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The cusp overlap technique has standardized implantation for self-expanding valves with the goal of achieving more consistent implantation depths and lowering permanent pacemaker (PPM) implantation rates. We retrospectively compared short-term outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding valve implanted using the cusp overlap technique vs. the traditional coplanar technique in a large tertiary referral center. We conducted a retrospective study among PPM-naïve patients who underwent TAVR using the CoreValve Evolut PRO/PRO+. We compared in-hospital PPM rates in patients who underwent TAVR using the cusp overlap technique vs. the coplanar technique. Additional outcomes included in-hospital all-cause mortality, stroke, major vascular complications, annular rupture, and >mild paravalvular leak. Furthermore, we compared outcomes over time to see whether there was evidence of a learning curve. Of the 528 patients included, 270 underwent TAVR using the coplanar technique and 258 underwent TAVR using the cusp overlap technique. The rate of new PPM implantation did not differ between cohorts (17.0 % vs. 16.7 %; p = 0.910). Additionally, rates of in-hospital all-cause mortality (0.0 % vs. 0.4 %; p = 0.328), stroke (3.7 % vs. 1.6 %; p = 0.124), major vascular complications (0.7 % vs. 1.2 %; p = 0.617), annular rupture (0.4 % vs. 0.0 %; p = 0.328) and >mild paravalvular leak (0.0 % vs. 0.4 %; p = 0.444) were similar. Our secondary analysis did not identify any evidence of a learning curve. The cusp overlap technique may not yield a reduction in PPM rates when compared with the coplanar technique. Other confounders should be explored to further minimize in-hospital PPM rates. In-hospital outcomes. [Display omitted] • We analyzed short-term outcomes after TAVR with self-expanding valves. • We compared the cusp overlap technique vs. the traditional coplanar technique. • New PPM implantation rate did not differ between cohorts (17.0 % vs 16.7 %; p = 0.910). • Cusp overlap technique may not yield lower PPM rates vs. coplanar technique. [ABSTRACT FROM AUTHOR]

Transcatheter cardiovascular interventions increasingly rely on advanced imaging. X-ray fluoroscopy provides excellent visualization of catheters and devices, but poor visualization of anatomy. In contrast, magnetic resonance imaging (MRI) provides excellent visualization of anatomy and can generate real-time imaging with frame rates similar to X-ray fluoroscopy. Realization of MRI as a primary imaging modality for cardiovascular interventions has been slow, largely because existing guidewires, catheters and other devices create imaging artifacts and can heat dangerously. Nonetheless, numerous clinical centers have started interventional cardiovascular magnetic resonance (iCMR) programs for invasive hemodynamic studies or electrophysiology procedures to leverage the clear advantages of MRI tissue characterization, to quantify cardiac chamber function and flow, and to avoid ionizing radiation exposure. Clinical implementation of more complex cardiovascular interventions has been challenging because catheters and other tools require re-engineering for safety and conspicuity in the iCMR environment. However, recent innovations in scanner and interventional device technology, in particular availability of high performance low-field MRI scanners could be the inflection point, enabling a new generation of iCMR procedures. In this review we review these technical considerations, summarize contemporary clinical iCMR experience, and consider potential future applications. [ABSTRACT FROM AUTHOR]

Mitral valve disease is insidious and associated with a decreased quality of life and survival over time. Despite surgery being the standard of care, many patients are at prohibitive surgical risk. Furthermore, a substantial proportion of patients with symptomatic mitral valve disease fail stringent screening criteria for transcatheter mitral valve replacement (TMVR). The natural history of patients who fail screening is not well-characterized, and data are limited on the reasons for screen failure in this population. The Mitral Valve Screening Survey (MVSS) seeks to detail the clinical profile and natural history of patients who fail screening for TMVR. The MVSS is a prospective, multicenter registry enrolling up to 1000 consecutive subjects who, after screening for TMVR, are deemed not to be candidates. Subjects will be followed for 30 days after failing screening for TMVR and annually for up to 5 years with clinical evaluations. The primary study endpoint of the MVSS registry is all-cause mortality at 1 year. Additional secondary endpoints include all-cause mortality, hospitalizations, subsequent mitral valve intervention (transcatheter or surgical), reason for screen failure, and quality-of-life assessments at 30 days and annually up to 5 years of follow-up. The MVSS registry is the first prospective multicenter study to characterize the clinical and anatomical profile of patients who fail screening for TMVR while providing longitudinal clarification on the natural history and outcomes of these patients. Mitral Valve Screening Survey (MVSS), https://clinicaltrials.gov/ct2/show/NCT04736667 , NCT04736667 • Mitral valve disease is associated with a decreased quality of life and survival. • MVSS seeks to detail the clinical profiles of patients who fail screening for TMVR. • MVSS is a prospective registry enrolling up to 1000 consecutive subjects. • Primary study endpoint of the MVSS registry is all-cause mortality at 1 year. • The MVSS registry is the first prospective, multicenter study of its kind. [ABSTRACT FROM AUTHOR]

