Long-term outcomes of a rapid deployment aortic valve: data up to 5 years

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 va...

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Bibliographic Details
Published in:	European journal of cardio-thoracic surgery 2017-08, Vol.52 (2), p.281-287
Main Authors:	Laufer, Günther, Haverich, Axel, Andreas, Martin, Mohr, Friedrich W, Walther, Thomas, Shrestha, Malakh, Rahmanian, Parwis, Holzhey, David, Roth, Matthias, Schmitz, Christoph, Schramm, René, Giot, Christophe, Wahlers, Thorsten C.W
Format:	Article
Language:	eng
Subjects:	Aged Aged, 80 and over Aortic Valve - surgery Female Heart Valve Prosthesis Heart Valve Prosthesis Implantation - instrumentation Heart Valve Prosthesis Implantation - methods Heart Valve Prosthesis Implantation - mortality Heart Valve Prosthesis Implantation - statistics & numerical data Hemodynamics Humans Kaplan-Meier Estimate Male Prospective Studies Treatment Outcome
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Summary:	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 cm2, 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.
ISSN:	1010-7940 1873-734X