Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients.

BACKGROUND: Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. METHODS: We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. RESULTS: A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group. CONCLUSIONS: TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .).

Open Surgical Access for Transfemoral TAVR Should Not Be a Contraindication for Conscious Sedation.

OBJECTIVES: The use of monitored anesthesia care (MAC) for transcatheter aortic valve replacement (TAVR) is gaining favor in the United States, although general anesthesia (GA) continues to be common for these procedures. Open surgical cutdown for transfemoral TAVR has been a relative contraindication for TAVR with MAC at most centers. The objective of this study was to review the authors' results of transfemoral TAVR performed in patients with open surgical cutdown with the use of MAC. DESIGN: Retrospective study design from a prospectively recorded database. SETTING: Tertiary academic (teaching) hospital. PARTICIPANTS: Two hundred eighty-two patients undergoing transfemoral TAVR with open surgical cutdown under MAC from 2015 to 2017. INTERVENTIONS: Transfemoral TAVR under MAC with surgical cutdown for femoral vascular access. MEASUREMENTS AND MAIN RESULTS: The study cohort consisted of 282 patients with severe aortic stenosis (mean area 0.65 [± 0.16] cm2, mean gradient of 48.9 [±13.3] mmHg, and mean age of 82.7 [± 7.31] years). Eleven (3.9%) patients required conversion to GA. First postoperative pain score (0-10) was 2.9 and highest postoperative pain score was 4.6. Major and minor vascular complications occurred in 2 (0.7%) and 6 (2.1%) patients, respectively. Twenty-nine (10.3%) patients were readmitted within 30 days, and 6 (2.1%) patients had in-hospital mortality. CONCLUSIONS: Open surgical cutdown for transfemoral TAVR can be performed safely using MAC and ilioinguinal block with low rates of conversion to general anesthesia and acceptable postoperative outcomes and pain scores.

Cardiac amyloidosis is prevalent in older patients with aortic stenosis and carries worse prognosis.

BACKGROUND: Non-invasive cardiac imaging allows detection of cardiac amyloidosis (CA) in patients with aortic stenosis (AS). Our objective was to estimate the prevalence of clinically suspected CA in patients with moderate and severe AS referred for cardiovascular magnetic resonance (CMR) in age and gender categories, and assess associations between AS-CA and all-cause mortality. METHODS: We retrospectively identified consecutive AS patients defined by echocardiography referred for further CMR assessment of valvular, myocardial, and aortic disease. CMR identified CA based on typical late-gadolinium enhancement (LGE) patterns, and ancillary clinical evaluation identified suspected CA. Survival analysis with the Log rank test and Cox regression compared associations between CA and mortality. RESULTS: There were 113 patients (median age 74 years, Q1-Q3: 62-82 years), 96 (85%) with severe AS. Suspected CA was present in 9 patients (8%) all > 80 years. Among those over the median age of 74 years, the prevalence of CA was 9/57 (16%), and excluding women, the prevalence was 8/25 (32%). Low-flow, low-gradient physiology was very common in CA (7/9 patients or 78%). Over a median follow-up of 18 months, 40 deaths (35%) occurred. Mortality in AS + CA patients was higher than AS alone (56% vs. 20% at 1-year, log rank 15.0, P < 0.0001). Adjusting for aortic valve replacement modeled as a time-dependent covariate, Society of Thoracic Surgery predicted risk of mortality, left ventricular ejection fraction, CA remained associated with all-cause mortality (HR = 2.92, 95% CI = 1.09-7.86, P = 0.03). CONCLUSIONS: Suspected CA appears prevalent among older male patients with AS, especially with low flow, low gradient AS, and associates with all-cause mortality. The importance of screening for CA in older AS patients and optimal treatment strategies in those with CA warrant further investigation, especially in the era of transcatheter aortic valve implantation.

Revascularization heart team recommendations as an adjunct to appropriate use criteria for coronary revascularization in patients with complex coronary artery disease.

