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  • Title: Immediate and 6-month outcomes of transapical and transfemoral Edwards-Sapien prosthesis implantation in patients with aortic stenosis.
    Author: Chodór P, Wilczek K, Przybylski R, Krasoń M, Głowacki J, Niklewski T, Podolecki T, Kalarus Z, Poloński L, Zembala M.
    Journal: Kardiol Pol; 2010 Oct; 68(10):1124-31. PubMed ID: 20967708.
    Abstract:
    BACKGROUND: severe symptomatic aortic valve stenosis is an unequivocal indication for surgical valve replacement, assuring symptoms relief and increasing survival. About one third of elderly patients is not being operated due to, among others, high peri-procedural risk and comorbidities. Transcatheter aortic valve implantation (TAVI) has recently become a valuable therapeutic option for these patients. AIM: to present early results of first TAVI Edwards-Sapien procedures in our hospital, performed in symptomatic patients with high operational risk or other contraindications for conventional surgery, as well as the results of 6-month follow-up. METHOD: twelve patients referred for TAVI were included in the analysis. The valve was implanted in 11 patients and in 1 patient the procedure was finished with aortic valve valvuloplasty. Eight (72.7%) patients underwent transapical (TA) and 3 (27.3%) patients transfemoral (TF) TAVI. Seven (63.6%) 26 mm valves and 4 (34.4%) 23 mm valves were implanted. RESULTS: the efficacy of the procedure was 92%: 100% in the TA group, and 75% in the TF group. During the procedure 1 patient developed ventricular fibrillation. Atrial fibrillation and right ventricle perforation by the endocavitary electrode was observed in another patient. Prolonged wound healing occurred in 4 patients and contrast-induced renal failure occurred in 2 patients. There were no deaths at 30-days. Two patients had a pacemaker implanted during hospitalisation. A significant improvement of echocardiographic parameters was observed: maximum gradient across the aortic valve was 104.4 ± 23.9 mm Hg before vs 25.2 ± 6.1 mm Hg after the intervention, p = 0.000001, mean gradient - 63.8 ± 18.3 vs 12.7 ± 3.7 mm Hg, p = 0.000004, and valvular surface - 0.7 ± 0.2 vs 1.5 ± 0.2 cm2, p = 0.000106, respectively. During the 6-month follow-up period 1 patient died of multiorgan failure and 6 patients required another hospitalisation. After 6 months an improvement in physical capacity was observed in all but one patients (NYHA II - 9 patients, NYHA III - 1 patient). CONCLUSIONS: 1. The authors' initial experiences with TAVI Edwards-Sapien procedure confirm its efficacy and safety in patients with symptomatic aortic stenosis and high surgical risk. 2. Echocardiographic parameters of the implanted valves, assessed during hospitalisation and 6 month later, are satisfactory. 3. Due to the risk of complications, patients require careful observation in the postoperative period and during short-term follow-up.
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