The cost of ASD in the U.S. is estimated using a forecast model that for the first time accounts for the true historical increase in ASD. Model inputs include ASD prevalence, census population projections, six cost categories, ten age brackets, inflation projections, and three future prevalence scenarios. Future ASD costs increase dramatically: total base-case costs of $223 (175–271) billion/year are estimated in 2020; $589 billion/year in 2030, $1.36 trillion/year in 2040, and $5.54 (4.29–6.78) trillion/year by 2060, with substantial potential savings through ASD prevention. Rising prevalence, the shift from child to adult-dominated costs, the transfer of costs from parents onto government, and the soaring total costs raise pressing policy questions and demand an urgent focus on prevention strategies. [ABSTRACT FROM AUTHOR]

Background: Most pivotal transcatheter aortic valve replacement (TAVR) trials have excluded patients with bicuspid aortic stenosis (AS). This study compared TAVR in low-risk patients with bicuspid AS to those with tricuspid AS, incorporating data from prospective trials.Methods: We selected prospective US low-risk TAVR trials containing a bicuspid arm for this meta-analysis, examining outcomes at 30 days. Study results were pooled using a hierarchical Bayesian random-effects model.Results: Included were 3 Food and Drug Administration (FDA)-approved investigational device exemption (IDE) trials that enrolled a total of 1810 low-risk patients with symptomatic severe AS for TAVR. We compared 380 bicuspid patients with 1430 tricuspid patients. Event rates at 30 days overall were low, with similar mortality (odds ratio [OR], 0.38; 95% credible interval [CrI]: 0.08, 1.78; I2, 0%), non-disabling stroke (OR, 0.45; 95% CrI: 0.15, 1.07; I2, 9%), and permanent pacemaker implantation (OR, 0.86; 95% CrI: 0.41, 1.47; I2, 59%). There were statistically significant differences in disabling stroke (OR, 0.16; 95% CrI: 0.01, 0.90; I2, NA) and coronary obstruction (OR, 0.21; 95% CrI: 0.05, 0.91) that disappeared after sensitivity analysis by adding a single event to the tricuspid arm. Hemodynamics were similar at 30 days.Conclusions: Preliminary data from the FDA-approved IDE trials of low-risk patients with bicuspid AS undergoing TAVR demonstrated 30-day outcomes comparable to low-risk tricuspid patients, except for a trend toward higher stroke in bicuspid patients. Randomized trials are warranted to reassure the safety and long-term outcome of TAVR in patients with severe bicuspid AS. [ABSTRACT FROM AUTHOR]

Background: Prospective bicuspid low-risk transcatheter aortic valve replacement (TAVR) registries' data demonstrated encouraging short-term results. Detailed data on transcatheter heart valve (THV) geometry after deployment using contemporary devices are lacking. This study sought to examine valve geometry after TAVR in patients with bicuspid aortic stenosis (AS).Methods: The study population was patients from the LRT (Low Risk TAVR) trial who underwent TAVR using the SAPIEN 3 THV for bicuspid and tricuspid AS. THV geometry measured on 30-day computed tomography (CT) included valve height, angle, depth, and eccentricity. Additionally, THV hemodynamics and outcomes post-TAVR were compared among patients with bicuspid and tricuspid AS.Results: A total of 107 patients from the LRT trial using the SAPIEN 3 THV were included in our analysis. On 30-day CT, the valve height ratio (1.07 vs. 1.07; p = 0.348), depths (right [5.6 mm vs. 6.2 mm; p = 0.223], left [5.3 mm vs. 4.4 mm; p = 0.082] and non [4.8 mm vs. 4.5 mm; p = 0.589] coronary cusps), eccentricities (1.08 vs. 1.07; p = 0.9550), and angles (except the right [3.9 degrees vs. 6.3 degrees; p = 0.003] and left [3.6 degrees vs. 6.0 degrees; p = 0.007]) were similar between bicuspid and tricuspid patients. Hemodynamics, stroke, and mortality were similar at 1 year.Conclusion: Despite challenging bicuspid anatomy of the aortic valve, our comprehensive CT analysis supports similar THV geometry between patients with bicuspid and tricuspid AS undergoing TAVR using the SAPIEN 3 THV in low-risk patients. This translated to excellent short-term clinical outcomes and THV hemodynamics in both aortic valve morphologies.Trial Registry: NCT02628899, https://clinicaltrials.gov/ct2/show/NCT02628899. [ABSTRACT FROM AUTHOR]

