Clinical impact of right ventricular pacing burden in patients with post-transcatheter aortic valve replacement permanent pacemaker implantation.

AIMS: Patients who undergo permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR) have a worse outcome. The aim of this study was to identify risk factors of worse outcomes in patients with post-TAVR PPM implantation. METHODS AND RESULTS: This is a single-centre, retrospective study of consecutive patients who underwent post-TAVR PPM implantation from 11 March 2011 to 9 November 2019. Clinical outcomes were evaluated by landmark analysis with cut-off at 1 year after the PPM implantation. Of the 1389 patients underwent TAVR during the study duration and a total of 110 patients were included in the final analysis. Right ventricular pacing burden (RVPB) ≥ 30% at 1 year was associated with a higher likelihood of heart failure (HF) readmission [adjusted hazard ratio (aHR): 6.333; 95% confidence interval [CI]: 1.417-28.311; P = 0.016] and composite endpoint of overall death and/or HF (aHR: 2.453; 95% CI: 1.040-5.786; P = 0.040). The RVPB ≥30% at 1 year was associated with higher atrial fibrillation burden (24.1 ± 40.6% vs. 1.2 ± 5.3%; P = 0.013) and a decrease in left ventricular ejection fraction (-5.0 ± 9.8% vs. + 1.1 ± 7.9%; P = 0.005). The predicting factors of the RVPB ≥30% at 1 year were the presence of RVPB ≥40% at 1 month and the valve implantation depth measured from non-coronary cusp ≥4.0 mm (aHR: 57.808; 95% CI: 12.489-267.584; P < 0.001 and aHR: 6.817; 95% CI: 1.829-25.402; P = 0.004). CONCLUSIONS: The RVPB ≥30% at 1 year was associated with worse outcomes. Clinical benefit of minimal RV pacing algorithms and biventricular pacing needs to be investigated.

A New WATCHMAN Sizing Algorithm Utilizing Cardiac CTA.

BACKGROUND: The WATCHMAN left atrial appendage (LAA) occlusion device has emerged as an alternative for anticoagulation in patients with non-valvular atrial fibrillation who cannot tolerate oral anticoagulation therapy. Cardiac computed tomography (CTA) is increasingly being utilized to guide WATCHMAN device sizing, however no consensus algorithm exists. We present our experience with a new cardiac CTA LAA ostium area based sizing algorithm. METHODS: This is a single center, prospective study analyzing consecutive patients who underwent cardiac CTA and WATCHMAN device implantation between March 2017 and October 2019 at University Hospitals Cleveland Medical Center. Patients baseline characteristics, procedural data, and clinical outcomes were collected and analyzed. RESULTS: 115 patients were included in our study. The mean age of our population was 76.5 years ±8.3 years. 70.4% of our patients had preserved ejection fraction. The predominant indication for device implantation was gastrointestinal bleeding in 57.4% of patients. The mean CHADSVASC score was 4.68 ± 1.4. The procedure success rate was 99.1% and the mean number of device used per case of 1.15 ± 0.4 devices. Our CTA LAA ostium area based sizing algorithm accurately predicted the final deployed WATCHMAN device size in 95.6% of cases. CONCLUSION: Our study demonstrates that cardiac CTA LAA ostium area based sizing algorithm is highly accurate at predicting WATCHMAN device size and demonstrates excellent clinical outcomes with lower device utilization per case than what is reported in literature.

Comparison of automated beam hardening correction (ABHC) algorithms for myocardial perfusion imaging using computed tomography.

