Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.

BACKGROUND: The CLASP IID randomized trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial) demonstrated the safety and effectiveness of the PASCAL system for mitral transcatheter edge-to-edge repair (M-TEER) in patients at prohibitive surgical risk with significant symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES: This study describes the echocardiographic methods and outcomes from the CLASP IID trial and analyzes baseline variables associated with residual mitral regurgitation (MR) ≤1+. METHODS: An independent echocardiographic core laboratory assessed echocardiographic parameters based on American Society of Echocardiography guidelines focusing on MR mechanism, severity, and feasibility of M-TEER. Factors associated with residual MR ≤1+ were identified using logistic regression. RESULTS: In 180 randomized patients, baseline echocardiographic parameters were well matched between the PASCAL (n = 117) and MitraClip (n = 63) groups, with flail leaflets present in 79.2% of patients. Baseline MR was 4+ in 76.4% and 3+ in 23.6% of patients. All patients achieved MR ≤2+ at discharge. The proportion of patients with MR ≤1+ was similar in both groups at discharge but diverged at 6 months, favoring PASCAL (83.7% vs 71.2%). Overall, patients with a smaller flail gap were significantly more likely to achieve MR ≤1+ at discharge (adjusted OR: 0.70; 95% CI: 0.50-0.99). Patients treated with PASCAL and those with a smaller flail gap were significantly more likely to sustain MR ≤1+ to 6 months (adjusted OR: 2.72 and 0.76; 95% CI: 1.08-6.89 and 0.60-0.98, respectively). CONCLUSIONS: The study used DMR-specific echocardiographic methodology for M-TEER reflecting current guidelines and advances in 3-dimensional echocardiography. Treatment with PASCAL and a smaller flail gap were significant factors in sustaining MR ≤1+ to 6 months. Results demonstrate that MR ≤1+ is an achievable benchmark for successful M-TEER. (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID]; NCT03706833).

Mechanisms, predictors, and evolution of severe peri-device leaks with two different left atrial appendage occluders.

AIMS: Incomplete left atrial appendage occlusion (LAAO) due to peri-device leak (PDL) is a limitation of the therapy. The Amulet IDE trial is the largest randomized head-to-head trial comparing the Amulet and Watchman 2.5 LAAO devices with fundamentally different designs. The predictors and mechanistic factors impacting differences in PDLs within the Amulet IDE trial are assessed in the current analysis. METHODS AND RESULTS: An independent core lab analysed all images for the presence or absence of severe PDL (>5 mm). The incidence, mechanistic factors, predictors using propensity score-matched controls, and evolution of severe PDLs through 18 months were assessed. Of the 1878 patients randomized in the trial, the Amulet occluder had significantly fewer severe PDLs than the Watchman device at 45 days (1.1 vs. 3.2%, P < 0.001) and 12 months (0.1 vs. 1.1%, P < 0.001). Off-axis deployment or missed lobes were leading mechanistic PDL factors in each device group. Larger left atrial appendage (LAA) dimensions including orifice diameter, landing zone diameter, and depth predicted severe PDL with the Watchman device, with no significant anatomical limitations noted with the Amulet occluder. Procedural and device implant predictors were found with the Amulet occluder attributed to the learning curve with the device. A majority of Watchman device severe PDLs did not resolve over time through 18 months. CONCLUSION: The dual-occlusive Amplatzer Amulet LAA occluder provided improved LAA closure compared with the Watchman 2.5 device. Predictors and temporal observations of severe PDLs were identified in the Amulet IDE trial. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov Unique identifier NCT02879448.

Characterization of Primary Mitral Regurgitation With Flail Leaflet and/or Wall-Impinging Flow.

