The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time.

Background: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry. Methods: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions. Results: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47–1.07; P =0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%). Conclusions: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.

Background and Purpose-Cerebral microembolism detected by transcranial Doppler occurs systematically during cardiac catheterization, but its clinical relevance remains unknown. Studies suggest that asymptomatic embolic cerebral infarction detectable by diffusion-weighted (DW) MRI might exist after percutaneous cardiac interventions, especially after retrograde catheterization of the aortic valve in patients with valvular aortic stenosis, with a frequency as high as 22% of cases. We investigated the incidence of new ischemic lesions on serial cerebral DW MRI after cardiac catheterization. Methods-This prospective study involved 46 patients with severe aortic valve stenosis. To assess the occurrence of cerebral infarction, all patients underwent cerebral DW MRI and neurological assessment within 24 hours before and 48 hours after cardiac catheterization and retrograde catheterization of the aortic valve. A subgroup was monitored by transcranial power M-mode Doppler during cardiac catheterization to observe cerebral blood flow and track emboli. Results-One patient had a focal diffusion abnormality on DW MRI before cardiac catheterization. After catheterization, we detected only 1 additional acute cerebral diffusion abnormality in a single case (2.2%), although cerebral microemboli were detected in all transcranial Doppler-monitored patients during cardiac catheterization, as expected. All patients remained asymptomatic. Based on these results a mid-point incidence of 5.9% (95% CI, 0.01 to 12.5) for abnormalities on DW MRI in asymptomatic cardiac catheterization patients in our center can be assigned. Conclusions-Unsuspected cerebral infarctions can be detected by DW MRI after cardiac catheterization, but this phenomenon remains unfrequent in our series. Further studies are needed to identify factors explaining the discrepancy between these results and those of previous studies.

BackgroundEchocardiographic ratio of peak tricuspid regurgitant velocity to the right ventricular outflow tract time-velocity integral (TRV/TVI rvot) was presented as a reliable non-invasive method of estimating pulmonary vascular resistance (PVR). Studies using this technique in patients with moderate to high PVR are scarce. Left ventricular outflow tract time-velocity integral (TVI lvot) can be easier to measure than TVI rvot, especially in patients with severe pulmonary hypertension (PH) with significant anatomical modifications of the right structures.AimsWe wanted to determine whether the TRV/TVI rvot and TRV/TVI lvot ratios would form a reliable non-invasive tool to estimate PVR in a cohort of patients with moderate to severe pulmonary vascular disease.MethodsDoppler echocardiographic examination and right heart catheterisation were performed in 37 patients. Invasive PVR was compared with TRV/TVI rvot and TRV/TVI lvot ratios using regression analysis. Two equations were modelled and the results compared with invasive measurements using the Bland-Altman analysis. Using receiver-operating characteristics curve analysis, a cut-off value for the two ratios was generated.ResultsCorrelation coefficients between invasive PVR and TRV/TVI rvot then TRV/TVI lvot were respectively 0.76 and 0.74. Two new equations were found but the Bland-Altman analysis showed wide standard deviations (respectively 3.8 and 3.9 Wood units). A TRV/TVI rvot then TRV/TVI lvot ratio cut-off value of 0.14 had a sensitivity of 93% and a specificity of 57% for the first and a sensitivity of 87% and a specificity of 57% for the second to determine PVR > 2 Wood units.ConclusionEchocardiography is useful for the screening of patients with pulmonary hypertension and PVR > 2 WU. It remains disappointing for accurate assessment of high PVR. TVI lvot may be an alternative to TVI rvot for patients for whom accurate TVI rvot measurement is not possible.

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