PURPOSE: Myocardial perfusion imaging using computed tomography (MPI-CT) and coronary CT angiography (CTA) have the potential to make CT an ideal noninvasive imaging gatekeeper exam for invasive coronary angiography. However, beam hardening can prevent accurate blood flow estimation in dynamic MPI-CT and can create artifacts that resemble flow deficits in single-shot MPI-CT. In this work, we compare four automatic beam hardening correction algorithms (ABHCs) applied to CT images, for their ability to produce accurate single images of contrast and accurate MPI flow maps using images from conventional CT systems, without energy sensitivity. METHODS: Previously, we reported a method, herein called ABHC-1, where we iteratively optimized a cost function sensitive to beam hardening artifacts in MPI-CT images and used a low order polynomial correction on projections of segmentation-processed CT images. Here, we report results from two new algorithms with higher order polynomial corrections, ABHC-2 and ABHC-3 (with three and seven free parameters, respectively), having potentially better correction but likely reduced estimability. Additionally, we compared results to an algorithm reported by others in the literature (ABHC-NH). Comparisons were made on a digital static phantom with simulated water, bone, and iodine regions; on a digital dynamic anthropomorphic phantom, with simulated blood flow; and on preclinical porcine experiments. We obtained CT images on a prototype spectral detector CT (Philips Healthcare) scanner that provided both conventional and virtual keV images, allowing us to quantitatively compare corrected CT images to virtual keV images. To test these methods' parameter optimization sensitivity to noise, we evaluated results on images obtained using different mAs. RESULTS: In images of the static phantom, ABHC-2 reduced beam hardening artifacts better than our previous ABHC-1 algorithm, giving artifacts smaller than 1.8 HU, even in the presence of high noise which should affect parameter optimization. Taken together, the quality of static phantom results ordered ABHC-2> ABHC-3> ABHC-1>> ABHC-NH. In an anthropomorphic MPI-CT simulator with homogeneous myocardial blood flow of 100 ml⋅min-1 ⋅100 g-1 , blood flow estimation results were 122 ± 24 (FBP), 135 ± 24 (ABHC-NH), 104 ± 14 (ABHC-1), 100 ± 12 (ABHC-2), and 108 ± 18 (ABHC-3) ml⋅min-1 ⋅100 g-1 , showing ABHC-2 as a clear winner. Visual and quantitative evaluations showed much improved homogeneity of myocardial flow with ABHC-2, nearly eliminating substantial artifacts in uncorrected flow maps which could be misconstrued as flow deficits. ABHC-2 performed universally better than ABHC-1, ABHC-3, and ABHC-NH in simulations with different acquisitions (varying noise and kVp values). In the presence of a simulated flow deficit, all ABHC methods retained the flow deficit, and ABHC-2 gave the most accurate flow ratio and homogeneity. ABHC-3 corrected phantom flow values were slightly better than ABHC-2, in noiseless images, suggesting that reduced quality in noisy images was due to reduced estimability. In an experiment with a pig expected to have uniform flow, ABHC-2 applied to conventional images improved flow maps to compare favorably to those from 70keV images. CONCLUSION: The automated algorithm can be used with different parametric BH correction models. ABHC-2 improved MPI-CT blood flow estimation as compared to other approaches and was robust to noisy images. In simulation and preclinical experiments, ABHC-2 gave results approaching gold standard 70 keV measurements.

Comparison of Stent Expansion Using a Volumetric Versus the Conventional Method Through Optical Coherence Tomography in an All-Comers Population.

INTRODUCTION: A volumetric approach to measure stent expansion derived from optical coherence tomography (OCT) is superior in regards to clinical outcomes when compared to the conventional method. The current software already performs a semi-automatic assessment and it is available as a clinical tool, however data is still scarce. We evaluated the stent expansion analysis that uses a volumetric vessel model, called minimum expansion index - MEI and compared to the conventional model, which utilizes the minimum stent area expansion (MSAx) indexed to the references, and its potential impact on procedural decision-making strategy in percutaneous coronary intervention. METHODS: This was a prospective, all-comers single center study, from all patients undergoing OCT-guided PCI between September 2018 and May 2019. We utilized the APTIVUE™ OPTIS 5.2 software (Abbott, Santa Clara, CA) to evaluate MEI and MSAx measurements after reference adjustments. RESULTS: We included 100 patients with mean age of 64 ± 12.5 years, 68% were men, and the main arteries analyzed through OCT were LAD (48%), RCA (31%) and LCx (21%). The mean MEI was 77.6% ± 16.7% and the mean MSAx was 71.6% ± 16.9%. MEI location differed from MSAx in 70% of cases, and in those cases the mean distance between MEI and MSAx was 15.3 mm ± 12.4 mm. In 53% of the times, the stent underexpansion based on MEI was located proximally to the MSAx by 18.1 mm ± 11.8 mm. Furthermore, in 42% of the total cases, MEI would change the intervention strategy based on the stent underexpansion being in a different location ≥10 mm in comparison to MSAx (34%) associated with the discrepancy between expansion indexes for MEI and MSAx (22%). CONCLUSION: We concluded that MEI location did not correlate to the conventional MSAx in two thirds of the cases. Moreover, compared to MEI, the MSAx assessment yielded lower expansion values in different stent positions, potentially changing the appropriate post-stent optimization, which thus would impact the decision-making strategy in almost half of the patients.