BACKGROUND: Echocardiography guidelines note that a flail leaflet is a specific criterion for severe mitral regurgitation (MR) and that regurgitant severity is underestimated in wall-impinging jets (Coanda effect). Both findings are often considered to be pathognomonic of severe MR. OBJECTIVES: In this study, the authors sought to determine the association of flail leaflet and Coanda effect with MR severity quantified by means of cardiac magnetic resonance (CMR). METHODS: The authors enrolled 158 consecutive patients with primary MR according to echocardiography and CMR. The presence of a flail leaflet or Coanda was determined for each patient. CMR regurgitant volume (RV) and regurgitant fraction (RF) were quantified for all patients. RESULTS: There were 55 patients (35%) with a flail leaflet, 52 (33%) with Coanda, and 22 (14%) with a flail leaflet and Coanda. The mean CMR mitral RV and RF progressively increased in patients without a Coanda or flail, a Coanda, a flail, or a Coanda and a flail (RV: 28 ± 21 mL vs 43 ± 23 mL vs 58 ± 29 mL vs 64 ± 25 mL [P < 0.001]; RF: 25% ± 16% vs 34% ± 14% vs 41% ± 12% vs 45% ± 12% [P < 0.001]). With the use of CMR RV, 35%, 46%, and 59% of patients had severe MR with the presence of a Coanda, flail leaflet, or both, respectively. With the use of CMR RF, 25%, 31%, and 40% of patients had severe MR with the presence of a Coanda, flail leaflet, or both, respectively. CONCLUSIONS: While the presence of a flail leaflet and Coanda effect on echocardiography are associated with higher regurgitant volumes and fractions, they are frequently not associated with severe MR as assessed by means of CMR. (Comparison Study of Echocardiography and Cardiovascular Magnetic Resonance Imaging in the Assessment of Mitral and Aortic Regurgitation; NCT04038879).

Cardiovascular Imaging in Infective Endocarditis: A Multimodality Approach.

Multimodality imaging plays a pivotal role in the evaluation and management of infective endocarditis (IE)-a condition with high morbidity and mortality. The diagnosis of IE is primarily based on the modified Duke criteria with echocardiography as the first-line imaging modality. Both transthoracic and transesophageal echocardiography delineate vegetation location and size, assess for paravalvular extension of infection, and have the added advantage of defining the hemodynamic effects of valvular or device infection. Native and prosthetic valve IE, infections relating to cardiac implantable electronic devices, and indwelling catheters are effectively evaluated with echocardiography. However, complementary imaging is occasionally required when there remains diagnostic uncertainty following transesophageal echocardiography. Multidetector computed tomography and nuclear imaging techniques such as positron emission tomography and white blood cell scintigraphy have been shown to reduce the rate of misdiagnosed IE particularly in the setting of prosthetic valve endocarditis, paravalvular extension of infection, and cardiac implantable electronic devices. In this review, we describe a modern approach to cardiac imaging in native and prosthetic valve endocarditis, as well as cardiac implantable electronic devices including pacing devices and left ventricular assist devices. Current guidelines addressing the role of multimodality imaging in IE are discussed. The utility of imaging in the assessment of local and distant endocarditis complications such as pericardial sequelae, myocarditis, and embolic events is also addressed.

Hemodynamic impact of coronary stenosis using computed tomography: comparison between noninvasive fractional flow reserve and 3D fusion of coronary angiography with stress myocardial perfusion.

Vasodilator-stress CT perfusion imaging in addition to CT coronary angiography (CTCA) may provide a single-test alternative to nuclear stress testing, commonly used to assess hemodynamic significance of stenosis. Another alternative is fractional flow reserve (FFR) calculated from cardiac CT images. We studied the concordance between these two approaches and their relationship to outcomes. We prospectively studied 150 patients with chest pain, who underwent CTCA and regadenoson CT. CTCA images were interpreted for presence and severity of stenosis. Fused 3D displays of subendocardial X-ray attenuation with coronary arteries were created to detect stress perfusion defects (SPD) in each coronary territory. In patients with stenosis > 25%, CT-FFR was quantified. Significant stenosis was determined by: (1) combination of stenosis > 50% with an SPD, (2) CT-FFR ≤ 0.80. Patients were followed-up for 36 ± 25 months for death, myocardial infarction or revascularization. After excluding patients with normal arteries and technical/quality issues, in final analysis of 76 patients, CTCA depicted stenosis > 70% in 13/224 arteries, 50-70% in 24, and < 50% in 187. CT-FFR ≤ 0.80 was found in 41/224 arteries, and combination of SPD with > 50% stenosis in 31/224 arteries. Inter-technique agreement was 89%. Despite high incidence of abnormal CT-FFR (30/76 patients), only 7 patients experienced adverse outcomes; 6/7 also had SPDs. Only 1/9 patients with CT-FFR ≤ 0.80 but normal perfusion had an event. Fusion of CTCA and stress perfusion can help determine the hemodynamic impact of stenosis in one test, in good agreement with CT-FFR. Adding stress CT perfusion analysis may help risk-stratify patients with abnormal CT-FFR.

