Hemodynamic performance of the St. Jude Medical Epic Supra aortic stented valve.

BACKGROUND AND AIM OF THE STUDY: The study aim was to evaluate the hemodynamic performance of the St. Jude Medical Epic Supra bioprosthesis during the early six-month follow up period, and to confirm the safety and efficacy of the valve by collecting details of adverse events and NYHA functional classification. METHODS: Fifty-seven patients undergoing aortic valve replacement (AVR) with the Epic Supra valve between September 2007 and January 2009 at three centers in Canada were evaluated for the study. The subjects were monitored preoperatively, at discharge, and at six months postoperatively. Echocardiographic data were available from 50 subjects at the six-month follow up. In order to prevent observer variability, all echocardiograms were sent to an independent Echocardiography Core Laboratory (ECL) for interpretation of the data. RESULTS: The mean subject age was 74 years. Concomitant coronary artery bypass grafting (CABG) was performed in 44% of the procedures. The mean pressure gradients were 11.2, 12.5, 10.8, 8.4 and 11.3 mmHg, respectively, for valves sized 19 mm (n = 2), 21 mm (n = 20), 23 mm (n = 22), 25 mm (n = 5) and 27 mm (n = 1). The average effective orifice areas (EOAs) were 1.44, 1.57, 1.69, 1.93 and 1.81 cm2 for the .valves sized 19, 21, 23, 25 and 27 mm, respectively. CONCLUSION: The results of the six-month echocardiographic follow up indicated that the Epic Supra valve offered excellent hemodynamic performance in the 21, 23 and 25 mm sizes. However, additional data are still required for the 19 and 27 mm valves to characterize their performance. The mean gradients and EOA-values were comparable to those of other supra-annular stented tissue valves. The EOA index indicated an absence of prosthesis-patient mismatch, with values in all subjects at or near 0.85 cm2/m2. The percentage of subjects without aortic insufficiency (AI) at follow up was 92%; only four subjects showed trivial AI.

Nineteen-millimeter prosthetic aortic valves allow normalization of left ventricular mass in elderly women.

BACKGROUND: Implantation of small aortic valve prostheses has been reported to be associated with impaired left ventricular (LV) mass regression and incomplete resolution of symptoms although these data have been generated largely with male patients. Therefore we sought to determine the clinical and hemodynamic outcomes of female patients who received a 19-mm aortic valve. METHODS: Between May 1995 and December 2000, 38 female patients (average age 73 years, range 42 to 89) underwent isolated aortic valve replacement (AVR; n = 22) or AVR plus coronary artery bypass graft surgery (CABG; n = 16) with a 19-mm aortic prosthesis. The average New York Heart Association (NYHA) class was 3.08 and of the 26 patients who had angina, 47.2% were in CCS class III or IV. Clinical and echocardiographic follow-up was done an average of 33.4 months (8 to 72) after surgery. RESULTS: Operative mortality was 10.5%. Overall survival at an average of 33 months was 71.1%. The average NYHA class was 1.52 +/- 0.34 postoperatively (p < 0.001 versus preoperative) and 95% had no anginal symptoms or were in Canadian Cardiovascular Society class I. The LV mass index showed significant regression (114 +/- 11 g/m2 to 89 +/- 9 g/m2, p = 0.001) despite an effective orifice area index (EOAI) of 0.64 +/- 0.09 cm2/m2. CONCLUSIONS: Despite a very small EOAI, elderly female patients with 19-mm prosthetic aortic valves can experience a satisfactory improvement in symptoms and normalization of LV mass. This finding suggests that small prosthetic aortic valves continue to have an application in contemporary cardiac surgical practice. The current perception of patient-prosthesis mismatch may need to be reconsidered for select populations.