Cardiovascular Intervention and Therapeutics最新文献

The relation between Body Mass Index (BMI) and adverse outcomes after endovascular therapy (EVT) for patients with lower extremity artery disease (LEAD) remains incompletely understood. From April 2010 to March 2020, 199 consecutive patients who underwent EVT for LEAD were retrospectively analyzed. The patients were divided into three groups based on BMI; underweight < 18.5 kg/m², normal weight ≥ 18.5 and < 25.0 kg/m², and overweight ≥ 25.0 kg/m². The endpoint of this study was a composite of all-cause mortality, major amputation, and major bleeding. Patients who were underweight often exhibited anemia (53.3 vs. 22.3 vs. 15.4%, respectively; p = 0.001) and severe chronic kidney disease (50.0 vs. 30.8 vs. 20.5%, respectively; p = 0.03). Furthermore, these patients had higher incidences of Trans-Atlantic Inter-Society Consensus class C or D lesions (40.0 vs. 20.0 vs. 10.3%, respectively; p = 0.01). During the median follow-up duration of 3.6 years (interquartile range: 1.2 to 6.7 years), there were 73 incidents of the composite endpoint. When the overweight group was assigned as the reference group, the adjusted hazard ratios for the composite endpoint for the underweight and normal weight patients were 3.67 (95% confidence interval [CI] 1.39-10.83, p = 0.008) and 2.35 (95% CI 1.06-6.23, p = 0.03), respectively. Kaplan-Meier curve demonstrated that the freedom from the composite endpoint for underweight, normal weight, and overweight patients was 41.6%, 60.0%, 83.8%, respectively (p < 0.001). These results suggest that there was an inverse association between BMI and adverse outcomes composed of mortality, limb amputation, and bleeding in patients with LEAD undergoing EVT.

This study aims to evaluate the safety and efficacy of the dedicated Inno-Xmart braided venous stent system (Suzhou Innomed Medical Device Co., Ltd., Jiangsu, China) in treating symptomatic iliofemoral venous obstruction. This clinical study followed a prospective, multicentre, single-arm design with the application of an objective performance goal. Patients diagnosed with symptomatic iliofemoral venous obstruction who met the eligibility criteria of this study were enrolled and treated with the Inno-Xmart venous stent system. The safety endpoints included the assessment of stent fracture, satisfaction of delivery system and 12-month incidence rate of major adverse events (MAEs). The primary efficacy endpoint focused on evaluating the 12-month primary patency rate through venography as determined by core laboratory. Secondary efficacy endpoints included surgical success rate, 6-month primary patency rate and the changes in quality of life from baseline to 6- and 12-month follow-up intervals. Between September 18, 2019, and April 26, 2021, 193 patients were successfully enrolled across 18 research institutions. The surgical success rate was 95.3% (184/193), the 12-month MAE rate was 5.1% (9/178) with no stent fractures or migrations. The 12-month primary patency rate for the participants was 96.1%, significantly surpassing the literature-derived objective performance of 80% (95% confidence interval [CI], 92.1-98.4; P < 0.0001). In addition, the mean venous clinical severity score (VCSS) and Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) scores at the 6- and 12-month follow-ups were significantly lower than the preoperative scores (P < 0.001). The innovative, dedicated braided venous stent designed to address symptomatic iliofemoral venous obstruction demonstrates a high technical success rate, low complication rates, and impressive mid-term (12-month) patency. It effectively enhanced the quality of life for patients and holds promising prospects for a wide range of applications. The clinical study was officially registered in the "Chinese Clinical Trial Registry" (Registration number: ChiCTR2000040216, date of registration: November 25th, 2020).

Primary Percutaneous Coronary Intervention (PCI) has significantly contributed to reducing the mortality of patients with ST-segment elevation myocardial infarction (STEMI) even in cardiogenic shock and is now the standard of care in most of Japanese institutions. The Task Force on Primary PCI of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) proposed an expert consensus document for the management of acute myocardial infarction (AMI) focusing on procedural aspects of primary PCI in 2018 and updated in 2022. Recently, the European Society of Cardiology (ESC) published the guidelines for the management of acute coronary syndrome in 2023. Major new updates in the 2023 ESC guideline include: (1) intravascular imaging should be considered to guide PCI (Class IIa); (2) timing of complete revascularization; (3) antiplatelet therapy in patient with high-bleeding risk. Reflecting rapid advances in the field, the Task Force on Primary PCI of the CVIT group has now proposed an updated expert consensus document for the management of ACS focusing on procedural aspects of primary PCI in 2024 version.

Critical limb ischemia (CLI) is associated with systemic cardiovascular and non-cardiovascular diseases. Treatments primarily targeting limb-related outcomes may not improve overall life prognosis. We aimed to describe in-hospital mortality and the underlying etiologies in Japanese patients with CLI. We analyzed the Diagnosis Procedure Combination (DPC) database from approximately 1200 Japanese acute-care hospitals between April 2018 and March 2020. The definition of patients with CLI was based on the diagnostic codes listed as the most resource-intensive diagnosis and information regarding invasive procedures (endovascular treatment, bypass, or amputation). The DPC database provides information on whether in-hospital death was caused by the most resource-intensive diagnosis. Among 15,228 distinct patients with CLI, we identified 18,970 records, including 5,378 amputations. In-hospital death occurred in 1238 (6.5%) patients. Among them, 811 (65.5%) were due to causes unrelated to CLI. In patients who underwent amputation (n = 5378), causes unrelated to CLI accounted for 70.0% of in-hospital deaths, whereas among patients who did not undergo amputation (n = 13,592), this proportion was 60.1%. When compared to patients who died due to causes related to CLI, the prevalence of male patients was higher (62.6% vs 52.7%, p = 0.001), and amputation was more frequently performed (58.0% vs 47.1%, p < 0.001) in those who died due to causes unrelated to CLI. The majority of in-hospital deaths among patients with CLI necessitating endovascular treatment, bypass, or amputation were attributable to factors unrelated to the primary condition of CLI. Managing systemic cardiovascular and non-cardiovascular diseases beyond the affected limb is crucial to improve the prognosis of these patients.

The MitraClip G4 device has controlled gripper actuation (CGA) system, which allows the anterior and posterior grippers operate separately in transcatheter edge-to-edge repair (TEER). We investigated the indications and outcomes of the use of CGA system during TEER for significant mitral regurgitation (MR). We reviewed 158 patients undergoing TEER with MitraClip G4 from September 2020 to July 2023. The CGA indications were: (1) for grasping and (2) for leaflet insertion confirmation. Leaflet grasping was completed with CGA in 18 patients (11 and 7 patients for grasping and leaflet insertion confirmation, respectively). Patients with flail leaflets or coaptation gap more frequently required CGA, indicating more complex mitral valve anatomy. The procedural success and adverse event rates (death, leaflet tear and single leaflet device attachment) were not different between the CGA and non-CGA groups. In patients requiring CGA, single leaflet device attachment was observed in 1 patient and leaflet tear in 1 patient during follow-up. In these two cases, CGA was required for grasping, and the clip was moved over a large distance (6.5 and 12.4 mm, respectively). In patients who had undergone CGA for confirmation, no device-related adverse event or MR recurrence was noted. In patients with complex mitral valve anatomy, CGA may be a safe and effective method for confirming leaflet insertion. It should be noted that when using CGA for leaflet grasping, especially when the clip is moved significantly, attention should be paid to leaflet adverse events.