Nationwide Trends and Outcomes for Coronary Artery Bypass Grafting in End-Stage Kidney Disease and Stable Coronary Artery Disease.

Patients with end-stage kidney disease (ESKD) on dialysis have an increased burden of coronary artery disease (CAD). This study assessed the trend and outcomes for coronary artery bypass surgery (CABG) in patients with ESKD and stable CAD. We conducted a longitudinal study using the United States Renal Data System of patients with ESKD and stable CAD who underwent CABG from the years 2009 to 2017. The outcomes included in-hospital, long-term mortality, and repeat revascularization. The follow-up was until death, end of Medicare AB coverage, or December 31, 2018. A total of 11,952 patients were identified. The mean age was 62.8 years, 68% were male, and 67% were white. The common co-morbidities included hypertension (97%), diabetes mellitus (75%), and congestive heart failure (53%). A significant decrease in CABG procedures from 2.9 to 1.3 procedures per 1,000 patients with ESKD (p <0.001) was noted during the years studied. The overall in-hospital mortality rate was 5.9%, and there was a significant decrease over the study period (p = 0.01). Although the 30-day mortality rate was 6.9% and remained steady (p = 0.14), the 1-year mortality rate was 22.8% and decreased significantly (p <0.001). At 5 years, the overall survival rate was 35%, and patients with internal mammary artery grafts showed better survival than those without (36% vs 25%). In conclusion, there has been a decrease in CABG procedures performed in patients with ESKD with stable CAD with decreasing in-hospital and 1-year mortality. Those with an internal mammary artery graft do better, but the overall long-term survival remains dismal in this population. There remains need for caution and individualization of revascularization decisions in this high-risk population.

Outcomes of peripheral artery disease and polyvascular disease in patients with end-stage kidney disease.

OBJECTIVE: Patients with peripheral artery disease (PAD) and end-stage kidney disease are a high-risk population, and concomitant atherosclerosis in coronary arteries (CAD) or cerebral arteries (CVD) is common. The aim of the study was to assess long-term outcomes of PAD and the impact of coexistent CAD and CVD on outcomes. METHODS: The United States Renal Data System was used to identify patients with PAD within 6 months of incident dialysis. Four groups were formed: PAD alone, PAD with CAD, PAD with CVD, and PAD with CAD and CVD. PAD-specific outcomes (chronic limb-threatening ischemia, major amputation, percutaneous/surgical revascularization, and their composite, defined as major adverse limb events [MALE]) as well as all-cause mortality, myocardial infarction, and stroke were studied. RESULTS: The study included 106,567 patients (mean age, 71.2 years; 40.8% female) with a median follow-up of 546 days (interquartile range, 214-1096 days). Most patients had PAD and CAD (49.8%), 25.8% had PAD alone, and 19.2% had all three territories involved. MALE rate in patients with PAD was 22.3% and 35.0% at 1 and 3 years, respectively. In comparison to PAD alone, the coexistence of both CAD and CVD (ie, polyvascular disease) was associated with a higher adjusted rates of all-cause mortality (hazard ratio [HR], 1.28; 95% confidence interval [CI], 1.24-1.31), myocardial infarction (HR, 1.78; 95% CI, 1.69-1.88), stroke (HR, 1.66; 95% CI, 1.52,1.80), and MALE (HR, 1.07; 95% CI, 1.04-1.11). CONCLUSIONS: Patients with end-stage kidney disease have a high burden of PAD with poor long-term outcomes, which worsen, in an incremental fashion, with the involvement of each additional diseased arterial bed.

Impact of preexisting coronary artery and peripheral artery disease on outcomes in diabetic patients after kidney transplant.

