Journal of the American College of Cardiology最新文献

Background: ADVANTAGE AF examined the safety and efficacy of pulsed field ablation (PFA) to treat persistent atrial fibrillation (AF). During AF ablation, typical atrial flutter (AFL) is commonly treated with cavotricuspid isthmus (CTI) ablation.

Objectives: Adjunctive CTI ablation in ADVANTAGE AF was performed with radiofrequency ablation (RFA; phase 1) or bipolar linear PFA (phase 2). Here, we compared lesion characteristics, CTI ablation efficacy, and safety between the ablation modalities.

Methods: A preclinical study assessed lesion dimensions with a novel 2.0 kV bipolar linear PFA catheter. In ADVANTAGE AF, after AF ablation with a pentaspline PFA catheter, CTI ablation was performed: in phase 1 with irrigated RFA, and in phase 2 with the linear PFA catheter (Farapoint). Before PFA CTI ablation ,patients were treated with a vasopressor bolus followed by high-dose intravenous nitroglycerin.

Results: Preclinical assessment showed lesion depth increasing at higher field strength and plateauing after 2 applications. In ADVANTAGE AF, 50 and 141 patients received CTI ablation with RFA and PFA, respectively. Patient characteristics across the 2 cohorts were similar (RFA vs PFA). Acute CTI conduction block was similar between techniques (50 of 50 RFA [100%] vs 139 of 141 PFA [98.6%]; P = 1.00). PFA was associated with a shorter CTI ablation time (median: RFA 5 min [Q1-Q3: 4-8 min] vs 14 min [Q1-Q3: 9-19 min]; P = 0.001). RFA and PFA had similar safety event rates (RFA 2.0% vs PFA 2.1%; P = 0.96). With the use of nitroglycerin pretreatment, there was no clinical manifestation of coronary artery spasm with PFA.

Conclusions: This subanalysis of ADVANTAGE AF extends the primary results by allowing comparison of bipolar linear PFA and RF ablation for CTI, integrating preclinical lesion modeling with clinical dosing, and establishing a standardized reliable coronary safety protocol. Although not randomized comparisons, these findings suggest that CTI ablation with a linear PFA catheter is associated with safety and efficacy similar to RF ablation and greater efficiency. (A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation [ADVANTAGE AF; NCT05443594]).

Background: Cardiovascular disease (CVD) is increasing among young adults. The American Heart Association's PREVENT (Predicting Risk of Cardiovascular Disease Events) equations estimate risk of CVD, atherosclerotic cardiovascular disease (ASCVD), and heart failure (HF) for primary prevention. Augmented equations additionally include zip code-based social deprivation index (SDI) to address adverse social exposures.

Objectives: We assessed performance and algorithmic fairness of base and SDI-augmented PREVENT equations in young adults aged 30 to 39 years, defining fairness as similar performance across racial and ethnic groups. An exploratory analysis was conducted among young adults aged 20 to 29 years.

Methods: We included Kaiser Permanente Southern California members aged 20 to 39 years without prior CVD between 2008 and 2009, followed through 2019. We compared 10-year predicted and observed CVD, ASCVD, and HF events for base and SDI-augmented PREVENT models. Performance (Harell's C, calibration slopes, mean calibration) and fairness (concordance imparity, fair calibration) were estimated by race and ethnicity and age group (30-39 years [primary analysis], 20-29 years [exploratory analysis]).

Results: Among 161,202 young adults aged 30 to 39 years (60.0% women; 51.7% Hispanic, 26.9% non-Hispanic White, 12.5% Asian/Pacific Islander, 8.9% non-Hispanic Black), 10-year CVD incidence was 0.7%. Race-specific Harrell's C-statistics for the base PREVENT CVD model ranged from 0.68 to 0.72, yielding low concordance imparity (0.04; 95% CI: 0.02-0.22) which implies fair discrimination. Mean calibration showed underprediction in non-Hispanic Black participants (0.54; 95% CI: 0.48-0.65) vs other groups (range: 0.96-1.07). In fair calibration testing, prediction errors differed across racial and ethnic groups. Results were similar for ASCVD and HF. Adding SDI did not improve performance or fairness despite disparities across groups. In exploratory analyses among 80,978 individuals aged 20 to 29 years, performance and fairness results were similar.

Conclusions: This large, diverse cohort of young adults demonstrates how the PREVENT equations may perform when applied in real-world clinical settings, reflecting the true operational environment faced by large health systems. Applications of PREVENT in clinical patient care, eg, early initiation of preventive strategies, should consider variations in model performance across age, race, and ethnicity.

Background: For patients with asymptomatic severe aortic stenosis (AS), the EARLY TAVR trial demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS).

Objectives: In this study, the authors sought to evaluate whether baseline left ventricular (LV) health altered the treatment effect of early intervention and to examine longitudinal LV health under different treatment strategies.

Methods: At 75 centers in the United States and Canada, 901 patients underwent randomization to TAVR (n = 455) or CS (n = 446). Echocardiographic measurements were made in a core laboratory. The protocol defined integrated LV health as the composite of absolute LV global longitudinal strain (GLS) ≥15%, LV mass index (LVMi) <115 g/m² (men) or <95 g/m² (women), and left atrial volume index (LAVi) ≤34 mL/m². Integrated LV health was a prespecified secondary endpoint and the protocol outlined longitudinal measurements to be made in the intention-to-treat (ITT) and valve implant populations. As a stratification variable for effect-modification testing, LV health was not prespecified, so those analyses are exploratory. The trial's primary endpoint and 2 secondary composites were examined.

Results: At randomization, in the ITT population, 27% had normal integrated LV health (64% normal LVMi, 42% normal LAVi, 88% normal GLS). Abnormal integrated LV health and each component were generally associated with higher event rates across several composite endpoints. Benefit of early TAVR, compared with CS, was consistently observed regardless of whether LV health (evaluated as an integrated measure and as individual components) was normal or not. In the ITT population, the CS group exhibited normal LV health less frequently at 2 years than those treated early according to the integrated LV health measure (35.9% vs 48.1%; P < 0.001) and component measures. Among CS patients undergoing delayed AVR, LV health tended to decline from randomization to preprocedure (P < 0.10 for all measures except GLS), but baseline LV health did not predict timing of conversion to AVR nor severity of presentation.

Conclusions: For patients with asymptomatic severe AS, the benefit of early TAVR, compared with CS, is consistent regardless of baseline LV health according to integrated or individual measures. These exploratory findings suggest limited value for measures of LV health to guide the timing of TAVR in asymptomatic patients. Whether the worsening of LV health associated with CS and delayed aortic valve replacement underlies increased clinical events in that treatment arm requires further study. (Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis [EARLY TAVR]; NCT03042104).