OBJECTIVES: To evaluate how a comprehensive evidence-based clinical review by a multidisciplinary revascularization heart team on treatment decisions for revascularization in patients with complex coronary artery disease using SYNTAX scores combined with Society of Thoracic Surgeons-derived clinical variables can be additive to the utilization of Appropriate Use Criteria for coronary revascularization. BACKGROUND: Decision-making regarding the use of revascularization for coronary artery disease has come under major scrutiny due to inappropriate overuse of revascularization. There is little data in routine clinical practice evaluating how a structured, multidisciplinary heart team approach may be used in combination with the Appropriate Use Criteria for revascularization. METHODS: From May 1, 2012 to January 1, 2015, multidisciplinary revascularization heart team meetings were convened to discuss evidence-based management of 301 patients with complex coronary artery disease. Heart team recommendations were adjudicated with the Appropriate Use Criteria for coronary revascularization for each clinical scenario using the Society for Cardiovascular Angiography and Interventions' Quality Improvement Toolkit (SCAI-QIT) Appropriate Use Criteria App. RESULTS: Concordance of the Heart Team to Appropriate Use Criteria had a 99.3% appropriate primary indication for coronary revascularization. Among patients who underwent percutaneous revascularization, 34.9% had an inappropriate or uncertain indication as recommended by the Heart Team. Patients with uncertain or inappropriate percutaneous coronary interventions had significantly higher SYNTAX score (27.3 ± 6.6; 28.5 ± 5.5; 19.2 ± 6; P < 0.0001) and Society of Thoracic Surgeons-Predicted Risk of Mortality (6.1% ± 4.7%; 8.1% ± 6.3%; 3.7% ± 4.1%; P < 0.0081) compared to appropriate indications, frequently had concomitant forms of advanced comorbidities and frailty in the setting of symptomatic coronary artery disease. CONCLUSIONS: A formal, multidisciplinary revascularization heart team can provide proper validation for clinical decisions and should be considered in combination with the Appropriate Use Criteria for coronary revascularization to formulate revascularization strategies for individuals in a patient-centered fashion. © 2015 Wiley Periodicals, Inc.

Wetting and evaporative aggregation of nanofluid droplets on CVD-synthesized hydrophobic graphene surfaces.

The wetting and evaporative aggregation of alumina nanofluids (Al2O3) are examined for CVD-synthesized graphene-coated (GC) surfaces that are known as strongly hydrophobic (θcontact ≈ 90°). Our findings are compared to those associated with a hydrophilic cover glass (CG) substrate (θcontact ≈ 45°). The nanofluidic self-assemblies on the GC substrate are elaborately characterized in terms of the droplet wetting/crack formation, the particle migration time over the evaporative time (CR), the Derjaguin-Landau-Verwey-Overbeek forces (FDLVO), and the relative thermal conductivity (KR). The GC substrate forms relatively thicker and larger cracks and requires a longer evaporation time. Both the GC and CG substrates share approximately the same time constant CR, which suggests the formation of coffee-ring patterns for both substrates. The GC shows negative FDLVO, which implies a repulsive force between the nanoparticles and the substrate, and the CG shows a positive FDLVO of attraction. Furthermore, a more than 3 order of magnitude larger thermal conductivity of GC compared to that of CG drives significantly different particle/fluid motions near the drop edge areas between the two substrates.

Pbx1 inactivation disrupts pancreas development and in Ipf1-deficient mice promotes diabetes mellitus.

Pbx1 is a member of the TALE (three-amino acid loop extension) class of homeodomain transcription factors, which are components of hetero-oligomeric protein complexes thought to regulate developmental gene expression and to maintain differentiated cell states. In vitro studies have shown that Pbx1 regulates the activity of Ipf1 (also known as Pdx1), a ParaHox homeodomain transcription factor required for the development and function of the pancreas in mice and humans. To investigate in vivo roles of Pbx1 in pancreatic development and function, we examined pancreatic Pbx1 expression, and morphogenesis, cell differentiation and function in mice deficient for Pbx1. Pbx1-/- embryos had pancreatic hypoplasia and marked defects in exocrine and endocrine cell differentiation prior to death at embryonic day (E) 15 or E16. In these embryos, expression of Isl1 and Atoh5, essential regulators of pancreatic morphogenesis and differentiation, was severely reduced. Pbx1+/- adults had pancreatic islet malformations, impaired glucose tolerance and hypoinsulinemia. Thus, Pbx1 is essential for normal pancreatic development and function. Analysis of trans-heterozygous Pbx1+/- Ipf1+/- mice revealed in vivo genetic interactions between Pbx1 and Ipf1 that are essential for postnatal pancreatic function; these mice developed age-dependent overt diabetes mellitus, unlike Pbx1+/- or Ipf1+/- mice. Mutations affecting the Ipf1 protein may promote diabetes mellitus in mice and humans. This study suggests that perturbation of Pbx1 activity may also promote susceptibility to diabetes mellitus.

