American heart journal最新文献

Background: Transcatheter aortic valve implantation (TAVI) has emerged as an effective and safe treatment for patients with symptomatic aortic stenosis. The indication to TAVI should be agreed upon by a Heart Team, and the procedure should be performed in centers with on-site cardiac surgery. However, TAVI complications requiring emergent cardiac surgery (ECS) have become very rare. Concurrently, access disparities and prolonged waiting times are pressing issues due to increasing clinical demand of TAVI. Many solutions have been proposed and one of them is the possibility of performing TAVI in centers without on-site cardiac surgery.

Methods and design: The TRanscatheter Aortic-Valve Implantation with or without on-site Cardiac Surgery (TRACS) trial is a prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of outcomes. Patients with symptomatic severe aortic stenosis and deemed inoperable, at high surgical risk, or presenting with at least one clinical factor compromising the benefit/risk ratio for ECS, will be randomized to undergo TAVI either in centers with or without on-site cardiac surgery. The primary endpoint will be the composite occurrence of all-cause death, stroke, and hospital readmission for cardiovascular causes at one year. The safety endpoint will include death attributable to periprocedural complications actionable by ECS. The study aims to enroll 566 patients.

Implications: The TRACS trial aims to address critical gaps in knowledge regarding the safety and efficacy of TAVI procedures performed in centers without on-site cardiac surgery, potentially improving access and outcomes for high-risk patients.

Trial registration: ClinicalTrials.gov NCT05751577.

Background: Deep vein thrombosis (DVT) is a common medical condition that is associated with clinically significant sequelae, including postthrombotic syndrome (PTS). Anticoagulation alone remains the guideline-recommended treatment for many patients with iliofemoral DVT. Recent technological advances have led to an increase in the use of mechanical thrombectomy for DVT, but mechanical thrombectomy-based procedures have not yet been compared with standard-of-care anticoagulation therapy in randomized studies.

Methods: The DEFIANCE study (ClinicalTrials.gov: NCT05701917) is an international and actively enrolling randomized controlled trial (RCT) in lower extremity DVT assessing an interventional strategy that includes mechanical thrombectomy with the ClotTriever System (Inari Medical, Irvine, CA) versus anticoagulation alone. Approximately 300 patients with unilateral iliofemoral DVT and symptom duration ≤12 weeks will be randomized 1:1. Study conduct includes an independent core laboratory for duplex ultrasound assessment, an independent medical monitor for safety adjudication, and evaluation of PTS severity on the Villalta scale using best clinical practices. The primary endpoint is a composite outcome structured as a hierarchal win ratio of 1) the occurrence of treatment failure or therapy escalation as adjudicated by the medical monitor, with failure defined as amputation or gangrene of the target leg or venous thromboembolism-related mortality, and 2) the assessment of PTS severity at the 6-month follow-up visit. In addition to being a component of the primary endpoint, the severity of PTS at 6 months is also evaluated as a stand-alone secondary endpoint. An additional secondary endpoint is a composite of outcomes at the 10-day visit and is structured as a hierarchal win ratio of 1) vessel compressibility on duplex ultrasound, 2) patient-reported pain, and 3) improvement of edema. The safety endpoints are access site complications requiring endovascular or surgical repair and the occurrence through the 30-day visit of mortality, major bleeding, or new symptomatic pulmonary embolism.

Conclusions: DEFIANCE will be the first RCT to evaluate a mechanical thrombectomy-based interventional approach versus anticoagulation therapy alone for DVT. The results will inform the treatment of patients with iliofemoral DVT and the prevention of PTS-associated morbidity.

Trial registration: DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis (DEFIANCE), ClinicalTrials.gov: NCT05701917, URL: https://clinicaltrials.gov/study/NCT05701917?cond=Deep%20Vein%20Thrombosis&term=defiance&rank=1.

