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Introduction: Mixed reality (MR) head-mounted displays (HMDs) have been used in a variety of industrial applications. The safety and feasibility of HMDs in cardiac catheterization laboratories (CCLs) for image and procedure guidance have not been studied. Hypothesis: We assessed the hypothesis that MR HMDs are safe and feasible for procedure guidance in CCLs. Methods: 50 patients undergoing diagnostic coronary angiography and right heart catheterization at the University of Minnesota Medical Center were prospectively enrolled in a single-arm trial using an MR HMD for image and procedure guidance including vascular access, fluoroscopy, telemetry, and vital monitoring. Traditional 2D displays were available as back-up. A CCL specific MR HMD (SG Devices LLC, MN) was used. Pearson’s correlation coefficient was used to assess the relationships between procedural outcomes. Results: A total of 62 procedures were performed (47% coronary angiograms, 90% radial). Median age was 64 (58-69) with 66% males (Table 1). Mean procedure time was 22 min (+/- 12) with a mean fluoroscopy time of 3.2 min (+/- 4.1). Contrast volume used was 59 cc (+/-5). Fluoroscopy time was correlated to procedure time (R=0.54, p Conclusion: Dedicated CCL MR HMDs are safe and feasible for invasive diagnostic procedures in the CCL, and may improve procedure time, reduce contrast use, and radiation exposure.

Introduction: Transcatheter aortic valve replacement (TAVR) is currently the mainstay of treatment of severe aortic stenosis (AS). We aim to investigate the evolution of transaortic mean gradients in surgical aortic valve replacement (SAVR) patients before and after the Food and Drug Administration (FDA) approval of TAVR. Hypothesis: We assessed the hypothesis that mean gradients across the aortic valve were higher in 2011-2012 before FDA approval of TAVR. Methods: Patients who underwent SAVR in 2011-2012 (n=138) and 2019-2020 (n=134) at the University of Minnesota Medical Center were included. Those with implanted mechanical valves (n=602) were excluded. Valve size and mean aortic gradients were compared between the 2 study groups. Results: Out of 272 patients included in this study, 65.8% were males. Patients underwent SAVR at an older age in 2011-2012 (median 74, IQR 65-82) compared to 2019-2020 (median 67, IQR 60-73). The mean aortic valve gradient post-SAVR was higher in 2011-2012 (median 12, IQR 8-18 vs. median 10, IQR 7-13 in 2019-2020, p=0.016). The median valve size was smaller in 2011-2012 (21 mm vs. 23 mm, p(table) . Conclusion: Patients who underwent SAVR in 2011-2012 were older, more likely to receive smaller valve sizes, and had higher mean aortic valve gradients after SAVR.

Background There is no effective method to predict paravalvular regurgitation prior to transcatheter aortic valve replacement (TAVR). Methods We retrospectively analyzed pre-TAVR computed tomography (CT) scans of 20 patients who underwent TAVR for severe, calcific aortic stenosis and subsequently printed 3-dimensional (3D) aortic root models of each patient. Models were printed using Ninjaflex thermoplastic polyurethane (TPU) (Ninjatek Manheim, PA) and TPU 95A (Ultimaker, Netherlands) on Ultimaker 3 Extended 3D printer (Ultimaker, Netherlands). The models were implanted at nominal pressure with same sized Sapien balloon-expandable frames (Edwards Lifesciences, CA) as received in-vivo. Ex-vivo implanted TAVR models (eTAVR) were scanned using Siemens SOMATOM flash dual source CT (Siemens, Malvern, PA) and then analyzed with Mimics software (Materialize NV, Leuven, Belgium) to evaluate relative stent appositions. eTAVR were then compared to post-TAVR echocardiograms for each patient to assess for correlations of identified and predicted paravalvular leak (PVL) locations. Results A total of 20 patients (70% male) were included in this study. The median age was 77.5 (74-83.5) years. Ten patients were characterized to elicit mild (9/10) or moderate (1/10) PVL, and 10 patients presented no PVL. In patients with echocardiographic PVL, eTAVR 3D model analyses correctly identified the site of PVL in 8/10 cases. In patients without echocardiographic PVL, eTAVR 3D model analyses correctly predicted the lack of PVL in 9/10 cases. Conclusion 3D printing may help predict the potential locations of associated PVL post-TAVR, which may have implications for optimizing valve selection and sizing.