Outcomes in Multivessel Coronary Disease Stratified by The Society of Thoracic Surgeons Risk.

BACKGROUND: Surgical risk stratified outcomes after contemporary revascularization strategies have not been well described. We report these outcomes in patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for multivessel coronary disease. METHODS: A total of 5836 patients with multivessel disease who underwent CABG (n = 4420) or PCI (n = 1416) were included in this retrospective observational analysis. Data were stratified based on The Society of Thoracic Surgeons risk score. A score less than 4% was considered low risk and a score greater than or equal to 4% was considered intermediate-high risk. Outcomes included mortality, inpatient readmissions, and repeat revascularizations. RESULTS: In the CABG population, 3863 (87.3%) were low risk and 557 (12.6%) were intermediate-high risk. The 5-year mortality for the low-risk cohort was 10.9% (95% confidence interval [CI], 9.83%-12.05%), and for the intermediate-high-risk cohort it was 40.1% (95% CI, 35.76%-44.54%). Among those undergoing PCI, 1163 (82.1%) were low risk, while 249 (17.6%) were intermediate-high risk. The 5-year mortality for the low-risk cohort was 21.6% (95% CI, 19.10%-24.26%), and for the intermediate-high-risk cohort it was 61.8% (95% CI, 54.72%-68.70%). CONCLUSIONS: This study reports outcomes stratified by surgical risk after PCI or CABG in patients with multivessel coronary disease. These data can help guide the revascularization strategy choice for individual patients.

A comparison of bare-metal and drug-eluting stents for off-label indications.

BACKGROUND: Recent reports suggest that off-label use of drug-eluting stents is associated with an increased incidence of adverse events. Whether the use of bare-metal stents would yield different results is unknown. METHODS: We analyzed data from 6551 patients in the National Heart, Lung, and Blood Institute Dynamic Registry according to whether they were treated with drug-eluting stents or bare-metal stents and whether use was standard or off-label. Patients were followed for 1 year for the occurrence of cardiovascular events and death. Off-label use was defined as use in restenotic lesions, lesions in a bypass graft, left main coronary artery disease, or ostial, bifurcated, or totally occluded lesions, as well as use in patients with a reference-vessel diameter of less than 2.5 mm or greater than 3.75 mm or a lesion length of more than 30 mm. RESULTS: Off-label use occurred in 54.7% of all patients with bare-metal stents and 48.7% of patients with drug-eluting stents. As compared with patients with bare-metal stents, patients with drug-eluting stents had a higher prevalence of diabetes, hypertension, renal disease, previous percutaneous coronary intervention and coronary-artery bypass grafting, and multivessel coronary artery disease. One year after intervention, however, there were no significant differences in the adjusted risk of death or myocardial infarction in patients with drug-eluting stents as compared with those with bare-metal stents, whereas the risk of repeat revascularization was significantly lower among patients with drug-eluting stents. CONCLUSIONS: Among patients with off-label indications, the use of drug-eluting stents was not associated with an increased risk of death or myocardial infarction but was associated with a lower rate of repeat revascularization at 1 year, as compared with bare-metal stents. These findings support the use of drug-eluting stents for off-label indications.

Cardiovascular Disease Risk-Based Statin Utilization and Associated Outcomes in a Primary Prevention Cohort: Insights From a Large Health Care Network.

