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.

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.

scholarly journals Transcatheter mitral valve-in-valve implantation: a 10-year single center experience

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M Akodad ◽  
G Sathananthan ◽  
A G Chatfield ◽  
C Trpkov ◽  
Y Lounes ◽  
...  
Keyword(s):  
Heart Failure ◽  
Mitral Valve ◽  
Mitral Regurgitation ◽  
Valve Replacement ◽  
Left Ventricular ◽  
Surgical Risk ◽  
High Surgical Risk ◽  
Valve In Valve

Abstract Background Transcatheter mitral valve-in-valve (TMVIV) appears a reasonable alternative to surgical redo mitral valve replacement in patients with degenerated mitral prosthesis and high surgical risk with favorable early and mid-terms outcomes. Long-term outcomes are limited by high mortality in a comorbid population. Purpose We aimed to evaluate early prosthesis hemodynamic performance and late clinical outcomes following TMVIV. Methods All patients who underwent TMVIV for degenerated surgical mitral bioprostheses from 2011 to 2020 in our center were included. Prospectively collected demographic, clinical, procedural, and imaging variables were analyzed. Clinical and echocardiographic outcomes were defined according to Mitral Valve Academic Research Consortium (MVARC) definitions and assessed at 30-day and at the latest follow-up available. Results A total of 67 patients were included; mean age 76.9±9.6 years, mean STS score 11.0±6.2%, 53.7% male (n=36). Mechanisms of bioprosthetic failure were mitral stenosis (n=32, 47.8%), mitral regurgitation (n=24, 35.8%), and mixed (n=11, 16.4%). Mean time from mitral valve surgery to TMVIV was 10.2±4.3 years. Access was mostly transapical (n=45; 67.2%), followed by transseptal (n=22; 32.8%). Following the first transseptal procedure in 2016; transseptal access accounted for the majority of procedures (22 of 37 cases, 59.4%). Technical success was achieved in 65 patients (97.0%). Mean hospitalization was 9.2±10.0 days; shorter with the transseptal as opposed to the transapical approach (6.3±8.1 days versus 11.0±10.5 days, p=0.001). At 30-day echographic follow-up, mean mitral valve gradient was 7.3±2.7 and 1 patient (1.9%) had mitral regurgitation &gt;mild. At 30-day follow-up, 3 patients had died (4.5%); due to left ventricular outflow tract obstruction (1), heart failure (1), and stroke (1). New pacemakers were required in 2 patients (3.0%) and pacemaker lead dislodgement occurred in 1 patient (1.5%), 4 patients (6.2%) were hospitalized for heart failure. At a median follow-up of 3.8 years [1.7–5.1], 29 patients had died (43.3%), valve thrombosis was found in 6 (8.9%) and endocarditis in 4 patients (6.2%). Mitral valve reintervention was performed in 4 patients (6.2%); redo TMVIV due to valve migration in 1 (1.9%), surgical valve replacement in 1 (1.9%), and delayed redilation with a non-compliant balloon due to underexpansion in 2 patients (3.8%). Conclusion TMVIV is associated with acceptable 30-day mitral valve hemodynamics. Long-term mortality remains high in this high-surgical risk comorbid group. FUNDunding Acknowledgement Type of funding sources: None.

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 &gt;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 &gt; 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 &gt;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 &gt; 1+, p 0.203) and in cardiac death (37.8% in patients with residual MR ≤ 1+ vs. 42.6% in patients with residual MR &gt; 1+, p 0.921). Cox regression analysis identified residual MR &gt; 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 &gt; 1+ emerged as an indipendent predictor of re-hospitalization.

Safety and Efficacy of Carotid Angioplasty/Stenting in 100 Consecutive High Surgical Risk Patients: Immediate and Long-Term Follow-up

2008 ◽  
Vol 42 (5) ◽  
pp. 433-439 ◽  
Author(s):  
Ali F. AbuRahma ◽  
Mark C. Bates ◽  
Kris Eads ◽  
Lauren Armistead ◽  
Sarah K. Flaherty
Keyword(s):  
Carotid Angioplasty ◽  
Surgical Risk ◽  
Safety And Efficacy ◽  
High Surgical Risk ◽  
Long Term Follow Up ◽  
Risk Patients

Long term survival in high-risk patients after percutaneous mitral leaflet repair in a single centre: comparable mortality regardless of aetiology

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L Connolly ◽  
P Rajani ◽  
B M-Labbe ◽  
A Davies ◽  
A Duncan ◽  
...  
Keyword(s):  
High Risk ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Mitral Leaflet ◽  
Single Centre ◽  
High Risk Patients ◽  
Risk Patients ◽  
Baseline Characteristics