Seizure symptoms and ambulatory EEG findings: incidence of epileptiform discharges.

AIMS: Ambulatory video-EEG monitoring has been utilized as a cost-effective alternative to inpatient video-EEG monitoring for non-surgical diagnostic evaluation of symptoms suggestive of epileptic seizures. We aimed to assess incidence of epileptiform discharges in ambulatory video-EEG recordings according to seizure symptom history obtained during clinical evaluation. METHODS: This was a retrospective cohort study. We queried seizure symptoms from 9,221 consecutive ambulatory video-EEG studies in 35 states over one calendar year. We assessed incidence of epileptiform discharges for each symptom, including symptoms that conformed to a category heading, even if not included in the ILAE 2017 symptom list. We report incidences, odds ratios, and corresponding p values using Fisher's exact test and univariate logistic regression. We applied multivariable logistic regression to generate odds ratios for the six symptom categories that are controlled for the presence of other symptoms. RESULTS: History that included motor symptoms (OR=1.53) or automatisms (OR=1.42) was associated with increased occurrence of epileptiform discharges, whereas history of sensory symptoms (OR=0.76) predicted lack of epileptiform discharges. Patient-reported symptoms that were associated with increased occurrence of epileptiform discharges included lip-smacking, moaning, verbal automatism, aggression, eye-blinking, déjà vu, muscle pain, urinary incontinence, choking and jerking. On the other hand, auditory hallucination memory deficits, lightheadedness, syncope, giddiness, fibromyalgia and chronic pain predicted absence of epileptiform discharges. The majority of epileptiform discharges consisted only of interictal sharp waves or spikes. CONCLUSIONS: Our study shows that the use of ILAE 2017 symptom categories may help guide ambulatory video-EEG studies.

Transcatheter Valve Implantation for Failed Surgical Aortic and Mitral Bioprostheses: A Single-Center Experience.

OBJECTIVES: We share our center's experience with the use of transcatheter valvular therapies in the setting of failed bioprostheses. BACKGROUND: As medicine continues to advance, the lifespan of individuals continues to increase, and current surgical valvular therapies begin to degrade prior to a person's end of life. It is important to evaluate the efficacy and durability of transcatheter valves within failed surgical bioprostheses. METHODS: Baseline characteristics, periprocedural complications, and long-term outcomes were collected and assessed in patients who received transcatheter valves for failing surgical aortic valve bioprostheses and mitral valve and ring bioprostheses from March 2011 to July 2018. RESULTS: From our cohort of 1048 patients, we identified 45 individuals (4.3%) who underwent transcatheter replacement of a failed bioprosthetic valve or ring. Mean age at presentation was 80.8 ± 10.7 years and 75.5 ± 9.3 years, mean STS score was 9.3 ± 5.1 and 13.3 ± 8.7, and mean time to failure was 12.0 ± 5.2 years and 7.3 ± 4.5 years for aortic and mitral positions, respectively. At 1 year, time to event analysis suggested a 16.4% mortality rate for aortic replacement and 12.8% mortality rate for mitral replacement. CONCLUSIONS: We demonstrate outcomes from one of the largest single-center United States based cohorts of transcatheter replacements of failed surgical bioprostheses. Our center has demonstrated that it is feasible to pursue the replacement of failed surgical bioprostheses in the aortic and mitral positions with transcatheter valves given appropriate patient selection.

An assessment of the quality of optical coherence tomography image acquisition.