Background: Before its voluntary recall, the mechanically expandable LOTUS Edge transcatheter heart valve (THV) offered a number of unique features, notably sealing against paravalvular leak (PVL) and the ability to be fully deployed, re-captured, and re-deployed.Methods: We performed a detailed review of all patients at our institution who underwent transcatheter aortic valve replacement (TAVR) using the LOTUS Edge THV from 2019 to 2020. We describe procedural and in-hospital outcomes.Results: In brief, 59 patients underwent TAVR using the LOTUS Edge, of whom 18 were high-risk (most of whom had moderate or severe left ventricular outflow tract [LVOT] calcium), 36 were intermediate-risk enrolled in the REPRISE IV trial (one of whom had a bicuspid valve), and 5 were low-risk bicuspid patients enrolled in the LRT trial. Conduction disturbances were common (new left bundle branch block in 64.4%), with high rates of new permanent pacemaker (PPM) implantation across all risk groups (16.9%). Overall, stroke occurred in 11.9% of patients, and in 3/5 low-risk bicuspid patients, but occurred less frequently in patients with cerebral embolic protection.Conclusions: In our experience, in patients with heavy LVOT calcium burden and/or bicuspid valves, the LOTUS Edge THV offered excellent seal against PVL. However, the high rates of periprocedural stroke and new PPM implantation were a concern. [ABSTRACT FROM AUTHOR]

Background/purpose: This sub-analysis of the prospective Low Risk TAVR (LRT) trial determined anatomical characteristics associated with hypoattenuated leaflet thickening (HALT), which may contribute to early transcatheter heart valve (THV) degeneration.Methods/materials: The LRT trial enrolled 200 low-risk patients between February 2016 and February 2018. All subjects underwent baseline and 30-day CT studies, analyzed by an independent core laboratory. Additional measurements, namely THV expansion, eccentricity, depth, and commissural alignment, were made by consensus of three independent readers. HALT was observed only in the Sapien 3 THV, so Evolut valves were excluded from this analysis.Results: In the LRT trial, 177 subjects received Sapien 3 THVs, of whom 167 (94.3%) had interpretable 30-day CTs and were eligible for this analysis. Twenty-six subjects had HALT (15.6%). Baseline characteristics were similar between groups. There was no difference in THV size implanted and baseline aortic-root geometry between groups. In patients who developed HALT, THV implantation depth was shallower than in patients who did not develop HALT (2.6 ± 1.1 mm HALT versus 3.3 ± 1.8 mm no-HALT, p = 0.03). There were more patients in the HALT group with commissural malalignment (40% vs. 28%; p = 0.25), but this did not reach statistical significance. In a univariable regression model, no predetermined variables were shown to independently predict the development of HALT.Conclusions: This study did not find anatomical or THV implantation characteristics that predicted the development of HALT at 30 days. This study cannot exclude subtle effects or interaction between factors because of the small number of events. [ABSTRACT FROM AUTHOR]

Background: The advent of transcatheter aortic valve replacement (TAVR) has changed which patients undergo surgical aortic valve replacement (SAVR). We sought to understand the impact of TAVR on the characteristics of SAVR patients in the United States.Methods: A cohort of 2959 patients who underwent isolated SAVR at 11 US hospitals that perform both TAVR and SAVR from 2013 through 2017 were grouped by the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database version (v)2.73 (2011-2014), v2.81 (2014-2017), and v2.9 (2017) to assess temporal trends in patient characteristics.Results: Over time, SAVR patients were younger with fewer preoperative comorbidities. There was a significant decrease in median STS predicted risk of mortality (PROM) score (2.0 vs. 1.8 vs. 1.3, p < 0.001, in v2.73 vs. v2.81 vs. v2.9). Specifically, there were fewer high-risk (STS PROM > 8%: 4.3% vs. 4.7% vs. 1.2%, p = 0.03) and intermediate-risk (STS PROM 4% to 8%: 16.3% vs. 11.7% vs. 4.3%, p < 0.001) patients. The proportion of patients with bicuspid aortic valve disease increased significantly (11.2% vs. 26.9% vs. 36.6%, p < 0.001). There were no differences in operative mortality (1.9% vs. 2.1% vs. 1.4%, p = 0.75).Conclusions: The introduction of TAVR has already impacted the demographics, clinical characteristics and risk profiles of patients undergoing SAVR in the US. Now that TAVR is approved for low-risk patients, SAVR is likely to be reserved for younger patients who are willing to receive a mechanical valve and for patients with aortopathy, coronary artery disease, or concomitant mitral or tricuspid pathology. [ABSTRACT FROM AUTHOR]

Transcatheter electrosurgery refers to a family of procedures using radiofrequency energy to vaporize and traverse or lacerate tissue despite flowing blood. The authors review theory, simulations, and benchtop demonstrations of how guidewires, insulation, adjunctive catheters, and dielectric medium interact. For tissue traversal, all but the tip of traversing guidewires is insulated to concentrate current. For leaflet laceration, the "Flying V" configuration concentrates current at the inner lacerating surface of a kinked guidewire. Flooding the field with non-ionic dextrose eliminates alternative current paths. Clinical applications include traversing occlusions (pulmonary atresia, arterial and venous occlusion, and iatrogenic graft occlusion), traversing tissue planes (atrial and ventricular septal puncture, radiofrequency valve repair, transcaval access, Potts and Glenn shunts), and leaflet laceration (BASILICA, LAMPOON, ELASTA-Clip, and others). Tips are provided for optimizing these techniques. Transcatheter electrosurgery already enables a range of novel therapeutic procedures for structural heart disease, and represents a promising advance toward transcatheter surgery. [ABSTRACT FROM AUTHOR]

