Single-center five-year outcomes after interventional edge-to-edge repair of the mitral valve

Background: The MitraClip procedure was established as a therapeutic alternative to mitral valve surgery for symptomatic patients with severe mitral regurgitation (MR) at prohibitive surgical risk. In this study, the aim was to evaluate 5-year outcomes after MitraClip.Methods: Consecutive patients undergoing the MitraClip system were prospectively included. All patients underwent clinical follow-up and transthoracic echocardiography.Results: Two hundred sixty-five patients (age: 81.4 ± 8.1 years, 46.7% female, logistic EuroSCORE: 19.7 ± 16.7%) with symptomatic MR (60.5% secondary MR [sMR]). Although high procedural success of 91.3% was found, patients with primary MR (pMR) had a higher rate of procedural failure (sMR: 3.1%, pMR: 8.6%; p = 0.04). Five years after the MitraClip procedure, the majority of patients presented with reduced symptoms and improved functional capacity (functional NYHA class: p = 0.0001; 6 minutes walking test: p = 0.04). Sustained MR reduction (≤ grade 2) was found in 74% of patients, and right ventricular (RV) function was significantly increased (p = 0.03). Systolic pulmonary artery pressure (sPAP) was significantly reduced during follow-up only in sMR patients (p = 0.05, p = 0.3). Despite a pronounced clinical and echocardiographical amelioration and low interventional failure, 5-year mortality was significantly higher in patients with sMR (p = 0.05). The baseline level of creatinine (HR: 0.695), sPAP (HR: 0.96) and mean mitral valve gradient (MVG) (HR: 0.82) were found to be independent predictors for poor functional outcome and mortality.Conclusions: Transcatheter mitral valve repair with the MitraClip system showed low complication rates and sustained MR reduction with improved RV function and sPAP 5 years after the procedure was found in all patients, predominantly in patients with sMR. Despite pronounced functional amelioration with low procedure failure, sMR patients had higher 5-year mortality and worse outcomes. Baseline creatinine, MVG, and sPAP were found to be independent predictors of poor functional outcomes and 5-year mortality

Pulmonary Hypertension in Patients with Chronic Kidney Disease on Dialysis and without Dialysis: Results of the PEPPER-Study

Pulmonary hypertension (PH) is common in patients with dialysis-dependent chronic kidney disease and is an independent predictor of mortality. However, specific hemodynamics of the pulmonary circulation, changes induced by hemodialysis and characterization into pre- or postcapillary PH have not been evaluated in patients with chronic kidney disease. We assessed consecutive patients with end-stage chronic kidney disease in WHO FC≥II with dyspnea unexplained by other causes on hemodialysis (group 1, n = 31) or without dialysis (group 2, n = 31) using right heart catheterization (RHC). In group 1, RHC was performed before and after dialysis. In end-stage chronic kidney disease, prevalence of precapillary PH was 13% (4/31), and postcapillary PH was discovered in 65% (20/31). All four cases of precapillary PH were unmasked after dialysis. In group 2, two cases of precapillary PH were detected (6%), and postcapillary PH was diagnosed in 22 cases (71%). This is the first study examining a large cohort of patients with chronic kidney disease invasively by RHC for the prevalence of PH. The prevalence of precapillary PH was 13% in patients with end-stage kidney disease. That suggests careful screening for precapillary PH in this selected patient population. RHC should be performed after hemodialysis

Left atrial thrombus resolution in atrial fibrillation or flutter:Results of a prospective study with rivaroxaban (X-TRA) and a retrospective observational registry providing baseline data (CLOT-AF)

BackgroundData on left atrial/left atrial appendage (LA/LAA) thrombus resolution after non–vitamin K antagonist (VKA) oral anticoagulant treatment are scarce. The primary objective of X-TRA was to explore the use of rivaroxaban for the resolution of LA/LAA thrombi in patients with nonvalvular atrial fibrillation (AF) or atrial flutter, with the CLOT-AF registry providing retrospective data after standard-of-care therapy in this setting.MethodsX-TRA was a prospective, single-arm, open-label, multicenter study that investigated rivaroxaban treatment for 6 weeks for LA/LAA thrombus resolution in patients with nonvalvular AF or atrial flutter and LA/LAA thrombus confirmed at baseline on a transesophageal echocardiogram (TEE). CLOT-AF retrospectively collected thrombus-related patient outcome data after standard-of-care anticoagulant treatment for 3 to 12 weeks in patients with nonvalvular AF or atrial flutter who had LA/LAA thrombi on TEE recorded in their medical file.ResultsIn X-TRA, patients were predominantly (95.0%) from Eastern European countries. The adjudicated thrombus resolution rate was 41.5% (22/53 modified intention-to-treat [mITT] patients, 95% CI 28.1%-55.9%) based on central TEE assessments. Resolved or reduced thrombus was evident in 60.4% (32/53 mITT patients, 95% CI 46.0%-73.6%) of patients. In CLOT-AF, the reported thrombus resolution rate was 62.5% (60/96 mITT patients, 95% CI 52.0%-72.2%) and appeared better in Western European countries (34/50; 68.0%) than in Eastern European countries (26/46; 56.5%).ConclusionX-TRA is the first prospective, multicenter study examining LA/LAA thrombus resolution with a non-VKA oral anticoagulant in VKA-naïve patients or in patients with suboptimal VKA therapy. Rivaroxaban could be a potential option for the treatment of LA/LAA thrombi

Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: Results of a multicenter, single-blind, interindividual, randomized clinical phase III trial

The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine, for magnetic resonance imaging (MRI) in patients with known or suspected focal renal lesions. Using a multicenter, single-blind, interindividual, randomized study design, both contrast agents were compared in a total of 471 patients regarding their diagnostic accuracy, sensitivity, and specificity to correctly classify focal lesions of the kidney. To test for noninferiority the diagnostic accuracy rates for both contrast agents were compared with CT results based on a blinded reading. The average diagnostic accuracy across the three blinded readers ('average reader') was 83.7% for gadobutrol and 87.3% for gadopentate dimeglumine. The increase in accuracy from precontrast to combined precontrast and postcontrast MRI was 8.0% for gadobutrol and 6.9% for gadopentate dimeglumine. Sensitivity of the average reader was 85.2% for gadobutrol and 88.7% for gadopentate dimeglumine. Specificity of the average reader was 82.1% for gadobutrol and 86.1% for gadopentate dimeglumine. In conclusion, this study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentate dimeglumine in the diagnostic assessment of renal lesions with CE-MRI