Key result
Edwards SAPIEN TAVR demonstrates 100% procedural success and no early mortality in high-risk severe AS.
Observational (n=15)
No
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Early experience with TAVR in Japan demonstrates feasibility, safety, and significant hemodynamic improvement in high-risk patients with severe aortic stenosis.
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a new alternative treatment with acceptable early results for patients with aortic valve stenosis considered to be inoperable. The first TAVR was performed in Japan in October 2009, and a total of 51 have been performed up to February 2012. METHODS AND RESULTS: Because it is not possible to disclose details for 36 patients at the time of writing due to ongoing clinical trials, the early and mid-term results of 15 patients are presented for the Edwards SAPIEN valves. Age was 83.4 ± 6.1 years. Mean pressure gradient and aortic valve area were 60.3 ± 21.1 mmHg and 0.64 ± 0.19 cm(2), respectively. Left ventricular ejection fraction was 55.5 ± 15.4%. The Logistic EuroSCORE, EuroSCORE II, and Society of Thoracic Surgeons score were 28.5 ± 21.5%, 11.1 ± 15.8%, and 10.0 ± 7.4%, respectively. All of the procedures were successful and did not require conversion to surgery. Perioperative stroke did not occur, although pacemakers were implanted in 2 patients (13.3%). At discharge, mean pressure gradient and aortic valve area were improved to 10.8 ± 4.4 mmHg and 1.77 ± 0.36 cm(2), respectively. Except for 1 patient who died of cancer 7 months after operation, all patients were alive at the time of writing (11-848 days after procedure; mean follow-up period, 184 days). CONCLUSIONS: Satisfactory early and mid-term results have been achieved with TAVR, indicating that this is a good alternative to treat aortic valve stenosis.
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Maeda et al. (2012) conducted an observational in Severe aortic stenosis (n=15). Transcatheter Aortic Valve Replacement (TAVR) with Edwards SAPIEN prosthesis was evaluated on 30-day mortality.
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