Summary Background Heart failure with preserved ejection fraction (HFPEF) is a common, globally recognised, form of heart failure for which no treatment has yet been shown to improve symptoms or ...prognosis. The pathophysiology of HFPEF is complex but characterised by increased left atrial pressure, especially during exertion, which might be a key therapeutic target. The rationale for the present study was that a mechanical approach to reducing left atrial pressure might be effective in HFPEF. Methods The REDUCe Elevated Left Atrial Pressure in Patients with Heart Failure (REDUCE LAP-HF) study was an open-label, single-arm, phase 1 study designed to assess the performance and safety of a transcatheter interatrial shunt device (IASD, Corvia Medical, Tewkesbury, MA, USA) in patients older than 40 years of age with symptoms of HFPEF despite pharmacological therapy, left ventricular ejection fraction higher than 40%, and a raised pulmonary capillary wedge pressure at rest (>15 mm Hg) or during exercise (>25 mm Hg). The study was done at 21 centres (all departments of cardiology in the UK, Netherlands, Belgium, France, Germany, Austria, Denmark, Australia, and New Zealand). The co-primary endpoints were the safety and performance of the IASD at 6 months, together with measures of clinical efficacy, including functional capacity and clinical status, analysed per protocol. This study is registered with ClinicalTrials.gov , number NCT01913613. Findings Between Feb 8, 2014, and June 10, 2015, 68 eligible patients were entered into the study. IASD placement was successful in 64 patients and seemed to be safe and well tolerated; no patient had a peri-procedural or major adverse cardiac or cerebrovascular event or need for cardiac surgical intervention for device-related complications during 6 months of follow-up. At 6 months, 31 (52%) of 60 patients had a reduction in pulmonary capillary wedge pressure at rest, 34 (58%) of 59 had a lower pulmonary capillary wedge pressure during exertion, and 23 (39%) of 59 fulfilled both these criteria. Mean exercise pulmonary capillary wedge pressure was lower at 6 months than at baseline, both at 20 watts workload (mean 32 mm Hg SD 8 at baseline vs 29 mm Hg 9 at 6 months, p=0·0124) and at peak exercise (34 mm Hg 8 vs 32 8, p=0·0255), despite increased mean exercise duration (baseline vs 6 months: 7·3 min SD 3·1 vs 8·2 min 3·4, p=0·03). Sustained device patency at 6 months was confirmed by left-to-right shunting (pulmonary/systemic flow ratio: 1·06 SD 0·32 at baseline vs 1·27 0·20 at 6 months, p=0·0004). Interpretation Implantation of an interatrial shunt device is feasible, seems to be safe, reduces left atrial pressure during exercise, and could be a new strategy for the management of HFPEF. The effectiveness of IASD compared with existing treatment for patients with HFPEF requires validation in a randomised controlled trial. Funding Corvia Medical Inc.
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.
Echocardiography-guided interventions Silvestry, Frank E; Kerber, Richard E; Brook, Michael M ...
Journal of the American Society of Echocardiography,
03/2009, Letnik:
22, Številka:
3
Journal Article
Recenzirano
Odprti dostop
A major advantage of echocardiography over other advanced imaging modalities (magnetic resonance imaging, computed tomographic angiography) is that echocardiography is mobile and real time. ...Echocardiograms can be recorded at the bedside, in the cardiac catheterization laboratory, in the cardiovascular intensive care unit, in the emergency room-indeed, any place that can accommodate a wheeled cart. This tremendous advantage allows for the performance of imaging immediately before, during, and after various procedures involving interventions. The purpose of this report is to review the use of echocardiography to guide interventions. We provide information on the selection of patients for interventions, monitoring during the performance of interventions, and assessing the effects of interventions after their completion. In this document, we address the use of echocardiography in commonly performed procedures: transatrial septal catheterization, pericardiocentesis, myocardial biopsy, percutaneous transvenous balloon valvuloplasty, catheter closure of atrial septal defects (ASDs) and patent foramen ovale (PFO), alcohol septal ablation for hypertrophic cardiomyopathy, and cardiac electrophysiology. A concluding section addresses interventions that are presently investigational but are likely to enter the realm of practice in the very near future: complex mitral valve repairs, left atrial appendage (LAA) occlusion devices, 3-dimensional (3D) echocardiographic guidance, and percutaneous aortic valve replacement. The use of echocardiography to select and guide cardiac resynchronization therapy has recently been addressed in a separate document published by the American Society of Echocardiography and is not further discussed in this document. The use of imaging techniques to guide even well-established procedures enhances the efficiency and safety of these procedures.
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.
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.
Appropriateness criteria were applied to outpatient transthoracic echocardiographic (TTE) studies.
