Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results.

BACKGROUND: Severe tricuspid regurgitation (TR) is independently associated with increased morbidity and mortality. Percutaneous transcatheter approaches may offer an alternative for patients not amenable to surgery. METHODS: TriCLASP is a prospective, single-arm, multicenter European post-market clinical follow-up study (NCT04614402) to evaluate the safety and performance of the PASCAL system (Edwards Lifesciences) in patients with severe or greater TR. At 30 days, a composite of major adverse events (MAEs) adjudicated by a clinical events committee, echocardiographic parameters adjudicated by core laboratory, and clinical, functional, and quality-of-life measures were evaluated. RESULTS: Mean age of the 74 enrolled patients was 80.3 years, with 58.1% female, 90.5% systemic hypertension, and 77.0% in New York Heart Association (NYHA) class III/IV. Mean Society for Thoracic Surgeons score (MV repair) was 9.0%. TR severity was significantly reduced at discharge (p < 0.001) and sustained at 30 days (p < 0.001), and 90.0% of patients achieved ≤moderate TR. The composite MAE rate at 30 days was 3.0%, including 4 events in 2 patients: cardiovascular mortality 1.5%, stroke 1.5%, renal complications requiring unplanned dialysis or renal replacement therapy 1.5%, and severe bleeding 1.5%. There were no nonelective tricuspid valve reinterventions, major access site and vascular complications, major cardiac structural complications, or device embolizations. NYHA class I/II was achieved in 55.8%, 6-minute walk distance improved by 38.2 m (p < 0.001), and Kansas City cardiomyopathy questionnaire scores improved by 13.4 points (p < 0.001). CONCLUSION: Experience with the PASCAL transcatheter valve repair system in a European post-market setting confirms favorable safety and effectiveness at 30 days. TR significantly reduced, and clinical, functional, and quality-of-life outcomes significantly improved. This study is ongoing. Clinical Trial Registration: The study is ongoing and registered on ClinicalTrials.gov as NCT04614402. The current analysis is an interim report.

[Myocarditis in the differential diagnosis of cardiomyopathies. Endomyocardial biopsy or MRI?]. / Myokarditis in der Differenzialdiagnose von Kardiomyopathien. Endomyokardiale Biopsie oder MRT?

Myocarditis is an inflammatory disease of the heart muscle commonly caused by viral pathogens. Dilated cardiomyopathy is a major long-term sequela of myocarditis and at least in part related to post-viral immune-mediated responses. Establishing a diagnosis of myocarditis represents a major challenge because of the variable clinical picture and the lack of readily available, non-invasive diagnostic tests. In recent years, cardiac magnetic resonance imaging (cMRI) has emerged as a promising additional diagnostic tool in patients with suspected myocarditis: cMRI not only provides important insights into structural and functional abnormalities of the heart but relevant tissue pathologies can also be visualized. The diagnostic accuracy of three tissue criteria, i.e. the edema ratio, early gadolinium enhancement ratio and late gadolinium enhancement, has been characterized in several studies. Endomyocardial biopsy (EMB) is widely considered to be the reference standard for diagnosis of myocarditis. Although limited by sampling error, EMB is the only diagnostic procedure that can be used to confirm myocarditis. Laboratory analyses of EMB may provide information about specific causes of myocarditis and are, at least in part, of prognostic relevance. In a subset of patients the results of EMB may guide therapeutic decision-making. Additional efforts are needed in cardiac imaging, molecular characterization of EMB and evaluation of serum biomarkers to improve the diagnostic work-up in patients with suspected myocarditis and to identify potential novel targets for a cause-specific therapy of myocarditis.