Optical coherence tomography (OCT) provides excellent image resolution, however OCT optimal acquisition is essential but could be challenging owing to several factors. We sought to assess the quality of OCT pullbacks and identify the causes of suboptimal image acquisition. We evaluated 784 (404 pre-PCI; 380 post-PCI) coronary pullbacks from an anonymized OCT database from our Cardiovascular Imaging Core Laboratory. Imaging of the region-of-interest (ROI-lesion or stented segment plus references) was incomplete in 16.1% pullbacks, caused by pullback starting too proximal (63.7%), inappropriate pullback length (17.1%) and pullback starting too distal (11.4%). The quality of image acquisition was excellent in 36.3% pullbacks; whereas 4% pullbacks were unanalyzable. Pullback quality was most commonly affected by poor blood displacement from inadequate contrast volume (27.4%) or flow (25.6%), followed by artifacts (24.1%). Acquisition mode was 'High-Resolution' (54 mm) in 74.4% and 'Survey' (75 mm) in 25.6% of cases. The 54 mm mode was associated with incomplete ROI imaging (p = 0.020) and inadequate contrast volume (p = 0.035). We observed a substantial frequency of suboptimal image acquisition and identified its causes, most of which can be addressed with minor modifications during the procedure, ultimately improving patient outcomes.

SLICR super-voxel algorithm for fast, robust quantification of myocardial blood flow by dynamic computed tomography myocardial perfusion imaging.

We created and evaluated a processing method for dynamic computed tomography myocardial perfusion imaging (CT-MPI) of myocardial blood flow (MBF), which combines a modified simple linear iterative clustering algorithm (SLIC) with robust perfusion quantification, hence the name SLICR. SLICR adaptively segments the myocardium into nonuniform super-voxels with similar perfusion time attenuation curves (TACs). Within each super-voxel, an α-trimmed-median TAC was computed to robustly represent the super-voxel and a robust physiological model (RPM) was implemented to semi-analytically estimate MBF. SLICR processing was compared with another voxel-wise MBF preprocessing approach, which included a spatiotemporal bilateral filter (STBF) for noise reduction prior to perfusion quantification. Image data from a digital CT-MPI phantom and a porcine ischemia model were evaluated. SLICR was ∼ 50 -fold faster than voxel-wise RPM and other model-based methods while retaining sufficient resolution to show clinically relevant features, such as a transmural perfusion gradient. SLICR showed markedly improved accuracy and precision, as compared with other methods. At a simulated MBF of 100 mL/min-100 g and a tube current-time product of 100 mAs (50% of nominal), the MBF estimates were 101 ± 12 , 94 ± 56 , and 54 ± 24 mL / min - 100 g for SLICR, the voxel-wise Johnson-Wilson model, and a singular value decomposition-model independent method with STBF, respectively. SLICR estimated MBF precisely and accurately ( 103 ± 23 mL / min - 100 g ) at 25% nominal dose, while other methods resulted in larger errors. With the porcine model, the SLICR results were consistent with the induced ischemia. SLICR simultaneously accelerated and improved the quality of quantitative perfusion processing without compromising clinically relevant distributions of perfusion characteristics.

Real World Utilization of Computed Tomography Derived Fractional Flow Reserve: Single Center Experience in the United States.

BACKGROUND: Fractional flow reserve derived from computed tomography (FFRct) has shown higher accuracy for detection of significant coronary artery disease (CAD) compared to coronary computed tomography angiography (CCTA). The performance of a combined comprehensive qualitative interpretation of both CCTA and FFRct in patient management is unknown. We aimed to explore the clinical application of this combined approach. METHODS: We retrospectively reviewed cases referred to FFRct testing at our institution over a one-year period. Patients had documentation of whether invasive coronary angiography (ICA) was performed and revascularization were needed. Interpretations and recommendations of the adopted comprehensive approach (C-FFRct), that took into account focal versus diffuse disease, depth of ischemia and myocardium at risk, were compared to those of CCTA (binary > 50% stenosis) alone and FFRct binary approach (FFRct ≤ 0.8). C-FFRct performance was measured against the decision made upon revascularization. RESULTS: A total of 207 cases were referred to FFRct testing, 163 (79%) accepted and 44 (21%) rejected for quality. C-FFRct changed interpretations and recommendations of 39 (24%) and 14 (9%) CCTA and FFRct, respectively. ICA was deferred in 32 (59%) and 13 (32%) cases; whereas ICA referral rate was 7 (6%) and 1 (0.8%) cases, based on CCTA and FFRct, respectively. No major cardiac events were observed during follow up time (median = 6 months). C-FFRct sensitivity, specificity, and accuracy compared to decision upon revascularization were 89%, 79% and 82%. C-FFRct number needed to treat was 4, and 6, compared to CCTA and FFRct, respectively. CONCLUSION: FFRct is a feasible tool to improve the diagnostic performance of CCTA in CAD real-world workup. However, qualitative interpretation of the FFRct report combined with CCTA findings may yield more impactful results on patient management. Further prospective studies are warranted to validate the application of this approach and better define its components.