Background/purpose: Women are underrepresented in cardiovascular clinical studies. Black women have a higher ischemic heart disease mortality risk than their white counterparts. However, there exist limited outcome data comparing black women and white women after percutaneous coronary intervention (PCI). The aim of this retrospective analysis was to evaluate for racial disparities in 1-year major adverse cardiovascular events (MACE) in women undergoing PCI.Methods/materials: Within our PCI database, we identified 4776 female patients who underwent PCI between 2003 and 2016. Of those, 1916 were black and 2860 were white. Endpoints included MACE, death, myocardial infarction, target vessel revascularization (TVR) and stent thrombosis (ST) at 30 days and 1 year. A proportional Cox hazard model analysis was performed to assess outcomes after adjustment for confounding factors.Results: Black women presented at a younger age and had a significantly higher prevalence of risk factors. Periprocedural and in-hospital outcomes were similar in the 2 groups. At 30 days and 1 year, the rates of myocardial infarction, TVR and ST were significantly higher in black women. After adjustment for baseline differences, only ST appears to be more likely to occur in black women than in white women.Conclusions: In this large cohort of women with coronary artery disease undergoing PCI, we observed racial disparities primarily in baseline characteristics indicative of need for interventions to achieve early diagnosis and better prevention in black women. Future directions should include efforts to identify and better characterize the factors underlying and contributing to cardiovascular outcomes in women after PCI.Summary: In this real-world analysis from a large cohort of women with coronary artery disease undergoing percutaneous coronary intervention at a US tertiary-care center, racial disparities were observed, especially in baseline characteristics, indicating late presentation. [ABSTRACT FROM AUTHOR]

• Hypertension is the leading preventable cause of MI, stroke, and death worldwide. • FDA's Circulatory System Devices Panel discussed device-based management of HTN • Device targets include RDN, baroreflex amplification and hemodynamic modification. • Summary of published data and ongoing randomized clinical trials is presented. • Panel and industry supported renaissance of device-based antihypertensive therapies [ABSTRACT FROM AUTHOR]

Migration is a critical aspect of ocean ecosystems, and understanding this phenomenon answers ecological and management questions. Given the difficulty in tracking ocean animals across large distances, the extent to which different ray species perform long‐distance movements, such as migrations, remains unknown. This study used passive acoustic telemetry to track the movements of endemic diamond Gymnura natalensis and critically endangered duckbill Aetomylaeus bovinus rays along the South African coastline using a collaborative nationwide network of coastal acoustic receivers for up to 7 years. Duckbill rays were detected significantly more frequently than diamond rays, but both species moved between the south and east coasts of South Africa (traveling up to 1167 km). Tagged individuals were detected significantly more often in their tagging locations during summer months but traveled significantly further distances during winter months. Furthermore, movement models fitted to individual duckbill rays' annual net‐squared displacement identified most individual annual movements as migratory. This evidence suggests that both diamond and duckbill rays make eastward winter migrations and return to specific areas along the coastline during the summer months. The exceptions to this were diamond rays tagged on the east coast that were not found to migrate seasonally, which supports previous research that there is intraspecific variability in migrations for ray species. These findings have implications for understanding ray migration not only on a global scale but also locally for spatial management interventions and population delineation. [ABSTRACT FROM AUTHOR]

The self-expanding CoreValve Evolut PRO/PRO+ transcatheter aortic valve was designed to overcome the limitations of its forerunner, Evolut R. Evolut PRO/PRO+ offers the lowest delivery profile for 23–29 mm valves, with an external tissue wrap on all valve sizes. We compared safety and efficacy of Evolut PRO/PRO+ and Evolut R. We analyzed 300 patients enrolled in the EPROMPT Registry against a historical control cohort of 242 patients who received Evolut R. The two arms were matched (1:1) via propensity-score methodology by accounting for differences in Society of Thoracic Surgeons Predicted Risk of Mortality scores, yielding 440 patients. The endpoints included in-hospital safety clinical outcomes, all-cause mortality, and echocardiographic parameters at 30 days and 1 year. After propensity-score matching, cardiac death (0.5% vs. 0.5%, p = 0.995), stroke (1.6% vs. 2.8%, p = 0.410), life-threatening bleeding (1.1% vs. 3.3%, p = 0.139), major vascular complications (0.5% vs. 0.9%, p = 0.653), and pacemaker implantation (16.9% vs. 13.6%, p = 0.345) were comparable between the Evolut PRO/PRO+ and Evolut R groups. Likewise, the rates of all-cause mortality were similar both at 30 days (0.5% vs. 1.4%, p = 0.315) and 1 year (1.8% vs. 4.1%, p = 0.159). The rates of moderate paravalvular leak (5.7% vs. 2.6%, p = 0.402), and mean gradient (7.27 ± 3.25 mmHg vs. 8.84 ± 4.36 mmHg, p = 0.105) were also comparable between groups at 1 year. Our largest-to-date observational study suggests that the Evolut PRO/PRO+ system is safe and effective in treating severe aortic stenosis, with commensurate 30-day and 1-year mortality and similar 1-year echocardiographic hemodynamic outcomes in comparison to Evolut R. [Display omitted] • Evolut PRO/PRO+ valve was designed to improve upon Evolut R. • We compared safety and efficacy of the two valves. • Our study suggests Evolut PRO/PRO+ is safe and effective in treating severe AS. • Evolut PRO/PRO+ showed similar survival and hemodynamics compared to Evolut R. [ABSTRACT FROM AUTHOR]

A correction is presented to article, "Autism Tsunami: The Impact of Rising Prevalence on the Societal Cost of Autism in the U.S." published in the previous issues of periodical.

