Cardiovascular Center Bethanien

The 21st Century Cures Act, which took effect in January2021, allowed Medicare beneficiaries with end-stage renal disease to enroll in Medicare Advantage (MA) plans. The dialysis industry is highly concentrated, with two large chains providing 75percent of Medicare dialysis treatments. Their market dominance allows them to negotiate substantially higher dialysis reimbursements from MA plans than from traditional Medicare, making MA enrollment financially beneficial to them. Applying a difference-in-differences approach to Medicare enrollment and claims data from the period 2017-22, we found that MA enrollment increased by a 5.7-percentage-point higher rate among patients treated in chain-owned facilities relative to those treated in independent facilities after the Cures Act, for an increase of 130percent of the pre-Cures Act mean within chain facilities. The differential MA growth in chain facilities was larger for racial and ethnic minority, dual-eligible, and rural patients. These findings suggest that the Cures Act may increase the financial strength of chain facilities, with disproportionate increases in MA enrollment among low-income and racial and ethnic minority populations with kidney failure who are treated in these facilities.

Heavy menstrual bleeding (HMB) is a common complication of anticoagulant therapy in menstruating women with venous thromboembolism (VTE). Direct oral anticoagulants (DOAC) used for VTE treatment may differ in their menstrual bleeding profiles. Therefore, the prospective multicenter noninterventional investigator-initiated HEMBLED registry (HE: avy M: enstrual BLE: eding in patients treated with D: OAC) was performed to analyze spontaneous menstrual bleeding in women treated with therapeutic DOAC doses.A modified pictorial blood assessment chart (PBAC) score was used to define the severity of menstrual bleeding. Patients were only included when they did not use hormonal or intrauterine contraception methods. The prospective follow-up was 4 months. The primary endpoint was the comparison of the PBAC scores between the individual DOAC groups.Overall, 73 patients with 213 monthly assessments of the PBAC scores were analyzed. Patients were on average 35 years old and were anticoagulated with apixaban (62%), rivaroxaban (26%), edoxaban (7%), or dabigatran (6%). The PBAC scores of the rivaroxaban group (mean: 145 points) were significantly increased by 54% compared with the apixaban group (mean: 93 points, p = 0.0193). HMB (PBAC score > 100 points) at least once was detected in 53% of the apixaban group compared with 79% of the rivaroxaban group (p = 0.0913). The duration of menstrual bleeding was numerically shorter in the apixaban group compared with the rivaroxaban group (p = 0.1894).DOAC differ in their influence on the intensity of spontaneous menstrual bleeding. This should be taken into account when advising young women with VTE who need an oral anticoagulant.

BackgroundVOYAGER PAD (Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities) demonstrated that antiplatelet therapy with rivaroxaban 2.5 mg twice daily compared with placebo reduced the first event in a composite end point in patients with peripheral artery disease after revascularization. The purpose of this analysis was to (1) evaluate whether rivaroxaban decreased the most severe events and (2) compare the harm and benefit of rivaroxaban on the same scale.MethodsTwo exploratory, hierarchical analyses of the primary efficacy composite outcome and one exploratory analysis of the net clinical benefit composite outcome were prespecified. The global rank method and the win ratio method ranked components of the composite outcome by clinical importance. The net clinical benefit included both efficacy and safety outcomes.ResultsThe global rank method demonstrated that participants on rivaroxaban had fewer or later events than their placebo counterparts when events were compared in a hierarchical manner (primary ranking, P=0.0158). The win ratio approach demonstrated fewer or later fatal and nonfatal ischemic events in the rivaroxaban arm (win ratio, 1.16 [95% CI, 1.03–1.30]; P=0.0167). The net clinical benefit analysis revealed an overall beneficial effect of rivaroxaban when different efficacy and safety end points were included (P<0.001).ConclusionsEvaluation of the VOYAGER PAD primary outcome exploring ranking of components revealed that (1) rivaroxaban decreased the most severe ischemic events and (2) that across different efficacy and safety outcomes, results consistently supported a favorable benefit–risk profile. These results help inform shared decision making on the use of rivaroxaban 2.5 mg twice daily with daily antiplatelet therapy.RegistrationURL: https://www.clinicaltrials.gov; unique identifier: NCT02504216.

Patients with tricuspid regurgitation (TR) are at high risk for morbidity and mortality, with poorer outcomes associated with increasing TR severity. Tricuspid transcatheter edge-to-edge repair (T-TEER) has emerged as a promising treatment option. TriCLASP is a prospective, single-arm, European post-market study evaluating the safety and effectiveness of T-TEER with the PASCAL system to treat patients with ≥severe TR. The TriCLASP study enrolled 300 patients to evaluate the safety and performance of T-TEER. Major adverse events (MAE), reduction in TR grade, and clinical, functional, and quality-of-life outcomes were assessed at 1 year. Enrolled patients had a mean age of 80.1 years, 52.0% were female, and 75.8% had ≥severe TR. Tricuspid regurgitation was reduced to ≤moderate in 87.7% of patients (p<0.001). The composite MAE rate was 1.7% at 30 days and 12.7% at 1 year. Kaplan-Meier estimates for survival and freedom from heart failure hospitalisation (HFH) were 88.3±1.9% and 83.2±2.3%, respectively. Annualised HFH rates decreased by 72.2% in the 12 months pre- versus post-procedure (p<0.001). Significant functional and quality-of-life improvements were observed from baseline to 1 year, including 74.5% of patients in New York Heart Association Class I/II, a 29.4-metre increase in the 6-minute walk distance, and an 8.3-point increase in the Kansas City Cardiomyopathy Questionnaire score (p<0.001). The 1-year results of the TriCLASP study confirm the safety and effectiveness of T-TEER with the PASCAL system in patients with ≥severe TR. Patients experienced significant TR reduction, low mortality, high freedom from HFH, and significant improvements in symptoms, functional capacity, and quality of life.

Interventional closure of symptomatic paravalvular leaks (PVL) after valve replacement has developed to an attractive treatment option for patients at high operative risk. However, prospective and long-term data are sparse. We analysed data from a multicentre prospective registry on interventional PVL closure. 41 patients with symptomatic PVL were included in the plug registry at nine German hospitals from 2014 until 2020. In total 50 interventions with 67 plug implantations were recorded, 46.3% of procedures were performed for aortic and 53.7% for mitral PVLs. In 82% of patients PVL closure was performed once, in 16% twice and 2% underwent three procedures. Indication for PVL closure was symptomatic heart failure with NYHA class ≥ II (63.4%), haemolysis (4.9%), or NYHA class ≥ II and haemolysis (31.7%). PVL closure was completely successful in 76%, partially successful in 10% and failed in 14%. Acute improvement of one NYHA class was achieved in 56.4% and of two NYHA classes in 15.4%. Postprocedural no residual severe aortic PVL was described and residual severe mitral PVL was seen in 4.8%. Postinterventional complications occurred in 21.9%. In-hospital mortality rate was 4.9%. A follow-up was performed after 30days, 12months, 3 and 5years. Calculated mortality rates were 10.1% at 1-year-, 18.5% at 3-year- and 32.5% at 5-year-follow-up. The estimated rates for mortality and/or reintervention (surgical or interventional) were 25.6% at 1-year, 36.8% at 3-year and 45.1% at 5-year follow-up. The multicentre German Plug-Registry describes a high procedural success rate with clinical improvement in most patients and acceptable long-term outcomes after percutaneous PVL closure. NCT03179969.