Calibration-free beam hardening correction for myocardial perfusion imaging using CT.

PURPOSE: Computed tomography myocardial perfusion imaging (CT-MPI) and coronary CTA have the potential to make CT an ideal noninvasive imaging gatekeeper exam for invasive coronary angiography. However, beam hardening (BH) artifacts prevent accurate blood flow calculation in CT-MPI. BH correction methods require either energy-sensitive CT, not widely available, or typically, a calibration-based method in conventional CT. We propose a calibration-free, automatic BH correction (ABHC) method suitable for CT-MPI and evaluate its ability to reduce BH artifacts in single "static-perfusion" images and to create accurate myocardial blood flow (MBF) in dynamic CT-MPI. METHODS: In the algorithm, we used input CT DICOM images and iteratively optimized parameters in a polynomial BH correction until a BH-sensitive cost function was minimized on output images. An input image was segmented into a soft tissue image and a highly attenuating material (HAM) image containing bones and regions of high iodine concentrations, using mean HU and temporal enhancement properties. We forward projected HAM, corrected projection values according to a polynomial correction, and reconstructed a correction image to obtain the current iteration's BH corrected image. The cost function was sensitive to BH streak artifacts and cupping. We evaluated the algorithm on simulated CT and physical phantom images, and on preclinical porcine with optional coronary obstruction and clinical CT-MPI data. Assessments included measures of BH artifact in single images as well as MBF estimates. We obtained CT images on a prototype spectral detector CT (SDCT, Philips Healthcare) scanner that provided both conventional and virtual keV images, allowing us to quantitatively compare corrected CT images to virtual keV images. To stress test the method, we evaluated results on images from a different scanner (iCT, Philips Healthcare) and different kVp values. RESULTS: In a CT-simulated digital phantom consisting of water with iodine cylinder insets, BH streak artifacts between simulated iodine inserts were reduced from 13 ± 2 to 0 ± 1 HU. In a similar physical phantom having higher iodine concentrations, BH streak artifacts were reduced from 48 ± 6 to 1 ± 5 HU and cupping was reduced by 86%, from 248 to 23 HU. In preclinical CT-MPI images without coronary obstruction, BH artifact was reduced from 24 ± 6 HU to less than 5 ± 4 HU at peak enhancement. Standard deviation across different regions of interest (ROI) along the myocardium was reduced from 13.26 to 6.86 HU for ABHC, comparing favorably to measurements in the corresponding virtual keV image. Corrections greatly reduced variations in preclinical MBF maps as obtained in normal animals without obstruction (FFR = 1). Coefficients of variations were 22% (conventional CT), 9% (ABHC), and 5% (virtual keV). Moreover, variations in flow tended to be localized after ABHC, giving result which would not be confused with a flow deficit in a coronary vessel territory. CONCLUSION: The automated algorithm can be used to reduce BH artifact in conventional CT and improve CT-MPI accuracy particularly by removing regions of reduced estimated flow which might be misinterpreted as flow deficits.

The role of acquisition and quantification methods in myocardial blood flow estimability for myocardial perfusion imaging CT.

