Circulation: Cardiovascular Interventions最新文献

Background: Heart failure (HF) remains a significant burden following transcatheter aortic valve replacement, adversely impacting survival and quality of life. Identification of patients who may benefit from closer monitoring or adjunctive medical therapy to reduce the risk of HF is an unmet need. The objective of this study was to develop and internally validate a clinical prediction model to determine the 1-year risk of HF hospitalization or death after transcatheter aortic valve replacement.

Methods: Using the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, we analyzed patients who underwent successful transcatheter aortic valve replacement for aortic stenosis and survived to discharge between 2016 and 2019. Covariates were selected based on expert opinion and prior literature. A hierarchical cumulative odds regression model was used to predict a composite outcome of (1) all-cause death, (2) ≥2 HF readmissions, or (3) 1 HF readmission at 1 year.

Results: Among 78 384 patients (median age, 82 years; 45.6% female), 17.4% experienced the composite outcome, including death (10.9%), ≥2 HF readmissions (1.6%), and 1 HF readmission (4.9%). The model demonstrated good discrimination (C statistic, 0.753 derivation and 0.747 validation) and excellent calibration. Among 1-year survivors, performance in predicting HF readmission as an isolated outcome was similar (C statistic, 0.753). A simplified model, including the top 12 variables from the full model, maintained comparable performance (C statistics, 0.74-0.75).

Conclusions: This prediction model effectively stratifies post-transcatheter aortic valve replacement patients by risk of death or HF readmission, supporting its use to guide clinical surveillance and clinical trial enrollment for adjunctive medical therapies aimed at mitigating this risk.

Background: Over the past decade, balloon pulmonary angioplasty (BPA) for chronic thromboembolic pulmonary hypertension has shown improved outcomes with procedural refinement in expert hospitals with high procedural volume. Whether the outcomes of BPA are reproducible in hospitals with limited procedural volumes remains unknown. The Japan BPA registry was designed to assess the outcomes of contemporary BPA from a nationwide perspective, including hospitals with low treatment volume.

Methods: This prospective multicenter registry enrolled 1202 consecutive patients with chronic thromboembolic pulmonary hypertension who underwent BPA at 44 hospitals between April 2018 and March 2023. We assessed the efficacy and safety of BPA and survival rates, comparing high- and low-volume hospitals based on the BPA center definition (≥50 procedures per year) from the seventh World Symposium on Pulmonary Hypertension.

Results: A total of 5207 procedures were performed. Thirty-five low-volume hospitals (79.5%) performed 40.8% of all BPA procedures. BPA significantly improved symptoms, clinical parameters, and hemodynamics (55.6% reduction in pulmonary vascular resistance), with 0.2% periprocedural BPA-related mortality. Severe lung injury (0.3%), balloon overdilatation (0.67%), and mechanical ventilation (0.3%) were less common in high-volume hospitals than in low-volume hospitals (1.3%, 1.7%, and 1.5%, respectively; P<0.001). In the Kaplan-Meier analysis, the survival rate of all patients at 3 years was 94.7% (95% CI, 92.5%-96.3%). Multivariable Cox regression analysis showed an increased mortality risk with higher right atrial pressure, and high-volume hospitals were associated with a reduced mortality risk.

Conclusions: This nationwide registry demonstrated the outcomes of contemporary BPA in patients with chronic thromboembolic pulmonary hypertension. No significant differences were observed in efficacy and periprocedural mortality between low- and high-volume hospitals. However, the significantly lower rate of severe complications in high-volume hospitals indicates that BPA may be safer in high-volume hospitals.

Background: While balloon postdilation (BPD) during transcatheter aortic valve replacement may enhance hemodynamic performance by optimizing valve expansion, it was also linked with leaflet mechanical stress, potentially reducing valve durability. The aim of this study was to investigate the impact of BPD on long-term bioprosthetic valve durability.

Methods: We analyzed the data of a prospective single-center registry including consecutive patients undergoing transcatheter aortic valve replacement between May 2007 and March 2024 alive at 1-year and without a valve-in-valve procedure. To reduce imbalance in baseline and procedural characteristics, the effect of BPD on events was assessed using a propensity score-matched population (215 patients with BPD versus 761 patients without BPD, out of a total of 1911 patients). The primary end point was the occurrence of stage 2 or 3 hemodynamic valve deterioration according to Valve Academic Research Consortium-3.

Results: In the propensity-score matched population, BPD was associated with a lower risk of stage 2 or 3 hemodynamic valve deterioration occurrence compared with no-BPD (2.8% versus 5.8%; subdistribution hazard ratio, 0.37 [95% CI, 0.15-0.95]; P=0.039), and a lower rate of bioprosthetic valve failure (2.8% versus 5.1%; subdistribution hazard ratio, 0.39 [95% CI, 0.15-0.98]; P=0.046). Long-term echocardiographic follow-up up to 10 years showed better hemodynamic parameters over time in patients with BPD. A trend toward a higher prevalence of heart failure hospitalization was observed in patients with BPD.

Conclusions: BPD was associated with a lower incidence of stage 2 and 3 hemodynamic valve deterioration and bioprosthetic valve failure, along with improved bioprosthetic valve hemodynamic parameters over time. Further studies are warranted.

Background: There is a paucity of data regarding the longer-term durability of transcatheter heart valves. This analysis aimed to describe the 5-year clinical outcomes and valve durability for patients treated with the Portico transcatheter heart valves across 3 studies harmonized in their prospective enrollment, inclusion/exclusion criteria, centralized independent core laboratory echocardiographic analysis, and independent clinical events committee adjudication.