Background/purpose: Right ventricular (RV) mechanical circulatory support remains an important adjunctive therapy for RV failure refractory to medical therapy. Impella RP (Abiomed, Danvers, MA) is approved for providing temporary RV support for patients with acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Robust data on the most commonly reported complications and failure modes for the Impella RP are lacking. We analyzed the post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to assess these endpoints.Materials/methods: The MAUDE database was queried for the time period January 1, 2009, through December 31, 2018, for Impella devices by Searching for the following event types: "injury", "malfunction", "death", and "other". The search yielded 436 device reports. Impella RP medical device reports were screened, and 35 reports were included for the final analysis.Results: In cases of reported complications, Impella RP was placed most commonly for right ventricular failure (RVF) developing in postcardiotomy patients (20%). The most commonly reported complications included bleeding (42.9%) and vascular complications (22.8%). The modes of failure included damage or fracture of the device elements (34.2%); thrombus, or clot in the system (17.1%); and device detachment (8.6%).Conclusions: Findings from the MAUDE database highlight the failure modes of the Impella RP device that should be addressed in order to improve the device performance and obtain improved clinical outcomes when utilized for RVF. [ABSTRACT FROM AUTHOR]

Background/purpose: Surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis (AS) and prior chest radiation is associated with poor outcomes in comparison with patients without prior radiation. Our objective was to compare clinical outcomes of patients with and without prior chest radiation undergoing transcatheter aortic valve replacement (TAVR) for symptomatic severe AS.Methods/materials: Between January 2003 and January 2017, 1150 patients underwent TAVR at our institution. Of these, 44 had prior chest radiation. Baseline demographic and clinical characteristics, procedural details, and clinical outcomes were prospectively collected.Results: Patients with prior chest radiation were younger, 76 ± 13 years, compared with those without prior chest radiation, 82 ± 8 years (p = 0.002). Median Society of Thoracic Surgeons score for chest radiation patients was 7 ± 4, compared to 8 ± 5 in those without prior radiation. Despite higher prevalence of complete heart block, there was no significant difference between the 2 groups with regard to the need for permanent pacemaker implantation. There was a trend toward longer length of intensive care unit stay in chest radiation patients, but there was no significant difference in 30-day or 1-year mortality.Conclusions: Thus, TAVR appears to be a safe treatment option in the short and medium term for patients with symptomatic severe AS and prior chest radiation. [ABSTRACT FROM AUTHOR]

Medicare coverage for transcatheter aortic valve replacement (TAVR) in the United States (US) is governed by the 2012 National Coverage Determination (NCD 20.32), which enshrined minimum numbers of TAVR, surgical aortic valve replacement, and percutaneous coronary intervention that centers must perform to begin or maintain TAVR programs. In July 2018, the Centers for Medicare and Medicaid Services (CMS) convened a meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to review the evidence for setting minimum procedure volume requirements and to evaluate the impact of such requirements on access to care. In this paper, we summarize the MEDCAC panel deliberations, the evidence presented to the panel, and how the panel members voted. CMS is expected to publish a draft decision in March 2019 that may reshape the TAVR landscape in the US for years to come. [ABSTRACT FROM AUTHOR]

Background: Transcatheter aortic valve replacement (TAVR) is now the standard of care for patients with symptomatic severe aortic stenosis who are extreme, high, or intermediate risk for surgical aortic valve replacement (SAVR).Objectives: The authors sought to evaluate TAVR in a prospective multicenter trial involving low-risk patients.Methods: The Low Risk TAVR (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis) trial was the first U.S. Food and Drug Administration-approved Investigational Device Exemption trial to enroll in the United States. This investigator-led trial was a prospective, multicenter, unblinded, comparison to historical controls from the Society of Thoracic Surgeons (STS) database. The primary endpoint was all-cause mortality at 30 days.Results: The authors enrolled 200 low-risk patients with symptomatic severe aortic stenosis at 11 centers to undergo TAVR. The authors compared outcomes with an inverse probability weighting-adjusted control cohort of 719 patients who underwent SAVR at the same institutions using the STS database. At 30 days, there was zero all-cause mortality in the TAVR group versus 1.7% mortality in the SAVR group. There was zero in-hospital stroke rate in the TAVR group versus 0.6% stroke in the SAVR group. Permanent pacemaker implantation rates were similar between TAVR and SAVR (5.0% vs. 4.5%). The rates of new-onset atrial fibrillation (3.0%) and length of stay (2.0 ± 1.1 days) were low in the TAVR group. One patient (0.5%) in the TAVR group had >mild paravalvular leak at 30 days. Fourteen percent of TAVR patients had evidence of subclinical leaflet thrombosis at 30 days.Conclusions: TAVR is safe in low-risk patients with symptomatic severe aortic stenosis, with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days. Subclinical leaflet thrombosis was observed in a minority of TAVR patients at 30 days. (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis [Low Risk TAVR; NCT02628899). [ABSTRACT FROM AUTHOR]