In this work, we clarified the role of acquisition parameters and quantification methods in myocardial blood flow (MBF) estimability for myocardial perfusion imaging using CT (MPI-CT). We used a physiologic model with a CT simulator to generate time-attenuation curves across a range of imaging conditions, i.e. tube current-time product, imaging duration, and temporal sampling, and physiologic conditions, i.e. MBF and arterial input function width. We assessed MBF estimability by precision (interquartile range of MBF estimates) and bias (difference between median MBF estimate and reference MBF) for multiple quantification methods. Methods included: six existing model-based deconvolution models, such as the plug-flow tissue uptake model (PTU), Fermi function model, and single-compartment model (SCM); two proposed robust physiologic models (RPM1, RPM2); model-independent singular value decomposition with Tikhonov regularization determined by the L-curve criterion (LSVD); and maximum upslope (MUP). Simulations show that MBF estimability is most affected by changes in imaging duration for model-based methods and by changes in tube current-time product and sampling interval for model-independent methods. Models with three parameters, i.e. RPM1, RPM2, and SCM, gave least biased and most precise MBF estimates. The average relative bias (precision) for RPM1, RPM2, and SCM was ⩽11% (⩽10%) and the models produced high-quality MBF maps in CT simulated phantom data as well as in a porcine model of coronary artery stenosis. In terms of precision, the methods ranked best-to-worst are: RPM1 > RPM2 > Fermi > SCM > LSVD > MUP [Formula: see text] other methods. In terms of bias, the models ranked best-to-worst are: SCM > RPM2 > RPM1 > PTU > LSVD [Formula: see text] other methods. Models with four or more parameters, particularly five-parameter models, had very poor precision (as much as 310% uncertainty) and/or significant bias (as much as 493%) and were sensitive to parameter initialization, thus suggesting the presence of multiple local minima. For improved estimates of MBF from MPI-CT, it is recommended to use reduced models that incorporate prior knowledge of physiology and contrast agent uptake, such as the proposed RPM1 and RPM2 models.

Rupture of a Non-Obstructive Plaque.

An invasive and non-invasive imaging series representing a classic rupture of a non-obstructive plaque with thin-cap fibroatheroma.

Left Atrium Wall-mapping Application for Wall Thickness Visualisation.

The measurement method for the LA wall thickness (WT) using cardiac computed tomography (CT) is observer dependent and cannot provide a rapid and comprehensive visualisation of the global LA WT. We aim to develop a LA wall-mapping application to display the global LA WT on a coplanar plane. The accuracy, intra-observer, and inter-observer reproducibility of the application were validated using digital/physical phantoms, and CT images of eight patients. This application on CT-based LA WT measures were further validated by testing six pig cardiac specimens. To evaluate its accuracy, the expanded maps of the physical phantom and pig LA were generated from the CT images and compared with the expanded map of the digital phantom and LA wall of pig heart. No significant differences (p > 0.05) were found between physical phantom and digital phantom as well as pig heart specimen and CT images using our application. Moreover, the analysis was based on the LA physical phantom or images of clinical patients; the results consistently demonstrated high intra-observer reproducibility (ICC > 0.9) and inter-observer reproducibility (ICC > 0.8) and showed good correlation between measures of pig heart specimen and CT data (r = 0.96, p < 0.001). The application can process and analyse the LA architecture for further visualisation and quantification.

SLIC robust (SLICR) processing for fast, robust CT myocardial blood flow quantification.

There are several computational methods for estimating myocardial blood flow (MBF) using CT myocardial perfusion imaging (CT-MPI). Previous work has shown that model-based deconvolution methods are more accurate and precise than model-independent methods such as singular value decomposition and max-upslope. However, iterative optimization is computationally expensive and models are sensitive to image noise, thus limiting the utility of low x-ray dose acquisitions. We propose a new processing method, SLICR, which segments the myocardium into super-voxels using a modified simple linear iterative clustering (SLIC) algorithm and quantifies MBF via a robust physiologic model (RPM). We compared SLICR against voxel-wise SVD and voxel-wise model-based deconvolution methods (RPM, single-compartment and Johnson-Wilson). We used image data from a digital CT-MPI phantom to evaluate robustness of processing methods to noise at reduced x-ray dose. We validate SLICR in a porcine model with and without partial occlusion of the LAD coronary artery with known pressure-wire fractional flow reserve. SLICR was ~50 times faster than voxel-wise RPM and other model-based methods while retaining sufficient resolution to show all clinically interesting features (e.g., a flow deficit in the endocardial wall). SLICR showed much better precision and accuracy than the other methods. For example, at simulated MBF=100 mL/min/100g and 100 mAs exposure (50% of nominal dose) in the digital simulator, MBF estimates were 101 ± 12 mL/min/100g, 160 ± 54 mL/min/100g, and 122 ± 99 mL/min/100g for SLICR, SVD, and Johnson-Wilson, respectively. SLICR even gave excellent results (103 ± 23 ml/min/100g) at 50 mAs, corresponding to 25% nominal dose.