BACKGROUND: Atherosclerotic cardiovascular disease is highly prevalent in patients with end-stage kidney disease (ESKD). Kidney transplant (KT) improves patient survival and cardiovascular outcomes. The impact of preexisting coronary artery disease (CAD) and peripheral artery disease (PAD) on posttransplant outcomes remains unclear. METHODS: This is a retrospective study utilizing the United States Renal Data System. Adult diabetic dialysis patients who underwent first KT between 2006 and 2017 were included. The study population was divided into four cohorts based on presence of CAD/PAD: (1) polyvascular disease (CAD + PAD); (2) CAD without PAD; (3) PAD without CAD; (4) no CAD or PAD (reference cohort). The primary outcome was 3-year all-cause mortality. Secondary outcomes were incidence of posttransplant myocardial infarction (MI), cerebrovascular accidents (CVA), and graft failure. RESULTS: The study population included 19,329 patients with 64.4% men, mean age 55.4 years, and median dialysis duration of 2.8 years. Atherosclerotic cardiovascular disease was present in 28% of patients. The median follow up was 3 years. All-cause mortality and incidence of posttransplant MI were higher with CAD and highest in patients with polyvascular disease. The cohort with polyvascular disease had twofold higher all-cause mortality (16.7%, adjusted hazard ratio (aHR) 1.5, p < 0.0001) and a fourfold higher incidence of MI (12.7%, aHR 3.3, p < 0.0001) compared to the reference cohort (8.0% and 3.1%, respectively). There was a higher incidence of posttransplant CVA in the cohort with PAD (3.4%, aHR 1.5, p = 0.01) compared to the reference cohort (2.0%). The cohorts had no difference in graft failure rates. CONCLUSIONS: Preexisting CAD and/or PAD result in worse posttransplant survival and cardiovascular outcomes in patients with diabetes mellitus and ESKD without a reduction in graft survival.

Transcatheter Repair for Patients with Tricuspid Regurgitation.

BACKGROUND: Severe tricuspid regurgitation is a debilitating condition that is associated with substantial morbidity and often with poor quality of life. Decreasing tricuspid regurgitation may reduce symptoms and improve clinical outcomes in patients with this disease. METHODS: We conducted a prospective randomized trial of percutaneous tricuspid transcatheter edge-to-edge repair (TEER) for severe tricuspid regurgitation. Patients with symptomatic severe tricuspid regurgitation were enrolled at 65 centers in the United States, Canada, and Europe and were randomly assigned in a 1:1 ratio to receive either TEER or medical therapy (control). The primary end point was a hierarchical composite that included death from any cause or tricuspid-valve surgery; hospitalization for heart failure; and an improvement in quality of life as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), with an improvement defined as an increase of at least 15 points in the KCCQ score (range, 0 to 100, with higher scores indicating better quality of life) at the 1-year follow-up. The severity of tricuspid regurgitation and safety were also assessed. RESULTS: A total of 350 patients were enrolled; 175 were assigned to each group. The mean age of the patients was 78 years, and 54.9% were women. The results for the primary end point favored the TEER group (win ratio, 1.48; 95% confidence interval, 1.06 to 2.13; P = 0.02). The incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. The KCCQ quality-of-life score changed by a mean (±SD) of 12.3±1.8 points in the TEER group, as compared with 0.6±1.8 points in the control group (P<0.001). At 30 days, 87.0% of the patients in the TEER group and 4.8% of those in the control group had tricuspid regurgitation of no greater than moderate severity (P<0.001). TEER was found to be safe; 98.3% of the patients who underwent the procedure were free from major adverse events at 30 days. CONCLUSIONS: Tricuspid TEER was safe for patients with severe tricuspid regurgitation, reduced the severity of tricuspid regurgitation, and was associated with an improvement in quality of life. (Funded by Abbott; TRILUMINATE Pivotal ClinicalTrials.gov number, NCT03904147.).

Burden of Hypertensive Crisis in Patients With End-Stage Kidney Disease on Maintenance Dialysis: Insights From United States Renal Data System Database.

