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

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.

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

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

scholarly journals Conceiving MitraClip as a tool: percutaneous edge-to-edge repair in complex mitral valve anatomies

2020 ◽  
Vol 21 (10) ◽  
pp. 1059-1067
Author(s):  
Mara Gavazzoni ◽  
Maurizio Taramasso ◽  
Michel Zuber ◽  
Giulio Russo ◽  
Alberto Pozzoli ◽  
...  
Keyword(s):  
High Risk ◽  
Mitral Valve ◽  
Mitral Regurgitation ◽  
Clinical Studies ◽  
Mitral Insufficiency ◽  
Heart Team ◽  
Severe Mitral Regurgitation ◽  
Review Of The Literature ◽  
Surgical Risk ◽  
High Surgical Risk

Abstract Improvements in procedural technique and intra-procedural imaging have progressively expanded the indications of percutaneous edge-to-edge technique. To date in higher volume centres and by experienced operators MitraClip is used for the treatment of complex anatomies and challenging cases in high risk-inoperable patients. This progressive step is superimposable to what observed in surgery for edge-to-edge surgery (Alfieri’s technique). Moreover, the results of clinical studies on the treatment of patients with high surgical risk and functional mitral insufficiency have confirmed that the main goal to be achieved for improving clinical outcomes of patients with severe mitral regurgitation (MR) is the reduction of MR itself. The MitraClip should therefore be considered as a tool to achieve this goal in addition to medical therapy. Nowadays, evaluation of patient’s candidacy to MitraClip procedure, discussed in local Heart Team, must take into account not only the clinical features of patients but even the experience of the operators and the volume of the centre, which are mostly related to the probability to achieve good procedural results. This ‘relative feasibility’ of challenges cases by experienced operators should always been taken into account in selecting patients for MitraClip. Here, we present a review of the literature available on the treatment of complex and challenging lesions.

Percutaneous Rotational Lithotripsy of Gallbladder Stones

1993 ◽  
Vol 34 (3) ◽  
pp. 273-278 ◽  
Author(s):  
C.-G. Lindberg ◽  
B. Jeppsson ◽  
C. Lundstedt ◽  
J. Willner ◽  
H. Stridbeck
Keyword(s):  
High Risk ◽  
Elderly Patients ◽  
Acute Cholecystitis ◽  
Emergency Treatment ◽  
The Other ◽  
Surgical Risk ◽  
High Risk Patients ◽  
Gallbladder Stones ◽  
High Surgical Risk ◽  
Risk Patients

Ten patients (aged 39–94 years) with cholecystolithiasis were selected for percutaneous rotational lithotripsy with the Rotolith lithotriptor either because they were considered high-risk patients for cholecystectomy or because they had refused surgery. The procedure was completed in 7 patients. Five of these were stone-free at cholangiography 1 to 2 days after lithotripsy. Conclusive cholangiograms were not obtained in 2 patients due to gallbladder leakage, which in itself did not cause any serious sequelae. At ultrasonography after one month, one of these 2 patients had no visible gallbladder, the other one had small residual gallbladder stones. Rotational lithotripsy is an alternative to cholecystectomy in patients at high surgical risk, especially elderly patients who have undergone cholecystostomy as an emergency treatment for acute cholecystitis.

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