Bicuspid valves have been excluded from large randomized studies due to known challenge with valve apposition. Paravalvular leak is a known problem, but little is known regarding its durability. 473 patients underwent transcatheter aortic valve replacement (TAVR) between 2012 and 2018 at the

Mitral regurgitation (MR) grade is a poor predictor of functional outcomes after a MitraClip. There is a paucity of data on invasive hemodynamics as a predictor of outcomes. 78 patients underwent MC for symptomatic mitral regurgitation (MR) between 2014 and 2018 at the University of Minnesota

The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) transcatheter valve therapy (TVT) transcatheter aortic valve replacement (TAVR) score was developed to predict in-hospital mortality in patients undergoing commercial TAVR in the United States. Veterans Affairs (VA) hospitals are not included in the TVT registry.The STS/ACC TVT-TAVR score was estimated in 195 veterans undergoing TAVR from 2015-2017. Discrimination was estimated by calculating the area under the receiver operating characteristics curve (AUC) for two outcomes of interest: in-hospital and 30-day mortality. The cohort was then divided into quartiles of TAVR and STS predicted risk of mortality (PROM) scores and long-term mortality was assessed with Kaplan-Meier curves.The mean age of the cohort was 77 ± 8 years and the population was 99% males. The median TAVR and STS-PROM risk scores were 3.1 (interquartile range [IQR], 2.1-5.1) and 4.5 (IQR, 2.6-7.4), respectively. Observed in-hospital and 30-day mortality rates were 2.6% and 4.6%, respectively. The AUCs for the TAVR risk score were 0.68 and 0.64 for in-hospital and 30-day mortality, respectively. During a mean follow-up period of 1.9 years, a total of 37 patients (20%) died. Long-term survival was similar in different quartiles of STS-PROM scores (P=.52). In contrast, patients in the highest quartile of TAVR risk score (8.4; IQR, 5.8-9.9) had significantly worse survival (P.01). This group included 20 out of the 37 deaths (50%).Developed and validated in commercial United States cases, the TAVR risk score has a similar performance in the veteran population for predicting short-term outcomes. In addition, the TAVR score predicts long-term mortality. Our results have implications for optimal patient selection.

United States veterans have substantially worse baseline health status than the general population, which may limit the health benefits of transcatheter aortic valve replacement (TAVR). The aim of this study is to quantify the health benefits of TAVR in veterans undergoing the procedure within the United States Department of Veterans Affairs (VA) health-care system.We prospectively evaluated heath status in 131 elderly veterans undergoing TAVR in the VA healthcare system between 2015 and 2017. Health status was assessed at baseline and 30 days post procedure using the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12). Totals and domain-specific (physical limitation, symptoms, quality of life, and social limitation) health statuses were measured and analyzed with a paired t-test. We also conducted stratified analysis by baseline New York Heart Association functional class and N-terminal pro-b type natriuretic peptide levels.Mean patient age was 77 ± 8 years and average Society of Thoracic Surgeons (STS) score was 4.4 (interquartile range, 3-7). Transfemoral access and balloon-expandable valves were used in 118 cases (92%) and 108 cases (83%), respectively. At baseline, overall health status was poor (overall score, 43 ± 19). After TAVR, significant improvements in overall health status (30 ± 18) and domain-specific health status were seen (improvements in physical limitation, 12 ± 20; symptoms, 23 ± 23; quality of life, 20 ± 17; social limitation, 22 ± 21; all P.001). The majority of patients (88%) had moderate to large improvements in health status. A favorable outcome (alive with KCCQ-12 overall score60 at 30 days) was seen in 78% of patients.Among elderly veterans with severe aortic stenosis, TAVR is associated with significant improvements in short-term health status.

