81)13 (81)12 (80) Body mass index26 (23–30)27.5 (23–30)25.4 (23–31) Diabetes7 (23)2 (13)5 (33) Ischemic cardiomyopathy14 (45)8 (50)6 (40) Previous stroke or TIA2 (7)1 (7)1 (7) Previous NVAF or flutter19 (61)11 (69)8 (53) Persistent atrial fibrillation14 (45)9 (56)5 (33) CRT implantation time before inclusion, d1510 (700–2555)1699 (829–2829)1012 (268–2555) Percentage of biventricular CRT stimulation, %98 (95–99)98 (94.5–99)99 (95–100) Anterior LV lead position000 Mean GFR, mL/min59±1856.4±1861.7±19 EUROSCORE II3.96 (3.1–7)4.23 (3.2–7.5)3.75 (2.7–6.1) NYHA class II4 (13)1 (6)3 (20) III25 (81)13 (81)12 (80) IV (ambulatory)2 (7)2 (13)0 Previous hospitalization for HF in the last year19 (61)12 (75)7 (47) Number of hospitalizations for HF in the last year (median)2 (1–3)1.5 (1–3)2 (1–3) BNP667 (373–1183)623 (373–1341)711 (433–1176) 6MWT, m384±96353±99407±90 HF medical treatment ACEI/ARB11 (35)5 (35)5 (33) ARNI10 (32)6 (38)4 (27) Beta-blockers29 (94)15 (94)14 (93) MRA25 (81)13 (81)12 (80) Hydralazine4 (13)1 (6)3 (20) Nitrates4 (13)1 (6)3 (20) Digoxin3 (10)1 (6)2 (13) Loop diuretics30 (97)16 (100)14 (93)Baseline echocardiographic characteristics MR severity Moderate (grade 2)1 (3)1 (6)0 Moderate-severe (grade 3)8 (26)3 (19)5 (33) Severe (grade 4)22 (71)12 (75)10 (67) ERO area*0.51±0.120.54±0.460.46±0.10 LVEF, %21 (17–25)20 (16.5–27)22 (19–25) LVESD, mm58.4±8.7258.8±8.0157.9±9.68 LVEDD, mm70.0±7.7871.2±8.0168.8±7.61 LVES volume (indexed)107.3±37.0107.1±40.9107.6±33.7 LVED volume (indexed)136.8±40.6136.3±43.1137.4±39.0 LA volume (indexed)74.4±5.476.5±27.972.4±30.8 Spap48.5±14.649.6±12.447.5±16.6Procedural outcomes (TMVr group) Implant success rate15 (100)† Patients with procedure- or device-related SAEs0 Vascular complication0 Atrial septum lesion0 Cardiogenic shock resulting in intravenous inotropic support0 Cardiac embolism0 Cardiac tamponade0 Urgent conversion to hear surgery0 Admission days related to procedure2.93±1.7 Procedural MR severity after clip implantation Mild (1)14 (93) Moderate (2)7 (1) Moderate to severe (3)0 Severe (4)0Total (n=31)TMVr group (n=16)Control group (n=15)P valueClinical follow-up at 12 mo Combined end point (CV death, HF rehospitalization, heart transplant)12 (39; 95% CI, 21.8–57.8)2 (13; 95% CI, 1.6–38.3)10 (67; 95% CI, 38.8–88.2)0.003 All-cause mortality5 (16; 95% CI, 5.5–33.8)2 (13; 95% CI, 1.6–38.4)3 (20; 95% CI, 4.3–48.1)0.65 Cardiovascular mortality3 (10; 95% CI, 5.5–33.8)1 (7; 95% CI, 0.15–30.2)2 (13; 95% CI, 1.7–40.5)0.60 HF rehospitalization11 (37; 95% CI, 19.9–56.1)1 (7; 95% CI, 0.1–32.9)10 (67; 95% CI, 38.4–88.2)0.002 Number of HF hospitalizations0.003 019 (63)14 (93)5 (33) 18 (27)1 (7)7 (7) 21 (3)01 (7) 31 (3)01 (7) 41 (3)01 (7) Heart transplant2 (7; 95% CI, 0.79–21.4)02 (13; 95% CI, 1.7–40.5)0.23 NYHA class<0.001 I2 (7)2 (14)0 II11 (41)10 (72)1 (8) III9 (33)2 (14)7 (54) IV5 (19)015 (38) 6MWT distance, m402.7±89.1410.4±97.8393.7±86.10.75 Change in distance on 6MWT from baseline19.33±77.282.5±57.5−31.2±47.50.014 BNP level457 (280–992)543 (280–1889)385.5 (254–550)0.35 Change in BNP level−130.2±1329.9−186±1719.6−46.5±455.10.85Total (n=31)TMVr group (n=16)Control group (n=15)P value Increase in diuretic treatment14 (50; 95% CI, 30.7–69.4)2 (14; 95% CI, 1.8–42.8)12 (86; 95% CI, 57.2–98.2)<0.001Echocardiographic follow-up at 12 mo MR severity Mild (1)6 (24)5 (39)1 (8)0.005 Moderate (2)8 (32)6 (46)2 (17) Moderate-to-severe (3)4 (16)2 (15)2 (17) Severe (4)7 (28)07 (58) LVEF, %20 (18–25)22 (19–25)20 (16–25)0.23 Change in LVEF, %−0.28±5.810±7.12−0.58±4.360.81 LVES volume (indexed)103.7±40.1111.5±43.295.9±37.10.38 Change in LVES volume2.48±19.48.8±16.7−3.8±20.50.13 LVED volume (indexed)134.7±45.4144±48.6126.2±42.80.39 Change in LVED volume3.97±21.579.29±16.65−0.87±25.040.29 sPAP, mm Hg45.9±10.946.6±10.445.1±12.20.81 Change in sPAP, mm Hg−2.94±14.4−7.44±14.32.86±13.30.16Values are expressed as n (%), mean±SD‚ or median (IQR). 6MWT indicates 6-minute walking test; BNP, B-type natriuretic peptide level; ACEI, angiotensin convertering enzyme inhibitor; ARB, angiotensin receptor blocker; ARNI, angiotensin receptor-neprilysin inhibitor; CRT, cardiac resynchronization therapy; CV, cardiovascular; ERO, effective regurgitant orifice; GFR, glomerular filtration rate; HF, heart failure; LA, left atrium; LV, left ventricle; LVED, left ventricle end-diastolic; LVEDD, left ventricle end-diastolic diameter; LVEF, left ventricle ejection fraction; LVES, left ventricle end-systolic; LVESD, left ventricle end-systolic diameter; MR, mitral regurgitation; MRA, mineralocorticoid receptor antagonist; NVAF, nonvalvular atrial fibrillation; NYHA, New York Heart Association; SAE, serious adverse event; sPAP, systolic pulmonary artery pressure; TIA, transient ischemic attack; and TMVr, transcatheter mitral valve repair.