In-hospital outcomes of transcatheter versus surgical aortic valve replacement in end stage renal disease.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) for patients with severe symptomatic aortic stenosis (AS) who are at intermediate and high risk for surgery. Commercial use of TAVR has expanded to patients with end stage renal disease (ESRD). OBJECTIVES: Compare in-hospital outcomes of TAVR versus SAVR in ESRD patients requiring hemodialysis (HD). METHODS: ESRD patients on HD undergoing TAVR (n = 328) or SAVR (n = 697) between 2012 and 2014 were identified in the National Inpatient Sample (NIS). Propensity-score matching method was used to minimize selection bias. Baseline characteristics and in-hospital outcomes were compared. RESULTS: TAVR patients were older (75.3 vs. 61.6 years, P < 0.001) and had more comorbidities, including congestive heart failure (16.2% vs. 7.5%), diabetes mellitus (28.4% vs. 22.5%), chronic lung disease (27.7% vs. 20.4%), and peripheral vascular disease (35.1% vs. 21.2%). Propensity-score matching yielded 175 pairs of patients matched on 30 baseline covariates. Overall in-hospital mortality was high (9.9%) and similar between TAVR and SAVR (8% vs. 10.3%, P = 0.58). TAVR was associated with shorter length of stay (LOS) (8 vs. 14 days, P < 0.001), lower hospitalization cost ($276,448 vs. $364,280, P = 0.01), lower in-hospital complications (60.6% vs. 76%, P = 0.003), and higher rate of home discharge (31.4% vs. 17.7%, P = 0.004) compared with SAVR. CONCLUSIONS: Regardless of treatment modality, patients with AS on HD have high in-hospital mortality. TAVR and SAVR have comparable in-hospital mortality in this population. However, TAVR is associated with shorter LOS, lower hospitalization costs, lower in-hospital complications, and higher rates of home discharge.

New insight to estimate under-expansion after stent implantation on bifurcation lesions using optical coherence tomography.

Optical coherence tomography (OCT) allows full volumetric segmentation of the lumen. However, for the estimation of stent under-expansion we still rely on the conventional method (CM) of single cross-sectional narrowing compared with reference vessel, likely masking true lesion significance, especially for bifurcations and tapered vessels. We, therefore, suggest a novel concept of volumetric metrics that take into account vessel tapering and major side branches and is capable of obtaining ideal lumen area for every frame of the stent by OCT. Forty-four patients with bifurcation lesions were enrolled. In volumetric metrics, expansion index was calculated as [(actual lumen area/ideal lumen area) × 100] in all frames. While minimum expansion index (MEI) was often located in the proximal segment to the major side branch, minimum stent area (MSA) by CM was frequently located in the distal segment (p < 0.001). Furthermore, the frequency of the under-expansion was significantly greater in newly metrics compared with CM [21 (47.7%) and 11 (25.0%), p = 0.045]. New metrics changed the presence of the under-expansion in 40.9% (18/44) of patients and the locations of MEI and MSA were different in 72.7% (32/44) of cases. Volumetric assessment enables to more accurately assess stent under-expansion.

Design of the Magnetic Resonance Imaging Evaluation of Mineralocorticoid Receptor Antagonism in Diabetic Atherosclerosis (MAGMA) Trial.

