Circulation: Cardiovascular Interventions最新文献

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.

Background: Drug-coated balloons (DCBs) are now a Food and Drug Administration-approved treatment option for the management of in-stent restenosis (ISR) based on superior outcomes compared with plain old balloon angioplasty (POBA) alone. However, the efficacy of DCB compared with drug-eluting stent (DES; repeat stenting) for ISR is uncertain, with prior studies showing inferiority of DCB. We aimed to compare the outcomes of DES, DCB, or POBA in patients with coronary ISR.

Methods: We searched PubMed, EMBASE, and clinicaltrials.gov databases (until August 1, 2025) for randomized clinical trials that compared DCB, DES, or POBA alone for ISR. Outcomes included major adverse cardiovascular events, target lesion revascularization, all-cause mortality, cardiovascular mortality, stent thrombosis, late lumen loss, and postprocedure minimum lumen diameter.

Results: From 18 randomized clinical trials that randomized 3820 patients with ISR, at mean follow-up of 18 months, compared with POBA, both DCB and DES were associated with reduction in major adverse cardiovascular events (odds ratio, 0.34 [95% CI, 0.24-0.50]; odds ratio, 0.37 [95% CI, 0.25-0.54]) driven by reduction in target lesion revascularization (odds ratio, 0.28 [95% CI, 0.15-0.50]; odds ratio, 0.21 [95% CI, 0.10-0.42]). DCB had a lower postprocedure minimum lumen diameter but lower late lumen loss (mean difference, -0.16 [95% CI, -0.29 to -0.04] mm) compared with DES with no difference in other clinical outcomes.

Conclusions: In patients with ISR, DCB reduced major adverse cardiovascular events/target lesion revascularization compared with POBA. There was no significant difference in clinical outcomes between DCB and DES.

Registration: URL: https://www.crd.york.ac.uk/PROSPERO; Unique identifier: CRD42024598433.

Background: The Minima Stent System is the first stent designed, tested, and Food and Drug Administration-approved for use in neonates, infants, and children. Our objective was to evaluate the safety and efficacy of Minima implantation for pulmonary artery stenosis (PAS) and coarctation of the aorta (CoA).

Methods: Multicenter, single-arm, prospective, nonrandomized trial. Primary end points included stenosis relief, freedom from device-related serious adverse events or surgical intervention through 6 months, and maintenance of vessel lumen diameter on computed tomography or catheter angiography at 6 months.

Results: Forty-two patients (21 PAS, 15 recurrent CoA, and 6 native CoA) underwent Minima implantation at a median age and weight of 9 (range, 0.4-112) months and 7.8 (3.4-28.3) kg. Implantation was successful in 41 (97.6%) and resulted in a median increase in minimal vessel diameter of 131% (46%-483%) and reduction in median pressure gradients from 25 (0-63) to 0 (0-6; P<0.001) mm Hg in patients with CoA. Two acute PAS stent embolizations occurred; both stents were secured in the contralateral PA, and one was treated with an additional Minima stent. Seven patients with CoA, all under 6 kg, experienced transient femoral artery thrombosis. At 6 months, there were no explants or device-related serious adverse events. Luminal diameter was maintained at 89% (59%-137%) of the implant diameter. During a median follow-up of 596 (412-979) days, 13 (31%; 7 CoA and 6 PAS) patients underwent planned stent expansion without complications.

Conclusions: The Minima system is safe and effective for treating PAS and CoA in infants and small pediatric patients. Luminal patency was preserved, and planned reinterventions for somatic growth seem well-tolerated in early follow-up.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05086016.