Aortic valve replacement with a novel anti-calcification technology platform

Abstract

This early clinical experience using an aortic bioprosthetic valve treated with a novel anti-calcification tissue processing technology demonstrated excellent valve performance, durability, and safety. No valve-related complications were noted. Longer-term follow-up is needed to verify these promising results.

Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-year outcomes

“…The RESILIA™ bioprosthetic heart valve was developed to produce consistent long-term resistance to SVD. Early and late clinical outcomes and haemodynamic performance of RESILIA™ tissue valves were first studied in a series of 20 patients [6]. The current prospective, multicentre, single-arm study extends these previously published observations from 20 to 133 patients, including 34 young adults under the age of 60 years [6].…”

“…Early and late clinical outcomes and haemodynamic performance of RESILIA™ tissue valves were first studied in a series of 20 patients [6]. The current prospective, multicentre, single-arm study extends these previously published observations from 20 to 133 patients, including 34 young adults under the age of 60 years [6]. Data from the current study demonstrate that the haemodynamic performance of RESILIA™ tissue valves is acceptable and is similar to C-E Perimount valves [8], and C-E Perimount Magna Ease [9], with low rates of adverse events at one-year follow-up.…”

“…The Model 11000A incorporates RESILIA™ tissue leaflets created with EIP™ technology, which is an advanced tissue technology that preserves tissue integrity and is designed to produce consistent long-term resistance to SVD by stable capping, which permanently blocks calcium CT -computed tomography; MRI -magnetic resonance imaging (Ca 2+ ) binding sites [4,5]. The surgical approach and technique of implantation was at the discretion of the investigator per his/her routine surgical practice and performed via full or partial sternotomy using previously described techniques [6]. At the discretion of the investigator, bioprosthetic heart valve recipients should be maintained on anticoagulant therapy (except when contraindicated) during the initial healing stages after implant, 2-3 months in accordance with the American College of Cardiology/American Heart Association 2008 Guidelines for the Management of Patients with Valvular Heart Disease [7].…”

“…In preclinical in vitro and in vivo ovine and rabbit studies, RESILIA™ tissue demonstrated significantly less Ca 2+ accumulation when compared with conventional tissue [4,5]. In addition, initial clinical data on the first 20 patients with severe aortic stenosis, who underwent isolated aortic valve replacement (AVR) with RESILIA™ tissue valves, has demonstrated improved haemodynamic performance over baseline values, and durability and safety at up to one year of follow-up [6]. