Experience with the ACURATE neo and neo2 transcatheter aortic valves in Spain. The PRECISA (PRospective Evaluation Complementing Investigation with ACURATE devices) registry.

BACKGROUND: Previous studies have documented a high rate of implantation success with the ACURATE neo2 valve, as well as a reduction in paravalvular leak (PVL) compared to its predecessor, the ACURATE neo. However, there are no studies that have reviewed and compared the long-term clinical and hemodynamic outcomes of these patients. AIMS: This study aimed to evaluate the results of the ACURATE neo transcatheter aortic valve in a real-world context, and to compare the results of the outcomes of both generations of this device (ACURATE neo and ACURATE neo2), with a specific focus on procedural success, safety, and long-term effectiveness. METHODS: A prospective study including all consecutive patients treated with the ACURATE neo device in seven hospitals was conducted (Clinical Trials Identification Number: NCT03846557). The primary endpoint consisted of a composite of adverse events, including mortality, aortic insufficiency, and other procedural complications. As the second-generation device (ACURATE neo2) replaced the ACURATE neo during the study period, hemodynamic and clinical results before admission, at 30 days, and at 1 year of follow-up were compared between the two generations. RESULTS: A total of 296 patients underwent transcatheter aortic valve implantation with the ACURATE device, with 178 patients receiving the ACURATE neo and 118 patients receiving the ACURATE neo2. In the overall population, the absence of device success occurred in 14.5%. The primary reason for the absence of device success was the presence of para-valvular regurgitation ≥ 2. There were no instances of coronary occlusions, valve embolization, annulus rupture, or procedural deaths. ACURATE neo2 was associated with a significantly higher device success rate (91.7% vs. 82%, p = 0.04), primarily due to a significantly lower rate of para-valvular regurgitation, which remained significant at 1 year. CONCLUSION: The use of ACURATE neo and neo2 transcatheter aortic valves is associated with satisfactory clinical results and an extremely low rate of complications. The ACURATE neo2 enables a significantly higher device success rate, primarily attributed to a significant reduction in the rate of PVL.

Drug-Eluting Balloons in Calcified Coronary Lesions: A Meta-Analysis of Clinical and Angiographic Outcomes.

Background: The usefulness of drug-eluting balloons (DEBs) has not been fully elucidated in calcified coronary lesions (CCLs). This meta-analysis aimed to evaluate the efficacy of DEBs compared to a drug-eluting stent (DES) in this setting. Methods: PubMed, EMBASE and Cochrane were searched through December 2023. The primary endpoint was 12 months major adverse cardiac events (MACE). Secondary endpoints included clinical outcomes and angiographic results after PCI and at a 12-month follow-up. Results: Five studies and a total of 1141 patients with 1176 coronary lesions were included. Overall, the DEB was comparable to DES in MACE (RR = 0.86, 95% CI: 0.62-1.19, p = 0.36), cardiac death (RR = 0.59, 95% CI: 0.23-1.53, p = 0.28), myocardial infarction (RR = 0.89, 95% CI: 0.25-3.24, p = 0.87) and target lesion revascularization (RR = 1.1, 95% CI: 0.68-1.77, p = 0.70). Although the DEB was associated with worse acute angiographic outcomes (acute gain; MD = -0.65, 95% CI: -0.73, -0.56 and minimal lumen diameter; MD = -0.75, 95% CI: -0.89, -0.61), it showed better results at 12 months follow-up (late lumen loss; MD = -0.34, 95% CI: -0.62, -0.07). Conclusions: This meta-analysis showed that the DEB strategy is comparable to DES in the treatment of CCLs in terms of clinical outcomes. Although the DEB strategy had inferior acute angiographic results, it may offer better angiographic results at follow-up.

Percutaneous pulmonary thrombectomy with aspiration catheters in patients with high-risk pulmonary embolism and absolute contraindication to systemic thrombolysis.

BACKGROUND: High-risk Pulmonary Embolism (PE) mortality remains very high. Systemic thrombolysis is effective but carries significant complications and contraindications related to the hemorrhagic risk. Percutaneous thrombectomy using aspiration catheters may be an alternative in patients with a high bleeding risk. OBJECTIVE: This study aimed to evaluate the results of catheter-directed thrombectomy using aspiration dedicated catheters in patients with high-risk PE and absolute contraindication to systemic thrombolysis, with specific focus on procedural success, safety, and in-hospital outcomes. METHODS: A prospective study enrolled all consecutive patients diagnosed with high-risk pulmonary embolism and absolute contraindication to systemic thrombolysis, who underwent percutaneous pulmonary thrombectomy using dedicated aspiration catheters. The study documented the effectiveness and complications of the procedure, as well as patient outcomes at discharge and during the follow-up period. RESULTS: Thirteen patients underwent percutaneous pulmonary thrombectomy using aspiration dedicated catheters. The procedure was successful for all patients, resulting in hemodynamic and respiratory improvement within the first 24 h. No deaths attributable to cardiovascular or respiratory causes occurred during admission or follow-up. Furthermore, no serious adverse events or complications were reported during the procedure or hospitalization. CONCLUSIONS: Percutaneous pulmonary thrombectomy with dedicated aspiration catheters in patients with high-risk pulmonary embolism and contraindications to systemic thrombolysis was associated with excellent clinical results and low rate of complications.