Background Transfemoral transcatheter aortic valve replacement (TAVR) was superior to surgical aortic valve replacement (SAVR) in the placement of aortic transcatheter valves (PARTNER) 2A trial (P2). The generalizability of the trial results to the broader population of patients with intermediate surgical risk remains unknown. Objective To compare the outcomes of SAVR and TAVR among patients with intermediate surgical risk treated in the VA Healthcare System. Methods We retrospectively analyzed the clinical characteristics and outcomes on all SAVR (1987-2014) and TAVR procedures (2015-2017) performed at the Minneapolis VA Healthcare System. Patients were divided into three groups based on their estimated 30-day mortality risk. The primary outcome was a composite of death or stroke at 30-days. Results A total of 1,049 patients underwent SAVR with (n = 468, 45%) or without CABG (n = 581, 55%) and 110 underwent TAVR during the study period. Intermediate-risk patients represented 29.4% and 40% of patients undergoing SAVR and TAVR, respectively. The predicted 30-day mortality risk of intermediate-risk patients was 5.5% for the SAVR group and 5.2% for the TAVR group (P = 0.54). The observed combined rate of stroke or death at 30-days for intermediate-risk patients treated with SAVR and TAVR was 11% and 2.2%, respectively (P = 0.05). The results for SAVR and TAVR at the VA were comparable to the P2 trial and STS database (all P = NS). The results did not change when the analysis was restricted to a more contemporary (2005-2014) surgical cohort or isolated SAVR. The number needed to treat to prevent one death/stroke with TAVR was 10. Conclusions Adoption of TAVR as the preferred treatment modality in intermediate-risk patients may result in significant improvements in morbidity and mortality.

Paravalvular leak (PVL) carries a high morbidity and mortality after transcatheter aortic valve replacement (TAVR), but there is no effective method to predict PVL prior to valve implantation. Using pre-TAVR computed tomography (CT) scans, 3-dimensional (3D) aortic root models were printed for 16

Background Subclinical leaflet thrombosis (SCLT) can be seen in up to 12% of patients after transcatheter aortic valve replacement (TAVR). Anticoagulation appears to prevent and reverse SCLT but concerns exist about bleeding risk. Methods Our program adopted a strategy of routine anticoagulation after TAVR, starting warfarin on post-procedure day 0 and continuing for 3 months in 10/2015. We report the initial safety and efficacy outcomes of this approach. Bleeding events were assessed using Valve Academic Research Consortium (VARC) and Bleeding Academic Research Consortium (BARC) definitions. Results The median (IQR) age of the population (n = 191) was 82 years (72–87) and the median (IQR) STS score was 5.6% (3–8). A total of 101 (53%) patients were discharged on anticoagulation (warfarin 97%) while 90 (47%) received antiplatelet therapy alone. The mean duration of anticoagulation therapy was 81 ± 17 days. During follow-up 7 patients (4%) had a stroke or TIA , 3 (3%) in the anticoagulation group and 4 (4%) in the antiplatelet group ( p = 0.71). A total of 8 patients (4.2%) had BARC bleeding events during follow-up, 3 patients in the anticoagulation group (2.9%) and 5 in the antiplatelet group (5.5%, p = 0.48). All bleeding events (VARC and BARC) were numerically lower in the anticoagulation group (8% versus 13%, p = 0.20). Conclusions A strategy of routine anticoagulation for 3-months after TAVR is well tolerated and associated with similar or lower bleeding risk compared to antiplatelet therapy.

Objectives. To evaluate whether collaboration between existing and new transcatheter aortic valve replacement (TAVR) programs could help reduce the number of cases needed to achieve optimal efficiency. Background. There is a well-documented learning curve for achieving procedural efficiency and safety in TAVR procedures. Methods. A multidisciplinary collaboration was established between the Minneapolis VA Medical Center (new program) and the University of Minnesota (established program since 2012, n=219) 1 year prior to launching the new program. Results. 269 patients treated with TAVR (50 treated in the first year at the new program). Mean age was 76 (±18) years and STS score was 6.8 (±6). Access included transfemoral (n=35, 70%), transapical (n=8, 16%), transaortic (n=2, 4%), and subclavian (n=5, 10%) types. Procedural efficiency (procedural time 158±59 versus 148±62, p=0.27), device success (96% versus 87%, p=0.08), length of stay (5±3 versus 6±7 days, p=0.10), and safety (in hospital mortality 4% versus 6%, p=0.75) were similar between programs. We found no difference in outcome measures between the first and last 25 patients treated during the first year of the new program. Conclusions. Establishing a partnership with an established program can help mitigate the learning curve associated with these complex procedures.