BACKGROUND: Current American College of Cardiology/American Heart Association guidelines recommend using the 10-year atherosclerotic cardiovascular disease (ASCVD) risk to guide statin therapy for primary prevention. Real-world data on adherence and consequences of nonadherence to the guidelines in primary are limited. We investigated the guideline-directed statin intensity (GDSI) and associated outcomes in a large health care system, stratified by ASCVD risk. METHODS: Statin prescription in patients without coronary artery disease, peripheral vascular disease, or ischemic stroke were evaluated within a large health care network (2013-2017) using electronic medical health records. Patient categories constructed by the 10-year ASCVD risk were borderline (5%-7.4%), intermediate (7.5%-19.9%), or high (≥20%). The GDSI (before time of first event) was defined as none or any intensity for borderline, and at least moderate for intermediate and high-risk groups. Mean (±SD) time to start/change to GDSI from first interaction in health care and incident rates (per 1000 person-years) for each outcome were calculated. Cox regression models were used to calculate hazard ratios for incident ASCVD and mortality across risk categories stratified by statin utilization. RESULTS: Among 282 298 patients (mean age ≈50 years), 29 134 (10.3%), 63 299 (22.4%), and 26 687 (9.5%) were categorized as borderline, intermediate, and high risk, respectively. Among intermediate and high-risk categories, 27 358 (43%) and 8300 (31%) patients did not receive any statin, respectively. Only 17 519 (65.6%) high-risk patients who were prescribed a statin received GDSI. The mean time to GDSI was ≈2 years among the intermediate and high-risk groups. At a median follow-up of 6 years, there was a graded increase in risk of ASCVD events in intermediate risk (hazard ratio=1.15 [1.07-1.24]) and high risk (hazard ratio=1.27 [1.17-1.37]) when comparing no statin use with GDSI therapy. Similarly, mortality risk among intermediate and high-risk groups was higher in no statin use versus GDSI. CONCLUSIONS: In a real-world primary prevention cohort, over one-third of statin-eligible patients were not prescribed statin therapy. Among those receiving a statin, mean time to GDSI was ≈2 years. The consequences of nonadherence to guidelines are illustrated by greater incident ASCVD and mortality events. Further research can develop and optimize health care system strategies for primary prevention.

Long term mortality and readmissions after transcatheter aortic valve replacement.

BACKGROUND: Readmissions following transcatheter aortic valve replacement (TAVR) are common but detailed analysis of cardiac and non-cardiac inpatient readmissions beyond thirty days to different levels of care are limited. METHODS: Our study population was 1,037 consecutive patients who underwent TAVR between 2011-2017 within a multi-hospital quaternary health system. A retrospective chart review was performed and readmissions were adjudicated and classified based on primary readmission diagnosis (cardiac versus noncardiac) and level of care [intensive care unit (ICU) admission vs. non-ICU admission]. Incidence, causes, and outcomes of readmissions to up to three years post procedure were evaluated. RESULTS: Of the 1,017 patients who survived their index hospitalization, there were readmissions due to noncardiac causes in 350 (34.4%) and cardiac causes in 208 (20.5%) during a mean 1.96 years of follow-up. The most common non-cardiac causes of readmission were sepsis/infection (14.3%), gastrointestinal (8.3%), and respiratory (4.8%), whereas heart failure (14.0%) and arrhythmias (4.6%) were the most common cardiac causes of readmission. A total of 191 (18.8%) patients were readmitted to the ICU and 372 patients (36.6%) were non-ICU readmissions. The risk of a noncardiac readmission was highest in the period immediately following TAVR (~4.5% per month) with an early high hazard phase that gradually declined over months. However, the risk of cardiac readmission remained stable at ~1% per month throughout. TAVR patients that were readmitted for any cause had markedly increased mortality; this was especially true for patients readmitted to an ICU. CONCLUSIONS: In TAVR patients who survived their index hospitalization, non-cardiac readmissions were more prevalent than cardiac. The risk of readmission and subsequent mortality was highest immediately post-procedure and declined thereafter. Readmission to ICU portends the highest risk of subsequent death in this cohort. Patient baseline co-morbidities are an important consideration for TAVR patients and play a significant role in readmissions and outcomes.

Baseline global longitudinal strain by computed tomography is associated with post transcatheter aortic valve replacement outcomes.

