Haemodynamic benefits of rapid deployment aortic valve replacement via a minimally invasive approach: 1-year results of a prospective multicentre randomized controlled trial

Abstract

MIS-RDAVR is associated with a significantly reduced cross-clamp time and better valvular haemodynamic function than FS-AVR. However, paravalvular leak rates are higher with MIS-RDAVR.

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

“…Stroke occurred in 1.9% of all cases, and no severe PVL was observed whereas a mild PVL was identified in only 3.2% of patients at discharge. These findings correspond to the current large reports on the Intuity [5,6,8] and Perceval RDVs [4,7,10] that show early valve-related mortality and stroke rates ranging from 0.5% to 2.1% and 1.6 to 4%, respectively. In these trials, early PVL was mild in 2.0% to 6.9% of patients, and only 0% to 1.4% of patients had severe PVL that required redo conventional AVR.…”

“…77 years; mean additive EuroSCORE 6.8) with more than 46% of patients undergoing a combined procedure with CABG, an acceptable all-cause 30-day mortality (3.2%) and postoperative complication rate that is comparable to previous studies that included patients with similar or lower risk profile using the Perceval S [4,7,10] or Intuity RDV [5,8,16,17]. For the Perceval RDV, the largest multicenter experience reported a 30-day mortality rate of 3.4% for a total of 731 patients [10].…”

“…For the Perceval RDV, the largest multicenter experience reported a 30-day mortality rate of 3.4% for a total of 731 patients [10]. Similarly, the recently published Cavalier trial [4] [8,6]. Although preoperative risk stratification, such as the EuroSCORE or The Society of Thoracic Surgeons score are currently not considered as an indication for or against a RDAVR at our institution, the 30-day mortality was 1.9% in the TRITON study and 4% in the CANDENCE-MIS study after isolated AVR using the Intuity RDV, both reflecting our 2.6% 30-day mortality rate for the Intuity group.…”

“…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.…”