This cross-sectional study included 18,797 participants from six longitudinal cohorts (CARDIA, FHS Gen III, HCHS/SOL, MESA, MiHeart, and REGARDS). 5,806 of them were with high-sensitivity C-reactive protein (hs-CRP) measurements. We found that among exclusive electronic cigarette (EC) use was associated with significantly lower high-sensitivity C-reactive protein (hs-CRP) levels compared to exclusive combustible cigarette use, suggesting a potentially lower inflammatory burden. hs-CRP levels in dual users and former smokers currently using EC were comparable to those observed in exclusive cigarette smokers. In contrast, individuals who exclusively used ECs showed no significant difference in hs-CRP levels compared to never smokers. These findings have important implications for tobacco regulation, public health, and clinical practice, highlighting the need for continued monitoring of EC-related health impacts.

Background: The management of myocardial infarction without ST segment elevation (NSTEMI) in elderly patients remains challenging, in particular the benefit/risk balance of routine revascularization remains uncertain.

Study design: EVAOLD is s a multicenter, prospective, open-label trial with 2 parallel arms in NSTEMI patients ≥ 80 years of age. The aim of the trial is to test whether a strategy of selective invasive management guided by ischemia stress imaging (IMG group) will be non-inferior in preventing Major Adverse Cardiac and Cerebrovascular Events (MACCE, ie all-cause death, non-fatal myocardial infarction, non-fatal stroke) rates at 1 year compared with a routine invasive strategy (INV Group). Geriatric assessment and cost- effectiveness analysis will also be performed. A sample size of 1756 patients (assuming a 10% rate of patients lost to follow-up) is needed to show non-inferiority with 80% power. Non-inferiority based on exponential survival curves will be declared if the upper limit of the one-sided 97.5% confidence interval for the hazard ratio is lower than 1.24, corresponding to a non-inferiority margin of 7% in absolute difference and an event rate of 40% in the INV group.

Conclusion: EVAOLD is a nationwide, prospective, open-label trial testing the non-inferiority of a strategy of selective invasive management guided by ischemia stress imaging versus routine invasive strategy in elderly NSTEMI patients.

Clinicaltrials: gov Identifier: NCT03289728.

Background: The use of Extracorporeal Membrane Oxygenation (ECMO) remains associated with high rates of complications, weaning failure and mortality which can be partly explained by a knowledge gap on how to properly manage patients on ECMO support. To address relevant patient management issues, we designed a "Randomized Embedded Multifactorial Adaptive Platform (REMAP)" in the setting of ECMO (REMAP ECMO) and a first embedded randomized controlled trial (RCT) investigating the effects of routine early left ventricular (LV) unloading through intra-aortic balloon pumping (IABP).

Methods: REMAP ECMO describes a registry-based platform allowing for the embedding of multiple response adaptive RCTs (trial domains) which can perpetually address the effect of relevant patient management issues on ECMO weaning success. A first trial domain studies the effects of LV unloading by means of an IABP as an adjunct to veno-arterial (V-A) ECMO versus V-A ECMO alone on ECMO weaning success at 30 days in adult cardiogenic shock patients admitted to the Intensive Care Unit (ICU). The primary outcome of this trial is "successful weaning from ECMO" being defined as a composite of survival without the need for mechanical circulatory support, heart transplantation, or left ventricular assist device (LVAD) at 30 days after initiation of ECMO. Secondary outcomes include the need for interventional escalation of LV unloading strategy, mechanistic endpoints, survival characteristics until 1 year after ECMO initiation, and quality of life. Trial data will be analysed using a Bayesian statistical framework. The adaptive design allows for a high degree of flexibility, such as response adaptive randomization and early stopping of the trial for efficacy or futility. The REMAP ECMO LV unloading study is approved by the Medical Ethical Committee of the Erasmus Medical Center and is publicly registered.

Conclusion: This REMAP ECMO trial platform enables the efficient roll-out of multiple RCTs on relevant patient management issues. A first embedded trial domain will compare routine LV unloading by means of an IABP as an adjunct to V-A ECMO versus V-A ECMO alone.

Trial registration: ClinicalTrials.gov, NCT05913622.