Repeat MitraClip Therapy for Significant Recurrent Mitral Regurgitation in High Surgical Risk Patients

2015 ◽  
Vol 8 (11) ◽  
pp. 1480-1489 ◽  
Author(s):  
Felix Kreidel ◽  
Christian Frerker ◽  
Michael Schlüter ◽  
Hannes Alessandrini ◽  
Thomas Thielsen ◽  
...  
Keyword(s):  
Mitral Regurgitation ◽  
Surgical Risk ◽  
High Surgical Risk ◽  
Risk Patients ◽  
Mitraclip Therapy

scholarly journals Residual mitral regurgitation impact on outcomes after mitraclip therapy: five-year follow-up from the GRASP registry

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
AM Caggegi ◽  
P Capranzano ◽  
S Scandura ◽  
S Mangiafico ◽  
G Castania ◽  
...  
Keyword(s):  
Mitral Valve ◽  
Mitral Regurgitation ◽  
Mitral Valve Repair ◽  
Primary Endpoint ◽  
Left Ventricular ◽  
Valve Repair ◽  
Surgical Risk ◽  
High Surgical Risk ◽  
Mitraclip Therapy

Abstract Funding Acknowledgements Type of funding sources: None. Background – Although percutaneous mitral valve repair is an attractive alternative treatment option for patients with severe mitral regurgitation (MR) at high surgical risk, residual MR is commonly observed after the procedure and little is known about its impact on outcomes after MitraClip therapy, expecially in patients with severe left ventricular (LV) impairment. Purpose – The aim of this prospective, observational study was to evaluate the impact of residual MR (MR ≤1+ vs. MR >1+) on long-term outcomes of mitral valve repair with the MitraClip System in high surgical risk patients presenting with moderate-to-severe or severe MR and with severe reduction of LV ejection fraction (EF). Methods – Patients enrolled in the prospective Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation (GRASP) with functional MR and EF ≤30% who were eligible at almost five-year follow-up were included in the present analysis.  The primary endpoint was death at 5-year follow-up.  Also echocardiographic parameters at baseline and 5-year follow-up and rehospitalization rates were assessed. Results – A total of 139 patients were included: 92 (66.2%) with post-procedural residual MR ≤1+ and 47 (33.8%) with residual MR > 1+ (41 patients with residual MR 2+, 5 with residual MR 3+, 1 with residual MR 4+).  Comparable clinical and echocardiographic baseline characteristics were observed between the two groups except for NYHA functional class IV and implanted pace-maker (more frequent in patients with residual MR >1+) and previous myocardial infarction (more frequent  in patients with residual MR ≤1+). At 5-year follow-up, no significant differences were reported in the primary endpoint (49.6% in patients with residual MR ≤ 1+ vs. 65.3% in patients with residual MR > 1+, p 0.203) and in cardiac death (37.8% in patients with residual MR ≤ 1+ vs. 42.6% in patients with residual MR > 1+, p 0.921). Cox regression analysis identified residual MR > 1+ as an independent predictor of re-hospitalization (HR 0.51, 95% CI 0.28-0.92, p =0.026). At 5-year follow-up,  a significant reduction in left ventricular end-systolic volume was  observed in patients with residual MR ≤ 1+. Conclusions – At 5-year follow no significant differences in survival emerged in patients with severe  LV dysfunction undergoing MitraClip therapy regardless residual MR. Nevertheless residual MR > 1+ emerged as an indipendent predictor of re-hospitalization.

scholarly journals THE EVEREST II HIGH SURGICAL RISK COHORT: EFFECTIVENESS OF TRANSCATHETER REDUCTION OF SIGNIFICANT MITRAL REGURGITATION IN HIGH SURGICAL RISK PATIENTS

2013 ◽  
Vol 61 (10) ◽  
pp. E1958 ◽  
Author(s):  
Scott Lim ◽  
Saibal Kar ◽  
Peter Fail ◽  
Brian Whisenant ◽  
William Gray ◽  
...  
Keyword(s):  
Mitral Regurgitation ◽  
Surgical Risk ◽  
High Surgical Risk ◽  
Risk Patients

scholarly journals TCT-93 Percutaneous Reduction of Severe Mitral Regurgitation in Elderly High Surgical Risk Patients

2013 ◽  
Vol 62 (18) ◽  
pp. B30
Author(s):  
Michael Rinaldi ◽  
Saibal Kar ◽  
D. Scott Lim ◽  
James Hermiller ◽  
Richard Smalling ◽  
...  
Keyword(s):  
Mitral Regurgitation ◽  
Severe Mitral Regurgitation ◽  
Surgical Risk ◽  
Percutaneous Reduction ◽  
High Surgical Risk ◽  
Risk Patients

