TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve

Background: The TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) trial (NCT01700439) evaluated the performance of the INTUITY rapid deployment aortic valve replacement (RDAVR) system in patients with severe aortic stenosis. Methods: TRANSFORM was a prospective, nonrandomized, multicenter (n 1�4 29), single-arm trial. INTUITY is comprised of a cloth-covered balloon- expandable frame attached to a Carpentier-Edwards PERIMOUNT Magna Ease aortic valve. Primary and effectiveness endpoints were evaluated at 1 year. Results: Between 2012 and 2015, 839 patients underwent RDAVR. Mean age was 73.5 8.3 years. Full sternotomy (FS) was used in 59% and minimally invasive surgical incisions in 41%. Technical success rate was 95%. For isolated RDAVR, mean crossclamp and cardiopulmonary bypass times for FS were 49.3 26.9 minutes and 69.2 34.7 minutes, respectively, and for minimally invasive surgical 63.1 25.4 minutes and 84.6 33.5 minutes, respectively. These times were favorable compared with Society of Thoracic Surgeons data- base comparators for FS: 76.3 minutes and 104.2 minutes, respectively, and for minimally invasive surgical, 82.9 minutes and 111.4 minutes, respectively (P<.001). At 30 days, all-cause mortality was 0.8%; valve explant, 0.1%; throm- boembolism, 3.5%; and major bleeding, 1.3%. In patients with isolated aortic valve replacement, the rate of permanent pacemaker implantation was 11.9%. At 1 year, mean effective orifice area was 1.7 cm2; mean gradient, 10.3 mm Hg; and moderate and severe paravalvular leak, 1.2% and 0.4%, respectively

Permanent Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement.

BACKGROUND: Expandable, rapid deployment aortic valves may interfere with the cardiac conduction system, which can lead to permanent pacemaker implantation (PPI). We sought to characterize PPI after rapid deployment aortic valve replacement with the Edwards Intuity valve system (Edwards Lifesciences, Irvine, CA) and investigate associated factors. METHODS: We analyzed 708 patients from 29 centers in the Multicenter Experience With Rapid Deployment Edwards Intuity Valve System for Aortic Valve Replacement (TRANSFORM) trial undergoing rapid deployment aortic valve replacement with or without coronary artery bypass graft surgery without preexisting pacemakers. Intrinsic conduction status was recorded as well as PPI incidence through 1 year. The PPI indications were categorized based on expert review of patient PPI source documents. Multivariate analysis was conducted to identify characteristics associated with PPI. RESULTS: After rapid deployment aortic valve replacement, the PPI incidence through 30 days (PPI CONCLUSIONS: Patient factors associated with PPI after rapid deployment aortic valve replacement were right bundle branch block, atrioventricular block, female gender, and larger valve size. Interestingly, a strong center-level effect was associated with PPI. This effect may reflect differences in practice patterns, such as postoperative drug management or timing to PPI. These findings provide a deeper understanding of PPI after rapid deployment aortic valve replacement and help guide clinical practice and patient management