BACKGROUND: There is paucity of information on the incidence, clinical characteristics, admission trends, and outcomes of hypertensive crisis (HTN-C) in patients with end-stage kidney disease (ESKD) who are on maintenance dialysis. METHODS: We conducted a retrospective observational study of HTN-C admissions in patients with end-stage kidney disease using the United States Renal Data System. We identified patients with end-stage kidney disease aged ≥18 years on dialysis and were hospitalized for HTN-C from January 2006 to August 2015. RESULTS: A total of 54 483 patients with end-stage kidney disease were hospitalized for HTN-C during the study period. After study exclusions, 37 214 patients were included in the analysis. A majority of patients were Black, there were more women than men and the South region of the country accounted for a great majority of patients. During the study period, hospitalization rates increased from 1060 per 100 000 beneficiary years to 1821 (Ptrend<0.0001). Overall, in-hospital mortality, 30-day, and 1-year mortality were 0.6%, 2.3%, and 21.8%, respectively, and 30-day readmission rate was 31.1%. During the study period, most study outcomes showed a significant decreasing trend (in-hospital mortality 0.6%-0.5%, 30-day mortality 2.4%-1.9%, 1-year mortality 23.9%-19.7%, Ptrend<0.0001 for all). CONCLUSIONS: Hospitalizations for HTN-C have increased consistently during the decade studied. Although temporal trends showed improving mortality and readmission rates, the absolute rates were still high with 1 in 3 patients readmitted within 30 days and 1 in 5 patients dying within 1 year of index hospitalization.

2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients.

BACKGROUND: The Evolut Low Risk Trial (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients) showed that transcatheter aortic valve replacement (TAVR) with a supra-annular, self-expanding valve was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. This finding was based on a Bayesian analysis performed after 850 patients had reached 1 year of follow-up. OBJECTIVES: The goal of this study was to report the full 2-year clinical and echocardiographic outcomes for patients enrolled in the Evolut Low Risk Trial. METHODS: A total of 1,414 low-surgical risk patients with severe aortic stenosis were randomized to receive TAVR or surgical AVR. An independent clinical events committee adjudicated adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints. RESULTS: An attempted implant was performed in 730 TAVR and 684 surgical patients from March 2016 to May 2019. The Kaplan-Meier rates for the complete 2-year primary endpoint of death or disabling stroke were 4.3% in the TAVR group and 6.3% in the surgery group (P = 0.084). These rates were comparable to the interim Bayesian rates of 5.3% with TAVR and 6.7% with surgery (difference: -1.4%; 95% Bayesian credible interval: -4.9% to 2.1%). All-cause mortality rates were 3.5% vs 4.4% (P = 0.366), and disabling stroke rates were 1.5% vs 2.7% (P = 0.119), respectively. Between years 1 and 2, there was no convergence of the primary outcome curves. CONCLUSIONS: The complete 2-year follow-up from the Evolut Low Risk Trial found that TAVR is noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke, with event rates that were slightly better than those predicted by using the Bayesian analysis. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients [Evolut Low Risk Trial]; NCT02701283).

Outcomes in Patients With Asymptomatic Aortic Stenosis (from the Evolut Low Risk Trial).

Transcatheter aortic valve implantation (TAVI) has comparable outcomes with surgical aortic valve replacement (SAVR) in symptomatic patients with severe aortic stenosis, including those at low risk for surgery. Less is known about TAVI outcomes in asymptomatic patients. This analysis compares clinical, hemodynamic, and quality of life (QOL) outcomes after TAVI or SAVR for low-risk asymptomatic patients. The randomized Evolut Low Risk trial enrolled asymptomatic patients treated with TAVI (n = 76) and SAVR (n = 62). New York Heart Association functional class I identified patients without symptoms. Clinical outcomes, echocardiographic findings, and QOL in both groups were compared 30 days and 12 months after AVR. Asymptomatic patients had a mean Society of Thoracic Surgeons score of 1.7 ± 0.6, 73% were men, and mean age was 74.2 ± 5.8 years. The composite end point of all-cause mortality or disabling stroke was similar at 12 months in patients with TAVI (1.3%) and SAVR (6.5%; p = 0.11), although patients with SAVR tended to have higher rates of all-cause mortality (4.8%) compared with patients with TAVI (0.0%, p = 0.05). Patients with TAVI had lower mean aortic valve gradients (8.1 ± 3.2 mm Hg) and larger mean effective orifice area (2.3 ± 0.6 mm Hg) than patients with SAVR (10.8 ± 3.8; p <0.001 and 1.9 ± 0.6; p = 0.001, respectively), and showed significant improvement in Kansas City Cardiomyopathy Questionnaire scores from baseline to 30 days (∆12.1 ± 23.6; p <0.001), whereas patients with SAVR did not (∆2.2 ± 20.3; p = 0.398). Patients with TAVI and SAVR had a significant improvement in QOL by 12 months compared with baseline. In conclusion, low risk asymptomatic patients with severe aortic stenosis who underwent TAVI had comparable clinical outcomes to SAVR, with superior valve performance and faster QOL improvement.