A common clinical dilemma regarding treatment of patients with a mechanical valve is the need for concomitant antiplatelet therapy for a variety of reasons, referred to as triple therapy. Triple therapy is when a patient is prescribed aspirin, a P2Y12 antagonist, and an oral anticoagulant. Based on the totality of the available evidence, best practice in 2017 for patients with mechanical valves undergoing percutaneous coronary intervention (PCI) is unclear. Furthermore, the optimal duration of dual antiplatelet therapy after PCI is evolving. With better valve designs that are less thrombogenic, the thromboembolic risks can be reduced at a lower international normalized ratio target, thus decreasing the bleeding risk. This review will offer an in-depth survey of current guidelines, current evidence, suggested approach for PCI in this cohort, and future studies regarding mechanical valve patients undergoing PCI. [ABSTRACT FROM AUTHOR]

The lack of detailed life history (LH) information (e.g. age, growth, size at maturity, sex composition etc.) for many species of conservation importance limits the implementation of appropriate conservation measures. Typically, LH information is acquired using lethal sampling techniques, which undermines the goal of conservation. This is particularly problematic for many shark species that have low fecundity and slow growth rates. Here we tested the use of non-invasive laser photogrammetry to measure body morphometry in vivo. We used random forest classification models to identify allometric relationships (ratios between body measurements) that discriminated between the sex and stage of sexual maturity of Scyliorhinus canicula. We coupled the use of allometric ratios (determined from cadavers) with parallel laser photogrammetry, in order to collect total length (TL) and finer scale morphometrics from 37 free-swimming individuals. TL measurements proved to be accurate (SE = 5.2%) and precise (CV = 1.8%), and did not differ significantly from the known TL of the respective animal ( t36 = 0.7, P = 0.5). Conditional Inference tree model predictions of free-swimming sharks correctly predicted 100% of mature males and 79% of immature males. Our results suggest that when used together, allometric ratios and parallel laser photogrammetry have the potential to be a promising alternative to collect essential life history information from free swimming animals and avoids the need for destructive sampling. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate balloon-expandable and self-expanding third-generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes.Background: Two competing third-generation TAVR technologies are currently commercially available in the US. There are no published head-to-head comparisons of the relative performance of these two devices.Methods: 257 consecutive patients undergoing TAVR with a third-generation balloon-expandable (Edwards Sapien 3) or self-expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included. Choice of TAVR device was at the discretion of the multidisciplinary Heart Team. Baseline clinical characteristics, echocardiographic and CT imaging, procedural and 30-day outcomes were prospectively collected.Results: 74 patients received a self-expanding valve (SEV) and 183 received a balloon-expandable valve (BEV). Patients selected for SEV were more frequently women, with lower body surface area and smaller calcified iliofemoral arteries. Three SEV patients required implantation of a second valve to successfully treat paravalvular leak. Only one BEV patient had moderate paravalvular regurgitation. There was no difference in the rate of stroke, major vascular complication or bleeding. Permanent pacemaker implantation rate was significantly higher with SEV (12.7% vs 4.7%, P = 0.49) and hospital length of stay was longer (8.3% vs 6.5%, P = 0.043), but 30-day mortality was comparable (1.4% vs 1.6%, P = 1.00).Conclusions: Short-term outcomes were equivalent between the two technologies. Clinically significant paravalvular regurgitation was rare. SEV were more frequently selected in women and patients with challenging transfemoral access, but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay. [ABSTRACT FROM AUTHOR]

Background: Quantification of cardiac output and pulmonary vascular resistance (PVR) are critical components of invasive hemodynamic assessment, and can be measured concurrently with pressures using phase contrast CMR flow during real-time CMR guided cardiac catheterization. Methods: One hundred two consecutive patients underwent CMR fluoroscopy guided right heart catheterization (RHC) with simultaneous measurement of pressure, cardiac output and pulmonary vascular resistance using CMR flow and the Fick principle for comparison. Procedural success, catheterization time and adverse events were prospectively collected. Results: RHC was successfully completed in 97/102 (95.1%) patients without complication. Catheterization time was 20 ± 11 min. In patients with and without pulmonary hypertension, baseline mean pulmonary artery pressure was 39 ± 12 mmHg vs. 18 ± 4 mmHg (p < 0.001), right ventricular (RV) end diastolic volume was 104 ± 64 vs. 74 ± 24 (p = 0.02), and RV end-systolic volume was 49 ± 30 vs. 31 ± 13 (p = 0.004) respectively. 103 paired cardiac output and 99 paired PVR calculations across multiple conditions were analyzed. At baseline, the bias between cardiac output by CMR and Fick was 5.9% with limits of agreement -38.3% and 50.2% with r = 0.81 (p < 0.001). The bias between PVR by CMR and Fick was -0.02 WU.m² with limits of agreement -2.6 and 2.5 WU.m² with r = 0.98 (p <0. 001). Correlation coefficients were lower and limits of agreement wider during physiological provocation with inhaled 100% oxygen and 40 ppm nitric oxide. Conclusions: CMR fluoroscopy guided cardiac catheterization is safe, with acceptable procedure times and high procedural success rate. Cardiac output and PVR measurements using CMR flow correlated well with the Fick at baseline and are likely more accurate during physiological provocation with supplemental high-concentration inhaled oxygen. Trial registration: Clinicaltrials.gov NCT01287026, registered January 25, 2011. [ABSTRACT FROM AUTHOR]

