Key result
Rapid-deployment aortic valve replacement yielded similar 3-year survival to conventional replacement (90% vs 89%; P=0.521), but more pacemaker implantations (9% vs 2%; P=0.014).
Why the study?
Does rapid-deployment aortic valve replacement improve survival, adverse events, or hemodynamics compared to conventional aortic valve replacement in patients with aortic stenosis?
Cohort (n=248)
No
Does rapid-deployment aortic valve replacement improve survival, adverse events, or hemodynamics compared to conventional aortic valve replacement in patients with aortic stenosis?
Absolute Event Rate: 90% vs 89%
p-value: p=0.521
May facilitate minimally invasive AVR with comparable hemodynamics in smaller sizes; leaves open questions on pacemaker implantation and adverse event profiles.
OBJECTIVES: Sutureless and rapid-deployment valves were recently introduced into clinical practice. The Edwards INTUITY valve system is a combination of the Edwards Magna pericardial valve and a subvalvular stent-frame to enable rapid deployment. We performed a parallel cohort study for comparison of the two valve types. METHODS: All patients receiving either an Edwards Magna Ease valve or an Edwards INTUITY valve system due to aortic stenosis from May 2010 until July 2014 were included. Patients undergoing bypass surgery, an additional valve procedure, atrial ablation surgery or replacement of the ascending aorta were excluded. Preoperative characteristics, operative specifications, survival, valve-related adverse events and transvalvulvar gradients were compared. RESULTS: One hundred sixteen patients underwent rapid-deployment aortic valve replacement [mean age 75 years (SD: 8); 62% female] and 132 patients underwent conventional aortic valve replacement [70 years (SD: 9); 31% female; P < 0.001]. Conventional valve patients were taller and heavier. The mean EuroSCORE II was 3.1% (SD: 2.7) and 4.4% (SD: 6.0) for rapid-deployment and conventional valve patients, respectively (P = 0.085). The mean implanted valve size was higher in the conventional group [23.2 mm (SD: 2.0) vs 22.5 mm (SD: 2.2); P = 0.007], but postoperative transvalvular mean gradients were comparable [15 mmHg (SD: 6) vs 14 mmHg (SD: 5); P = 0.457]. A subgroup analysis of the most common valve sizes (21 and 23 mm; implanted in 63% of patients) revealed significantly reduced mean postoperative transvalvular gradients in the rapid-deployment group [14 mmHg (SD: 4) vs 16 mmHg (SD: 5); P = 0.025]. A significantly higher percentage received minimally invasive procedures in the rapid-deployment group (59 vs 39%; P < 0.001). The 1- and 3-year survival rate was 96 and 90% in the rapid-deployment group and 95 and 89% in the conventional group (P = 0.521), respectively. Valve-related pacemaker implantations were more common in the rapid-deployment group (9 vs 2%; P = 0.014) and postoperative stroke was more common in the conventional group (1.6 vs 0% per patient year; P = 0.044). CONCLUSIONS: We conclude that this rapid-deployment valve probably facilitates minimally invasive surgery. Furthermore, a subgroup analysis showed reduced transvalvular gradients in smaller valve sizes compared with the conventionally implanted valve of the same type. The favourable haemodynamic profile and the potentially different spectrum of valve-related adverse events should be addressed in further clinical trials.
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Andreas et al. (2016) conducted a cohort in aortic stenosis (n=248). Edwards INTUITY valve system (rapid-deployment) vs. Edwards Magna Ease valve (conventional) was evaluated on 3-year survival rate (p=0.521). Rapid-deployment aortic valve replacement yielded similar 3-year survival to conventional replacement (90% vs 89%; P=0.521), but more pacemaker implantations (9% vs 2%; P=0.014).
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