Comparison of Direct Oral Anticoagulants vs Vitamin K Antagonists After Transcatheter Mitral Valve Replacement.

BACKGROUND: There is currently no established recommendation for antithrombotic treatment following transcatheter mitral valve replacement (TMVR). However, based on the analogy with surgical mitral bioprosthesis, vitamin K antagonists (VKAs) are predominantly used. OBJECTIVES: The purpose of this study was to compare bleeding and thrombotic events associated with direct oral anticoagulants (DOACs) or VKAs in a prospective cohort of TMVR patients. METHODS: We enrolled consecutive patients who underwent transseptal TMVR using a SAPIEN family prosthesis at our center between 2011 and 2023. The primary outcome was the occurrence of bleeding. VKAs were administered to patients until October 2019, after which DOACs were prescribed. The median follow-up was 4.7 months (Q1-Q3: 2.6-6.7 months). RESULTS: A total of 156 patients were included. The mean age was 65 ± 18.5 years, and 103 patients (66%) were women. The median EuroSCORE II was 7.48% (Q1-Q3: 3.80%-12.97%). Of the participants, 20.5% received DOACs and 79.5% were treated with VKAs. The primary outcome was observed in 50 (40%) patients in the VKA group and 3 (9%) patients in the DOAC group (adjusted HR: 0.21; 95% CI: 0.06-0.74; P = 0.02). Treatment with DOAC was associated with a shorter length of hospital stay. No significant differences were found in terms of thrombotic events, major vascular complications, stroke, or death. CONCLUSIONS: The use of DOACs after TMVR, compared with VKAs, appears to reduce the risk of bleeding complications and decrease the length of hospital stay for patients, without a significant increase in the risk of thrombotic events.

European Society of Cardiology guidelines and 1 year outcomes of acute heart failure treatment in Central Asia and Europe.

AIMS: Outcomes reported for patients with hospitalization for acute heart failure (AHF) treatment vary worldwide. Ethnicity-associated characteristics may explain this observation. This observational study compares characteristics and 1-year outcomes of Kyrgyz and Swiss AHF patients against the background of European Society of Cardiology guidelines-based cardiovascular care established in both countries. METHODS AND RESULTS: The primary endpoint was 1 year all-cause mortality (ACM); the secondary endpoint was 1 year ACM or HF-related rehospitalization. A total of 538 Kyrgyz and 537 Swiss AHF patients were included. Kyrgyz patients were younger (64.0 vs. 83.0 years, P < 0.001); ischaemic or rheumatic heart disease and chronic obstructive pulmonary disease were more prevalent (always P < 0.001). In Swiss patients, smoking, dyslipidaemia, hypertension, and atrial flutter/fibrillation were more frequent (always P ≤ 0.035); moreover, left ventricular ejection fraction (LVEF) was higher (47% vs. 36%; P < 0.001), and >mild aortic stenosis was more prevalent (P < 0.001). Other valvular pathologies were more prevalent in Kyrgyz patients (P < 0.001). At discharge, more Swiss patients were on vasodilatory treatment (P < 0.006), while mineralocorticoid receptor antagonists (P = 0.001), beta-blockers (P = 0.001), or loop diuretics (P < 0.001) were less often prescribed. In Kyrgyz patients, unadjusted odds for the primary and secondary endpoints were lower [odds ratio (OR) 0.68, 95% confidence interval (CI): 0.51-0.90, P = 0.008; OR 0.72, 95% CI: 0.56-0.91, P = 0.006, respectively]. After adjustment for age and LVEF, no difference remained (primary endpoint: OR 1.03, 95% CI: 0.71-1.49, P = 0.894; secondary endpoint: OR 0.82, 95% CI: 0.60-1.12, P = 0.206). CONCLUSIONS: On the background of identical guidelines, age- and LVEF-adjusted outcomes were not different between Central Asian and Western European AHF patients despite of large ethnical disparity.

Screening of Native Valvular Heart Disease Using a Pocket-Sized Transthoracic Echocardiographic Device.

BACKGROUND: The authors assessed the performance of pocket-sized transthoracic echocardiography (pTTE) compared with standard transthoracic echocardiography (sTTE) and auscultation for early screening of valvular heart disease (VHD). Early diagnosis of significant VHD is a challenge, but it enables appropriate follow-up and implementation of the best therapeutic strategy. METHODS: sTTE, pTTE, and auscultation were performed by three different experienced physicians on 284 unselected patients. All cases of VHD detected by each of these three techniques were noted. sTTE was the gold standard. Each physician performed one examination and was blinded to the results of other examinations. RESULTS: We diagnosed a total of 301 cases of VHD, with a large predominance of regurgitant lesions: 269 cases (89.3%) of regurgitant VHD and 32 (10.7%) of stenotic VHD. pTTE was highly sensitive (85.7%) and specific (97.9%) for screening for VHD, while auscultation detected only 54.1%. All significant cases of VHD (at least mild severity) were detected on pTTE. The weighted κ coefficient between pTTE and sTTE for the assessment of mitral regurgitation was 0.71 (95% CI, 0.70-0.72), indicating good agreement. The weighted κ coefficients between pTTE and sTTE for the assessment of aortic regurgitation and aortic stenosis were 0.97 (95% CI, 0.96-0.98) and 0.98 (95% CI, 0.97-0.99), respectively, indicating excellent agreement. CONCLUSIONS: pTTE performed by physicians with level III competency in echocardiography is reliable for identifying significant VHD and should be proposed as a new screening tool.

