Temporal Trends and Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis.

OBJECTIVES: The purpose of this study was to assess the temporal trends of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic stenosis (AS), and to compare the outcomes between TAVR and surgical aortic valve replacement (SAVR) in this population. BACKGROUND: Randomized trials comparing TAVR to SAVR in AS with bicuspid valve are lacking. METHODS: The study queried the National Inpatient Sample database (years 2012 to 2016) to identify hospitalizations for bicuspid AS who underwent isolated aortic valve replacement. A propensity-matched analysis was used to compare outcomes of hospitalizations for TAVR versus SAVR for bicuspid AS and TAVR for bicuspid AS versus tricuspid AS. RESULTS: The analysis included 31,895 hospitalizations with bicuspid AS, of whom 1,055 (3.3%) underwent TAVR. TAVR was increasingly utilized during the study period for bicuspid AS (ptrend = 0.002). After matching, TAVR and SAVR had similar in-hospital mortality (3.1% vs. 3.1%; odds ratio: 1.00; 95% confidence interval: 0.60 to 1.67). There was no difference between TAVR and SAVR in the rates of cardiac arrest, cardiogenic shock, acute kidney injury, hemopericardium, cardiac tamponade, or acute stroke. TAVR was associated with lower rates of acute myocardial infarction, post-operative bleeding, vascular complications, and discharge to nursing facility as well as a shorter length of hospital stay. On the contrary, TAVR was associated with a higher incidence of complete heart block and permanent pacemaker insertion. TAVR for bicuspid AS was associated with similar in-hospital mortality compared with tricuspid AS. CONCLUSIONS: This nationwide analysis showed similar in-hospital mortality for TAVR and SAVR in patients with bicuspid AS. TAVR for bicuspid AS was also associated with similar in-hospital mortality compared with tricuspid AS. Further studies are needed to evaluate long-term outcomes of TAVR for bicuspid AS.

City-Level Measures of Health, Health Determinants, and Equity to Foster Population Health Improvement: The City Health Dashboard.

OBJECTIVES: To support efforts to improve urban population health, we created a City Health Dashboard with area-specific data on health status, determinants of health, and equity at city and subcity (census tract) levels. METHODS: We developed a Web-based resource that includes 37 metrics across 5 domains: social and economic factors, physical environment, health behaviors, health outcomes, and clinical care. For the largest 500 US cities, the Dashboard presents metrics calculated to the city level and, where possible, subcity level from multiple data sources, including national health surveys, vital statistics, federal administrative data, and state education data sets. RESULTS: Iterative input from city partners shaped Dashboard development, ensuring that measures can be compared across user-selected cities and linked to evidence-based policies to spur action. Reports from early deployment indicate that the Dashboard fills an important need for city- and subcity-level data, fostering more granular understanding of health and its drivers and supporting associated priority-setting. CONCLUSIONS: By providing accessible city-level data on health and its determinants, the City Health Dashboard complements local surveillance efforts and supports urban population health improvement on a national scale.

Early Recovery of Left Ventricular Systolic Function After CoreValve Transcatheter Aortic Valve Replacement.

BACKGROUND: Approximately one third of patients with symptomatic aortic stenosis have reduced left ventricular ejection fraction (LVEF) before transcatheter aortic valve replacement. The incidence, predictors, and significance of early LVEF recovery after CoreValve transcatheter aortic valve replacement have not been described. METHODS AND RESULTS: We studied 156 patients from the CoreValve Extreme and High-Risk trials with LVEF ≤40% at baseline who had 30-day LVEF data. All patients underwent core laboratory echocardiographic assessment of LVEF at baseline, post procedure, discharge, 30 days, 6 months, and 1 year. Early LVEF recovery was defined as an absolute increase of ≥10% in EF at 30 days. One-year outcomes were compared between patients with and without early recovery. Multivariable analysis was performed to determine independent predictors of early recovery. Early LVEF recovery occurred in 62% of patients, generally before discharge. By 30 days LVEF increased >17% compared with baseline in the early recovery group with minimal increase in the no-early recovery group (48.9±8.8% versus 31.5±6.9%; P<0.001). One-year all-cause mortality was numerically (but not statistically) higher in the no-early recovery group (24% versus 12%; P=0.07). Absence of previous myocardial infarction (odds ratio, 0.44; 95% confidence interval, 0.19-1.03) and baseline mean gradient ≥40 mm Hg (odds ratio, 4.59; 95% confidence interval, 1.76-11.96) were identified as predictors of early LVEF recovery. CONCLUSIONS: Nearly two thirds of patients with reduced LVEF will have a marked early improvement after transcatheter aortic valve replacement. Early LVEF recovery is associated with improved clinical outcomes and is most likely among patients with higher baseline aortic valve gradients and no previous myocardial infarction. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01240902.

Mechanical complications after percutaneous coronary intervention in ST-elevation myocardial infarction (from APEX-AMI).