*Five missing values.† One patient was randomized to device group, but he finally refused the intervention.At 12 months follow-up, TMVr patients showed reduction of the combined end-point of CV death, heart transplantation, and HF hospitalizations (13% [95% CI, 1.6–38.3] versus 67% [95% CI, 38.8–88.2]; P=0.003; Table). Additionally, patients in the TMVr group reduced the number of HF hospitalizations, the need of diuretic scalation and also showed improved functional class and 6MWT distance. Transthoracic echocardiography at 12 months showed residual MR≤2 in 85% of TMVr patients and 25% of controls (P=0.005). No differences in left ventricle dimensions, and LVEF were observed between groups, but systolic pulmonary artery pressure values exhibited a trend toward a reduction in the TMVr group (Table). This observation may reflect the advanced status of the left ventricle dilatation/dysfunction or the limited number of included patients.In conclusion, in patients with DCM and CRT who were clinically nonresponders and present FMR >2, “edge-to-edge” TMVr, as compared with OMT, was associated with a reduction of the combined end point of CV death, heart transplantation, and CHF hospitalizations and a reduction in the number of CHF hospitalizations and the need of diuretic treatment scalation at 1 year. Regarding the safety end point, no procedure-related serious adverse events were observed in the TVMr group. The advance status of the DCM in both clinical and echocardiographic parameters of referred patients with the aforementioned inclusion criteria highlight the need to anticipate more preventive strategies. The limitations of this pilot study preclude using it for clinical decision-making, and they should be considered as hypothesis-generating. Further studies with larger samples are warranted.Article InformationSources of FundingThis was an investigator-initiated study supported by Abbott Medical. Dr Hernández-Enríquez received a formation grant from the Spanish Society of Cardiology.Disclosures Drs Freixa, Sitges, and Sanchis are proctors for Abbott Medical. Dr Rodés-Cabau has an institutional research grant from Boston Scientific.Footnotes*X. Freixa and J.M. Tolosana contributed equally.For Sources of Funding and Disclosures, see page 1159.Registration: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT02592889.Correspondence to: Xavier Freixa, PhD, or Jose María Tolosana, PhD, Hospital Clinic, Cardiology Department, C/Villarroel, 170, 08036 Barcelona, Spain. Email [email protected]cat or [email protected]catReferences1. Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, et al; COAPT Investigators.Transcatheter mitral-valve repair in patients with heart failure.N Engl J Med. 2018; 379:2307–2318. doi: 10.1056/NEJMoa1806640CrossrefMedlineGoogle Scholar2. Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefèvre T, Piot C, Rouleau F, Carrié D, et al; MITRA-FR Investigators.Percutaneous repair or medical treatment for secondary mitral regurgitation.N Engl J Med. 2018; 379:2297–2306. doi: 10.1056/NEJMoa1805374CrossrefMedlineGoogle Scholar3. 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Optimized implementation of cardiac resynchronization therapy: a call for action for referral and optimization of care: A joint position statement from the Heart Failure Association (HFA), European Heart Rhythm Association (EHRA), and European Association of Cardiovascular Imaging (EACVI) of the European Society of Cardiology.Eur J Heart Fail. 2020; 22:2349–2369. doi: 10.1002/ejhf.2046CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetails December 2022Vol 15, Issue 12 Advertisement Article InformationMetrics © 2022 American Heart Association, Inc.https://doi.org/10.1161/CIRCHEARTFAILURE.121.009501PMID: 36124767 Originally publishedSeptember 20, 2022 Keywordsretrospectiveprognosisheart failuremitral valvecardiomyopathy, dilatedPDF download Advertisement SubjectsCatheter-Based Coronary and Valvular InterventionsHeart Failure