Methods: Patient-level data from the PORTICO IDE randomized controlled trial, the PORTICO I postmarket study, and the PORTICO continued access protocol were pooled using a random-effects meta-analysis model. All 3 studies collected follow-up data at discharge, 30 days, and annually through 5 years. Adverse events and pooled echocardiographic data were assessed using Valve Academic Research Consortium-2 definitions. Durability definitions were adapted from Valve Academic Research Consortium-3 and European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery consensus guidelines.

Results: A total of 1464 patients with severe symptomatic aortic stenosis and high or extreme surgical risk were included. Median age was 83 years, 61.7% were women, and the median Society of Thoracic Surgeons score was 4.9%. At 5 years, all-cause mortality and stroke rates were 49.4% and 12.3%, respectively. Transvalvular gradient and effective orifice area at 5 years were 6.2 mm Hg and 1.83 cm², respectively, with paravalvular leak ≥moderate severity occurring in 1.9%. The 5-year bioprosthetic valve failure rate was 2.7%, including a 0.7% valve-related death rate and a 2.0% valve reintervention rate, but no patients with severe hemodynamic structural valve deterioration. Moderate hemodynamic structural valve deterioration occurred in 0.9% of the patients at 5 years. Hemodynamic performance and transcatheter heart valve durability remained stable irrespective of annular size.

Conclusions: The use of the Portico transcatheter heart valve system in patients at high or extreme surgical risk demonstrated favorable clinical outcomes and hemodynamic performance with low transvalvular gradients and greater than mild paravalvular leak. Furthermore, bioprosthetic valve failure rates were low with no incidence of severe hemodynamic structural valve deterioration at 5 years, irrespective of annular size.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02000115 and NCT01802788.

Background: The current study aims to describe outcomes after transcatheter valve replacement in adults with congenital heart disease.

Methods: Retrospective study of adults with congenital heart disease who underwent transcatheter valve replacement and had a 1-year follow-up postintervention at Mayo Clinic (2010-2024). The study period was divided into early (2010-2014), mid (2015-2019), and late (2020-2024) eras. The primary outcome was valve reintervention. The secondary outcomes were all-cause mortality and temporal change in prosthetic valve gradient and clinical indices of disease severity.

Results: Overall, 341 patients (age 38±17 years; 175 [51%] men) received 346 prostheses (pulmonary [N=236, 68%], tricuspid [N=75, 22%], aortic [N=22, 8%], and mitral [N=7, 2%]). The prostheses were Sapien (N=181, 52%), Melody (N=142, 41%), and Harmony prostheses (N=23, 7%). The number of transcatheter valve implantations increased from the early era (N=75), mid era (N=109), to the late era (N=162). The 10-year incidence of valve reintervention was 35%, and was similar between Sapien versus Melody prosthesis (41% versus 33%; P=0.11). The 10-year incidence of all-cause mortality was 13%. There was a temporal increase in prosthetic valve Doppler mean gradient (baseline versus 10 years) for pulmonary (12±5 versus 28±11 mmHg; P<0.001), tricuspid (3±1 versus 8±3 mmHg; P<0.001), and aortic prosthesis (13±5 versus 26±12 mmHg; P<0.001). There was a temporal increase in predicted peak oxygen consumption (absolute ∆, 9% [95% CI, 4-13]; P=0.006) and a decrease in NT-proBNP (N-terminal pro-B-type natriuretic peptide) level (absolute ∆, -138 pg/mL [95% CI, -209 to -64]; P<0.001) at 1-year postintervention.

Conclusions: There has been a temporal increase in the number of transcatheter valve implantations over time. Transcatheter valve replacement was associated with clinical improvement across multiple domains. However, there was a significant increase in prosthetic valve gradient within 10 years of follow-up, suggesting limited prosthesis longevity. There is a need for strategies to improve prosthetic valve longevity, which in turn may improve outcomes in this population.

Background: Impaired flow following percutaneous coronary intervention (PCI) is a known predictor of adverse outcomes. The pullback pressure gradient (PPG) is a novel physiological metric that differentiates focal from diffuse disease and enables prediction of post-PCI fractional flow reserve (FFR). This post hoc analysis of the PPG Global (NCT04789317) study aimed to evaluate the prognostic performance of a PPG model for predicting post-PCI FFR and to determine whether the predicted physiological outcome is associated with adverse events following PCI.

Methods: Prospective and multicenter study including patients with hemodynamically significant coronary artery disease undergoing PCI. A prediction model based on FFR and PPG was used to estimate post-PCI FFR. Based on the predicted values, vessels were classified as having either optimal or suboptimal post-PCI physiology. The primary end point was target vessel failure at 1 year. Target vessel failure was defined as a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target vessel revascularization.

Results: A total of 855 patients (890 vessels) were analyzed. The mean difference between predicted and measured post-PCI FFR was 0.001 (limits of agreement, -0.10 to 0.10). There was a strong correlation between predicted and measured delta FFR (r=0.92 [95% CI, 0.91-0.93]; P<0.001). Vessels with predicted suboptimal post-PCI physiology had a significantly higher incidence of target vessel failure (adjusted hazard ratio, 1.97 [95% CI, 1.24-3.15]; P=0.004). Predicted suboptimal physiology was independently associated with adverse clinical outcomes.

Conclusions: PPG-predicted post-PCI physiology was associated with target vessel failure at 1 year. These findings extend the role of coronary physiology beyond diagnostic assessment to include risk stratification and outcome prediction following PCI.