Daily Cardiology Research Analysis

OBJECTIVE: The optimal follow-up strategy for high-risk patients who underwent imaging-guided or physiology-guided percutaneous coronary intervention (PCI) remains uncertain. We investigated whether routine surveillance stress testing after PCI provides clinical benefit when the procedure is guided by intravascular ultrasonography (IVUS) or fractional flow reserve (FFR). METHODS: In the Pragmatic Trial Comparing Symptom-Oriented vs Routine Stress Testing in High-Risk Patients Undergoing PCI randomised trial, 1706 high-risk patients who underwent PCI were assigned to either routine functional testing at 1 year or standard care alone. In this prespecified subgroup analysis, patients were subsequently categorised according to whether IVUS or FFR was used at the index procedure. The primary outcome was a composite of death, myocardial infarction or hospitalisation for unstable angina over 2 years. RESULTS: Among the randomised population, 74% underwent IVUS-guided intervention and 36% underwent FFR-guided intervention. At 2 years, rates of the primary outcome were similar between routine testing and standard care both in patients treated with IVUS guidance (5.3% vs 6.7%; HR 0.79; 95% CI 0.50 to 1.24) and without IVUS guidance (5.7% vs 3.8%; HR 1.52; 95% CI 0.63 to 3.68; interaction p=0.21). Comparable results were observed in patients with FFR guidance (2.6% vs 3.9%; HR 0.65; 95% CI 0.26 to 1.58) and without FFR guidance (7.0% vs 7.1%; HR 0.99; 95% CI 0.63 to 1.55; interaction p=0.59). Routine functional testing was consistently associated with higher use of invasive coronary angiography and repeat revascularisation, without improvement in clinical outcomes. CONCLUSIONS: Among high-risk patients who underwent PCI, routine surveillance stress testing did not reduce the risk of death, myocardial infarction or unstable angina, regardless of the use of IVUS or FFR at the index procedure. Routine functional testing increased downstream invasive procedures without clinical benefit. These findings support guideline recommendations against routine surveillance testing after PCI. TRIAL REGISTRATION NUMBER: NCT03217877.

AIMS: Despite the potential of alginate hydrogel intramyocardial injections in the treatment of heart failure (HF), minimally invasive implantation techniques remain scarce. This study evaluated the safety and feasibility of percutaneous transcatheter endocardial alginate hydrogel injection (TEAi), facilitated by novel implants and a dedicated catheter-based device, in patients with HF with reduced ejection fraction (HFrEF). METHODS AND RESULTS: This first-in-human study enrolled HFrEF patients [New York Heart Association (NYHA) Class III-IV and left ventricular ejection fraction (LVEF) ≤35%]. The primary endpoint was the incidence of procedure- or device-related serious adverse events (SADEs) at 30 days. Secondary endpoints included the device success rate, HF hospitalization at 6 months, and change from baseline to 6 months post-procedure in the following parameters: LVEF as assessed by MRI; NYHA functional class; 6 min walk test distance (6MWT); the quality of life assessed by the Kansas City Cardiomyopathy Heart Failure Questionnaire (KCCQ); and serum N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) level. Pre- and post-procedural biomechanical analysis was also evaluated. Ten patients successfully underwent TEAi with no SADEs at 30 days. There was one death and two HF hospitalizations at 6 months. At 6 months, LVEF improved from 17.7% ± 3.8% to 24.9% ± 11.2% (P = 0.021), end-systolic volume decreased from 297.5 ± 67.9 mL to 264.8 ± 101.4 mL (P = 0.029), and KCCQ scores increased from 49.7 ± 3.9 to 79.0 ± 8.07 (P = 0.008). No statistically significant changes were observed in end-diastolic volume, NT-proBNP and 6MWT at six months compared with the baseline. Biomechanical analysis revealed a reduction in peak left ventricular end-diastolic wall stress (6.5 ± 1.1 kPa vs. 5.9 ± 1.3 kPa, P = 0.043). CONCLUSIONS: TEAi is feasible and safe for the treatment of HFrEF, warranting further randomized, efficacy clinical trials.

BACKGROUND AND OBJECTIVES: We aimed to evaluate the efficacy and safety of coronavirus disease 2019 (COVID-19) vaccination in patients with heart failure (HF) using national databases. METHODS: We retrospectively analyzed the data from the Korean nationwide COVID-19 cohort, including patients with HF from February 2021 to June 2022. The study population was divided into the vaccinated (≥2 doses) and unvaccinated (≤1 dose) groups. Clinical outcomes assessed included hospitalization for HF, COVID-19-related events, and cardiovascular complications. Patients were matched by age, sex, and comorbidities, and were followed up for up to 15 months to assess vaccination-associated risks. RESULTS: We included 651,127 patients with HF (mean age 69.5 years; 50.2% male), of whom 112,693 (17.3%) were unvaccinated, and 538,434 (82.7%) were vaccinated. After propensity score matching, 73,559 patients in each group were compared. Over a median follow-up of 6 months, vaccination was associated with a significantly reduced risk of COVID-19 (hazard ratio [HR], 0.27; 95% confidence interval [CI], 0.22-0.33) and critical COVID-19 infection (HR, 0.47; 95% CI, 0.31-0.71). The vaccinated group also had a significantly lower risk of hospitalization for HF (HR, 0.53; 95% CI, 0.52-0.55) and all-cause mortality (HR, 0.18; 95% CI, 0.17-0.18) compared with the unvaccinated group. Additionally, vaccination was associated with a significantly lower risk of stroke, myocardial infarction, myocarditis/pericarditis, and venous thromboembolism compared with the unvaccinated patients (all, p<0.0001). CONCLUSIONS: COVID-19 vaccination in patients with HF was associated with a reduced risk of hospitalization for HF, all-cause mortality, and other cardiovascular events.