Peak left atrial strain as a single measure for the non-invasive assessment of left ventricular filling pressures.

Echocardiographic assessment of left ventricular (LV) filling pressures is performed using a multi-parametric algorithm. Left atrial (LA) strain was recently found to accurately classify the degree of diastolic dysfunction. We hypothesized that LA strain could be used as a stand-alone marker and sought to identify and test a cutoff, which would accurately detect elevated LV pressures. We studied 76 patients with a spectrum of LV function who underwent same-day echocardiogram and invasive left-heart catheterization. Speckle tracking was used to measure peak LA strain. The protocol involved a retrospective derivation group (N = 26) and an independent prospective validation cohort (N = 50) to derive and then test a peak LA strain cutoff which would identify pre-A-wave LV diastolic pressure > 15 mmHg. The guidelines-based assessment of filling pressures and peak LA strain were compared side-by-side against invasive hemodynamic data. In the derivation cohort, receiver-operating characteristic analysis showed area under curve of 0.76 and a peak LA strain cutoff < 20% was identified as optimal to detect elevated filling pressure. In the validation cohort, peak LA strain demonstrated better agreement with the invasive reference (81%) than the guidelines algorithm (72%). The improvement in classification using LA strain compared to the guidelines was more pronounced in subjects with normal LV function (91% versus 81%). In summary, the use of a peak LA strain to estimate elevated LV filling pressures is more accurate than the current guidelines. Incorporation of LA strain into the non-invasive assessment of LV diastolic function may improve the detection of elevated filling pressures.

Fusion of Three-Dimensional Echocardiographic Regional Myocardial Strain with Cardiac Computed Tomography for Noninvasive Evaluation of the Hemodynamic Impact of Coronary Stenosis in Patients with Chest Pain.

BACKGROUND: Combined evaluation of coronary stenosis and the extent of ischemia is essential in patients with chest pain. Intermediate-grade stenosis on computed tomographic coronary angiography (CTCA) frequently triggers downstream nuclear stress testing. Alternative approaches without stress and/or radiation may have important implications. Myocardial strain measured from echocardiographic images can be used to detect subclinical dysfunction. The authors recently tested the feasibility of fusion of three-dimensional (3D) echocardiography-derived regional resting longitudinal strain with coronary arteries from CTCA to determine the hemodynamic significance of stenosis. The aim of the present study was to validate this approach against accepted reference techniques. METHODS: Seventy-eight patients with chest pain referred for CTCA who also underwent 3D echocardiography and regadenoson stress computed tomography were prospectively studied. Left ventricular longitudinal strain data (TomTec) were used to generate fused 3D displays and detect resting strain abnormalities (RSAs) in each coronary territory. Computed tomographic coronary angiographic images were interpreted for the presence and severity of stenosis. Fused 3D displays of subendocardial x-ray attenuation were created to detect stress perfusion defects (SPDs). In patients with stenosis >25% in at least one artery, fractional flow reserve was quantified (HeartFlow). RSA as a marker of significant stenosis was validated against two different combined references: stenosis >50% on CTCA and SPDs seen in the same territory (reference standard A) and fractional flow reserve < 0.80 and SPDs in the same territory (reference standard B). RESULTS: Of the 99 arteries with no stenosis >50% and no SPDs, considered as normal, 19 (19%) had RSAs. Conversely, with stenosis >50% and SPDs, RSAs were considerably more frequent (17 of 24 [71%]). The sensitivity, specificity, and accuracy of RSA were 0.71, 0.81, and 0.79, respectively, against reference standard A and 0.83, 0.81, and 0.82 against reference standard B. CONCLUSIONS: Fusion of CTCA and 3D echocardiography-derived resting myocardial strain provides combined displays, which may be useful in determination of the hemodynamic or functional impact of coronary abnormalities, without additional ionizing radiation or stress testing.

