TMVR with balloon-expandable aortic valves in extreme surgical risk patients with severe MAC is feasible but associated with high 30-day and 1-year mortality. Most patients who survive the 30-day post-procedural period are alive at 1 year and have sustained improvement of symptoms and transcatheter valve performance. The role of TMVR in patients with MAC requires further evaluation in clinical trials.

Background Takotsubo (or stress-induced) cardiomyopathy is characterized by transient left ventricular systolic dysfunction. Recent trends in patient volume, characteristics and outcomes in the United States are unknown. Methods Using 2007–2012 National Inpatient Sample data, we identified 22,005 adults (≥18 years) with a primary and 31,942 adults with a secondary discharge diagnosis of takotsubo cardiomyopathy (ICD-9 code 429.83) who underwent diagnostic coronary angiography. Results During 2007–2012, the incidence of takotsubo cardiomyopathy increased over 3-fold: 52/million discharges in 2007 to 178/million in 2012 (P < 0.001). We found a temporal increase in the prevalence of cardiac arrest, cardiogenic shock, cardiovascular risk factors (diabetes, hypertension) and psychiatric disorders (P trend<0.0001 for all). In-hospital mortality was 1.1% and remained unchanged over this period (P=0.22). Compared to the primary diagnosis group, mortality in the secondary diagnosis group was higher (1.1% vs. 3.2%), and was associated with higher incidence of cardiogenic shock, cardiac arrest and respiratory failure. Men represent 8% of patients in the primary diagnosis group and 12% in the secondary group. In both groups men had a higher incidence of shock, cardiac arrest and respiratory failure. While their mortality was higher than women in the primary group (3.0% vs. 0.9%; adjusted odds ratio [OR] 3.85; 1.74 – 8.51), it was comparable in the secondary group (4.8% vs. 3.0%). Conclusions We found a marked increase in the hospitalization for takotsubo cardiomyopathy in the U.S. in recent years, suggesting higher incidence than prior reports. Although outcomes have remained favorable, there is an increasing burden of cardiovascular and psychiatric disorders in this population with growing cost of care. Risk of mortality is higher in men and in patients with underlying critical illness. The excess mortality in these groups appears to be mediated by greater severity of disease.

IMPORTANCEThe outcomes of transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic valve stenosis have not been studied in a large scale, multicentered, prospective fashion.OBJECTIVE To evaluate the procedural safety, efficacy, and 30-day outcomes of TAVR in patients with bicuspid aortic stenosis at low surgical risk. DESIGN, SETTING, AND PARTICIPANTS The Low Risk Bicuspid Study is a prospective, single-arm trial study with inclusion/exclusion criteria developed from the Evolut Low Risk Randomized Trial. Follow-up is planned for 10 years. Patients underwent TAVR at 25 centers in the United States who were also participating in the Evolut Low Risk Randomized Trial from December 2018 to October 2019. Eligible patients had severe bicuspid aortic valve stenosis and met American Heart Association/American College of Cardiology guideline indications for aortic valve replacement. INTERVENTIONS Patients underwent attempted implant of an Evolut or Evolut PRO transcatheter aortic valve, with valve size based on annular measurements. MAIN OUTCOMES AND MEASURESThe prespecified primary end point was the incidence of all-cause mortality or disabling stroke at 30 days. The prespecified primary efficacy end point was device success defined as the absence of procedural mortality, the correct position of 1 bioprosthetic heart valve in the proper anatomical location, and the absence of more than mild aortic regurgitation postprocedure.RESULTS A total of 150 patients underwent an attempted implant. Baseline characteristics include mean age of 70.3 (5.5) years, 48.0% female (n = 72), and a mean Society of Thoracic Surgeons score of 1.4 (0.6%). Most patients (136; 90.7%) had Sievers type I valve morphology. The incidence of all-cause mortality or disabling stroke was 1.3% (95% CI, 0.3%-5.3%) at 30 days. The device success rate was 95.3% (95% CI, 90.5%-98.1%). At 30 days, the mean (SD) AV gradient was 7.6 (3.7) mm Hg and effective orifice area was 2.3 (0.7) cm 2 . A new permanent pacemaker was implanted in 22 patients (15.1%). No patients had greater than mild paravalvular leak. CONCLUSIONS AND RELEVANCETranscatheter aortic valve replacement in low-surgical risk patients with bicuspid aortic valve stenosis achieved favorable 30-day results, with low rates of death and stroke and high device success rate.

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BACKGROUND Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk. OBJECTIVES In a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels. METHODS ODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was <70 mg/dL (median 69.4 mg/dL; interquartile range: 64.3–74.0 mg/dL); in 14,573 patients (77.0%), both determinations were ≥70 mg/dL (median 94.0 mg/dL; interquartile range: 83.2–111.0 mg/dL). RESULTS In the lower LDL-C subgroup, MACE rates were 4.2 and 3.1 per 100 patient-years among placebo-treated patients with baseline lipoprotein(a) greater than or less than or equal to the median (13.7 mg/dL). Corresponding adjusted treatment hazard ratios were 0.68 (95% confidence interval [Cl]: 0.52–0.90) and 1.11 (95% Cl: 0.83–1.49), with treatment-lipoprotein(a) interaction on MACE ( P interaction = 0.017). In the higher LDL-C subgroup, MACE rates were 4.7 and 3.8 per 100 patient-years among placebo-treated patients with lipoprotein(a) >13.7 mg/dL or ≤13.7 mg/dL; corresponding adjusted treatment hazard ratios were 0.82 (95% Cl: 0.72–0.92) and 0.89 (95% Cl: 0.75–1.06), with P interaction = 0.43. CONCLUSIONS In patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402 )