Outcomes in patients with history of cocaine use presenting with chest pain to the emergency department: Insights from the Nationwide Emergency Department Sample 2016-2018.

OBJECTIVES: Cocaine use (CU) related chest pain (CP) is a common cause of emergency department (ED) visits in the United States. However, information on disposition and outcomes in these patients is scarce. We conducted a nationwide study to assess disposition from ED, hospitalization rates, in-hospital outcomes, and health care costs in patients with history of CU who presented to the ED with CP. METHODS: We queried the Nationwide Emergency Department Sample database from 2016-2018 for adult patients with CU presenting to the ED with CP. International Classification of Diseases, Tenth Revision codes were used to identify study patients. RESULTS: We identified 149,372 patients. The majority were male (76%), presented to metropolitan centers (91.3%), and had a high prevalence of cardiovascular risk factors (48.1% with hypertension, 24.4% with coronary artery disease, 18.2% with diabetes) and psychiatric illnesses (21%). Overall, 21.4% of patients were hospitalized, 68.6% were discharged from ED and 6.6% left against medical advice. Patients requiring admission were older (51.8 vs 45.0; P < 0.0001) and had a higher prevalence of coronary artery disease, peripheral arterial disease, hypertension, diabetes, and chronic kidney disease. Of those admitted, 45.7% were diagnosed with myocardial infarction (MI), constituting 9.7% of the total study population. Over 80% of these patients underwent coronary angiography and 38.6% had coronary intervention. Mortality was 1.2%. CONCLUSION: CU patients who present to ED are predominantly male, are from lower economic strata, and have significant comorbidity burden. One in 5 patients requires hospitalization and has more prevalent cardiovascular risk factors and comorbidities. In-hospital mortality is low, but incidence of MI and subsequent invasive procedures is high. CU may be considered a cardiac risk factor as it is associated with high rates of in-hospital MI.

The Impact of Transfusions on Mortality After Transcatheter or Surgical Aortic Valve Replacement.

BACKGROUND: An increasing body of evidence suggests that packed red blood cell (PRBC) transfusion may be associated with increased morbidity and mortality after transcatheter and surgical aortic valve replacement. It remains unclear whether PRBC transfusion is a surrogate marker or truly an independent risk factor for mortality after aortic valve replacement in different populations. METHODS: The Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial randomized 1660 patients with symptomatic, severe aortic stenosis at intermediate risk for operative death to transcatheter aortic valve replacement or surgical aortic valve replacement. Baseline characteristics and outcomes including all-cause and cardiovascular mortality at 30 days and thereafter were compared between participants with and participants without PRBC transfusion. Cox proportional hazards models with time-varying covariates were fitted to estimate the effect of PRBC transfusion on mortality after adjustment for comorbidities and procedural complications. RESULTS: Patients receiving PRBC were older, more commonly female and frail, with more comorbidities. The Society of Thoracic Surgeons Predicted Risk of Mortality baseline score was higher in the transfused group. After adjustment for these differences, PRBC transfusion was associated with mortality at 30 days, but not thereafter. The effect of PRBC on mortality (hazard ratio 1.04; 95% confidence interval, 0.96 to 1.11; P = .304) at 30 days was not independent of procedural complications (hazard ratio 21.04; 95% CI, 7.26 to 60.95; P < .001). CONCLUSIONS: Poor health status, procedural complications, PRBC transfusion, and mortality are correlated with each other. Transfusion of PRBC did not independently increase risk for mortality. In this intermediate-risk population, transfusion appears to be a risk marker of chronic conditions and periprocedural complications as opposed to a risk factor for postprocedural mortality. (Clinical trial registration: www.clinicaltrials.gov NCT01586910.).