Impact of Mitral Annular Calcium and Mitral Stenosis on Outcomes After Transcatheter Aortic Valve Implantation.

Mitral annular calcium (MAC) is a common finding in patients undergoing transcatheter aortic valve implantation (TAVI) and may be associated with mitral stenosis (MAC-MS). Their impact on post-TAVI outcomes remains controversial. We sought to assess the impact of MAC and MAC-MS on clinical outcomes following TAVI. We included 1,177 patients who consecutively underwent TAVI in our institution between January 2008 and May 2018. MAC diagnosis reposed on echocardiogram and computed tomography. The combination of MAC and a mean transmitral gradient ≥ 5 mmHg defined MAC-MS. The study included 1,177 patients, of whom 504 (42.8%) had MAC and 85 (7.2%) had MAC-MS. Patients with and without MAC had similar outcomes except for a higher rate of pacemaker implantation in MAC patients (adjusted HR: 1.32, 95% CI: 1.03-1.69, p = 0.03). The subgroup of patients with severe MAC had similar outcomes. However, MAC-MS was an independent predictor of all-cause mortality at 30 days (adjusted HR: 2.30, 95% CI: 1.08-4.86, p = 0.03) and 1 year (adjusted HR: 1.73, 95% CI: 1.04-2.89, p = 0.04). In conclusion, MAC is present in nearly half of the patients treated with TAVI but MAC-MS is far less frequent. In itself, even severe, MAC does not influence outcomes while MAC-MS is an independent predictor of all-cause 1-year mortality. Measurement of mean transmitral gradient identifies patients with MAC at high risk after TAVI.

Predictors and clinical impact of thrombosis after transcatheter mitral valve implantation using balloon-expandable bioprostheses.

AIMS: The aim of this study was to report the predictors and clinical impact of transcatheter heart valve (THV) thrombosis in patients undergoing transcatheter mitral valve implantation (TMVI). METHODS AND RESULTS: We included 130 patients who consecutively underwent TMVI. Transoesophageal echocardiography (TOE) and/or computed tomography (CT) were performed in 91.7% of patients at discharge, in 73.3% at three months and in 72% beyond three months. THV thrombosis was defined as the presence of at least one thickened leaflet with restricted motion confirmed by TOE or contrast CT and classified as immediate, early, or late according to the timing of diagnosis. THV thrombosis was observed in 16 (12.3%) patients: immediate in 43.7%, early in 37.5% and late in 18.8%. Most of these thromboses were subclinical (93.7%) and non-obstructive (87.5%). No thromboembolic event occurred. After optimisation of antithrombotic treatment, THV thromboses resolved in all but one patient. Predictors were shock for immediate (p<0.001), male sex for early (p=0.045) and absence of anticoagulation for both early (p=0.018) and late (p=0.023) THV thromboses. CONCLUSIONS: THV thrombosis is frequent after TMVI, occurs mainly within the first three months, is mostly subclinical and resolves after optimisation of antithrombotic treatment. An anticoagulation therapy for at least three months after the procedure is mandatory.

Valve-in-Valve and Valve-in-Ring Transcatheter Mitral Valve Implantation in Young Women Contemplating Pregnancy.

BACKGROUND: Transcatheter mitral valve implantation (TMVI) is emerging as an alternative to surgical mitral valve replacement in selected high-risk patients. Delaying definitive mechanical mitral valve replacement and the constraints of anticoagulation thanks to TMVI may be an attractive option in young women contemplating pregnancy and suffering from failure of mitral bioprosthesis or annuloplasty. The aim of the study was to evaluate the possibility, safety, and outcomes of pregnancy after TMVI in this population. METHODS: From 2013 to 2019, 12 young women contemplating pregnancy underwent transseptal valve-in-valve or valve-in-ring TMVI using the Edwards SAPIEN XT/3 valves and were prospectively followed up at 1 month, 6 months, 1 year, and yearly thereafter. RESULTS: Mean age of the patients was 30±6 years. Bioprosthesis degeneration was observed in 7 cases and annuloplasty failure in 5. Three valve-in-ring patients required the implantation of a second valve, which led to an overall procedural success rate of 75%. One delayed left ventricular outflow tract obstruction required elective surgical mitral valve replacement. At 6 months/1 year, 83% of the patients were in New York Heart Association classes I/II. Mitral regurgitation was ≤2+ in all the cases and mean gradient was 7±2 mm Hg. Four patients could complete 6 full-term pregnancies. One symptomatic thrombosis occurred and resolved under aspirin and anticoagulation therapy. All others pregnancies were uneventful. Predelivery mean gradient was 11 mm Hg, and systolic pulmonary artery pressure was 32 mm Hg. There were 4 vaginal deliveries and 2 cesarians. Newborns were alive and healthy. At last follow-up, there was no death, and 3 patients required elective surgical mitral valve replacement at 6- to 54-month follow-up. CONCLUSIONS: Our study suggests that, in young women, transseptal TMVI to treat failing bioprostheses may result in good short-term outcomes that allow uneventful pregnancies. The results are less favorable in women with failed annuloplasty rings.