Mineralocorticoid receptor (MR) activation plays an essential role in promoting inflammation, fibrosis, and target organ damage. Currently, no studies are investigating MR antagonism in patients with type 2 diabetes mellitus (T2DM) with chronic kidney disease, at high risk for cardiovascular complications, who are otherwise not candidates for MR antagonism by virtue of heart failure. Further, there is limited information on candidate therapies that may demonstrate differential benefit from this therapy. We hypothesized that MR antagonism may provide additional protection from atherosclerosis progression in higher-risk patients who otherwise may not be candidates for such a therapeutic approach. In this double-blind, randomized, placebo-controlled trial, subjects with T2DM with chronic kidney disease (≥ stage 3) will be randomized in a 1:1 manner to placebo or spironolactone (12.5 mg with eventual escalation to 25 mg daily over a 4-week period). The co-primary efficacy endpoint will be percentage change in total atheroma volume in thoracic aorta and left ventricular mass at 52 weeks in patients treated with spironolactone vs placebo. Secondary outcomes include 24-hour mean systolic blood pressure, central aortic blood pressure, and insulin resistance (HOMA-IR) at 6 weeks. A novel measure in the study will be changes in candidate miRNAs that regulate expression of NR3C2 (MR gene) as well as measuring monocyte/macrophage polarization in response to therapy with spironolactone. We envision that our strategy of simultaneously probing the effects of a drug combined with analysis of mechanisms of action and predictive response will likely provide key information with which to design event-based trials.

Improvements in Left Ventricular Diastolic Mechanics After Parachute Device Implantation in Patients With Ischemia Heart Failure: A Cardiac Computerized Tomographic Study.

BACKGROUND: Percutaneous ventricular restoration therapy with the use of a left ventricle (LV)-partitioning Parachute device has emerged as a clinical treatment option for LV apical aneurysm after extensive anterior myocardial infarction (AMI). We assessed changes of diastolic mechanics and functional improvements following LV Parachute device implantation by means of cardiac computerized tomography (CCT). METHODS AND RESULTS: CCT data were obtained from 28 patients before and after LV Parachute device implantation. Diastolic functional indices were determined by means of quantitative CCT assessment: 1) transmitral velocities in early (E) and late (A) diastole and ratio (E/A); 2) early diastolic mitral septal tissue velocity (Ea) and E/Ea; and 3) vortex formation time (VFT). Functional improvements were assessed with the use of New York Heart Association (NYHA) functional classification. Among the study patients, there were no significant differences in all transmitral velocities and E/A, though there was significantly increased Ea, reduced E/Ea, and greater VFT 6 months after LV Parachute device implantation. Finally, the improvement of diastolic functional indices after Parachute treatment correlated with observed clinical functional alterations (Δ E/Ea and Δ NYHA functional class:, r = 0.563; P = .002; Δ VFT and Δ NYHA functional class: r = -0.507; P = .006). CONCLUSIONS: LV Parachute device implantation therapy in heart failure caused by AMI and LV apical aneurysm formation showed improvements in several diastolic functional mechanics according to CCT-based measures.

Evaluating the quality of implantation of percutaneous ventricular restoration device (Parachute®) by cardiac computed tomography.

BACKGROUND: The Parachute is a novel percutaneously implanted ventricular partitioning device (VPD) that has emerged as a safe and feasible treatment option for patients with heart failure following anterior wall myocardial infarction. VPD efficacy is likely dependent on optimal device placement, but to date there are no published data examining the effect of device positioning on patient outcomes. METHODS AND RESULTS: We retrospectively identified 32 patients successfully implanted with the Parachute device, all of whom underwent cardiac computed tomography (CCT) at baseline and after 6 months of follow-up. Patients were divided into two groups based on self-reported improvement in New York Heart Association (NYHA) functional class: "not improved NYHA" (n = 12) and "improved NYHA" (n = 20). There were significant differences between both groups with regard to device positioning on follow-up CCT. Compared to patients with "improved NYHA," patients with "not improved NYHA" had longer distances from device foot to left ventricular apex (8.0 ± 4.9 vs. 2.9 ± 4.6 mm; P = 0.01), and higher lateral angles (18.0 ± 14 vs. 9.1 ± 6.8 degrees; P = 0.02), respectively. There was no significant difference between the two groups in landing zone (45.4 ± 7. vs. 45.1 ± 6.9 mm; P = 0.92) and inferior angle (14.0 ± 11.9 vs. 14.3 ± 10.1 degrees; P = 0.95). There was a numerically larger malapposition area in the "not improved NYHA" group (5.1 ± 4.5 vs. 3.2 ± 2.2 cm2; P = 0.12). CONCLUSION: Quality of Parachute implant impacted clinical outcome, these findings should be applied prospectively in helping operators to achieve optimal implant. © 2016 Wiley Periodicals, Inc.