Frank E. Silvestry

EAE/ASE Recommendations for the Use of Echocardiography in New Transcatheter Interventions for Valvular Heart Disease.

The introduction of devices for transcatheter aortic valve implantation, mitral repair, and closure of prosthetic paravalvular leaks has led to a greatly expanded armamentarium of catheter-based approaches to patients with regurgitant as well as stenotic valvular disease. Echocardiography plays an essential role in identifying patients suitable for these interventions and in providing intra-procedural monitoring. Moreover, echocardiography is the primary modality for post-procedure follow-up. The echocardiographic assessment of patients undergoing trans-catheter interventions places demands on echocardiographers that differ from those of the routine evaluation of patients with native or prosthetic valvular disease. Consequently, the European Association of Echocardiography in partnership with the American Society of Echocardiography has developed the recommendations for the use of echocardiography in new transcatheter interventions for valvular heart disease. It is intended that this document will serve as a reference for echocardiographers participating in any or all stages of new transcatheter treatments for patients with valvular heart disease.

Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II.

BACKGROUND 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. OBJECTIVES 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. METHODS 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. RESULTS 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 percutaneous repair, 78% of surgeries occurred within the first 6 months. Beyond 6 months, rates of surgery and moderate-to-severe MR were comparable between groups. Five-year mortality rates were 20.8% and 26.8% (p = 0.4) for percutaneous repair and surgery, respectively. In multivariable analysis, treatment strategy was not associated with survival. CONCLUSIONS Patients treated with percutaneous repair more commonly required surgery for residual MR during the first year after treatment, but between 1- and 5-year follow-up, comparably low rates of surgery for MV dysfunction with either percutaneous or surgical therapy endorse the durability of MR reduction with both repair techniques. (EVEREST II Pivotal Study High Risk Registry; NCT00209274).

Echocardiography-Guided Interventions

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.

Guidelines for the Echocardiographic Assessment of Atrial Septal Defect and Patent Foramen Ovale: From the American Society of Echocardiography and Society for Cardiac Angiography and Interventions

Target Audience 911 Objectives 91

Mitral valve hemodynamic effects of percutaneous edge-to-edge repair with the MitraClip™ device for mitral regurgitation

Introduction: The Endovascular Valve Edge‐to‐Edge REpair STudies (EVEREST) are investigating a percutaneous technique for edge‐to‐edge mitral valve repair with a repositionable clip. The effects on the mitral valve gradient (MVG) and mitral valve area (MVA) are not known. Methods: Twenty seven patients with moderate to severe or severe mitral regurgitation (MR) were enrolled. Echocardiography was performed preprocedure, at discharge, and at 1, 6, and 12 months. Mean MVG was measured by Doppler and MVA by planimetry and pressure half‐time, and evaluated in a central core laboratory. Pre‐ and postclip deployment, simultaneous left atrial/pulmonary capillary wedge and left ventricular pressures were obtained in eight patients. Results: Three patients did not receive a clip, six patients had their clip(s) explanted by 6 months (none for mitral stenosis), and four were repaired with two clips. Results are notable for a slight increase in mean MVG by Doppler postclip deployment (1.79 ± 0.89 to 3.31 ± 2.09 mm Hg, P < 0.01) and an expected decrease in MVA by planimetry (6.49 ± 1.61 to 4.46 ± 2.14 cm2, P < 0.001) and by pressure half time (4.35 ± 0.98 to 3.01 ± 1.42 cm2, P < 0.05). There were no significant changes in hemodynamic parameters postclip deployment by direct pressure measurements. There was no change in MVA by planimetry from discharge to 12 months (3.90 ± 1.90 to 3.79 ± 1.54 cm2, P = 0.78). Conclusions: Echocardiographic and hemodynamic measurements after percutaneous mitral valve repair with the MitraClip show an expected decrease in mitral valve area with no evidence of clinically significant mitral stenosis either immediately after clip deployment or after 12 months of follow‐up.