Three-Year Outcomes With a Contemporary Self-Expanding Transcatheter Valve From the Evolut PRO US Clinical Study.

BACKGROUND: Paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) is associated with increased morbidity and mortality. PVR continues to plague TAVR jeopardizing long-term results. New device iterations, such as the self-expandable Evolut PRO valve, aim to decrease PVR while maintaining optimal hemodynamics. This study sought to evaluate clinical and hemodynamic performance of the Evolut PRO system at 3 years. METHODS: The Evolut PRO US Clinical Study included 60 patients at high or extreme surgical risk undergoing TAVR with the Evolut PRO valve at 8 centers in the United States. Clinical outcomes were evaluated using Valve Academic Research Consortium (VARC)-2 criteria and included all-cause mortality, cardiovascular mortality, disabling stroke and valve complications. An independent core laboratory centrally assessed all echocardiographic measures. RESULTS: At 3 years, all-cause mortality was 25.8% (cardiovascular mortality 16.5%) and the disabling stroke rate was 10.7%. There were no cases of repeat valve intervention, endocarditis or coronary obstruction. Valve thrombosis was identified in 1 patient 2 years post-procedure and was treated medically. Hemodynamics at 3 years included a mean gradient of 7.2 ± 4.5 mm Hg, an effective orifice area of 2.0 ± 0.5 cm2, and 88.2% of patients had no or trace PVR. The remaining patients had mild PVR. Most of the surviving patients (80.6%) had New York Heart Association class I symptoms at 3 years. CONCLUSION: Outcomes at 3-years following TAVR with a contemporary self-expanding prosthesis are favorable, with no signal of valve deterioration, excellent hemodynamics including very low prevalence of PVR.

Vascular complications associated with percutaneous left ventricular assist device placement: A 10-year US perspective.

BACKGROUND: Over the last decade, there has been a significant increase in the use of percutaneous left ventricular assist devices(p-LVADs). p-LVADs are being increasingly used during complex coronary interventions and for acute cardiogenic shock. These large bore percutaneous devices have a higher risk of vascular complications. We examined the vascular complication rates from the use of p-LVAD in a national database. METHODS: We conducted a secondary analysis of the National In-patient Sample (NIS) dataset from 2005 till 2015. We used the ICD-9-CM procedure codes 37.68 and 37.62 for p-LVAD placement regardless of indications. We investigated common vascular complications, defining them by the validated ICD 9 CM codes. χ2 test and t test were used for categorical and continuous variables, respectively for comparison. RESULTS: A total of 31,263 p-LVAD placements were identified during the period studied. A majority of patients were male (72.68%) and 64.44% were white. The overall incidence of vascular complications was 13.53%, out of which 56% required surgical treatment. Acute limb thromboembolism and bleeding requiring transfusion accounted for 27.6% and 21.8% of all vascular complications. Occurrence of a vascular complication was associated with significantly higher in-hospital mortality (37.77% vs. 29.95%, p < .001), length of stay (22.7 vs. 12.2 days, p < .001) and cost of hospitalization ($ 161,923 vs. $ 95,547, p < .001). CONCLUSIONS: There is a high incidence of vascular complications with p-LVAD placement including need for vascular surgery. These complications are associated with a higher in-hospital, LOS and hospitalization costs. These findings should be factored into the decision-making for p-LVAD placement.

Impact of short term oral steroid use for intravenous contrast media hypersensitivity prophylaxis in diabetic patients undergoing nonemergent coronary angiography or interventions.

