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



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.



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.



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.
Swedish Heart and Vascular Institute, Structural Heart Program, Seattle, Wash. Electronic address: Glenn.Barnhart@swedish.org.
Glenn R
GR
Barnhart
Florida Hospital Cardiovascular Institute, Florida Hospital Orlando, Orlando, Fla.
Kevin D
KD
Accola
Department of Cardiothoracic Surgery, New York University School of Medicine, New York, NY.
Eugene A
EA
Grossi
Department of Cardiothoracic Surgery, Stanford University, Palo Alto, Calif.
Y Joseph
YJ
Woo
Cardiovascular & Thoracic Surgery, Pinnacle Health, Harrisburg, Pa.
Mubashir A
MA
Mumtaz
Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland, Ohio.
Joseph F
JF
Sabik
Mercy Medical Group, Mercy General Hospital, Sacramento, Calif.
Frank N
FN
Slachman
Cardiac Surgery Department, University of Michigan, Ann Arbor, Mich.
Himanshu J
HJ
Patel
Department of Surgery, Columbia University Medical Center, New York, NY.
Michael A
MA
Borger
Cardiovascular Surgery Clinic, Baptist Memorial Hospital, Memphis, Tenn.
H Edward
HE
Garrett
Saint Thomas Heart Program, Saint Thomas Heart Hospital, Nashville, Tenn.
Evelio
E
Rodriguez
Division of Cardiac Surgery, Northwestern Memorial Hospital, Chicago, Ill.
Patrick M
PM
McCarthy
Cardiac Surgery Specialists, Baylor Plano Heart Hospital, Plano, Tex.
William H
WH
Ryan
Edwards Lifesciences LLC, Irvine, Calif.
Francis G
FG
Duhay
Cardiac Surgery Specialists, Baylor Plano Heart Hospital, Plano, Tex.
Michael J
MJ
Mack
Department of Cardiovascular Sciences, East Carolina University, Greenville, NC.
W Randolph
WR
Chitwood
D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D002423:Cause of Death / Q000639:trends; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D015994:Incidence; D008297:Male; D019060:Minimally Invasive Surgical Procedures / Q000379:methods*; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011474:Prosthesis Design; D015996:Survival Rate / Q000639:trends; D000071062:Sutureless Surgical Procedures / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
aortic valve replacement; calcific aortic stenosis; minimally invasive surgery; rapid deployment valves; sutureless valves