Circulation: Cardiovascular Interventions最新文献

Background: The pullback pressure gradient (PPG) is a novel physiological metric that quantifies coronary artery disease patterns as focal or diffuse on a scale from 0 to 1. This study assessed the relationship between PPG and residual angina at 1 year.

Methods: PPG Global is a prospective, investigator-initiated, single-arm, multicenter study that enrolled patients with at least 1 lesion with a fractional flow reserve ≤0.80 intended to be treated with PCI. After the PPG calculation, physicians could revise treatment assignment to medical therapy or coronary artery bypass graft surgery instead of PCI. Focal and diffuse disease were defined based on the median PPG value of 0.62. Patient-reported outcomes were assessed using the Seattle Angina Questionnaire at baseline and 1-year follow-up.

Results: The study included 947 patients with PPG and the Seattle Angina Questionnaire at 1 year. The mean age was 67.6±10.2 years, 24% were female, and 29% had diabetes. At 1 year, patients with focal coronary artery disease reported less angina than those with diffuse coronary artery disease (Seattle Angina Questionnaire angina frequency score, 95.3±9.9 versus 92.5±15.0; P=0.006). PPG was independently associated with improvement in angina (P=0.017).

Conclusions: In patients with flow-limiting coronary artery disease, the presence of focal disease defined by high PPG was associated with greater symptomatic relief at 1 year compared with diffuse disease (low PPG). By reflecting the physiological pattern of disease and its relation to symptom relief after treatment, PPG may help inform revascularization strategies.

Background: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement field have been obtained from retrospective studies. This prespecified secondary analysis of the LYTEN randomized trial (Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprostheses) aims to compare the 3-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in valve-in-valve transcatheter aortic valve replacement.

Methods: Patients with a failed small (≤23 mm) surgical valve undergoing valve-in-valve transcatheter aortic valve replacement were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler echocardiography) evaluation at 3-year follow-up. Study outcomes were defined according to VARC (Valve Academic Research Consortium)-2/VARC-3 criteria. Intended performance of the valve was defined as mean gradient <20 mm Hg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate AR.

Results: Ninety-eight patients underwent transcatheter aortic valve replacement (46 BEV-SAPIEN 3/ULTRA-, 52 SEV-Evolut R-PRO-PRO+). At 3 years, patients receiving a SEV had a higher rate of intended valve performance (BEV: 27.6% versus SEV: 82.4%; P<0.001), with lower mean gradients (BEV: 20.40±9.12 versus SEV: 13.12±8.56 mm Hg; P=0.002), and larger indexed effective orifice area (BEV: 0.69±0.27 versus SEV: 0.93±0.32 cm²/m²; P=0.002). The rate of moderate aortic regurgitation was 0% in the BEV group versus 2.9% in the SEV group (P=0.582). Functional status and quality of life improved similarly in both groups. No differences were observed in the composite end point of death, stroke, or heart failure-related hospitalization (BEV: 32.6% versus SEV: 25.5%; P=0.489). Mortality was also not statistically different between groups (BEV: 23.3% versus SEV: 15.7%; P=0.375). No significant differences were observed in other adverse events.

Conclusions: In patients undergoing valve-in-valve transcatheter aortic valve replacement for failed small aortic bioprostheses, SEV demonstrated a superior valve hemodynamic performance at 3-year follow-up, with similar clinical outcomes and functional improvement compared with BEV.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03520101.

Background: Current clinical guidelines recommend considering both obstructive and nonobstructive causes of myocardial ischemia in patients with chronic coronary syndrome. Wire-based physiological assessment constitutes a valid approach for this purpose, but it remains underutilized. We evaluated the diagnostic yield and clinical impact of an alternative wire-free approach for this purpose.

Methods: This is a subanalysis of the multicenter, prospective AID-ANGIO study (Advanced Invasive Diagnosis for Patients with Chronic Coronary Syndromes Undergoing Coronary Angiography), evaluating the impact of a wire-free advanced invasive diagnosis (AID) strategy in the diagnostic workflow of patients with chronic coronary syndrome admitted to the catheterization laboratory. The wire-free AID strategy combined quantitative flow ratio for epicardial evaluation, contrast angiography-derived index of coronary microcirculatory resistance for microvascular assessment, and acetylcholine testing for the endothelial-dependent coronary function.

Results: The study included 262 patients. The wire-free AID strategy identified a cause of myocardial ischemia in 84.3% of patients, representing a 2-fold increase in the identification of a cause of myocardial ischemia, compared with coronary angiography alone (P<0.0001). In addition, the wire-free AID strategy demonstrated substantial agreement compared with the wire-based AID strategy (Cohen κ 0.78). The wire-free AID strategy led to a change in the initial therapeutic plan in 55.3% of patients compared with coronary angiography. Nevertheless, the wire-free AID strategy maintained good concordance with the wire-based AID strategy (16.8% of therapeutic changes).

Conclusions: This study supports the clinical utility of a wire-free AID strategy in patients with chronic coronary syndrome, demonstrating its potential to improve diagnostic yield and guide clinical decision-making compared with coronary angiography alone. In addition, it shows substantial agreement with the wire-based approach.