BACKGROUNDS: Subclinical myocardial dysfunction detected by global longitudinal strain (GLS) using echocardiography is associated with poor outcomes in patients with severe aortic stenosis (AS) despite normal left ventricular ejection fraction (LVEF). Computed tomography angiography derived GLS (CTA-GLS) has recently shown to be feasible, however the prognostic value remains unclear in severe AS patients treated with transcatheter aortic valve replacement (TAVR). METHODS: We analyzed consecutive patients who underwent TAVR with pre-TAVR retrospective gated acquisition CTA study with adequate image quality covering the entire left ventricle. CTA-GLS analysis was performed using 2D CT-Cardiac Performance Analysis prototype software (TomTec GmbH). Kaplan-Meier and Cox regression analyses were performed to evaluate the association of baseline CTA-GLS with all-cause mortality and a composite outcome of all-cause death and hospitalization for heart failure after TAVR. RESULTS: A total of 223 patients were included (mean age 83.5 ± 6.8 years, 45.7% female, mean CTA-LVEF 50.7 ± 14.5%). During a median follow-up of 32 months, 81 all-cause deaths and 134 composite outcomes occurred. When compared to patients with normal LVEF (≥50%) and preserved CTA-GLS (≤-20.5%), patients with normal LVEF but reduced CTA-GLS (>-20.5%) had higher all-cause mortality (Chi-square 6.89, p = 0.032) and the risk of composite outcome (Chi-square 7.80, p = 0.020) which was no different than those with impaired LVEF. Reduced CTA-GLS was independently associated with all-cause mortality (HR 1.71, 95% CI 1.01-2.90, p = 0.049) and the risk of composite outcome (HR 1.51, 95% CI 1.01-2.25, p = 0.044) on multivariable Cox regression analysis. CONCLUSIONS: Reduced CTA-GLS provides independent prognostic value above multiple clinical and echocardiographic characteristics.

Impact of Combined Pre and Postcapillary Pulmonary Hypertension on Survival after Transcatheter Aortic Valve Implantation.

We aimed to evaluate the association between pulmonary hypertension (PH) hemodynamic classification and all-cause mortality in patients with symptomatic severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). PH is common and associated with post-TAVI outcomes in patients with severe AS. Although PH in these patients is primarily driven by elevated left-sided pressures (postcapillary PH), some patients develop increased pulmonary vascular resistance (PVR) configuring the combined pre- and postcapillary PH (CpcPH). We analyzed severe AS patients with mean pulmonary artery pressure (mPAP) measured by right heart catheterization (RHC) before TAVI between 2011 and 2017. PH hemodynamic classification was defined as: No PH (mPAP < 25 mm Hg); precapillary PH (mPAP ≥ 25 mm Hg, pulmonary capillary wedge pressure (PCWP) ≤15 mm Hg); isolated postcapillary PH (IpcPH; mPAP ≥ 25 mm Hg, PCWP > 15 mm Hg, PVR ≤ 3 Wood units (WU); CpcPH (mPAP ≥ 25 mm Hg, PCWP > 15 mm Hg, PVR > 3 WU). Kaplan-Meier and Cox regression analyses were used to test the association of PH hemodynamic classification with post-TAVI all-cause mortality. We examined 561 patients (mean age 82 ± 8 years, 51% men, mean LVEF 54 ± 14%). The prevalence of no PH was 201 (36%); precapillary PH, 59 (10%); IpcPH, 189 (34%); and CpcPH, 112 (20%). During a median follow-up of 30 months, 240 all-cause deaths occurred. Patients with CpcPH had higher mortality than those with no-PH even after adjustment for baseline characteristics (Hazard ratio 1.56, 95% confidence interval 1.06 to 2.29, p = 0.025). There was no survival difference among patients with non-PH, precapillary PH and IpcPH. In conclusion, for patients with symptomatic severe AS treated with TAVI, CcpPH is independently associated with long-term all-cause mortality despite successful TAVI.

Surgical versus percutaneous multivessel coronary revascularization in patients with chronic kidney disease.

OBJECTIVES: This study compared contemporary outcomes following surgical versus percutaneous coronary revascularization for multivessel coronary artery disease (MVCAD) in patients with chronic kidney disease. METHODS: Patients with MVCAD and a reduced glomerular filtration rate (<60 ml/min) undergoing coronary bypass surgery (CABG) or percutaneous coronary intervention (PCI) at a single institution between 2010 and 2017 were included. The primary outcome was major adverse cardiac and cerebrovascular events (MACCE) defined as a composite outcome of death, stroke, myocardial infarction or repeat revascularization. Multivariable Cox regression models were used for risk-adjustment and propensity matching was also performed. RESULTS: A total of 1853 patients were included in the study (1269 CABG, 584 PCI). CABG was associated with greater 5-year freedom from MACCE (70.1% vs 47.3%, P < 0.0001), a finding that persisted after risk-adjustment. The rates of early and late mortality and readmission were also lower with CABG as were individual rates of myocardial infarction and repeat revascularization. A propensity-matched analysis generated 704 well-matched patients (352 in each arm) with similar results, including greater 5-year freedom from MACCE (72.8% vs 45.8%, P < 0.0001), improved 5-year survival (73.9% vs 52.3%, P < 0.0001), lower readmission (cause-specific hazard ratio 0.68, 95% confidence interval 0.58-0.80; P < 0.0001), lower individual rates of myocardial infarction (2.6% vs 9.7%, P < 0.0001) and repeat revascularization (1.1% vs 7.4%, P < 0.0001). CONCLUSIONS: CABG is associated with a lower MACCE rate than that of PCI in patients with MVCAD and chronic kidney disease. Multidisciplinary discussions regarding the optimal revascularization strategy are important in MVCAD, particularly in more complex scenarios such as chronic kidney disease.

