Background: This retrospective study was proposed to investigate outcomes of patients with severe aortic stenosis (AS) after implementation of various treatment strategies following dedicated Heart Team (HT) decisions. Methods: Primary and secondary endpoints and quality of life during a median follow-up of 866 days of patients with severe AS qualified after HT discussion to: optimal medical treatment (OMT) alone, OMT and transcather aortic valve replacement (TAVR) or OMT and surgical aortic valve replacement (SAVR) were evaluated. As the primary endpoint composite of all-cause mortality, non-fatal disabling strokes and non-fatal rehospitalizations for AS were considered, while other clinical outcomes were determined as secondary endpoints. Results: From 2016 to 2019, 176 HT meetings were held, and a total of 482 participants with severe AS and completely implemented HT decisions (OMT, TAVR and SAVR for 79, 318 and 85, respectively) were included in the final analysis. SAVR and TAVR were found to be superior to OMT for primary and all secondary endpoints (p < 0.05). Comparing interventional strategies only, TAVR was associated with reduced risk of acute kidney injury, new onset of atrial fibrillation and major bleeding, while the superiority of SAVR for major vascular complications and need for permanent pacemaker implantation was observed (p < 0.05). The quality of life assessed at the end of follow-up was significantly better for patients who underwent TAVR or SAVR than in OMT-group (p < 0.05). Conclusions: We demonstrated that after careful implementation of HT decisions interventional strategies compared to OMT only provide superior outcomes and quality of life for patients with AS.
Background: Tricuspid regurgitation (TR) is a common valvular heart disease that often causes disabling symptoms. Caval valve implantation with the TricValve system is one of the transcatheter treatment options proposed for TR symptom reduction. With this prospective registry, we aim to summarize our early experience with TricValve system implantation. Methods: Registry participants, selected out of patients who were referred for TR treatment but who were not eligible for the transcatheter tricuspid edge-to-edge valve repair (T-TEER), were qualified for the caval valve implantation following a HeartTeam discussion. Results: Four patients (four women; median age 71 years; 67.5–77 years) in whom a one-year follow-up was completed were included in the study. The patients were highly symptomatic in the NYHA class III despite intensive diuretic treatment; all of them were considered a high-mortality risk during conventional cardiac surgery. The TricValve system was successfully implanted in all patients. At 6-month follow-up, we observed a reduction in symptoms in three out of four patients. Up to 12 months, only one patient survived, with a reduction in symptoms of NYHA class II; two patients died because of heart failure; one died due to a progression in neoplastic disease. Conclusions: In highly symptomatic TR patients who were not eligible for the T-TEER and who had a prohibitive risk of cardiac surgery, TricValve implantation led to a reduction in symptoms in a 6-month perspective. Long-term survival was limited mainly by heart failure progression and severe concomitant disorders. Further studies are needed to fully elucidate the role of caval valve implantation in the treatment of TR patients.
Subclinical leaflet thrombosis is an imaging phenomenon observed after transcatheter aortic valve implantation (TAVI) and characterized by hypoattenuating leaflet thickening (HALT) on computed tomography angiography. The clinical implications and underlying causes remain uncertain. Hypercoagulability, a component of Virchow’s triad, may contribute to thrombus formation on bioprosthetic leaflets, but data on hypercoagulable disorders in TAVI patients and their impact on HALT are limited. The PROSTHESIS study (Prothrombotic States in Transcatheter Heart Valve Subclinical Leaflet Thrombosis) is a single-center observational cohort study aiming to include 130 TAVI patients. This pilot study aimed to (i) assess the effect of hypercoagulable disorders on HALT prevalence and (ii) evaluate their impact on the natural history of HALT. Patients were screened for common hypercoagulable disorders using genetic and functional assays and underwent multimodal imaging one year after TAVI to detect HALT. In patients with HALT, post-implant imaging was repeated after three months to assess its progression. Early results comparing 52 TAVI patients with 52 matched controls undergoing coronary angiography showed similar thrombophilia prevalence between the groups (16% vs. 12%, p = 0.565). HALT occurred in 15% of TAVI patients, more extensively in those with thrombophilia (712 mm3 vs. 135 mm3, p = 0.036). However, thrombophilia was not an independent predictor of HALT. One-year follow-up CTA revealed spontaneous HALT resolution in 63%, stability in 25%, and progression in 12%. This study aims to provide insights into HALT and its mechanisms, which may help prevent complications and improve bioprosthesis durability.
1 February 2019 in International Journal of Cardiology
Background Transcatheter tricuspid edge-to-edge repair (T-TEER) is the most widely used treatment option for patients with tricuspid regurgitation (TR). In real-world practice, a substantial proportion of referred patients are not eligible for T-TEER or do not achieve an adequate early TR reduction and may therefore require alternative transcatheter tricuspid valve interventions (TTVI) – orthotopic or heterotopic tricuspid valve implantation. The aim of the study was to characterize patients with severe TR referred for transcatheter treatment, and identify patients in whom alternative TTVI may be required. Methods The CAPTURE Study (NCT 06838611) enrolls consecutive patients referred for TR treatment. All patients undergo clinical and echocardiographic assessment to determine eligibility for T-TEER. Candidates for TTVI other than T-TEER were defined as patients disqualified from T-TEER due to anatomical ineligibility or those with unsuccessful T-TEER, defined as next-day TTE showing TR more than moderate. This pilot analysis includes patients enrolled from November 2023 to December 2024. Results 147 patients were enrolled, 77 (52.4%) patients were qualified for T-TEER and the procedure was performed in 71 (48.3%) patients, with successful TR reduction in 55 cases (77.5% of treated patients); a subset of 34 patients (23.1%) was identified as potential candidates for alternative TTVIs. These patients exhibited more advanced TR (torrential TR 76.5% vs. 18.2%; p<0.001) and right heart failure symptoms (ascites 44.1% vs. 12.7%; p<0.001). Additionally, they had significantly higher bilirubin concentration (1.09 [1.20] mg/dl vs. 0.61 [0.42] mg/dl; p=0.003), lower hemoglobin level (11.8 [1.7] g/dL vs. 12.3 [1.7] g/dL; p=0.017) and platelet count (161.0 [51.0] x 109/L vs. 183.0 [79.0] x 109/L; p=0.015) suggesting an increased bleeding risk. Conclusions In this preliminary single-center real-world cohort, approximately half of patients with severe TR were eligible for T-TEER, whereas more than 20% emerged as potential candidates for alternative TTVI strategies. This subgroup was characterized by more advanced right-sided remodeling and laboratory features suggestive of hepatic dysfunction and increased bleeding risk, which may have important implications for Heart Team decision-making and procedural planning.