Invasive Validation of the Echocardiographic Assessment of Left Ventricular Filling Pressures Using the 2016 Diastolic Guidelines: Head-to-Head Comparison with the 2009 Guidelines.

BACKGROUND: Recent American Society of Echocardiography (ASE)/European Association of Cardiovascular Imaging (EACVI) guidelines for echocardiographic evaluation of left ventricular (LV) diastolic function provide a practical, simplified diagnostic algorithm for estimating LV filling pressure. The aim of this study was to test the accuracy of this algorithm against invasively measured pressures and compare it with the accuracy of the previous 2009 guidelines in the same patient cohort. METHODS: Ninety patients underwent transthoracic echocardiography immediately before left heart catheterization. Mitral inflow E/A ratio, E/e', tricuspid regurgitation velocity, and left atrial volume index were used to estimate LV filling pressure as normal or elevated using the ASE/EACVI algorithm. Invasive LV pre-A pressure was used as a reference, with >12 mm Hg defined as elevated. RESULTS: Invasive LV pre-A pressure was elevated in 40 (44%) and normal in 50 (56%) patients. The 2016 algorithm resulted in classification of 9 of 90 patients (10%) as indeterminate but estimated LV filling pressures in agreement with the invasive reference in 61 of 81 patients (75%), with sensitivity of 0.69 and specificity of 0.81. The 2009 algorithm could not definitively classify 4 of 90 patients (4.4%), but estimated LV filling pressures in agreement with the invasive reference in 64 of 86 patients (74%), with sensitivity of 0.79 and specificity of 0.70. CONCLUSIONS: The 2016 ASE/EACVI guidelines for estimation of filling pressures are more user friendly and efficient than the 2009 guidelines and provide accurate estimates of LV filling pressure in the majority of patients when compared with invasive measurements. The simplicity of the new algorithm did not compromise its accuracy and is likely to encourage its incorporation into clinical decision making.

2D and 3D Echocardiography-Derived Indices of Left Ventricular Function and Shape: Relationship With Mortality.

OBJECTIVES: This study hypothesized that left ventricular (LV) ejection fraction (EF) and global longitudinal strain (GLS) derived from 3-dimensional echocardiographic (3DE) images would better predict mortality than those obtained by 2-dimensional echocardiographic (2DE) measurements, and that 3DE-based LV shape analysis may have added prognostic value. BACKGROUND: Previous studies have shown that both LVEF and GLS derived from 2DE images predict mortality. Recently, 3DE measurements of these parameters were found to be more accurate and reproducible because of independence of imaging plane and geometric assumptions. Also, 3DE analysis offers an opportunity to accurately quantify LV shape. METHODS: We retrospectively studied 416 inpatients (60 ± 18 years of age) referred for transthoracic echocardiography between 2006 and 2010, who had good-quality 2DE and 3DE images were available. Mortality data through 2016 were collected. Both 2DE and 3DE images were analyzed to measure LVEF and GLS. Additionally, 3DE-derived LV endocardial surface information was analyzed to obtain global shape indices (sphericity and conicity) and regional curvature (anterior, septal, inferior, lateral walls). Cardiovascular (CV) mortality risks related to these indices were determined using Cox regression. RESULTS: Of the 416 patients, 208 (50%) died, including 114 (27%) CV-related deaths over a mean follow-up period of 5 ± 3 years. Cox regression revealed that age and body surface area, all 4 LV function indices (2D EF, 3D EF, 2D GLS, 3D GLS), and regional shape indices (septal and inferior wall curvatures) were independently associated with increased risk of CV mortality. GLS was the strongest prognosticator of CV mortality, superior to EF for both 2DE and 3DE analyses, and 2D EF was the weakest among the 4 functional indices. A 1% decrease in GLS magnitude was associated with an 11.3% increase in CV mortality risk. CONCLUSIONS: GLS predicts mortality better than EF by both 3DE and 2DE analysis, whereas 3D EF is a better predictor than 2D EF. Also, LV shape indices provide additional risk assessment.