Abstract Background Percutaneous mitral leaflet repair (PMVR) is a safe and effective alternative to conventional surgery in high-risk patients with both degenerative (DMR) and functional (FMR) mitral regurgitation. We present an analysis of a large cohort of consecutive patients treated with PMVR at a high-volume UK centre. Purpose We sought to analyse the outcomes of a group of patients undergoing PMVR over a 7-year period at a single centre, where surgery had been excluded. We hypothesised that the long-term mortality in this group would be high and would differ depending on the aetiology of MR. Methods We identified 246 consecutive patients over the duration of the PMVR programme, where follow up and pre-procedural data were available. We collected baseline characteristics including age at procedure, left ventricular ejection fraction (LVEF), left ventricular indexed diastolic volumes (LVEDVi) and aetiology of MR. Post procedural data included MR at end of procedure, all-cause mortality and duration of follow up. Results Baseline characteristics for the group, as a whole, were as follows: mean age 76±11 years, 170 (69%) male, DMR 136 (55%) vs. FMR 110 (45%), LVEF 49±15%. Baseline data by aetiology subgroup: mean age DMR 80±9 vs. FMR 71±11 (p&lt;0.001), LVEF DMR 58±10 vs. FMR 40±14 (p&lt;0.001), LVEDVi DMR 71±25 FMR 85±25 (p&lt;0.001). 99% of patients were treated with the MitraClip® device (Abbott, US), 1% received the Pascal device (Edwards, US). Post-procedural MR grade was similar for both groups (DMR 1.5±0.8 vs. 1.4±0.8, p=NS). Overall procedural mortality was 0.4% and at a mean follow up of 1097 days (median 1021, IQR 289–1555) was 30.8%. Mortality was identical regardless of aetiology (DMR 30.9% vs. FMR 30.8%, p=NS). Conclusions This analysis of consecutive “real world” patients demonstrates encouraging survival outcome at a mean of 3 years after PMVR, regardless of MR aetiology. DMR patients tended to be older but with lower LVEDVi and significantly higher LVEF. These data compare favourably with the published literature, where mortality for mixed and similarly high-risk populations at 12 months averages approximately 20–25%. Mortality in our FMR group at 3 years was also similar to that seen in the recently published COAPT study at 2 years. We have demonstrated that PMVR is a safe option for our cohort of unselected high-risk patients presenting with either degenerative or functional MR. We hypothesise that the absence of survival difference could relate to the younger age of FMR patients despite the significantly lower baseline LVEF and higher ventricular volumes. This analysis encourages the more routine use of PMVR for FMR in the UK, where currently only DMR is commissioned. Funding Acknowledgement Type of funding source: None

scholarly journals EFFECTIVENESS OF TRANSCATHETER REDUCTION OF SIGNIFICANT MITRAL REGURGITATION IN HIGH SURGICAL RISK PATIENTS WITH MITRACLIP: FINAL 5 YEAR RESULTS OF THE EVEREST II HIGH RISK REGISTRY

2014 ◽  
Vol 63 (12) ◽  
pp. A1683 ◽  
Author(s):  
Saibal Kar ◽  
Patrick Whitlow ◽  
Wesley Pedersen ◽  
Scott Lim ◽  
Richard Smalling ◽  
...  
Keyword(s):  
High Risk ◽  
Mitral Regurgitation ◽  
Surgical Risk ◽  
High Surgical Risk ◽  
Risk Patients

scholarly journals Endovascular treatment of abdominal aortic aneurysms in high-surgical-risk patients

2009 ◽  
Vol 8 (1) ◽  
pp. 56-64 ◽  
Author(s):  
Célio Teixeira Mendonça ◽  
Ricardo Cesar Rocha Moreira ◽  
Cláudio Augusto de Carvalho ◽  
Bárbara D´Agnoluzzo Moreira ◽  
Janaína Weingärtner ◽  
...  
Keyword(s):  
Operative Mortality ◽  
Aortic Aneurysms ◽  
Long Term Results ◽  
Secondary Patency ◽  
Surgical Risk ◽  
Abdominal Aortic ◽  
High Surgical Risk ◽  
Risk Patients

Background: Following the publication of a prospective randomized trial (Endovascular Aneurysm Repair Trial 2 - EVAR2) that questioned the benefits of endovascular repair of abdominal aortic aneurysms (AAA) in high-surgical-risk patients, we decided to analyze our initial and long-term results with endovascular AAA repair in this patient population. Objective: To evaluate the operative mortality, long-term survival, frequency of secondary operations, outcome of the aneurysm sac, primary and secondary patency rates, and rupture rate after aortic stent-graft placement in high-surgical-risk patients. Methods: From April 2002 to February 2008, 40 high-surgical and anesthetic risk patients with an AAA managed by a bifurcated aortic endograft were entered in a prospective registry. Data concerning diagnosis, operative risk, treatment and follow-up were analyzed in all patients Results: Twenty-four Excluder® and 16 Zenith® stent-grafts were successfully implanted. Thirty patients (75%) were classed ASA III and 10 (25%) were ASA IV. Mean aneurysm diameter was 64 mm. Operative mortality was 2.5%. Two patients required reintervention during the mean follow-up of 28.5 months. Survival rate at 3 years was 95%. There were four endoleaks, one case of endotension, and one endograft limb occlusion. Primary and secondary patency rates at 3 years were 97.5 and 100%, respectively. There were no ruptures. Conclusions: Initial and long-term results with endovascular treatment of AAA in high-surgical-risk patients were satisfactory, and appear to justify such approach for this patient population.

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