ObjectiveIschemic mitral regurgitation (MR) is common, but its response to percutaneous coronary intervention (PCI) is poorly understood. This study tested the utility of myocardial perfusion imaging (MPI) for the stratification of MR response to PCI.MethodsMPI and transthoracic echocardiography (echo) were performed among patients undergoing PCI. MPI was used to assess stress/rest myocardial perfusion. MR was assessed via echo (performed before and after PCI).ResultsA total of 317 patients with abnormal myocardial perfusion on MPI underwent echo 25±39 days before PCI. MR was present in 52%, among whom 24% had advanced (≥moderate) MR. MR was found to be associated with left ventricular (LV) chamber dilation on MPI and echo (both P

There is a well-documented learning curve for achieving procedural efficiency and safety in transcatheter aortic valve replacement (TAVR) procedures. Collaboration between existing and new TAVR programs could help reduce the number of cases needed to achieve optimal efficiency. A multidisciplinary

Paravalvular regurgitation (PVL) is common after transcatheter aortic valve replacement (TAVR) and associated with worse long-term outcomes when moderate or severe. Three patients undergoing TAVR for severe, calcific aortic stenosis and at risk for PVL had Pre-TAVR CT images analyzed and segmented

Background: The lower end of the membranous septum (MS) represents an anatomic landmark for the emergence of the His Bundle into the left ventricle. Computed tomography (CT) assessment of the membranous septal anatomy prior to transcatheter aortic valve replacement (TAVR) may provide information

Recent clinical trial data suggest that Transcatheter Aortic Valve Replacement (TAVR) may be superior to surgical aortic valve replacement (SAVR) in intermediate risk patients. The Objective of this investigation was to assess the implications of expanding TAVR to intermediate risk patients using a

Left ventricular (LV) remodeling and myocardial fibrosis have been linked to adverse heart failure outcomes. Mid wall late gadolinium enhancement (MW-LGE) on cardiac magnetic resonance (CMR) imaging is well-associated with non-ischemic cardiomyopathy (NICM), but prevalence in ischemic cardiomyopathy (ICM) and association with remodeling are unknown. The population comprised patients with systolic dysfunction [LV ejection fraction (LVEF ≤ 40 %)]. CMR was used to identify MW-LGE, conventionally defined as fibrosis of the mid-myocardial or epicardial aspect of the LV septum. 285 patients were studied. MW-LGE was present in 12 %, and was tenfold more common with NICM (32 %) versus ICM (3 %, p < 0.001). However, owing to higher prevalence of ICM, 15 % of patients with MW-LGE had ICM. LV wall stress was higher (p = 0.02) among patients with, versus those without, MW-LGE despite similar systolic blood pressure (p = 0.24). In multivariate analysis, MW-LGE was associated with CMR-quantified LV end-diastolic volume (p = 0.03) independent of LVEF and mass. Incorporation of clinical and imaging variables demonstrated MW-LGE to be associated with higher LV end-diastolic volume (OR 1.13, CI 1.004–1.27 per 10 ml/m2, p = 0.04) after controlling for presence of NICM (OR 16.0, CI 5.8–44.1, p < 0.001). While more common in NICM, MW-LGE can occur in ICM and is a marker of LV chamber dilation irrespective of cardiomyopathic etiology.

Mitral regurgitation (MR) is common with coronary artery disease as altered myocardial substrate can affect valve performance. Single-photon emission computed tomography myocardial perfusion imaging (MPI) enables assessment of myocardial perfusion alterations. This study examined perfusion pattern in relation to MR. A total of 2,377 consecutive patients with known or suspected coronary artery disease underwent stress MPI and echocardiography within 1.6 ± 2.3 days. MR was present on echocardiography in 34% of patients, among whom 13% had advanced (moderate or more) MR. MR prevalence was higher in patients with abnormal MPI (44% vs 29%, p