3D echocardiographic analysis of aortic annulus for transcatheter aortic valve replacement using novel aortic valve quantification software: Comparison with computed tomography.

BACKGROUND: With the increasing use of transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis (AS), computed tomography (CT) remains the standard for annulus sizing. However, 3D transesophageal echocardiography (TEE) has been an alternative in patients with contraindications to CT. We sought to (1) test the feasibility, accuracy, and reproducibility of prototype 3DTEE analysis software (Philips) for aortic annular measurements and (2) compare the new approach to the existing echocardiographic techniques. METHODS: We prospectively studied 52 patients who underwent gated contrast CT, procedural 3DTEE, and TAVR. 3DTEE images were analyzed using novel semi-automated software designed for 3D measurements of the aortic root, which uses multiplanar reconstruction, similar to CT analysis. Aortic annulus measurements included area, perimeter, and diameter calculations from these measurements. The results were compared to CT-derived values. Additionally, 3D echocardiographic measurements (3D planimetry and mitral valve analysis software adapted for the aortic valve) were also compared to the CT reference values. RESULTS: 3DTEE image quality was sufficient in 90% of patients for aortic annulus measurements using the new software, which were in good agreement with CT (r-values: .89-.91) and small (<4%) inter-modality nonsignificant biases. Repeated measurements showed <10% measurements variability. The new 3D analysis was the more accurate and reproducible of the existing echocardiographic techniques. CONCLUSIONS: Novel semi-automated 3DTEE analysis software can accurately measure aortic annulus in patients with severe AS undergoing TAVR, in better agreement with CT than the existing methodology. Accordingly, intra-procedural TEE could potentially replace CT in patients where CT carries significant risk.

Non-invasive assessment of the haemodynamic significance of coronary stenosis using fusion of cardiac computed tomography and 3D echocardiography.

AIMS: Abnormal computed tomography coronary angiography (CTCA) often leads to stress testing to determine haemodynamic significance of stenosis. We hypothesized that instead, this could be achieved by fusion imaging of the coronary anatomy with 3D echocardiography (3DE)-derived resting myocardial deformation. METHODS AND RESULTS: We developed fusion software that creates combined 3D displays of the coronary arteries with colour maps of longitudinal strain and tested it in 28 patients with chest pain, referred for CTCA (256 Philips scanner) who underwent 3DE (Philips iE33) and regadenoson stress CT. To obtain a reference for stenosis significance, coronaries were also fused with colour maps of stress myocardial perfusion. 3D displays were used to detect stress perfusion defect (SPD) and/or resting strain abnormality (RSA) in each territory. CTCA showed 56 normal arteries, stenosis <50% in 17, and >50% in 8 arteries. Of the 81 coronary territories, SPDs were noted in 20 and RSAs in 29. Of the 59 arteries with no stenosis >50% and no SPDs, considered as normal, 12 (20%) had RSAs. Conversely, with stenosis >50% and SPDs (haemodynamically significant), RSAs were considerably more frequent (5/6 = 83%). Overall, resting strain and stress perfusion findings were concordant in 64/81 arteries (79% agreement). CONCLUSIONS: Fusion of CTCA and 3DE-derived data allows direct visualization of each coronary artery and strain in its territory. In this feasibility study, resting strain showed good agreement with stress perfusion, indicating that it may be potentially used to assess haemodynamic impact of coronary stenosis, as an alternative to stress testing that entails additional radiation exposure.

Transcatheter Therapy for a Large Mobile Right Atrial Thrombus and Massive Pulmonary Embolism.

A variety of interventional management approaches exist for the treatment of acute pulmonary embolism (PE). However, when PE is accompanied by residual right heart thrombus, the best therapeutic options are less clear. We describe a novel combined technique of percutaneous aspiration of unstable right atrial thrombus followed by ultrasound-directed thrombolysis of massive PE.