Abstract 13513: MitraClip ® for Functional Mitral Regurgitation: Outcomes in Over 600 Patients

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Gorav Ailawadi ◽  
D. Scott Lim ◽  
Irving L Kron ◽  
Alfredo Trento ◽  
Saibal Kar ◽  
...  
Keyword(s):  
Coronary Artery ◽  
High Risk ◽  
Mitral Regurgitation ◽  
Nyha Class ◽  
Class I ◽  
Symptom Improvement ◽  
Surgical Risk ◽  
High Risk Patients ◽  
High Surgical Risk ◽  
Risk Patients

Background: The treatment options for degenerative or primary mitral regurgitation (DMR) include mitral surgery and transcatheter edge-to-edge repair (MitraClip). However, the optimal therapy for patients with functional or secondary MR (FMR) remains unclear. The purpose of this study was to evaluate the 1 year outcomes of all patients with FMR undergoing MitraClip in the United States as part of the EVEREST (Endovascular Valve Edge-to-Edge Repair STudy) II study. Methods: Patients treated in the EVEREST II trial (randomized trial and continued access registries) with severe FMR were evaluated. Outcomes at 30 days and 1 year were analyzed and adjudicated by an independent core laboratory. Patients were further stratified by surgical risk (High risk= STS mortality score ≥12% or pre-specified risk factors). Results: A total of 619 patients (mean age=73.4 years) with FMR were treated with MitraClip. Comorbidities were common including coronary artery disease (81.1%), NYHA functional class III/IV (80.3%), and previous coronary artery bypass grafting (55.7%). Device implantation was achieved in 96.4% with a mean hospital stay of 3.3 days and an 87.2% discharge to home. At 30 days, mortality was 3.6% with a major adverse event rate of 9.2%. At 1 year, the survival was 78.3%, while the majority of survivors had MR≤2+ (84.5%) and significantly improved symptoms (83.2% NYHA Class I/II). The left ventricular end diastolic volume (LVEDV) improved from 162.5ml to 152.6ml (P<.001). When comparing high surgical risk patients (n=485; mean STS score=10.6±6.9%) to non-high risk patients (n=134), the 30 day mortality was similar (4.1% vs. 1.5%, P=.19), but the 1 year mortality was worse (22.7% vs. 13.4%, P=.02). Nevertheless, at 1 year, there were similar rates of MR reduction (MR≤2+: 83.9% vs. 87.3%) and improvement in LVEDV (-9.0ml vs -12.6ml). The non-high risk cases had greater symptom improvement (NYHA Class I/II: 91.2% vs. 80.2%, P=.001). Conclusions: MitraClip in patients with severe FMR is associated with excellent safety, positive ventricular remodeling, symptom improvement, and stable MR reduction at 1 year independent of surgical risk. Compared to high surgical risk patients, non-high risk patients may derive the greatest survival and symptom benefit.

Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients

Heart ◽  
2018 ◽  
Vol 105 (21) ◽  
pp. 1622-1628 ◽  
Author(s):  
Saibal Kar ◽  
Ted Feldman ◽  
Atif Qasim ◽  
Alfredo Trento ◽  
Samir Kapadia ◽  
...  
Keyword(s):  
High Risk ◽  
Mitral Regurgitation ◽  
Nyha Class ◽  
Left Ventricular ◽  
Functional Class ◽  
Surgical Risk ◽  
High Surgical Risk ◽  
Risk Patients

ObjectivesThis study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS).MethodsPatients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up.ResultsAt 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (−38.2 mL; 95% CI −55.0 to –21.4; p<0.0001) and LV end-systolic volume (−14.6 mL; 95% CI −27.7 to −1.5; p=0.0303) compared with baseline. The New York Heart Association (NYHA) functional class improved from baseline to 5 years (p<0.005), and septal-lateral annular dimensions remained stable with no indication of mitral annular dilation through 5 years.ConclusionsThe EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up.Trial registration numberNCT01940120.

Bivalvular transcatheter treatment of high-surgical-risk patients with coexisting severe aortic stenosis and significant mitral regurgitation

2013 ◽  
Vol 167 (3) ◽  
pp. 716-720 ◽  
Author(s):  
Volker Rudolph ◽  
Johannes Schirmer ◽  
Olaf Franzen ◽  
Michael Schlüter ◽  
Moritz Seiffert ◽  
...  
Keyword(s):  
Mitral Regurgitation ◽  
Aortic Stenosis ◽  
Severe Aortic Stenosis ◽  
Surgical Risk ◽  
High Surgical Risk ◽  
Risk Patients
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