Introduction Transcatheter aortic valve replacement (TAVR) is an option for patients with severe aortic stenosis who are declined conventional surgery. The Direct Flow Medical (DFM) valve is a non-metallic, double ring valve which is repositionable and retrievable and is relatively new to the UK market.
Aims The Freeman Hospital is the highest DFM volume centre in the UK. We wanted to compare the safety of this valve with the more established Sapien 3 (S3) TAVR valve.
Methods We retrospectively assessed all the S3 and DFM TAVR procedures performed under general and local anaesthetic at our centre since 04/11/2014 when we first started using DFM. Of 71 patients, 44 had the S3 valve inserted and 27 had the DFM valve inserted. The delivery approach was trans-femoral in all patients. In the DFM group 74% of the valves were inserted under local anaesthetic (LA) compared to 26% under general anaesthetic (GA) whereas in the S3 group 88% valves were inserted under LA and 12% under GA.
Results Both groups were similar with respect to age (82 vs 80.9), comorbidities, and EuroScore (15.9 vs 16.8). The severity of aortic stenosis was significantly greater in the S3 group (mean/peak gradient 46.5 vs 39; p = 0.018 and 77.3 vs 64.2mmHg; p < 0.005). Skin open to skin closure was significantly shorter in the S3 group (145 mins vs 101 mins; p < 0.001). There were no deaths or strokes in either group. 1 patient in the DFM group needed permanent pacing post procedure. 1 patient in the DFM group developed moderate aortic regurgitation. The mean gradient and peak gradient was significantly higher in the DFM group post procedure (17.9 vs 12.3; p = 0.016, and 31.1 vs 23.8mmHg; p = 0.013). In both groups there was no relationship between the size of the valve and the peak gradient using regression analysis (DFM; p = 0.181 and S3; p = 0.44). There was no difference in the mean number of days in hospital between both groups (2.6 vs 2.8; p = 0.47).
Conclusions There were no differences in safety between the Sapien 3 and DFM valves although we found the mean and peak gradients to be significantly higher with the DFM valve post procedure.
- Transcatheter aortic valve replacement
- Sapien 3 valve
- Direct Flow Medical valve
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