Comprehensive Two-Dimensional Interrogation of the Tricuspid Valve Using Knowledge Derived from Three-Dimensional Echocardiography.

BACKGROUND: Accurate identification of tricuspid valve (TV) leaflets by two-dimensional (2D) transthoracic echocardiography is difficult because of variability in the intersection between the imaging plane and leaflets. Using information obtained from multiplanar reconstruction (MPR) of three-dimensional (3D) data sets, the investigators sought to define "novel" 2D views that would allow targeted interrogation of TV leaflets using 2D transthoracic echocardiography. METHODS: Images of the TV in the standard 2D views (apical four chamber, right ventricular focused, right ventricular inflow, and parasternal short axis) and 3D data sets were acquired from the same probe position in 106 adults. Three-dimensional MPR was used to determine which leaflet combination was seen in the 2D image: anterior and septal, anterior and posterior, anterior alone, or posterior and septal. Using this analysis, 2D landmarks were identified to define nonstandard TV views tailored to depict specific leaflets. Two-dimensional images in these views and 3D data sets were then prospectively collected in 54 additional patients. Three independent readers analyzed these 2D views to determine TV leaflet combinations, and their interpretation was compared with 3D MPR-derived reference. RESULTS: Three-dimensional MPR views made it possible to define six nonstandard 2D views on the basis of anatomic clues and landmarks, which consistently depicted all the aforementioned leaflet combinations. When these six views were prospectively tested, the agreement of TV leaflet identification against 3D MPR was excellent (κ = 0.88, κ = 0.93, and κ = 0.98). CONCLUSION: The nonstandard 2D views defined in this study allow accurate TV leaflet identification and may thus be useful when localization of TV leaflet pathology is clinically important.

Echocardiographic Diagnosis of Acute Pulmonary Embolism in Patients with McConnell's Sign.

BACKGROUND: "McConnell's sign" (McCS), described as hypo- or akinesis of the right ventricular (RV) free wall with preservation of the apex, is associated with acute pulmonary embolism (aPE). However, the sensitivity of McCS for the detection of aPE is limited. We sought to evaluate in patients with McCS, whether echocardiographic parameters of global and regional RV function could differentiate between patients with and without aPE. METHODS: We reviewed echocardiograms of 81 patients with McCS, who underwent CT or V/Q studies for suspected PE, and 40 normal controls (NL). Echocardiograms were analyzed to measure pulmonary artery systolic pressure (PASP), tricuspid regurgitation (TR) by vena contracta width, conventional indices of RV function, and speckle tracking-derived longitudinal free wall strain. ROC analysis was performed to evaluate the diagnostic accuracy of these parameters for diagnosis of aPE. RESULTS: Fifty-five of eighty-one (68%) had PE (McCS + PE), while 26 of 81 (32%) did not (McCS - PE). Compared to NL, global and segmental RV strain were lower in patients with McCS, contrary to the notion of normal apical function. In McCS + PE, compared to McCS - PE: (1) PASP, fractional area change and TR were significantly lower; (2) strain magnitude was significantly lower globally and in basal and apical segments. Individual parameters had similar diagnostic accuracy by ROC analysis, which further improved by combining parameters. In McCS - PE, 69% of patients had pulmonary hypertension (PH). CONCLUSIONS: McCS and aPE are not synonymous. RV free wall strain may aid in differential diagnosis of patients with McCS evaluated for aPE. Specifically, McCS should prompt an inquiry for evidence of PH, which would indicate that aPE is less likely.

A Practical Scoring System to Select Optimally Sized Devices for Percutaneous Patent Foramen Ovale Closure.