Safety and Efficacy of Direct Oral Anticoagulants Versus Warfarin in Patients With Chronic Kidney Disease and Atrial Fibrillation.

Patients with atrial fibrillation (AF) commonly have impaired renal function. The safety and efficacy of direct oral anticoagulants (DOACs) in patients with chronic kidney disease (CKD) and end-stage renal disease has not been fully elucidated. This study evaluated and compared the safety outcomes of DOACs versus warfarin in patients with nonvalvular AF and concomitant CKD. Patients in our health system with AF prescribed oral anticoagulants during 2010 to 2017 were identified. All-cause mortality, bleeding and hemorrhagic, and ischemic stroke were evaluated based on degree of renal impairment and method of anticoagulation. There were 21,733 patients with a CHA2DS2-VASc score of ≥2 included in this analysis. Compared with warfarin, DOAC use in patients with impaired renal function was associated with lower risk of mortality with a hazard ratio (HR): 0.76 (95% confidence interval [CI] 0.70 to 0.84, p value <0.001) in patients with eGFR >60, HR 0.74 (95% CI 0.68 to 0.81, p value <0.001) in patients with eGFR >30 to 60, and HR 0.76 (95% CI 0.63 to 0.92, p value <0.001) in patients with eGFR ≤30 or on dialysis. Bleeding requiring hospitalization was also less in the DOAC group with a HR 0.93 (95% CI 0.82 to 1.04, p value 0.209) in patients with eGFR >60, HR 0.83 (95% CI 0.74 to 0.94, p value 0.003) in patients with eGFR >30 to 60, and HR 0.69 (95% CI 0.50 to 0.93, p value 0.017) in patients with eGFR ≤30 or on dialysis. In conclusion, in comparison to warfarin, DOACs appear to be safe and effective with a lower risk of all-cause mortality and lower bleeding across all levels of CKD.

Coronary Bypass Versus Percutaneous Revascularization in Multivessel Coronary Artery Disease.

BACKGROUND: This study focused on contemporary outcomes after coronary artery bypass graft (CABG) surgery versus percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (MVCAD). METHODS: This was a propensity-matched retrospective, observational analysis. Patients with MVCAD who underwent CABG or PCI between 2010 and 2018 and for whom data were available through the National Cardiovascular Data Registry or The Society of Thoracic Surgeons Adult Cardiac Surgery Database were included. The primary outcome was overall survival. Secondary outcomes included freedom from inpatient readmission and freedom from repeat revascularization. RESULTS: Of the initial 6,163 patients with MVCAD, the propensity-matched cohort included 844 in each group. The estimated 1-year mortality was 11.5% and 7.2% (p < 0.001) in the PCI and CABG groups, respectively, with an overall hazard ratio for mortality of PCI versus CABG of 1.64 (95% confidence interval [CI], 1.29 to 2.10; p < 0.001). The overall hazard ratio for readmission for PCI versus CABG was 1.42 (95% CI, 1.23 to 1.64; p < 0.001). The overall hazard ratio for repeat revascularization for PCI versus CABG was 4.06 (95% CI, 2.39 to 6.91; p < 0.001). Overall major adverse cardiovascular events and individual outcomes of mortality, readmission, and repeat revascularization all favored CABG across virtually all major clinical subgroups. CONCLUSIONS: This contemporary propensity-matched analysis of patients undergoing coronary revascularization for MVCAD demonstrates a significant mortality benefit with CABG over PCI, and this benefit is consistent across virtually all major patient subgroups. Futures studies are needed reflecting routine practice to assess how best to approach shared decision making and informed consent when it comes to revascularization decisions in any patient with MVCAD.

Longitudinal Outcomes of Women Undergoing Transcatheter Aortic Valve Replacement.

