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

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.

Impact of small prosthesis size on transcatheter or surgical aortic valve replacement outcomes

“…Moderate or greater PVL in TAVR has been associated with significant mortality , although notably none of our patients developed moderate or greater PVL postprocedurally. While new sutureless aortic valves offer larger effective orifice areas and lower rates of PVL , as future advancements are made in annular sealing technologies, the incidence of PVL after TAVR will likely decline.…”

Direct Comparison of the Edwards Intuity Elite and Sorin Perceval S Rapid Deployment Aortic Valves

“…Doppler flow velocities were recorded from apical four-chamber view using pulsed and continuous wave Doppler mode to assess Abbreviations and Acronyms AV = atrioventricular AVR = aortic valve replacement CABG = coronary artery bypass graft surgery CPB = cardiopulmonary bypass EOA = effective orifice area EuroSCORE = European System for Cardiac Operative Risk Evaluation iEOA = indexed effective orifice area PVL = paravalvular leak RDAVR = rapid deployment aortic valve replacement RDV = rapid deployment valve peak and mean gradients. The indexed effective orifice area (iEOA; cm 2 /m 2 ) was determined using the effective orifice area (EOA) [4,5] divided by the patient body surface area. Severe patient-prosthesis mismatch was defined as an iEOA of less than 0.65 cm 2 /m 2 [15].…”

“…Rapid deployment valves (RDV) for AVR (RDAVR) have been introduced throughout the past years to facilitate shorter operation times and minimize surgical access while maintaining the advantages of surgical excision of degenerated aortic valve tissue [4][5][6][7]. Their design with expandable stents enables easy and rapid implant and thereby reduces cardiopulmonary bypass (CPB) and aortic clamp times while providing excellent hemodynamic performance when compared with conventional stented valve prostheses [4][5][6][8][9][10][11]. Importantly, early and midterm data show good durability and hemodynamic performance and low valve-related complications [6-8, 10, 12], and suggest that the use of RDAVR could be of clinical benefit for patients at high operative risk requiring combined procedures or minimally invasive AVR.…”

“…The self-expandable, stentless and sutureless Perceval S (Sorin Group Italia Srl, Saluggia, Italy) and the balloonexpandable, stented Intuity valve (Edwards Lifesciences, Irvine, CA) are the most frequently implanted RDV worldwide for AVR and were introduced in our program during the past 4 years [4][5][6]8]. Although accumulating evidence underscoring the safety and efficacy for both RDV has been recently published from prospective, single-armed multicenter trials or trials comparing RDAVR to conventional AVR [4][5][6]8], there are no data comparing both RDV directly. The aim of this singlecenter analysis was to directly compare both RDV with respect to early clinical outcomes, valve performance, and valve-related complications in patients undergoing AVR.…”

Sutureless aortic valve prostheses

“…The Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement studied 839 patient across 29 centres who had undergone AVR with the Intuity valve 16. The majority of patients (59%) underwent surgery via full sternotomy, while the remaining 41% underwent minimally invasive surgery either via mini sternotomy or right anterior thoracotomy.…”