TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve
Author
Barnhart, Glenn R.; Accola, Kevin D.; Grossi, Eugene A.; Woo, Y. Joseph; Mumtaz, Mubashir A.; Sabik, Joseph F.; Slachman, Frank N.; Patel, Himanshu J.; Borger, Michael A.; Garrett, H. Edward Jr.; Rodriguez, Evelio; McCarthy, Patrick M.; Ryan, William H.; Duhay, Francis G.; Mack, Michael J.; Chitwood, W. Randolph; TRANSFORM Trial Investigators
Abstract
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.
Date
2017-02
Citation:
APA:
Barnhart, Glenn R., & Accola, Kevin D., & Grossi, Eugene A., & Woo, Y. Joseph, & Mumtaz, Mubashir A., & Sabik, Joseph F., & Slachman, Frank N., & Patel, Himanshu J., & Borger, Michael A., & Garrett, H. Edward Jr., & Rodriguez, Evelio, & McCarthy, Patrick M., & Ryan, William H., & Duhay, Francis G., & Mack, Michael J., & Chitwood, W. Randolph, & TRANSFORM Trial Investigators. (February 2017).
TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve.
,
(),
-
. Retrieved from
http://hdl.handle.net/10342/8436
MLA:
Barnhart, Glenn R., and Accola, Kevin D., and Grossi, Eugene A., and Woo, Y. Joseph, and Mumtaz, Mubashir A., and Sabik, Joseph F., and Slachman, Frank N., and Patel, Himanshu J., and Borger, Michael A., and Garrett, H. Edward Jr., and Rodriguez, Evelio, and McCarthy, Patrick M., and Ryan, William H., and Duhay, Francis G., and Mack, Michael J., and Chitwood, W. Randolph, and TRANSFORM Trial Investigators.
"TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve". .
. (),
February 2017.
May 29, 2023.
http://hdl.handle.net/10342/8436.
Chicago:
Barnhart, Glenn R. and Accola, Kevin D. and Grossi, Eugene A. and Woo, Y. Joseph and Mumtaz, Mubashir A. and Sabik, Joseph F. and Slachman, Frank N. and Patel, Himanshu J. and Borger, Michael A. and Garrett, H. Edward Jr. and Rodriguez, Evelio and McCarthy, Patrick M. and Ryan, William H. and Duhay, Francis G. and Mack, Michael J. and Chitwood, W. Randolph and TRANSFORM Trial Investigators,
"TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve," , no.
(February 2017),
http://hdl.handle.net/10342/8436 (accessed
May 29, 2023).
AMA:
Barnhart, Glenn R., Accola, Kevin D., Grossi, Eugene A., Woo, Y. Joseph, Mumtaz, Mubashir A., Sabik, Joseph F., Slachman, Frank N., Patel, Himanshu J., Borger, Michael A., Garrett, H. Edward Jr., Rodriguez, Evelio, McCarthy, Patrick M., Ryan, William H., Duhay, Francis G., Mack, Michael J., Chitwood, W. Randolph, TRANSFORM Trial Investigators.
TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve. .
February 2017;
():
.
http://hdl.handle.net/10342/8436. Accessed
May 29, 2023.
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