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J Thorac Cardiovasc Surg. 2017 Feb;153(2):241-251.e2. doi: 10.1016/j.jtcvs.2016.09.062. Epub 2016 Oct 15.

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 information

1
Swedish Heart and Vascular Institute, Structural Heart Program, Seattle, Wash. Electronic address: Glenn.Barnhart@swedish.org.
2
Florida Hospital Cardiovascular Institute, Florida Hospital Orlando, Orlando, Fla.
3
Department of Cardiothoracic Surgery, New York University School of Medicine, New York, NY.
4
Department of Cardiothoracic Surgery, Stanford University, Palo Alto, Calif.
5
Cardiovascular & Thoracic Surgery, Pinnacle Health, Harrisburg, Pa.
6
Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland, Ohio.
7
Mercy Medical Group, Mercy General Hospital, Sacramento, Calif.
8
Cardiac Surgery Department, University of Michigan, Ann Arbor, Mich.
9
Department of Surgery, Columbia University Medical Center, New York, NY.
10
Cardiovascular Surgery Clinic, Baptist Memorial Hospital, Memphis, Tenn.
11
Saint Thomas Heart Program, Saint Thomas Heart Hospital, Nashville, Tenn.
12
Division of Cardiac Surgery, Northwestern Memorial Hospital, Chicago, Ill.
13
Cardiac Surgery Specialists, Baylor Plano Heart Hospital, Plano, Tex.
14
Edwards Lifesciences LLC, Irvine, Calif.
15
Department of Cardiovascular Sciences, East Carolina University, Greenville, NC.

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

Comment in

PMID:
27817951
DOI:
10.1016/j.jtcvs.2016.09.062
[Indexed for MEDLINE]
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