Direct Flow Medical vs. Edwards Sapien 3 Prosthesis: A Propensity Matched Comparison on Intermediate Safety and Mortality.

Aims: To compare intermediate performance and mortality rates in patients, who underwent transcatheter aortic valve implantation (TAVI) with two different types of prostheses: Edwards Sapien 3 (ES3) and Direct Flow Medical (DFM). Methods and Results: 42 consecutive patients implanted with a DFM prosthesis for severe aortic stenosis were matched 1:1 with an equal number of patients, who received an ES3 during the same period. Primary endpoint was mortality. MACE, as a composite of all-cause death, stroke, and re-do-procedure (valve-in-valve), was defined as secondary endpoint. Moreover, we compared NYHA class, NT-proBNP-levels and the extent of restenosis. Patients were followed for 2 years. DFM patients showed echocardiographic elevated mean pressure gradients compared to ES3 patients before discharge (11.2 mmHg ± 5.3 vs. 3.5 mmHg ± 2.7; p < 0.001) and upon 6-months follow-up (20.3 mmHg ± 8.8 vs. 12.3 mmHg ± 4.4; p < 0.001). ES3 candidates showed superior NYHA class at follow-up (p = 0.001). Kaplan-Meier analysis revealed significantly worse survival in patients receiving a DFM prosthesis compared to ES3 (Breslow p = 0.020). MACE occurred more often in DFM patients compared to ES3 (Breslow p = 0.006). Conclusions: Patients receiving DFM valve prostheses showed worse survival and higher rates in MACE compared to ES3. Prosthesis performance regarding mean pressure gradients and patients' NYHA class also favored ES3.

Natural course of tricuspid regurgitation and prognostic implications.

OBJECTIVE: Functional tricuspid regurgitation (TR) is a frequent finding in echocardiography. Literature suggests significant TR is associated with poor prognosis. Still, data remain limited. This study aimed to evaluate long-term prognostic implications in patients with TR. METHODS: In this observational cohort study, data from 1650 consecutive patients were analysed. Primary endpoint was all-cause mortality. Mean follow-up time was 1090 days. TR grades at baseline and follow-up were compared. Survival analyses were performed to identify prognostic factors. RESULTS: At baseline, 14.1% patients showed no, 63.8% mild, 17.4% moderate and 4.7% severe TR. 359 patients (21.8%) died within the study period. TR at baseline was associated with excess mortality. Moderate and severe TR were of prognostic implication in all subgroups irrespective of systolic pulmonary artery pressure (sPAP) (

Right Ventricular Longitudinal Strain Predicts Survival in Patients With Functional Tricuspid Regurgitation.

BACKGROUND: Functional tricuspid regurgitation (TR) is a frequent finding in echocardiography. Despite general consent that right ventricular (RV) dysfunction impacts outcome of patients with TR, it is still unknown which echocardiographic parameters most accurately reflect prognosis. In this study we aimed to evaluate the prevalence of RV dysfunction and its prognostic value in patients with TR. METHODS: Data from 1089 consecutive patients were analysed. Tricuspid annular plane systolic excursion (TAPSE), fractional area change, and right ventricular free wall longitudinal strain (RV strain) were used to define RV dysfunction. Patients were followed for 2-year all-cause mortality. For prediction of survival, reclassification and C statistics of RV functional parameters using TR grade as reference model were performed. RESULTS: Among the patients studied, 13.9% showed no TR, 61.2% had mild TR, 19.6% had moderate TR, and 5.3% had severe TR. The TR grade was associated with increased mortality (log rank, P < 0.001). Impaired RV strain and TAPSE were independent predictors for mortality (RV: hazard ratio [HR], 1.130; 95% confidence interval [CI], 1.099-1.160; P < 0.001; TAPSE: HR, 1.131; 95% CI, 1.085-1.175; P < 0.001). Both RV strain and TAPSE improved the reference model for survival prediction (RV: integrated discrimination improvement [IDI], 0.184; 95% CI, 0.146-0.221; P < 0.001; TAPSE: IDI, 0.057; 95% CI, 0.037-0.077; P < 0.001). CONCLUSIONS: Echocardiographic evaluation of RV function appears to useful for patients with TR. Assessment of RV strain provides additional value for prediction of 2-year mortality.

How low is "low-flow" in aortic stenosis? A retrospective analysis of patients with true low-flow/low-gradient aortic stenosis undergoing TAVI.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a valuable treatment option for patients with reduced left ventricular ejection fraction (LVEF) and low-flow/low-gradient (LF/LG) aortic stenosis (AS). According to current literature, the presence of severe AS is unlikely in case of severely reduced LVEF and mean pressure gradient (meanPG) below 30 mmHg. However, a considerable number of patients presenting with typical clinical symptoms of severe AS, show gradients below 30 mmHg. We hypothesized, that these patients undergoing TAVI do have a measurable clinical benefit and an improved LVEF. METHODS: In this single center retrospective cohort study, data from 1199 patients undergoing TAVI between 2013 and 2017 was analyzed. A 6-month follow-up was performed to assess changes in NT-proBNP, NYHA-class, and LVEF. RESULTS: Thirty patients presented with LVEF<35%, an aortic valve area (AVA<1 cm2), and a meanPG below 30 mmHg. Mean logistic EuroSCORE II was 24.05±10.9. Most patients (56%) showed improved NYHA-class upon follow-up. NT-proBNP-levels decreased from 3.901 pg/mL IQR 10.880 to 1.491 pg/mL IQR 2.245 (P<0.001). LVEF increased from 30% IQR 6.25 to 40% IQR 15 (P<0.001). CONCLUSIONS: Based on our findings TAVI represents a valuable treatment option even in patients with LF/LG AS and PGmean below 30mmHg.

Visualisation of the tricuspid valve using a new 3D echocardiographic scoring system.

With rising focus on interventional treatment of the tricuspid valve (TV), the need for good echocardiographic imaging increases. Aim of this study was to develop a scoring system describing how accurate three dimensional (3D) echocardiographic imaging of TV and its anatomical structures is. METHODS AND RESULTS: In this retrospective exploratory cohort study, we analysed data from consecutive patients undergoing transoesophageal echocardiography (TOE) and transthoracic echocardiography (TTE). 3D sequences were stored using eight different views. In each view, scoring focused on visualisation of five (in TOE 6) anatomical structures with a maximum of three points per structure for excellent imaging quality. We compared the scores of patients with and without relevant tricuspid regurgitation (TR) (cut-off effective regurgitant orifice 0.4 cm² measured in two-dimensional (2D) TTE using velocity time integral and proximal isovolumetric velocity area). 108 consecutive patients were examined, 40.7% presented with relevant TR. With the exception of coaptation, a higher score was achieved for all structures in TOE than in TTE. TV ring (TVR) was easiest to visualise with TOE in four-chamber view (4 CV) (2.42±0.67 points) presenting the highest score independent of anatomical structure and view. Posterior leaflet had best imaging scores in TOE in 4 CV (2.0±0.86) compared with TTE in 4 CV (1.64±0.80), p=0.001. Patients with relevant TR had significantly better 3D imaging scores in 4 CV compared with patients without relevant TR (TTE p<0.013, TOE p<0.002). CONCLUSION: 4 CV delivers the most detailed information in TTE, whereas multiple views deliver good scores in TOE. As TVR is easiest to visualise, most of the patients would be suitable for a ring-based echocardiography-guided intervention. The score enables a standardised comparison of image quality.