Indications were rated as appropriate, inappropriate, or unclassifiable, considering provider-stated ...indications, previous TTE studies, symptom changes, and patient-stated indications. Clinically important new or unexpected findings were recorded.
Of 368 TTE studies, 206 (56%) were appropriate, 31 (8%) were inappropriate, and 131 (35%) were unclassifiable. Appropriateness was not correlated with patient or provider demographics. In 288 cases with prior TTE studies, there were 92 (32%) important new findings and 63 (22%) unexpected findings, of which 20% were from inappropriately ordered and 31% from unclassifiable TTE studies. Appropriateness was not associated with new (odds ratio, 1.23; 95% confidence interval, 0.48-3.18) or unexpected (odds ratio, 1.15; 95% confidence interval, 0.38-3.52) findings. Provider type and level of training were not correlated with new or unexpected findings.
Many indications for TTE studies were unclassifiable. A high percentage of inappropriately ordered TTE studies yielded important information. Care must be taken in judging the value of TTE studies solely on the basis of appropriateness criteria.
Mitral regurgitation (MR) is common, and definitive management of significant MR often requires percutaneous or surgical correction. Lone atrial fibrillation has been proposed to result in “atrial ...functional mitral regurgitation (AFMR)” via left atrial enlargement and mitral annular dilation. Patients with AFMR may represent a subgroup in which a rhythm control strategy may be preferred and catheter ablation is a promising nonsurgical therapy. This review discusses the anatomy of the mitral valve apparatus and MR classification schemes. Potential mechanisms in the pathogenesis of AFMR the implications for treatment will be discussed in detail.
Intracardiac echocardiographic (ICE) imaging is a modality increasingly used to guide percutaneous cardiac structural interventions. Until recently, ICE imaging has been limited by the presence of ...only two-dimensional imaging planes and requires considerable catheter manipulation to visualize certain targets. The aim of this study was to assess the feasibility of a new three-dimensional (3D) volumetric ICE system to provide imaging guidance in 15 patients undergoing percutaneous cardiac structural interventions.
The Siemens AcuNav 3D volumetric ICE catheter was used to guide interventions in 15 patients. Imaging was performed at 6 and 8 MHz without color Doppler flow mapping and at 4 and 6 MHz with color Doppler flow mapping. The images were independently reviewed, and the ability to visualize specific structures was assessed by two independent and expert ICE imagers.
The majority of patients (n = 11 73%) were undergoing percutaneous transcatheter closure of patent foramen ovales (n = 3 20%) or atrial septal defects (n = 8 53%). Three patients (20%) underwent balloon valvuloplasty for mitral stenosis. One patient (7%) underwent a diagnostic study for congenital heart disease. There were no significant differences in image scores between 3D and two-dimensional imaging without color Doppler in clinically important targets. With color Doppler, there were decreased image scores in the 3D images. Three-dimensional images provided improved imaging of devices and catheters and of the relationship between atrial septal defect devices and the aorta.
Three-dimensional volumetric ICE imaging can be successfully used to guide structural heart disease procedures. It has the potential to provide greater anatomic information during interventions. Further improvement in its imaging capabilities is required to improve color Doppler mapping and volume size capabilities.
Background Ejection fraction (EF) calculated from 2-dimensional echocardiography provides important prognostic and therapeutic information in patients with heart disease. However, quantification of ...EF requires planimetry and is time-consuming. As a result, visual assessment is frequently used but is subjective and requires extensive experience. New computer software to assess EF automatically is now available and could be used routinely in busy digital laboratories (>15 000 studies per year) and in core laboratories running large clinical trials. We tested Siemens AutoEF software (Siemens Medical Solutions, Erlangen, Germany) to determine whether it correlated with visual estimates of EF, manual planimetry, and cardiac magnetic resonance (CMR). Methods Siemens AutoEF is based on learned patterns and artificial intelligence. An expert and a novice reader assessed EF visually by reviewing transthoracic echocardiograms from consecutive patients. An experienced sonographer quantified EF in all studies using Simpson's method of disks. AutoEF results were compared to CMR. Results Ninety-two echocardiograms were analyzed. Visual assessment by the expert ( R = 0.86) and the novice reader ( R = 0.80) correlated more closely with manual planimetry using Simpson's method than did AutoEF ( R = 0.64). The correlation between AutoEF and CMR was 0.63, 0.28, and 0.51 for EF, end-diastolic and end-systolic volumes, respectively. Conclusion The discrepancies in EF estimates between AutoEF and manual tracing using Simpson's method and between AutoEF and CMR preclude routine clinical use of AutoEF until it has been validated in a number of large, busy echocardiographic laboratories. Visual assessment of EF, with its strong correlation with quantitative EF, underscores its continued clinical utility.
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