Günther Laufer1, Axel Haverich2, Martin Andreas1, Friedrich W Mohr3, Thomas Walther4, Malakh Shrestha2, Parwis Rahmanian5, David Holzhey3, Matthias Roth4, Christoph Schmitz6, René Schramm6, Christophe Giot7, Thorsten C W Wahlers5. 1. Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria. 2. Department of Cardiothoracic Surgery, Transplantation and Vascular Surgery, Medical University of Hanover, Hanover, Germany. 3. Department of Cardiac Surgery, Helios Clinics-Heart Center Leipzig, Leipzig, Germany. 4. Department of Cardiac Surgery Kerckhoff Klinik, Bad Nauheim, Germany. 5. Department of Cardiac and Thoracic Surgery, Medical University of Cologne, Cologne, Germany. 6. Department of Cardiac Surgery, LMU Munich, Munich, Germany. 7. Department of Clinical Affairs HVT, Edwards Lifesciences, Nyon, Switzerland.
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 ± 0.3 cm 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. CLINICALTRIALS.GOV: NCT01445171.
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 ± 0.3 cm 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. CLINICALTRIALS.GOV: NCT01445171.
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