Clinical trial experience with the MitraClip catheter based mitral valve repair system (original) (raw)
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Percutaneous Mitral Valve Repair with the MitraClip System in the Current Clinical Practice
Hearts, 2021
Severe mitral valve regurgitation (MR) carries a significant burden both in prognosis and quality of life of patients, as well as on healthcare systems, with high rates of hospitalization for heart failure. While mitral valve surgery constitutes the first-line treatment option for primary MR in suitable patients, surgical treatment for secondary severe MR remains controversial, with a substantial lack of evidence on a survival benefit. In recent decades, percutaneous mitral valve repair has emerged as an alternative treatment for patients deemed not suitable for surgery. Among several devices under development or evaluation, the MitraClip system is the most widespread and is supported by the strongest evidence. While the role of MitraClip in patients with chronic primary MR who are not deemed suitable for surgery is well established, with consistent data showing improvement in both prognosis and quality of life, MitraClip treatment in secondary MR is a rapidly evolving field. Two re...
Current state of transcatheter mitral valve repair with the MitraClip
Annals of cardiothoracic surgery, 2015
Many patients affected with mitral valve regurgitation suffer from multiple comorbidities. The MitraClip device provides a safe means of transcatheter valve repair in patients with suitable mitral valve anatomy who are at prohibitive risk for surgery. We describe our early procedural outcomes and present a summary of the current state of MitraClip technology in the United States. We performed a retrospective chart review of initial high-risk or inoperable patients who underwent MitraClip placement at our institution after completion of the EVEREST II study. We examined the primary outcome of 30-day mortality, and secondary outcomes included extent of reduction of mitral regurgitation (MR), New York Heart Association (NYHA) functional class improvement, length of stay, and major complications. A total of 115 high-risk patients (mean Society of Thoracic Surgeons predicted risk of mortality 9.4%±6.1%) underwent the MitraClip procedure at our institution between March 2009 and April 201...
Journal of the American College of Cardiology, 2015
In EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), treatment of mitral regurgitation (MR) with a novel percutaneous device showed superior safety compared with surgery, but less effective reduction in MR at 1 year. This study sought to evaluate the final 5-year clinical outcomes and durability of percutaneous mitral valve (MV) repair with the MitraClip device compared with conventional MV surgery. Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the device or conventional MV surgery in a 2:1 ratio (178:80). Patients prospectively consented to 5 years of follow-up. At 5 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the as-treated population was 44.2% versus 64.3% in the percutaneous repair and surgical groups, respectively (p = 0.01). The difference was driven by increased rates of 3+ to 4+ MR (12.3% vs. 1.8%; p = 0.02) and surgery (27.9% vs. 8.9%; p = 0.003) with percutaneous repair. After per...
Safety and efficacy of the MitraClip® system for severe mitral regurgitation
Catheterization and Cardiovascular Interventions, 2014
BackgroundThe MitraClip® system is a newer percutaneous device that has shown promising results but data on its safety and efficacy in low‐ and high‐surgical risk populations continues to evolve. We performed a systematic review of the published studies reporting the safety and efficacy of MitraClip® implantation for treatment of moderate to severe and severe mitral regurgitation (MR).MethodsReviewers independently searched for relevant articles in Medline and abstracted clinical information based on pre‐defined criteria and end‐points. Patients were classified as low‐ or high‐surgical risk for conventional mitral valve (MV) surgery based on Society of Thoracic Surgeons score, EuroSCORE, or surgeon discretion. Primary safety outcome was 30‐day mortality and primary efficacy outcomes were freedom from death, ≥3+ MR, and requirement for MV surgery during follow‐up.ResultsImmediate and long‐term outcomes of 16 studies, including 2980 patients (age 73.7 ± 0.6 years; 63.3% males) receivi...
Advances in Interventional Cardiology, 2013
P Pi io ot tr r K Kü üb bl le er r 1 1 , , D Do or ro ot ta a K Ku us st tr rz zy yc ck ka a--K Kr ra at to oc ch hw wi il l 1 1 , , A Ar rt tu ur r T Te el li ic ch ho ow ws sk ki i 1 1 , , T To om ma as sz z W Wi it tk ko ow ws sk ki i 1 1 , , W Wa al ld de em ma ar r B Ba an na as si ia ak k 1 1 , , E Ew wa a A A. . J Ja an nk ko ow ws sk ka a 1 1, ,2 2 , , P Pi io ot tr r P Po on ni ik ko ow ws sk ki i 1 1, ,2 2 , , K Kr rz zy ys sz zt to of f R Re ec cz zu A b s t r a c t Treatment of hemodynamically significant valvular heart diseases has been the domain of cardiac surgery for decades. However, a promising novel method is the MitraClip system, involving percutaneous connection of insufficient valve leaflets with special cobalt-chrome clips. Our study presents clinical characteristics, course of treatment with the MitraClip system, and immediate and 90-day clinical and echocardiographic follow-up of the first 3 patients treated in our institution. Subsequently, based on data from the literature and our own experience, the current position around the world, and the target group of patients who are most likely to benefit from treatment using the MitraClip system, are discussed.
Acute and 12-Month Results With Catheter-Based Mitral Valve Leaflet Repair
Journal of the American College of Cardiology, 2012
The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. Background Patients with severe MR (3 to 4ϩ) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. Methods Patients with severe symptomatic MR and an estimated surgical mortality rate of Ն12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care. Results Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, Ͼ50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p ϭ NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p ϭ 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of Յ2ϩ. Left ventricular enddiastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p ϭ 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p Ͻ 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p ϭ 0.014] and the mental component score from 45.5 to 48.7 [p ϭ 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p ϭ 0.034). Conclusions The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a