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

on behalf of the, TRANSFORM Trial Investigators

Research output: Contribution to journalArticle

48 Citations (Scopus)

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 = 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.

Original languageEnglish (US)
Pages (from-to)241-251.e2
JournalJournal of Thoracic and Cardiovascular Surgery
Volume153
Issue number2
DOIs
StatePublished - Feb 1 2017

Fingerprint

Aortic Valve
Clinical Trials
Sternotomy
Cardiopulmonary Bypass
Thromboembolism
Aortic Valve Stenosis
Hemodynamics
Databases
Hemorrhage
Mortality

Keywords

  • aortic valve replacement
  • calcific aortic stenosis
  • minimally invasive surgery
  • rapid deployment valves
  • sutureless valves

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

@article{24b34be3008e4ab9b63a826d5828c44b,
title = "TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve",
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 = 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.",
keywords = "aortic valve replacement, calcific aortic stenosis, minimally invasive surgery, rapid deployment valves, sutureless valves",
author = "{on behalf of the} and {TRANSFORM Trial Investigators} and 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} and Evelio Rodriguez and McCarthy, {Patrick M} and Ryan, {William H.} and Duhay, {Francis G.} and Mack, {Michael J.} and Chitwood, {W. Randolph}",
year = "2017",
month = "2",
day = "1",
doi = "10.1016/j.jtcvs.2016.09.062",
language = "English (US)",
volume = "153",
pages = "241--251.e2",
journal = "Journal of Thoracic and Cardiovascular Surgery",
issn = "0022-5223",
publisher = "Mosby Inc.",
number = "2",

}

TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial : Performance of a rapid deployment aortic valve. / on behalf of the; TRANSFORM Trial Investigators.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 153, No. 2, 01.02.2017, p. 241-251.e2.

Research output: Contribution to journalArticle

TY - JOUR

T1 - TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial

T2 - Performance of a rapid deployment aortic valve

AU - on behalf of the

AU - TRANSFORM Trial Investigators

AU - Barnhart, Glenn R.

AU - Accola, Kevin D.

AU - Grossi, Eugene A.

AU - Woo, Y. Joseph

AU - Mumtaz, Mubashir A.

AU - Sabik, Joseph F.

AU - Slachman, Frank N.

AU - Patel, Himanshu J.

AU - Borger, Michael A.

AU - Garrett, H. Edward

AU - Rodriguez, Evelio

AU - McCarthy, Patrick M

AU - Ryan, William H.

AU - Duhay, Francis G.

AU - Mack, Michael J.

AU - Chitwood, W. Randolph

PY - 2017/2/1

Y1 - 2017/2/1

N2 - 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 = 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.

AB - 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 = 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.

KW - aortic valve replacement

KW - calcific aortic stenosis

KW - minimally invasive surgery

KW - rapid deployment valves

KW - sutureless valves

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