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

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• 作者：Glenn R. Barnhart ; MD^a ; ^{Glenn.Barnhart@swedish.org} ; Kevin D. Accola ; MD^b ; Eugene A. Grossi ; MD^c ; Y. Joseph Woo ; MD^d ; Mubashir A. Mumtaz ; MD^e ; Joseph F. Sabik ; MD^f ; Frank N. Slachman ; MD^g ; Himanshu J. Patel ; MD^h ; Michael A. Borger ; MD ; PhDⁱ ; H. Edward Garrett Jr. ; MD^j ; Evelio Rodriguez ; MD^k ; Patrick M. McCarthy ; MD^l ; William H. Ryan ; MD^m ; Francis G. Duhay ; MD ; MBAⁿ ; Michael J. Mack ; MD^m ; W. Randolph Chitwood Jr. ; MD^o ; on behalf of the TRANSFORM Trial Investigators
• 关键词：aortic valve replacement ; rapid deployment valves ; sutureless valves ; calcific aortic stenosis ; minimally invasive surgery
• 刊名：The Journal of Thoracic and Cardiovascular Surgery
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：153
• 期：2
• 页码：241-251.e2
• 全文大小：1184 K
• 卷排序：153

文摘

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.MethodsTRANSFORM 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.ResultsBetween 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.ConclusionsINTUITY 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.