Background: Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcification to enhance vessel compliance and optimize stent deployment. The Disrupt CAD IV study enrolled patients with severe coronary artery calcification. The primary safety (30-day major adverse coronary events [MACE], 6.3%) and effectiveness (procedural success, 93.8%) endpoints were achieved. The present analysis evaluated the 2-year outcomes of the study.

Methods and Results: Disrupt CAD IV (NCT04151628) was a prospective, single-arm, multicenter study designed for regulatory approval of the Shockwave Coronary C²IVL system in Japan. Angiographic outcomes were analyzed by an independent core laboratory and adverse events were adjudicated by a Clinical Events Committee. Kaplan-Meier analysis was performed for MACE (composite of cardiac death, MI or target-vessel revascularization [TVR]), target lesion failure (TLF: composite of cardiac death, TV-MI, and target lesion revascularization [TLR]), and stent thrombosis (ST). At 2 years, 62 subjects had completed follow-up. MACE occurred in 12.6% (cardiac death 0.0%, MI 6.3%, TVR 7.9%) and TLF occurred in 7.8% of patients, with both rates driven by non-Q-wave MI events (6.3%). TLR was 3.2%; no ST occurred through 2 years.

Conclusions: Treatment with IVL in patients with severely calcified coronary lesions was associated with low rates of MACE, TLR, and ST at 2 years, demonstrating continued durable safety and effectiveness of coronary IVL in a Japanese population.

Background: A high score for controlling nutritional status (CONUT) due to poor nutritional status has been associated with adverse outcomes in patients with chronic heart failure. However, because little is known about the effect of CONUT score on mortality rates after transcatheter mitral valve repair, we evaluated nutrition screening tools for prognosis prediction in patients undergoing transcatheter mitral valve repair using the MitraClip^TMsystem.

Methods and Results: We retrospectively analyzed 148 patients with severe mitral regurgitation (MR) who underwent MitraClip^TMimplantation between April 2018 and April 2021. The preprocedural CONUT scores were assessed at the time of hospitalization, the primary outcome was all-cause death, and the analysis was of the mortality and incidence rates of cardiac events 1 year post-operation. Functional MR was of ischemic origin in the majority of patients (69.6%), with a mean left ventricular ejection fraction of 48.9±15.8%. Kaplan-Meier curves indicated that all-cause death was significantly worse in the high-CONUT score group than in the low-CONUT score group. Cox hazard analysis showed a significant association between all-cause death and CONUT score, as well as MitraScore.

Conclusions: Preprocedural CONUT score, as well as MitraScore, in patients undergoing transcatheter edge-to-edge mitral valve repair may predict an increased risk of all-cause death. This knowledge should allow the heart team to accurately assess the clinical implications and prognostic benefits of the procedure in individual patients.

Background: Subclinical leaflet thrombosis occasionally occurs after transcatheter aortic valve implantation (TAVI), but its exact etiology and relationship with thrombogenicity remain unknown.

Methods and Results: This study enrolled 35 patients who underwent TAVI. Thrombogenicity was evaluated using a total thrombus-formation analysis system (T-TAS) to compute the thrombus-formation area under the curve (PL₁₈-AUC₁₀and AR₁₀-AUC₃₀). Periprocedural thrombogenic parameters including T-TAS were investigated at pre-TAVI, 2 days, 7 days, and 3 months post-TAVI. Hypoattenuated leaflet thickening (HALT) and maximum leaflet thickness (MLT) were evaluated using contrast-enhanced computed tomography 7 days and 3 months post-TAVI. The associations between thrombogenicity and HALT or MLT were assessed. T-TAS parameters consistently decreased at 2 and 7 days post-TAVI, followed by improvement at 3 months. HALT was detected in 20% and 17% of patients at 7 days and 3 months, respectively, post-TAVI. The median MLT value was 1.60 mm at 7 days and 3 months post-TAVI. A significant positive correlation was observed between the decrease in the AR₁₀-AUC₃₀and MLT at 7 days post-TAVI. Univariate linear regression analysis revealed a decrease in the AR₁₀-AUC₃₀and an increase in the D-dimer level as a significant predictor of MLT deterioration.

Conclusions: The findings suggested that a transient decrease in thrombogenicity following TAVI predicts leaflet thrombosis, implying that monitoring thrombogenicity may be useful for predicting progression of leaflet thrombosis.

Background: The low implementation rate of guideline-directed medical therapy for heart failure (HF) remains a problem worldwide. To address this issue, we hypothesized that a smartphone application (app) based on behavioral economics that nudges physicians and patients towards optimal medical therapy would be a scalable approach.

Methods and Results: The app prototype was developed, and its usability was tested with 5 HF patients in the outpatient setting. Adherence to the app was outstanding, with a high usability rating from the patients.

Conclusions: It appears feasible to further study our app in a larger cohort to evaluate its efficacy.