A decrease in mechanical complications after ST-elevation myocardial infarction may have contributed to improved survival rates associated with reperfusion by primary percutaneous coronary intervention (PCI). Mechanical complications occurred in 52 of 5,745 patients (0.91%) in the largest reported randomized trial in which primary PCI was the reperfusion strategy. The frequencies were 0.52% (30) for cardiac free-wall rupture (tamponade), 0.17% (10) for ventricular septal rupture, and 0.26% (15) for papillary muscle rupture (3 patients had 2 complications). Ninety-day survival rates were 37% (11) for cardiac free-wall rupture, 20% (2) for ventricular septal rupture, and 73.3% (11) for papillary muscle rupture. These mechanical complications occurred at a median of 23.5 hours (interquartile range 5.0 to 76.8) after symptom onset and were associated with 44% (23 of 52) survival through 90 days, which accounted for 11% of the 90-day mortality. Factors associated with mechanical complications were older age, female gender, Q waves, presence of radiologic pulmonary edema, and increased prerandomization troponin levels. In conclusion, rates of mechanical complications are lower with primary PCI than those previously reported after fibrinolytic therapy.

Temporal trends in the use of early cardiac catheterization in patients with non-ST-segment elevation acute coronary syndromes (results from CRUSADE).

We evaluated temporal trends in the use of early (<48 hours) catheterization in patients with non-ST-segment elevation acute coronary syndromes with respect to baseline risk features since publication of the American College of Cardiology/American Heart Association guidelines, which include a class IA recommendation for an early invasive strategy for high-risk patients with non-ST-segment elevation acute coronary syndromes. Overall, we found that early catheterization use increased from 53% to 61% during the 3 years after the guidelines were released, but the increased use of early catheterization was highest (11%) in the group that was at lowest risk of predicted mortality, and it was lowest (6%) in the group at highest risk of predicted mortality who would potentially receive the most benefit from an aggressive treatment approach. In conclusion, despite the overall increase in the use of early catheterization, the gap between the use of an early invasive strategy in the highest and lowest risk patients remains large and tends to increase over time.

Lack of clopidogrel pretreatment effect on the relative efficacy of bivalirudin with provisional glycoprotein IIb/IIIa blockade compared to heparin with routine glycoprotein IIb/IIIa blockade: a REPLACE-2 substudy.

OBJECTIVES: The purpose of this study was to assess if clopidogrel pretreatment affects the relative efficacy of bivalirudin versus heparin with glycoprotein (GP) IIb/IIIa blockade for percutaneous coronary interventions (PCI). BACKGROUND: Although thienopyridine pretreatment may improve clinical outcomes with PCI, it is unknown if bivalirudin's efficacy compared with heparin is dependent upon such pretreatment. METHODS: The Randomized Evaluation in Percutaneous coronary intervention Linking Angiomax to reduced Clinical Events (REPLACE-2) trial was a double-blind, triple-dummy, randomized-controlled trial comparing heparin plus routine GP IIb/IIIa blockade (heparin group) with bivalirudin plus provisional GP IIb/IIIa blockade (bivalirudin group) during PCI. The primary end point was a composite of death, myocardial infarction (MI), urgent revascularization at 30 days, and major in-hospital bleeding. The secondary end point was a 30-day composite of death, MI, and urgent revascularization. Clopidogrel pretreatment was encouraged (300 mg loading, 75 mg/day). RESULTS: Of 6,010 patients enrolled, 5,893 received clopidogrel, with 85.8% in the bivalirudin and 84.6% in the heparin group receiving clopidogrel pretreatment. Bivalirudin (provisional GP IIb/IIIa blockade 7.2%) was noninferior to the heparin group for both primary and secondary end points. Clopidogrel pretreatment did not affect the relative efficacy of bivalirudin versus heparin with GP IIb/IIIa blockade, irrespective of pretreatment duration. Pretreatment was associated with significantly lower primary end point with bivalirudin (8.7% pretreatment vs. 12.9% no pretreatment, p = 0.007), and nonsignificantly with heparin (9.7% vs. 11.7%, respectively, p = 0.20). Multivariable models showed a trend toward lower primary and secondary end points with clopidogrel pretreatment. CONCLUSIONS: Clopidogrel pretreatment at the doses and time administered in this trial did not influence the relative efficacy of bivalirudin versus heparin plus GP IIb/IIIa blockade for PCI. However, pretreatment was associated with a trend towards lower clinical events after PCI.

Double jeopardy of renal insufficiency and anemia in patients undergoing percutaneous coronary interventions.

Anemia and renal insufficiency impart an increased risk of mortality in patients with congestive heart failure. There is a paucity of data on the mortality hazard associated with anemia and renal insufficiency in patients undergoing percutaneous coronary intervention in the setting of contemporary practice. We analyzed the short- and long-term outcomes among patients enrolled in EPIC, EPILOG and EPISTENT trials according to degree of kidney dysfunction (glomerular filtration rate [GFR] <60, 60 to 75, and >75 ml/min/1.73 m2) and by hematocrit (<35, 35 to 39 and 40). GFR was calculated as GFR = 186 x (serum creatinine-1.154) x (age-0.203) x 1.212 (if black) or x 0.742 (if female). There were 20 deaths (3.2%) among 638 patients with a hematocrit of <35, 41 deaths among 2,066 patients (2.0%) with a hematocrit of 35 to 39, and 43 deaths in 3,618 patients (1.2%) with a hematocrit >40 at 6 months (p <0.001). Similarly, a significant increase in mortality was seen with lower GFR [33 of 1,168 (2.9%) at GFR <60, 33 of 1,766 (1.9%) at GFR 60 to 75 and 37 of 3,317 (1.1%) at GFR >75, p <0.001)]. Further, GFR and anemia independently and in combination predicted mortality at 3 years. Thus, renal insufficiency and anemia are significant independent and additive predictors of short- and long-term complications in patients undergoing percutaneous coronary intervention.