OBJECTIVES: Oral steroids are routinely administered in the United States for prophylaxis of iodinated contrast media hypersensitivity (ICMH). We studied the impact of short-term steroid use in diabetic patients with ICMH undergoing nonemergent coronary angiography. METHODS: We retrospectively analyzed records of diabetic patients with and without ICMH who underwent nonemergent coronary angiography at our center. Primary study endpoint was 30-day major adverse cardiac events (MACE) and secondary endpoints were pre- and postprocedure fasting blood glucose (FBG), highest in hospital blood glucose, pre- and postprocedure systolic blood pressure (SBP), and use of intravenous insulin and antihypertensive medications. RESULTS: A total of 88 diabetics with ICMH (study group) and 76 diabetics without ICMH (control group) undergoing angiography were enrolled. Demographics and hemoglobin A1c values were similar in both groups. Preprocedural FBG was significantly higher in the study group. The study group had significantly higher post angiography FBG (239.93 + 96.88 mg/dl vs. 156.6 + 59.88 mg/dl) and greater use of intravenous (IV) insulin (67.27% vs. 32.43%). Further, those who received steroids had significantly higher systolic SBP postprocedure (146.16 + 25.35 mmHg vs. 130.8 + 21.59 mmHg), a higher incidence of severe hypertension and use of IV antihypertensive medications (80.95% vs. 19.05%) periprocedurally. There were no differences in 30-day MACE between groups. CONCLUSION: Short-term steroid use for ICMH results in a significant increase in surrogate markers for adverse clinical events after coronary procedures. Study findings highlight the need for better periprocedural management of these patients and to limit steroid prophylaxis to those with only true ICMH.

Prognostic significance, angiographic characteristics and impact of antithrombotic and anticoagulant therapy on outcomes in high versus low grade coronary artery ectasia: A long-term follow-up study.

OBJECTIVES: To assess the prognostic significance of high vs. low grade coronary artery ectasia (CAE) and the impact of antithrombotic or anticoagulant therapy on adverse cardiac outcomes. BACKGROUND: There is paucity of knowledge on the impact of angiographic characteristics in CAE or that of antithrombotic or anticoagulant therapy on outcomes. METHODS AND RESULTS: In this retrospective study, we reviewed angiograms and medical records of all cases of confirmed CAE (2001-2011). Extent of CAE was categorized using the Markis classification. Types 1 and 2 were categorized as high-grade and types 3 and 4 as low-grade CAE. Angiographic flow was recorded as normal or sluggish (

5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients.

BACKGROUND: The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients. OBJECTIVES: The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. METHODS: Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. RESULTS: A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. CONCLUSIONS: This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Safety and utility of dobutamine and pressure wire use in the hemodynamic assessment of low-flow, low-gradient aortic stenosis with reduced left ventricular ejection fraction.

BACKGROUND: The ACC/AHA guidelines recommend low-dose dobutamine challenge for hemodynamic assessment of the severity of AS in patients with low flow, low gradient aortic stenosis with reduced ejection fraction (EF) (LFLG-AS; stage D2). Inherent pitfalls of echocardiography could result in inaccurate aortic valve areas (AVA), which have downstream prognostic implications. Data on the safety and efficacy of coronary pressure wire and fluid-filled catheter use for low dose dobutamine infusion is sparse. METHODS: We retrospectively analyzed 39 consecutive patients with EF<50%, AVA<1cm2 and SVI<35ml/m2 on echocardiography who underwent simultaneous right and left heart catheterization. Hemodynamic assessments were performed at baseline and at every increment in the dobutamine infusion rate (The infusion was continued until maximal dose of dobutamine or a mean AV gradient>40mmHg was attained. The occurrence of sustained ventricular arrhythmias, symptomatic hypotension or intolerable symptoms leading to cessation of infusion was recorded. Transient ischemic attacks (TIAs) or clinically apparent strokes periprocedurally or up to 30days after the procedure were recorded. RESULTS: Dobutamine challenge confirmed true AS in 26 patients (67%) and pseudosevere AS in 34%. No sustained arrhythmias, hypotension or cessation of infusion from intolerable symptoms were observed. No clinical strokes or TIAs were observed up to 30days after procedure in any of these patients. CONCLUSIONS: Hemodynamic assessment of AS using a pressure wire with dobutamine challenge is a safe and effective tool in identifying truly severe AS in patients with LFLG-AS with reduced EF.