BACKGROUND: Patent foramen ovale (PFO) has been linked to cryptogenic stroke, and closure has been reported to improve clinical outcomes. However, there are no clear guidelines to direct device sizing. This study sought to use patient characteristics and echocardiographic findings to create a prediction score for device sizing. METHODS: This was a retrospective review of patients undergoing percutaneous PFO closure at our institution between July 2010 and December 2014. Demographic and clinical characteristics were recorded, and all pre- and intraprocedural echocardiography results were evaluated. RESULTS: Thirty-six patients underwent percutaneous PFO closure during the study period. All procedures were performed using an Amplatzer Septal Occluder "Cribriform" (ASOC) device in one of three disc diameters: 25, 30, or 35 mm. Closure was indicated for cryptogenic stroke/transient ischemic attack in 75% of cases. Every case (100%) was successful with durable shunt correction at the 6-month follow-up without complications of erosion or device embolization. The presence of atrial septal aneurysm (ASA) (p = 0.027) and PFO tunnel length >10 mm (p = 0.038) were independently associated with increased device size. A scoring system of 1 point for male sex, 1 point for ASA, and 1 point for PFO tunnel >10 mm long was associated with the size of closure device implanted (p = 0.006). CONCLUSIONS: A simple scoring system may be used to select an optimally sized device for percutaneous PFO closure using the ASOC device.

Phase I safety study of ranolazine in pulmonary arterial hypertension.

UNLABELLED: Pulmonary arterial hypertension (PAH) causes right ventricular ischemia, dysfunction, and failure. PAH patients may benefit from antianginal agents based on a shared pathophysiology with left ventricular ischemia. A single-center, randomized, placebo-controlled trial (1∶1) to assess the acute vasoreactivity and safety of ranolazine in PAH was conducted. Plasma samples for pharmacokinetic (PK) studies were drawn during hemodynamic measurements at 0, 60, 90, 120, 240, and 360 minutes from a Swan-Ganz catheter. All patients received 500-mg doses, uptitrated to 1,000 mg at week 4, monthly evaluations, and a complete objective assessment after 12 weeks, followed by an open-label extension. Thirteen patients were randomized and 12 enrolled (6 ranolazine, 6 placebo). All patients completed the acute phase; 10 completed the 12-week study. There were no acute changes in invasive hemodynamics. At 12 weeks ranolazine was well tolerated. Only 1 of the 5 patients on ranolazine had a serum concentration considered to be in the therapeutic range. Two serious adverse events required early withdrawal (both in the ranolazine group); gastrointestinal complaints were the most common adverse event. Efficacy measures did not demonstrate any differences between treatment groups. During the open-label trial, 2 additional patients reached a therapeutic concentration. Ranolazine in PAH appears safe, without acute hemodynamic effects after a 500-mg dose. Ranolazine administrated to PAH patients receiving background PAH therapies did not consistently reach therapeutic levels. Future studies should first perform PK analysis in PAH patients receiving PAH therapies and explore the safety and tolerability of the higher doses perhaps necessary to achieve therapeutic levels in PAH patients. ( TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT01757808.).

Factors Associated with the Use of Drug-Eluting Stents in Patients Presenting with Acute ST-Segment Elevation Myocardial Infarction.

Background. Drug-eluting stents (DES) have proven clinical superiority to bare-metal stents (BMS) for the treatment of patients with ST-segment elevation myocardial infarction (STEMI). Decision to implant BMS or DES is dependent on the patient's ability to take dual antiplatelet therapy. This study investigated factors associated with DES placement in STEMI patients. Methods. Retrospective analysis was performed on 193 patients who presented with STEMI and were treated with percutaneous coronary intervention at an urban, tertiary care hospital. Independent factors associated with choice of stent type were determined using stepwise multivariate logistic regression. Odds ratio (OR) was used to evaluate factors significantly associated with DES and BMS. Results. 128 received at least one DES, while 65 received BMS. BMS use was more likely in the setting of illicit drug or alcohol abuse ([OR] 0.15, 95% CI 0.05-0.48, p ≤ 0.01), cardiogenic shock (OR 0.26, 95% CI 0.10-0.73, p = 0.01), and larger stent diameter (OR 0.28, 95% CI 0.11-0.68, p ≤ 0.01). Conclusions. In this analysis, BMS implantation was associated with illicit drug or alcohol abuse and presence of cardiogenic shock. This study did not confirm previous observations that non-White race, insurance, or income predicts BMS use.