Introducing transcatheter aortic valve implantation with a new generation prosthesis: Institutional learning curve and effects on acute outcomes.

OBJECTIVES: We present our single-centre experience with the direct flow medical (DFM) trans-catheter aortic valve implantation (TAVI) prosthesis addressing the impact of learning curve upon outcomes. BACKGROUND: The DFM has been recently introduced for TAVI. The prosthesis presents original design and implantation features. METHODS: Patients were divided into three groups according to the chronological implantation sequence that reflected technical skills acquisition of the entire team. RESULTS: Group I included the first 20 patients (early learning phase), group II the second 20 patients (proctoring to other members of the team), and group III the following 93 patients (technique consolidation). Differences in baseline and procedural variables were analysed. Nonparametric correlation and linear regression were used to identify changes according to institutional cumulative experience. There was a significant correlation between catheterisation time and institutional experience (rho = -0.4; p < 0.0001) confirmed at linear regression (beta = -0.2; p = 0.001; CI: -0.3 - -0.08). Moreover, there was lower rate of valve retrieval in group III (15% vs. 20% vs. 10%; p = 0.5). No intra-procedural mortality was reported and improved early safety (at 30 days) was observed (80% vs. 85% vs. 87.1; p = 0.7). At hospital discharge, valve haemodynamic performance was satisfactory with only mild regurgitation in 10% (I), 20% (II), and 9.7% (III) (p = 0.8). CONCLUSIONS: DFM adequate sizing and implantation can be achieved after the early learning phases. A significant reduction in catheterisation time is reported after the first 20 patients. Results remain satisfactory during the proctoring and technical consolidation phase.

[Interdisciplinary differential treatment of structural heart disease : When operation and when catheter-based intervention?]. / Interdisziplinäre Differenzialtherapie struktureller Herzerkrankungen : Wann Operation und wann kathetergestützte Intervention?

The demographic changes in society lead to an increasing number of patients with aortic valve stenosis and mitral regurgitation. Simultaneously the higher age of patients is associated with an increase in multimorbidity with a high surgical risk so that they cannot be referred to surgery. Besides the current gold standard of surgery, minimally invasive therapeutic options are increasingly becoming established for these patients. For the differentiated indications and therapeutic success, a multidisciplinary heart team assumes an important role. The next generation of transcatheter aortic valve implantation (TAVI) systems will lead to improvement in the results, lower complication rates and mortality and as a result there is a general trend towards expanding the indications. New innovative minimally invasive mitral valve devices are still undergoing clinical trials and will define future therapy options.