Effectiveness and safety of early treatment with spironolactone for new-onset acute heart failure.

BACKGROUND: The effectiveness and safety of mineralocorticoid receptor antagonists (MRA) in acute heart failure (HF) is uncertain. We sought to describe the prescription of spironolactone during acute HF and whether early treatment is effective and safe in a real-world setting. METHODS: We performed a retrospective cohort study of adult (≥18 years) nonpregnant patients hospitalized with new-onset HF with reduced ejection fraction (HFrEF, defined by ejection fraction ≤40%) within 15 Kaiser Permanente Southern California medical centers between 2016 and 2021. Early treatment was defined by spironolactone prescription at discharge. The primary effectiveness outcome was a composite of HF readmission or all-cause mortality at 180 days. Safety outcomes were hypotension and hyperkalemia at 90 days. RESULTS: Among 2318 HFrEF patients, 368 (15.9%) were treated with spironolactone at discharge. After 1:2 propensity score matching, 354 early treatment and 708 delayed/no treatment patients were included in the analysis. The median age was 63 (IQR: 52-74) years; 61.6% were male, and 38.6% were White. By 90 days, ~20% had crossed over in the two groups. Early treatment was not associated with the composite outcome at 180 days (HR [95% CI]: 0.81 [0.56-1.17]), but a trend towards benefit by 365 days that did not reach statistical significance (0.78 [0.58-1.06]). Early treatment was also associated with hyperkalemia (subdistribution HR [95% CI]: 2.33 [1.30-4.18]) but not hypotension (0.93 [0.51-1.72]). CONCLUSIONS: Early treatment with spironolactone at discharge for new-onset HFrEF in a real-world setting did not reduce the risk of HF readmission or mortality in the first year after discharge. The risk of hyperkalemia was increased.

Association Between Coronary Artery Disease Testing in Patients with New-Onset Heart Failure and Heart Failure Readmission and Mortality.

BACKGROUND: In patients with new-onset heart failure (HF), coronary artery disease (CAD) testing remains underutilized. Whether widespread CAD testing in patients with new-onset HF leads to improved outcomes remains to be determined. OBJECTIVE: We sought to examine whether CAD testing, and its timing, among patients hospitalized with new-onset HF with reduced ejection fraction (HFrEF), is associated with improved outcomes. DESIGN: Retrospective cohort study. PARTICIPANTS: Adult (≥ 18 years) non-pregnant patients with new-onset HFrEF hospitalized within one of 15 Kaiser Permanente Southern California medical centers between 2016 and 2021. Key exclusion criteria included history of heart transplant, hospice, and a do-not-resuscitate order. MAIN MEASURES: Primary outcome was a composite of HF readmission or all-cause mortality through end of follow-up on 12/31/2022. KEY RESULTS: Among 2729 patients hospitalized with new-onset HFrEF, 1487 (54.5%) received CAD testing. The median age was 66 (56-76) years old, 1722 (63.1%) were male, and 1074 (39.4%) were White. After a median of 1.8 (0.6-3.4) years, the testing group had a reduced risk of HF readmission or all-cause mortality (aHR [95%CI], 0.71 [0.63-0.79]). These results were consistent across subgroups by history of atrial fibrillation, diabetes, renal disease, myocardial infarction, and elevated troponin during hospitalization. In a secondary analysis where CAD testing was further divided to early (received testing before discharge) and late testing (up to 90 days after discharge), there was no difference in late vs early testing (0.97 [0.81-1.16]). CONCLUSIONS: In a contemporary and diverse cohort of patients hospitalized with new-onset HFrEF, CAD testing within 90 days of hospitalization was associated with a lower risk of HF readmission or all-cause mortality. Testing within 90 days after discharge was not associated with worse outcomes.

Two-Year Outcomes of Valve-in-Valve Using New-Generation Transcatheter Devices Compared With Redo-SAVR.

Few studies have compared the clinical outcomes between valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) with new-generation valves and re-operative surgical aortic valve replacement (Redo-SAVR). We compared the clinical outcomes of patients who underwent ViV-TAVR with those of patients who underwent Redo-SAVR at Cedars-Sinai Medical Center between 2015 and 2021. New-generation valves were used for ViV-TAVR. A propensity score-matched (PSM) analysis was performed to adjust for differences in baseline characteristics. The primary end point was all-cause mortality at 30 days and 2 years. In-hospital procedural and clinical outcomes were also compared between the groups. A total of 256 patients (140 who underwent ViV-TAVR and 116 who underwent Redo-SAVR) were eligible for PSM. In the unmatched cohort, patients in the ViV-TAVR group were older and had more co-morbidities than those in the Redo-SAVR group. After PSM, there were no significant differences in all-cause death between the ViV-TAVR and Redo-SAVR groups at 30 days (3.9% vs 2.6%, p = 0.65) or 2 years (6.5% vs 7.8%, p = 0.75). The incidences of stroke and heart failure rehospitalization were similar at 30 days and 2 years. The cumulative complication rates during hospitalization were significantly lower in the ViV-TAVR group than in the Redo-SAVR group (11.7% vs 28.6% p = 0.015). The long-term outcomes of ViV-TAVR using new-generation valves were similar to those of Redo-SAVR, although ViV-TAVR was associated with lower rates of in-hospital complications.