OBJECTIVE: Recent data have suggested that women have a survival benefit at 1-year follow-up. However, long-term gender-based TAVR outcomes are lacking. METHODS: All patients undergoing isolated TAVR from 2011 to 2017 were included. Patients were stratified by gender. The primary outcomes of the study were 3-year mortality and 3-year hospital readmissions. Multivariable logistic regression analysis was used to evaluate the risk-adjusted impact of gender on TAVR outcomes. RESULTS: A total of 1,036 patients were divided into male (n = 518) and female (n = 518) cohorts. Women had a borderline significantly increased STS PROM (8.3% ± 5 vs. 7.7% ± 4.4; P = 0.05). The majority of procedures were performed under conscious sedation (male: 89% vs. female: 88%; P = 0.62) and via transfemoral access (male: 81.8% vs. female: 81.4%; P = 0.46). There was no difference in operative (30-day) mortality (male: 15 [3.3%] vs. female: 17 [3.7%]; P = 0.77) or 30-day readmissions (male: 40 [10.8%] vs. female: 44 [12.2%]; P = 0.56). Perioperative blood product usage was higher for women (male: 8.1% vs. female: 14.1%; P = 0.002). There was no significant difference in major vascular complications (male: 0.4% vs. female: 1.0%; P = 0.26) or major bleeding (male: 0.2% vs. female: 0.4%; P = 0.56). Permanent pacemaker placement was higher for males (11.6% vs. 7.0%; P = 0.01). On risk-adjusted multivariable analysis, gender was not a factor associated with mortality (HR 0.99 [0.76 to 1.30]; P = 0.99) or readmission (HR 0.90 [0.72 to 1.14]; P = 0.42) at 5 years. CONCLUSIONS: There was no difference in survival or readmissions on multivariable analysis for women undergoing TAVR at 3 years. Longitudinal multi-institutional data will be important to validate these findings.

Association of Structural and Functional Cardiac Changes With Transcatheter Aortic Valve Replacement Outcomes in Patients With Aortic Stenosis.

Importance: Severe aortic stenosis causes pressure overload of the left ventricle, resulting in progressive cardiac dysfunction that can extend beyond the left ventricle. A staging system for aortic stenosis has been recently proposed that quantifies the extent of structural and functional cardiac changes in aortic stenosis. Objectives: To confirm the reproducibility of a proposed staging system and expand the study findings by performing a survival analysis and to evaluate the association of aortic stenosis staging with both cardiac and noncardiac post-transcatheter aortic valve replacement (TAVR) readmissions. Design, Setting, and Participants: A cohort analysis was conducted involving patients with severe aortic stenosis who underwent TAVR at the University of Pittsburgh Medical Center between July 1, 2011, and January 31, 2017. Patients who had undergone TAVR for valve-in-valve procedures and had an incomplete or unavailable baseline echocardiogram study for review were excluded. Clinical, laboratorial, and procedural data were collected from the Society of Thoracic Surgeons database and augmented by electronic medical record review. Exposures: The aortic stenosis staging system is based on echocardiographic markers of abnormal cardiac function. The stages are as follows: stage 1 (left ventricle changes - increased left ventricular mass index; early mitral inflow to early diastolic mitral annulus velocity (E/e') >14; and left ventricular ejection fraction <50%), stage 2 (left atrial or mitral changes - left atrial volume index >34 mL/m2; moderate to severe mitral regurgitation; and atrial fibrillation), stage 3 (pulmonary artery or tricuspid changes - pulmonary artery systolic pressure ≥60 mm Hg; moderate to severe tricuspid regurgitation), and stage 4 (right ventricle changes - moderate to severe right ventricle dysfunction). Main Outcomes and Measures: Primary outcome was post-TAVR all-cause mortality. Secondary outcomes were composite outcomes of all-cause mortality and post-TAVR all-cause and cardiac-cause readmissions. Results: A total of 689 consecutive patients (351 [50.9%] were male, with a mean [SD] age of 82.4 [7.6] years) were included. The prevalence of stage 1 was 13%; stage 2, 62%; stage 3, 21%; and stage 4, 4%. Patients with higher staging had a greater burden of comorbidities as captured by the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM). Despite adjustment for STS-PROM, a graded association was found between aortic stenosis staging and all-cause mortality (hazard ratio [HR] stage 2 vs stage 1: 1.37 [95% CI, 0.81-2.31; P = .25]; stage 3 vs stage 1: 2.24 [95% CI, 1.28-3.92; P = .005]; and stage 4 vs stage 1: 2.83 [95% CI, 1.39-5.76; P = .004]). Stage 3 patients had higher post-TAVR readmission rates for both cardiac (HR, 1.84; 95% CI, 1.13-3.00; P = .01) and noncardiac causes. Conclusions and Relevance: Aortic stenosis staging appears to show a strong graded association between the extent of cardiac changes and post-TAVR all-cause mortality; such staging may improve patient care, risk stratification, assessment of prognosis, and shared decision making for patients undergoing TAVR.

