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Laufer, Günther; Haverich, Axel; Andreas, Martin; Mohr, Friedrich W.; Walther, Thomas; Shrestha, Malakh; Rahmanian, Parwis; Holzhey, David; Roth, Matthias; Schmitz, Christoph; Schramm, Rene; Giot, Christophe; Wahlers, Thorsten C. W. (2017): Long-term outcomes of a rapid deployment aortic valve: data up to 5 years. In: European Journal of Cardio-thoracic Surgery, Vol. 52, No. 2: pp. 281-287
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OBJECTIVES: Rapid deployment aortic valve replacement (AVR) has been developed to facilitate minimally invasive approaches for cardiac surgery and shorten procedural times. TRITON is a prospectively designed study to assess safety and efficacy of rapid deployment AVR with Edwards INTUITY valve system. This report presents the 5-year outcomes of the TRITON trial. METHODS: A total of 295 patients with aortic valve stenosis were enrolled in the TRITON trial and 287 patients received the study valve. Procedural, early (<= 30 days) and late (>30 days) outcomes were collected. Valve haemodynamic performance was evaluated at specified time points by an independent Echocardiography Core Laboratory and clinical events adjudicated by an independent Clinical Events Committee. RESULTS: Mean age was 75.3 +/- 6.7 years. A total of 158 patients underwent isolated AVR and 129 patients underwent AVR with concomitant procedures. The 5-year survival rates were 85.7 +/- 3.4% and 75.2 +/- 4.9% for isolated AVR and concomitant AVR, respectively. Overall, freedom from valve-related death at 5 years was 98.2 +/- 0.8%. At 5 years, the valve effective orifice area was 1.6 +/- 0.3cm(2), mean gradient was 10.5 +/- 5.4 mmHg and peak gradient was 18.9 +/- 9.3 mmHg. CONCLUSIONS: The 5-year outcomes of the TRITON trial demonstrate acceptable long-term safety and excellent haemodynamic performance of rapid deployment AVR with the Edwards INTUITY valve system.