Cardiovascular Intervention and Therapeutics最新文献

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).

Background: The tip-detection method and the retrograde approach have been acknowledged as a second-line strategies for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) when conventional antegrade wiring strategies are ineffective. The aim of this study is to compare the efficacy between both strategies for complex CTO PCI.

Methods: We retrospectively enrolled 170 consecutive CTO PCI cases and separated them into 295 adopted strategies. The rate of successful lesion crossing and its association with the time spent for each strategy were compared between the tip-detection method and the retrograde approach.

Results: We observed fifty-six attempts with the tip-detection methods with 46 (82.1%) successful lesion crossings. Sixty-one retrograde approaches were performed, in which 29 (47.5%) cases achieved procedural success. In the successful attempts, the wire-manipulation time was significantly shorter in the tip-detection method [20.0 (12.2-36.7) min] than the retrograde approach [35.0 (20.7-49.7) min] (p = 0.008). Cox-regression analysis showed time-dependent advantage for the tip-detection method over the retrograde approach [hazard ratio (HR) = 2.93, 95% CI = 1.84-4.67, p < 0.001]. Incomplete tip-detection CTO crossing (taking > 30 min) was seen in severely tortuous lesions [odds ratio 0.26, 95% confidence interval 0.06-0.97, p = 0.037].

Conclusion: The tip-detection method can reduce the wire-manipulation time for successful CTO PCI compared with the retrograde approach. However, the success rate of the tip-detection method is hampered by severe lesion tortuosity.

Balloon pulmonary angioplasty (BPA) is an innovative treatment for chronic thromboembolic pulmonary hypertension (CTEPH). We retrospectively examined the clinical outcomes and complications of BPA at Yokohama City University Hospital (YCUH) between 2012 and 2018. In 2012, we began to conduct BPA sessions in 46 patients with inoperable CTEPH; 34 completed the BPA scheme and the follow-up plan. A longitudinal sub-analysis was performed with cohorts 1 and 2 receiving BPA before and after April 2015. Significant improvements in the mean pulmonary arterial pressure, pulmonary vascular resistance, and other parameters were detected after BPA. The total rate of thoracic complications was 25%. Specifically, the increase in SaO₂ and home oxygen therapy discontinuation rate, and oral riociguat discontinuation rate was significantly higher in cohort 2 (+ 7.7, 75, and 59%) compared to cohort 1 (+ 3.1, 27, and 10%) (P < 0.05). Moreover, the need for non-invasive positive pressure ventilation was significantly lower: 0% (cohort 2) vs. 7% (cohort 1) (P < 0.05). The BPA sessions conducted at the YCUH resulted in significant improvements in patients with CTEPH. This study demonstrates a clear learning curve regarding the effectiveness of BPA both in normalizing SaO₂ and facilitating the cessation of home oxygen therapy, as well as in reducing the incidence of severe complications.

Intravascular ultrasound (IVUS) has become a standard procedure for performing coronary intervention, but its impact on peripheral endovascular therapy (EVT) remains unclear. To assess the usefulness of IVUS during EVT, this study analyzed over 2000 consecutive patients from the TOkyo-taMA peripheral vascular intervention research COmraDE (TOMA-CODE) registry with peripheral arterial disease (PAD) in Japan. The primary outcome was chronic limb events (a composite of clinically driven target lesion revascularization (cTLR) and major amputation) during a two-year follow-up period. The secondary outcomes included the procedural success rate, in-hospital major adverse limb events (MALE), and major cardiac and cerebrovascular events (MACCE). Patients with and without IVUS were compared using propensity score matching. Among the 2227 eligible cases enrolled, with a median follow-up period of 10.4 months, there were no significant differences in limb events between IVUS (784 patients) and non-IVUS (1443 patients) groups during the follow-up period (15.4% vs. 14.4%, P = 0.53, unadjusted; 14.8% vs. 15.4%, P = 0.77, adjusted). In contrast, the IVUS group had higher procedural success rates (98.7% vs. 96.7%, P = 0.02) and lower in-hospital MALE (1.6% vs. 4.1%, P = 0.01), even after multiple adjustments. Additionally, there was no significant difference in the MACCE incidence (10.9% vs. 12.2%, P = 0.47) between the groups. This study demonstrated that IVUS usage did not reduce the occurrence of limb events among EVT patients in the chronic phase, but IVUS may improve in-hospital outcomes. Further research is necessary to verify these findings.