Application of Appropriateness Criteria in Outpatient Transthoracic Echocardiography

BACKGROUND Appropriateness criteria were applied to outpatient transthoracic echocardiographic (TTE) studies. METHODS 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. RESULTS 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. CONCLUSIONS 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.

A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial

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 patent foramen ovale and atrial septal defect closure in adults: Results and device comparison in 100 consecutive implants at a single center

Closure of interatrial septal defects with percutaneous devices is increasingly common. However, the indications for closure and techniques for device implantation are diverse. We reviewed our first 100 consecutive implants to assess and compare the indications, results, complications, and evolution of techniques for percutaneous patent foramen ovale (PFO) and atrial septal defect (ASD) closure. The mean age of patients was 52 years and 70% were female. Paradoxical embolism was the predominant indication (94%) for PFO closure and significant left‐to‐right shunt was the most frequent indication (89%) for ASD closure. Implantation success was 94% with major complications in 3 patients (2.8%). Transesophageal echocardiography was utilized in the initial 27 procedures and then replaced by intracardiac echocardiography in subsequent ones, with an associated reduction in procedure and physician time. During 6 months of follow‐up, 3 patients were readmitted for atrial arrhythmias (2 patients) and an MRI‐negative neurologic event (1 patient). Echocardiography at 6 months in 83% of the PFO patients revealed moderate and severe positive contrast studies for right‐to‐left shunting in one third of patients, with differences between devices and insertion techniques. This single‐center experience with percutaneous device closure of PFO and ASD in adults demonstrates excellent results with few complications. Catheter Cardiovasc Interv 2005;64:197–203.

Extrinsic compression of the left main coronary artery by the pulmonary artery in patients with long-standing pulmonary hypertension.

Left main coronary artery compression by the pulmonary artery may be seen in patients with pulmonary hypertension who are undergoing cardiac catheterization. Cardiac magnetic resonance imaging is useful in these patients to document extrinsic compression, which might otherwise be mistaken for intrinsic atherosclerotic disease.

One-year outcomes after transcatheter insertion of an interatrial shunt device for the management of heart failure with preserved ejection fraction

Background—Heart failure with preserved ejection fraction has a complex pathophysiology and remains a therapeutic challenge. Elevated left atrial pressure, particularly during exercise, is a key contributor to morbidity and mortality. Preliminary analyses have demonstrated that a novel interatrial septal shunt device that allows shunting to reduce the left atrial pressure provides clinical and hemodynamic benefit at 6 months. Given the chronicity of heart failure with preserved ejection fraction, evidence of longer-term benefit is required. Methods and Results—Patients (n=64) with left ventricular ejection fraction ≥40%, New York Heart Association class II–IV, elevated pulmonary capillary wedge pressure (≥15 mm Hg at rest or ≥25 mm Hg during supine bicycle exercise) participated in the open-label study of the interatrial septal shunt device. One year after interatrial septal shunt device implantation, there were sustained improvements in New York Heart Association class (P<0.001), quality of life (Minnesota Living with Heart Failure score, P<0.001), and 6-minute walk distance (P<0.01). Echocardiography showed a small, stable reduction in left ventricular end-diastolic volume index (P<0.001), with a concomitant small stable increase in the right ventricular end-diastolic volume index (P<0.001). Invasive hemodynamic studies performed in a subset of patients demonstrated a sustained reduction in the workload corrected exercise pulmonary capillary wedge pressure (P<0.01). Survival at 1 year was 95%, and there was no evidence of device-related complications. Conclusions—These results provide evidence of safety and sustained clinical benefit in heart failure with preserved ejection fraction patients 1 year after interatrial septal shunt device implantation. Randomized, blinded studies are underway to confirm these observations. Clinical Trial Registration—URL: https://www.clinicaltrials.gov. Unique identifier: NCT01913613.