The AngelMed Guardian System is an implantable device similar to a single chamber pacemaker that continuously monitors the intracardiac electrogram for evidence of ST segment shift indicating acute coronary artery occlusion. The system aims to reduce time to presentation by alerting patients to present to a medical facility whether symptoms are present or not. In March 2016, the US Food and Drug Administration (FDA) assembled a meeting of the Circulatory System Devices Panel to review the results of the AngelMed for Early Recognition and Treatment of STEMI (ALERTS) pivotal trial and the accompanying premarket approval (PMA) application for regulatory approval of the AngelMed Guardian System in the US. In this review, we examine the ALERTS trial methodology and results, and describe the FDA panel's deliberations and recommendations. [ABSTRACT FROM AUTHOR]

The current iterations of balloon-expandable transcatheter aortic valve replacement (TAVR) valves consist of a maximum size of 29 mm, corresponding to maximum annulus area of 680 mm2. However, a number of patients who qualify for TAVR based on surgical risk may have anatomical features outside the FDA-approved descriptions. The technique of overexpansion of TAVR valves during deployment allows for more patients to be treated successfully. This particular case demonstrates that overexpansion is safe and efficacious in a very large annulus of >800 mm2. Careful planning and consideration of aortic root calcification is helpful for technique of overexpansion and, ultimately, the technique may increase the number of patients eligible for TAVR. [ABSTRACT FROM AUTHOR]

Background: CMR-guidance has the potential to improve tissue visualization during cardiovascular catheterization procedures and to reduce ionizing radiation exposure, but a lack of commercially available CMR guidewires limits widespread adoption. Standard metallic guidewires are considered to be unsafe in CMR due to risks of RF-induced heating. Here, we propose the use of RF-efficient gradient echo (GRE) spiral imaging for reduced guidewire heating (low flip angle, long readout), in combination with positive contrast for guidewire visualization. Methods: A GRE spiral sequence with 8 interleaves was used for imaging. Positive contrast was achieved using through-slice dephasing such that the guidewire appeared bright and the background signal suppressed. Positive contrast images were interleaved with anatomical images, and real-time image processing was used to produce a color overlay of the guidewire on the anatomy. Temperature was measured with a fiber-optic probe attached to the guidewire in an acrylic gel phantom and in vivo. Results: Left heart catheterization was performed on swine using the real-time color overlay for procedural guidance with a frame rate of 6.25 frames/second. Using our standard Cartesian real-time imaging (flip angle 60°), temperature increases up to 50 °C (phantom) and 4 °C (in vivo) were observed. In comparison, spiral GRE images (8 interleaves, flip angle 10°) generated negligible heating measuring 0.37 °C (phantom) and 0.06 °C (in vivo). Conclusions: The ability to use commercial metallic guidewires safely during CMR-guided catheterization could potentially expedite clinical translation of these methods. [ABSTRACT FROM AUTHOR]

Background: Conventional guidewires are not suitable for use during cardiovascular magnetic resonance (CMR) catheterization. They employ metallic shafts for mechanical performance, but which are conductors subject to radiofrequency (RF) induced heating. To date, non-metallic CMR guidewire designs have provided inadequate mechanical support, trackability, and torquability. We propose a metallic guidewire for CMR that is by design intrinsically safe and that retains mechanical performance of commercial guidewires. Methods: The NHLBI passive guidewire is a 0.035" CMR-safe, segmented-core nitinol device constructed using short nitinol rod segments. The electrical length of each segment is less than one-quarter wavelength at 1.5 Tesla, which eliminates standing wave formation, and which therefore eliminates RF heating along the shaft. Each of the electrically insulated segments is connected with nitinol tubes for stiffness matching to assure uniform flexion. Iron oxide markers on the distal shaft impart conspicuity. Mechanical integrity was tested according to International Organization for Standardization (ISO) standards. CMR RF heating safety was tested in vitro in a phantom according to American Society for Testing and Materials (ASTM) F-2182 standard, and in vivo in seven swine. Results were compared with a high-performance commercial nitinol guidewire. Results: The NHLBI passive guidewire exhibited similar mechanical behavior to the commercial comparator. RF heating was reduced from 13 °C in the commercial guidewire to 1.2 °C in the NHLBI passive guidewire in vitro, using a flip angle of 75°. The maximum temperature increase was 1.1 ± 0.3 °C in vivo, using a flip angle of 45°. The guidewire was conspicuous during left heart catheterization in swine. Conclusions: We describe a simple and intrinsically safe design of a metallic guidewire for CMR cardiovascular catheterization. The guidewire exhibits negligible heating at high flip angles in conformance with regulatory guidelines, yet mechanically resembles a high-performance commercial guidewire. Iron oxide markers along the length of the guidewire impart passive visibility during real-time CMR. Clinical translation is imminent. [ABSTRACT FROM AUTHOR]