The safety of early discharge following transfemoral transcatheter aortic valve replacement under general anesthesia.

Background: There is growing evidence of the safety of same-day discharge for low-risk conscious sedated TAVR patients. However, the evidence supporting the safety of early discharge following GA-TAVR with routine transesophageal echocardiography (TEE) is limited. Aims: To assess the safety of early discharge following transcatheter aortic valve replacement (TAVR) using General Anesthesia (GA-TAVR) and identify predictors for patient selection. Materials and methods: We used data from 2,447 TEE-guided GA-TAVR patients performed at Cedars-Sinai between 2016 and 2021. Patients were categorized into three groups based on the discharge time from admission: 24 h, 24-48 h, and >48 h. Predictors for 30-day outcomes (cumulative adverse events and death) were validated on a matched cohort of 24 h vs. >24 h using the bootstrap model. Results: The >48 h group had significantly worse baseline cardiovascular profile, higher surgical risk, low functional status, and higher procedural complications than the 24 h and the 24-48 h groups. The rate of 30-day outcomes was significantly lower in the 24 h than the >48 h but did not differ from the 24-48 h (11.3 vs. 15.5 vs. 11.7%, p = 0.003 and p = 0.71, respectively). Independent poor prognostic factors of 30-day outcomes had a high STS risk of ≥8 (OR 1.90, 95% CI 1.30-2.77, E-value = 3.2, P < 0.001), low left ventricle ejection fraction of <30% (OR 6.0, 95% CI 3.96-9.10, E-value = 11.5, P < 0.001), and life-threatening procedural complications (OR 2.65, 95% CI 1.20-5.89, E-value = 4.7, P = 0.04). Our formulated predictors showed a good discrimination ability for patient selection (AUC: 0.78, 95% CI 0.75-0.81). Conclusion: Discharge within 24 h following GA-TAVR using TEE is safe for selected patients using our proposed validated predictors.

New adverse coronary events in valve-in-valve TAVR and native TAVR-A 2-year matched cohort.

Objective: To assess the incidence of new adverse coronary events (NACE) following transcatheter aortic valve replacement (TAVR) and valve-in-valve TAVR (ViV-TAVR). Background: ViV-TAVR is an accepted treatment for degenerative prostheses among patients with high surgical-risk. TAVR studies have suggested an increased risk of coronary artery obstruction and flow stasis causing thrombus formation. Whether contemporary ViV-TAVR is associated with higher rate of coronary events compared to TAVR is unknown. Methods: We used data from 1,224 TAVR patients between 2016 and 2021. We propensity-matched patients following ViV-TAVR and TAVR by significant predictors to overcome confounders in patients' baseline characteristics and procedural factors. Results: The matched population included 129 patients in each group. In line with prior reports, there was a higher in-hospital coronary artery obstruction rate with ViV-TAVR (3.1 vs. 1.6%; p = 0.23). Despite this, 2-year cumulative NACE rates were similar between groups (4.7 vs. 6.2%, respectively, p = 0.79), with no difference between its components: myocardial infarction (MI) (p = 0.210), unplanned coronary catheterization (p = 0.477), or coronary artery bypass grafting (CABG) (p = 0.998). Moreover, hypoattenuated leaflets thickening (HALT) at 30-day CT was observed in nearly a quarter of the patients with no difference between groups (23.9 vs. 23.1%, HR 1.02, 95% CI 0.50-1.28, p = 0.872). The progression rate of the coronary artery calcium score (CACS), assessed in a third of patients, was similar between groups (p log-rank = 0.468, 95% CI 0.12-1.24). Low coronary artery height was an unfavorable predictor for in-hospital coronary obstruction and 2-year NACE rate (HR 1.20 and HR 1.25, p = 0.001 and p < 0.0001, respectively). Conclusion: At 2-year follow-up, ViV-TAVR was not associated with a higher rate of myocardial infarction, unplanned catheterization, coronary artery bypass grafting, or hypoattenuated leaflet thickening.