Long-term Hospital Readmissions After Surgical Vs Transcatheter Aortic Valve Replacement.

BACKGROUND: Limited data exist for rates and causes of readmission beyond short-term follow-up for patients undergoing surgical and transcatheter aortic valve replacement (SAVR and TAVR) METHODS: Patients undergoing isolated SAVR and TAVR between 2011 and 2017 at our institution were included in this study. The primary outcome was 5-year hospital readmission. The readmission cohort was identified from index readmission. Multivariable logistic regression analysis was used to evaluate the risk-adjusted impact of TAVR vs SAVR on outcomes. RESULTS: A total of 2379 patients were included: 1034 TAVR (43.5%) and 1345 SAVR (56.5%). Patients undergoing TAVR were on average older (81.8 ± 7.8 years vs 69.1 ± 11.85 years, P < .0001) and had more comorbidities than SAVR patients as represented by a greater Society of Thoracic Surgeons Predicted Risk of Mortality (7.96% ± 4.71% vs 2.73% ± 2.93%, P < .0001). Operative mortality was higher in the TAVR cohort (3.19% vs 1.12%, P < .004) and remained high at 5 years despite risk adjustment. Significantly more cardiac readmissions were found at 5-year follow-up in the TAVR group (73.3% vs 60.0%, P < .0001). Heart failure was the most common cause of cardiac readmission in the TAVR cohort (58.7% vs 42.1%, P = .0001). No difference was found in overall readmission risk at 30 days (hazard ratio [HR] 1.23, 95% confidence interval [CI]: 0.94 to 1.61, P = .12), 1 year (HR 0.93, 95% CI: 0.77 to 1.16, P = .52), and 5 years (HR 0.99, 95% CI: 0.83 to 1.18, P = .89). CONCLUSIONS: There is a disproportionately high rate of long-term hospital readmissions for cardiac causes, including heart failure, in patients who underwent TAVR. These data may support aggressive medical management of patients with careful follow-up in patients undergoing TAVR.

Right ventricle to pulmonary artery coupling in patients undergoing transcatheter aortic valve implantation.

OBJECTIVES: To evaluate the prognostic value of the ratio between tricuspid annular plane systolic excursion (TAPSE)-pulmonary artery systolic pressure (PASP) as a determinant of right ventricular to pulmonary artery (RV-PA) coupling in patients undergoing transcatheter aortic valve replacement (TAVI). BACKGROUND: RV function and pulmonary hypertension (PH) are both prognostically important in patients receiving TAVI. RV-PA coupling has been shown to be prognostic important in patients with heart failure but not previously evaluated in TAVI patients. METHODS: Consecutive patients with severe aortic stenosis who received TAVI from July 2011 through January 2016 and with comprehensive baseline echocardiogram were included. All individual echocardiographic images and Doppler data were independently reviewed and blinded to the clinical information and outcomes. Cox models quantified the effect of TAPSE/PASP quartiles on subsequent all-cause mortality while adjusting for confounders. RESULTS: A total of 457 patients were included with mean age of 82.8±7.2 years, left ventricular ejection fraction (LVEF) 54%±13%, PASP 44±17 mm Hg. TAPSE/PASP quartiles showed a dose-response relationship with survival. This remained significant (HR for lowest quartile vs highest quartile=2.21, 95% CI 1.07 to 4.57, p=0.03) after adjusting for age, atrial fibrillation, LVEF, stroke volume index, Society of Thoracic Surgeons Predicted Risk of Mortality. CONCLUSION: Baseline TAPSE/PASP ratio is associated with all-cause mortality in TAVI patients as it evaluates RV systolic performance at a given degree of afterload. Incorporation of right-side unit into the risk stratification may improve optimal selection of patients for TAVI.