TAV-in-TAV Versus TAV-in-SAV: A Troublesome Analysis and the Wrong Question. [Extracted from the article]

Background: Cardiovascular magnetic resonance (CMR) guided cardiovascular catheterizations can potentially reduce ionizing radiation exposure and enable new interventions. Commercially available paramagnetic X-Ray devices create a small signal void in CMR images, which is ambiguous and insufficient to guide catheterization procedures. This work aims to improve real-time CMR of off-the-shelf X-Ray devices by developing a real-time positive contrast sequence with color overlay of the device onto anatomy. Methods: A dual-echo bSSFP sequence was used to generate both a dephased positive contrast image and bSSFP image simultaneously. A variable flip angle scheme was implemented to reduce the specific absorption rate (SAR) and hence device heating. Image processing was used to isolate the device from background signal, and the device was overlaid in color on the anatomy, mimicking active device visualization. Proof-of-concept experiments were performed using a commercially available nitinol guidewire for left heart catheterization in Yorkshire swine. Results: The dual echo pulse sequence generated a temporal resolution of 175 ms (5.7 frames/second) with GRAPPA acceleration factor 4. Image processing was performed in real-time and color overlay of the device on the anatomy was displayed to the operator with no latency. The color overlay accurately depicted the guidewire location, with minimal background contamination, during left heart catheterization. Conclusions: The ability to effectively visualize commercially available X-Ray devices during CMR-guided cardiovascular catheterizations, combined with safe low-SAR pulse sequences, could potentially expedite the clinical translation of interventional CMR. [ABSTRACT FROM AUTHOR]

An abstract of the article "MRI Catheterization in Cardiopulmonary Disease" by Toby Rogers, Kanishka Ratnayaka, and Robert J. Lederman is presented.

Background: T1 imaging based on pixel-wise quantification of longitudinal relaxation has the potential to differentiate between normal and abnormal myocardium. The accuracy of T1 measurement has not been established nor systematically tested in the presence of health and disease. Methods: Intra-observer, inter-observer and inter-study reproducibility of T1 imaging was assessed in subjects with left ventricular hypertrophy (LVH, n = 25) or dilated cardiomyopathy (DCM, n = 43). Thirty-eight subjects with lowpretest likelihood of cardiomyopathy served as a control group. T1 values were acquired in a single mid-ventricular short axis slice using modified Look-Locker imaging prior and after the application of gadolinium contrast at 1.5 and 3 T. Analysis was performed with regions of interest (ROI) placed conservatively within the septum or to include the whole short axis (SAX) myocardium. Results: Intra-observer, inter-observer and inter-study repeated measurements within the septum showed smaller mean differences and narrower 95% confidence intervals than repeated short axis ROI measurements. Native T1 values were higher in septal ROIs compared with SAX values at both field strengths (1.5 T: 976 ± 37 vs. 952 ± 41, p < 0.01; 3 T: 1108 ± 67 vs. 1087 ± 60, p < 0.01). Native T1 values revealed significant mean differences between controls and patients with LVH for both septal (1.5 T: 26 ± 9, p < 0.01; 3 T: 50 ± 13, p < 0.01) and SAX ROIs (1.5 T: 19 ± 11, p < 0.05; 3 T: 47 ± 19, p < 0.05) with greater differences observed at 3 T versus 1.5 T field strength. Native T1 values revealed significant mean differences between controls and patients with DCM for septal ROI (1.5 T: 29 ± 15, p < 0.05; 3 T: 55 ± 16, p < 0.01) at both 1.5 T and 3 T, but only for SAX ROIs at 3 T (49 ± 17, p < 0.01). There were no significant differences in post-contrast T1 values or partition coefficient (λ) between controls and patients. Conclusion: Conservative septal ROI T1 measurement is a robust technique with excellent intra-observer, interobserver and inter-study reproducibility for native and post-contrast T1 value and partition coefficient measurements. Moreover, native septal T1 values reveal the greatest difference between normal and abnormal myocardium, which is independent of geometrical alterations of cardiac chamber and wall thickness. We propose the use of native T1 measurements using conservative septal technique as the standardized approach to distinguish health from disease assuming diffuse myocardial involvement. [ABSTRACT FROM AUTHOR]

Information about several papers discussed at the 2016 U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel Meeting held on March 16, 2016 is presented. Topics include presentations on AngelMed for Early Recognition and Treatment of STEMI (ALERTS) trial, early trial termination, and Bayesian framework. The meeting featured speakers from the FDA.