Abstract
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.
Item Type: | Journal article |
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Faculties: | Medicine |
Subjects: | 600 Technology > 610 Medicine and health |
ISSN: | 1010-7940 |
Language: | English |
Item ID: | 52641 |
Date Deposited: | 14. Jun 2018, 09:50 |
Last Modified: | 04. Nov 2020, 13:31 |