Impact of Annular Size on Outcomes After Surgical or Transcatheter Aortic Valve Replacement.

BACKGROUND: This analysis evaluates the relationship of annular size to hemodynamics and the incidence of prosthesis-patient mismatch (PPM) in surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) patients. METHODS: The CoreValve US Pivotal High Risk Trial, described previously, compared TAVR using a self-expanding valve with SAVR. Multislice computed tomography was used to categorize TAVR and SAVR subjects according to annular perimeter-derived diameter: large (≥26 mm), medium (23 to <26 mm), and small (<23 mm). Hemodynamics, PPM, and clinical outcomes were assessed. RESULTS: At all postprocedure visits, mean gradients were significantly lower for TAVR compared with SAVR in small and medium size annuli (p < 0.001). Annular size was significantly associated with mean gradient after SAVR, with small annuli having the highest gradients (p < 0.05 at all timepoints); gradients were similar across all annular sizes after TAVR. In subjects receiving SAVR, the frequency of PPM was significantly associated with annular size, with small annuli having the greatest incidence. No difference in PPM incidence by annular sizing was observed with TAVR. In addition, TAVR subjects had significantly less PPM than SAVR subjects in small and medium annuli (p < 0.001), with no difference in the incidence of PPM between TAVR and SAVR in large annuli (p = 0.10). CONCLUSIONS: Annular size has a significant effect on hemodynamics and the incidence of PPM in SAVR subjects, not observed in TAVR subjects. With respect to annular size, TAVR results in better hemodynamics and less PPM for annuli less than 26 mm and should be strongly considered when choosing a tissue valve for small and medium size annuli.

Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap.

OBJECTIVES: This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis. BACKGROUND: A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve. METHODS: The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. The 2 primary safety endpoints were the incidence of all-cause mortality at 30 days and the incidence of disabling stroke at 30 days. The primary efficacy endpoint was the proportion of patients with no or trace prosthetic valve regurgitation at 30 days. An independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota) was used to adjudicate all echocardiographic assessments. RESULTS: All 60 patients received the Evolut PRO valve. At 30 days, 1 patient (1.7%) died and 1 patient (1.7%) experienced a nonfatal disabling stroke. Paravalvular regurgitation at 30 days was absent or trace in 72.4% of patients and was mild in the remainder of patients, with no patients having worse than mild paravavlular leak. The mean atrioventricular gradient was 6.4 ± 2.1 mm Hg and effective orifice area was 2.0 ± 0.5 cm2 at 30 days. CONCLUSIONS: The safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853).

Safety and Feasibility of Rotational Atherectomy in Elderly Patients With Severe Aortic Stenosis.

BACKGROUND: Percutaneous coronary intervention (PCI) followed by transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis (AS) and coronary artery disease (CAD). In many, the coronary arteries are severely calcified and best treated with rotational atherectomy (RA). However, RA is not routinely performed in severe AS patients due to safety concerns. There is a paucity of data on the safety of RA in severe AS patients with calcific CAD. METHODS: We retrospectively analyzed the medical records of 29 patients with severe AS who underwent elective RA-facilitated PCI at our center between January 1, 2011 and December 31, 2015. RESULTS: Twenty-nine patients (mean age, 79.8 ± 8.8 years) were enrolled. Mean aortic valve area was 0.71 ± 0.20 cm², mean aortic valve gradient was 40.32 ± 9.88 mm Hg. All PCIs were successful (mean diameter stenosis, 86.3 ± 7.6%; mean burr size, 1.62 ± 0.19 mm). Nineteen patients (65.5%) required temporary pacemaker. Eight patients (27.6%) required vasopressors during PCI. There was a significant reduction in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR) during RA, but without clinical events. No procedure was aborted and there were no deaths or clinical myocardial infarctions. CONCLUSION: RA-facilitated PCI can be safely performed in elderly patients with severe AS and severely calcified CAD with low risk of complications. There was a significant but transient drop in SBP, DBP, MAP, and HR during RA. However, this was not associated with clinically significant adverse events.