Background Left atrial (LA) dilation provides a substrate for mitral regurgitation (MR) and atrial arrhythmias. ECG can screen for LA dilation but standard approaches do not assess LA geometry as a continuum, as does non-invasive imaging. This study tested ECG-quantified P wave area as an index of LA geometry. Methods and Results 342 patients with CAD underwent ECG and CMR within 7 (0.1±1.4) days. LA area on CMR correlated best with P wave area in ECG lead V1 (r = 0.42, p

Methods The study comprised patients with coronary artery disease (CAD) included in a multimodality registry. CineCMR (1.5T) was performed using a standard 2-dimensional steady state free precession (SSFP) pulse sequence (typical TR 3.5 msec, TE 1.6 msec, flip angle 60°, temporal resolution 30-50 msec). Cine-CMR evidenced mitral regurgitation (MR) severity was graded in accordance with established conventions based on size of MR associated inter-voxel dephasing of the regurgitant jet. LA size was measured on cine-CMR at atrial end-diastole using two established methods: [1] linear diameter (measured in 3-chamber long axis orientation), [2] area (planimetered in 4-chamber long axis orientation), with both indices indexed to body surface area. Clinical follow-up was performed via medical record review, with atrial fibrillation (AF) or flutter (AFl) verified based on physician documentation. Results 336 patients with CAD were studied (60 ± 12 yo, 79% M, 34% DM, 58% HTN); LA diameter (mean 2 ± 0.4 cm/m2) and area (12 ± 3 cm2/m2) yielded similar prevalence of chamber dilation (20% vs. 21%, p = 0.76) assigned using established cine-CMR population-based cutoffs. LA indices correlated highly (r = 0.74, p < 0.001; Figure 1), with similar magnitude of correlation among subgroups at risk for LA remodeling, such as patients

Background Mid-wall fibrosis (MWF) is a hallmark of non-ischemic cardiomyopathy (NICM) that confers increased risk for sudden cardiac death and mortality. The relationship between MWF and left ventricular (LV) remodeling is unknown. Methods The population comprised patients with advanced systolic dysfunction (LVEF ≤ 40%) undergoing CMR (1.5T, General Electric Signa). Ischemic vs. NICM etiology was classified in accordance with established convention based on obstructive CAD on invasive angiography. Delayed enhancement CMR (IR-GRE acquired 10-30 minutes post gadolinium [0.2 mmol/kg]) was used to identify MWF, defined as hyperenhancement confined to the mid-myocardial or epicardial aspect of the interventricular septum. LV mass and chamber volume were quantified by planimetry of contiguous SSFP cine-CMR short axis slices, with ejection fraction (EF) calculated as the proportional difference between end-diastolic (EDV) and end-systolic (ESV) volumes. Results 523 patients (61 ± 14 yo, 72% M, 66% ischemic CM) were studied: MWF was present in 16%, and was 6-fold more common in patients with angiographically classified NICM (37% vs. 6%; p < 0.001). Regarding LV remodeling, MWF was associated with higher EDV (134 ± 39 ml vs. 114 ± 34 ml; p < 0.001) and LV mass (102 ± 24 vs. 96 ± 28 gm; p < 0.001) and lower LVEF (26 ± 8% vs. 30 ± 8%; p ≤ 0.05). MWF was nearly 3-fold more common among patients in the highest tertile of EDV vs. the remainder of the population (29% vs. 10%; p < 0.001). Multivariate regression analysis was performed to further assess markers for MWF: Restricted to imaging indices, results (Table 1A) demonstrated EF and EDV to be independently associated with MWF (OR = 1.46, CI 1.03-2.10; p < 0.05, OR = 1.13, CI 1.04-1.20; p < 0.05, respectively) after controlling for mass (OR = 0.95, CI 0.85-1.00; p = 0.29). Regarding clinical variables, results (Table 1B) confirmed a strong association with NICM (OR = 8.4, CI 4.78-14.72; p < 0.001), independent of other clinical indices. A combined model incorporating both clinical and imaging variables demonstrated both NICM and LV volume to be independently associated with MWF even after controlling for EF (Table 1C). Overall strength of the combined clinical/imaging (c 2 = 91.2; p < 0.001) model for MWF was higher than that of isolated clinical (c 2 = 76.7; p < 0.001) and imaging (c 2 = 26.0; p < 0.001) models.