TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve.
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.
['Barnhart|Glenn R|GR|', 'Accola|Kevin D|KD|', 'Grossi|Eugene A|EA|', 'Woo|Y Joseph|YJ|', 'Mumtaz|Mubashir A|MA|', 'Sabik|Joseph F|JF|', 'Slachman|Frank N|FN|', 'Patel|Himanshu J|HJ|', 'Borger|Michael A|MA|', 'Garrett|H Edward|HE|', 'Rodriguez|Evelio|E|', 'McCarthy|Patrick M|PM|', 'Ryan|William H|WH|', 'Duhay|Francis G|FG|', 'Mack|Michael J|MJ|', 'Chitwood|W Randolph|WR|', '|||']
D000368:Aged D000369:Aged, 80 and over D001024:Aortic Valve Stenosis D002423:Cause of Death D004452:Echocardiography D005260:Female D005500:Follow-Up Studies D006350:Heart Valve Prosthesis D019918:Heart Valve Prosthesis Implantation D006801:Humans D015994:Incidence D008297:Male D019060:Minimally Invasive Surgical Procedures D011183:Postoperative Complications D011446:Prospective Studies D011474:Prosthesis Design D015996:Survival Rate D000071062:Sutureless Surgical Procedures D013997:Time Factors D016896:Treatment Outcome D014481:United States
aortic valve replacement calcific aortic stenosis minimally invasive surgery rapid deployment valves sutureless valves