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Barnhart, Glenn R., MD; Accola, Kevin D., MD; Grossi, Eugene A., MD; Woo, Y. Joseph, MD; Mumtaz, Mubashir A., MD; Sabik, Joseph F., MD; Slachman, Frank N., MD; Patel, Himanshu J., MD; Borger, Michael A., MD, PhD; Garrett, H. Edward, MD; Rodriguez, Evelio, MD; McCarthy, Patrick M., MD; Ryan, William H., MD; Duhay, Francis G., MD, MBA; Mack, Michael J., MD; Chitwood, W. Randolph, MD
The Journal of thoracic and cardiovascular surgery, 02/2017, Letnik: 153, Številka: 2Journal Article
Abstract Background The TRANSFORM (Multicen t er Experience With R apid Deployment Edw a rds I N TUITY Valve S ystem for Aortic Valve Replace m ent) 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 = 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 database 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%; thromboembolism, 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. Conclusions INTUITY RDAVR performed effectively in this North American trial. It may lead to a relative reduction in aortic crossclamp time and cardiopulmonary bypass time and has excellent hemodynamic performance. Pacemaker implantation rate observed was somewhat greater than European trials and requires further investigation.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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in: SICRIS
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