Background: Atrial secondary mitral regurgitation (aSMR) is a distinct subtype of SMR characterized by normal leaflets, annular dilatation, left atrial (LA) enlargement, and preserved left ventricular function. Treatment pathways for aSMR are undefined, and limited data exist regarding outcomes following mitral transcatheter edge-to-edge repair (MTEER). The analysis aimed to evaluate outcomes in patients with aSMR treated with MTEER from the EXPANDed studies.

Methods: One-year outcomes were assessed in patients from the EXPANDed studies (EXPAND and EXPAND G4) who met criteria for aSMR. aSMR was defined by the presence of atrial fibrillation, left ventricular ejection fraction ≥45%, and at least 1 dilated LA parameter per echocardiographic core laboratory assessment: LA volume index, LA diameter, or LA diameter index.

Results: Of the 967 patients with SMR treated with MTEER in the EXPANDed data set, 160 (17%) met criteria for aSMR. Patients with aSMR were elderly (78±8 years), symptomatic (Kansas City Cardiomyopathy Questionnaire Overall Summary score, 48±27 pts), and had small left ventricular and large LA dimensions at baseline. Acute procedural success was achieved in 97.5% of patients with aSMR, with MR reduction to ≤1+ in 95.2% at 1 year. There were significant 1-year improvements in quality of life (+19 pt Kansas City Cardiomyopathy Questionnaire Overall Summary) and functional capacity (New York Heart Association I/II 80%). The 1-year all-cause mortality rate was 9%, with patients experiencing a 56% reduction in 1-year heart failure hospitalization rates from pre- to post-MTEER.

Conclusions: In the largest population of patients with aSMR assessed by an echocardiographic core laboratory, MTEER safely and significantly reduced MR with improvements in quality of life and reduction in heart failure hospitalization through 1 year.

Background: The prognostic implications of bolus thermodilution-derived resting coronary blood flow in all-comer patients with chronic coronary syndrome are not known. We investigated the association of thermodilution-derived indices characterizing coronary flow with outcomes.

Methods: Patients with chronic coronary syndrome with and without obstructive coronary artery disease were included before undergoing coronary angiography in this prospective observational study. Measurements of the index of microcirculatory resistance, baseline resistance index, resting coronary blood flow (CBF), and hyperemic CBF were obtained with thermodilution in the left anterior descending coronary artery. Cox-regression analyses adjusted for age, sex, number of diseased vessels, and estimated creatinine clearance, as well as Kaplan-Meier plots, were used to evaluate the relation between flow indices and the primary composite outcome of all-cause mortality, nonfatal myocardial infarction, or heart failure hospitalization.

Results: Analyses included 410 patients with 55 events. Median follow-up was 5.4 years. Resting CBF was independently associated with the primary outcome (hazard ratio, 1.23 [95% CI 1.02-1.48]). Resting CBF was associated with the primary outcome in patients undergoing revascularization (hazard ratio, 1.30 [95% CI 1.04-1.64]) but not in patients not undergoing revascularization (hazard ratio, 1.15 [95% 0.82-1.60]; P interaction=0.771). Neither the index of microcirculatory resistance nor hyperemic CBF was associated with outcomes. Functional coronary microvascular dysfunction was associated with a higher incidence of death and nonfatal myocardial infarction versus no coronary microvascular dysfunction (log-rank P=0.041), whereas structural coronary microvascular dysfunction was not.

Conclusions: Elevated resting CBF in the left anterior descending coronary artery was associated with major adverse cardiovascular events in chronic coronary syndrome, whereas hyperemic microcirculatory resistance and flow were not.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06306066.

Background: Microaxial flow pump (mAFP) use in selected patients with ST-segment-elevation myocardial infarction complicated by cardiogenic shock improves survival. The present study aimed to assess the influence of delay from first symptoms to randomization on the benefit of an mAFP in patients with ST-segment-elevation myocardial infarction complicated by cardiogenic shock.

Methods: This was a secondary analysis of the international, multicenter, randomized, open-labeled DanGer Shock trial (Danish-German Cardiogenic Shock). A total of 345 of 355 patients with ST-segment-elevation myocardial infarction and cardiogenic shock were enrolled in this substudy. Patients were stratified into quartiles according to delay from first symptoms to randomization to either an mAFP or standard care alone. The end point was death from any cause at 180 days for treatment with an mAFP versus standard of care, according to time from onset of symptoms to randomization obtained by logistic regression analysis.

Results: Mortality at 180 days increased across quartiles of time from onset of symptoms to randomization: Q1 (0-140 minutes), 36%; Q2 (141-248 minutes), 53%; Q3 (249-650 minutes), 59%; and Q4 (> 651 minutes), 62%, respectively (log-rank P=0.002). However, those with longer delays were also older and more often women. Median age rose from 66 years (interquartile range, 57-73) in the earliest quartile to 71 years (interquartile range, 62-79) in the latest quartile (P=0.005), and the proportion of women increased from 15% to 34%, respectively. Combining the 3 lowest quartiles for the time from onset of symptoms to randomization, the mAFP treatment was associated with an odds ratio of 0.51 (95% CI, 0.31-0.84), whereas the odds ratio for the highest quartile was 0.92 (95% CI, 0.38-2.22; P for interaction = 0.26).

Conclusions: In patients with ST-segment-elevation myocardial infarction complicated with cardiogenic shock, treatment with an mAFP was associated with reduced all-cause mortality, but the treatment benefit appeared to weaken with prolonged time from the onset of symptoms to randomization.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01633502.