...many of these recommendations are based on expert consensus. The defining principle is that this effort is a joint, institutionally-based activity for cardiologists and cardiac surgeons (1,4). ......the specialty that provides some of these components will vary from program to program.
The aims of the echocardiographic substudy of this multicenter trial were to evaluate the use of quantitative assessment of mitral regurgitation (MR) severity using serial echocardiography and to ...assess the efficacy of percutaneous mitral valve repair. Previous surgical repair studies did not use quantitative echocardiographic methods. Results of a percutaneous mitral valve repair clip device in a core echocardiographic laboratory were evaluated. Published parameters for quantifying MR were used in a systematic protocol to qualify patients for study entry and evaluate treatment efficacy at discharge and 6 months after clip repair. Baseline results were presented for 55 patients, and follow-up results, for 49. Ninety-eight percent of required echocardiographic studies were submitted to the core laboratory, and >85% of required measurements were possible. At baseline, mean regurgitant volume was 54.8 ± 24 ml, regurgitant fraction was 46.9 ±16.2%, effective regurgitant orifice area was 0.71 ± 0.40 cm2 , and vena contracta width was 0.66 ± 0.20 cm. Based on a severity scale of 1 to 4, mean color flow grade was 3.4 ± 0.7, and mean pulmonary vein flow was 2.8 ± 1.2. In patients with a clip at 6 months, all measurements of MR severity were significantly decreased versus baseline, with mean regurgitant volume decreased from 50.3 to 27.5 ml (change −22.8 ml; p <0.0001), regurgitant fraction from 44.6% to 28.9% (change −15.7%; p <0.0001), color flow grade from an average of 3.4 to 1.8 (change −1.6; p <0.0001), and pulmonary vein flow from 2.8 to 1.8 (change −1.0; p <0.0018). In conclusion, quantitative assessment of MR is feasible in a multicenter trial, and percutaneous mitral repair with the MitraClip produces a sustained decrease in MR severity to moderate or less for ≥6 months.
Objectives The purpose of this study was to characterize patients with mitral regurgitation (MR) and atrial fibrillation (AF) treated percutaneously using the MitraClip device (Abbott Vascular, ...Abbott Park, Illinois) and compare the results with surgery in this population. Background The EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized controlled trial compared a less invasive catheter-based treatment for MR with surgery, providing an opportunity to assess the impact of AF on the outcomes of both the MitraClip procedure and surgical repair. Methods The study population included 264 patients with moderately severe or severe MR assessed by an independent echocardiographic core laboratory. Comparison of safety and effectiveness study endpoints at 30 days and 1 year were made using both intention-to-treat and per-protocol (cohort of patients with MR ≤2+ at discharge) analyses. Results Pre-existing AF was present in 27% of patients. These patients were older, had more advanced disease, and were more likely to have a functional etiology. Similar reduction of MR to ≤2+ before discharge was achieved in patients with AF (83%) and in patients without AF (75%, p = 0.3). Freedom from death, mitral valve surgery for valve dysfunction, and MR >2+ was similar at 12 months for AF patients (64%) and for no-AF patients (61%, p = 0.3). At 12 months, MR reduction to <2+ was greater with surgery than with MitraClip, but there was no interaction between rhythm and MR reduction, and no difference in all-cause mortality between patients with and patients without AF. Conclusions Atrial fibrillation is associated with more advanced valvular disease and noncardiac comorbidities. However, acute procedural success, safety, and 1-year efficacy with MitraClip therapy is similar for patients with AF and without AF.
Percutaneous mitral repair is rapidly developing as an alternative to cardiac surgery in select patients. The Evalve percutaneous E2E system uses the MitraClip to replicate the surgical suture-based ...approach. This procedure requires real-time echocardiographic guidance in a unique and significant collaboration between echocardiographer and interventionalist. transesophageal echocardiography (TEE) is used as the primary imaging modality to guide this procedure and is essential to its success.
In EVEREST I, the US multicenter phase I safety and feasibility trial, 47 patients with 3 or 4+ mitral regurgitation (MR) were enrolled. The trial involved a standardized echocardiographic imaging protocol with a standardized anatomic-based vocabulary, predetermined standard TEE views, preprocedural strategy meetings, and display of echocardiographic aids to optimize communication and procedural efficiency during placement of the clip.
TEE guidance facilitated the creation of a double-orifice mitral valve in all 47 patients enrolled (100%), and 40 patients were discharged with 1 or more clips (85%). At discharge, successful placement of a clip and <or= 2+ MR was present in 34 patients (74%). The standardized approach contributed to a reduction in the time to perform the procedure over the course of the trial at both initial and new sites.
TEE is essential to the guidance of percutaneous MitraClip E2E repair. A streamlined approach to echocardiographic guidance, using predetermined standardized views, a common anatomic-based vocabulary, preprocedural strategy meetings, and a display of echocardiographic aids in the catheterization laboratory shortens the procedure time and allows for efficient percutaneous repair.
Preamble With the evolution of transcatheter valve replacement, an important opportunity has arisen for cardiologists and surgeons to collaborate in identifying the criteria for performing these ...procedures. ...Additional Supporting Information may be found in the online version of this article. According to the ACC, a person has a relevant relationship IF: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) The company/ entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) The person or a member of the person's household has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues/content addressed in the document.
Training for structural and adult congenital heart disease interventions remains undeveloped. With the advent of recent percutaneous interventions for the treatment of structural and valvular heart ...disease, such as transcatheter aortic and pulmonary valve implantation, mitral valve repair, and the expansion of shunt closure procedures, there is a clear need to define the training requirements for this category of procedures. The training needs to be aligned with the goals and priorities of a basic or advanced level and be categorized into acquired and congenital. This document will define the training needs and knowledge base for the developing field of structural heart disease intervention.
Background We compared 30-day and 1-year survival among high-risk mitral regurgitation (MR) patients treated with the MitraClip (Abbott Vascular, Abbott Park, IL) with matched non-surgically treated ...patients from the Duke Echocardiography Laboratory Database (DELD). Methods and Results High-risk patients with 3+/4+ MR managed non-surgically between years 2000 and 2010 in the longitudinal DELD were matched to high-risk MitraClip patients. Patient matching was performed using the method of nearest available Mahalanobis distance metric within calipers defined by the propensity score. Kaplan-Meier estimates and stratified Cox proportional hazards models were used to compare survival at 30 days and 1 year. Among 953 high-risk DELD patients available for matching, 30-day and 1-year mortality were 6.5% and 26.2%. Close matches were obtained for 239 of the 351 MitraClip patients. The 30-day mortality in MitraClip patients was lower (4.2%) when compared with matched DELD patients (7.2%). The 1-year relative risk of mortality of the MitraClip compared with non-surgical treatment was 0.64 (95% CI 0.45-0.91; log-rank P = .013). These results in favor of the MitraClip remained significant upon further adjustment for baseline differences between groups ( P = .043). Conclusions This matched comparison of severe MR patients at high surgical risk supports the safety of the MitraClip relative to medical therapy at 30 days and a survival benefit at 1 year.
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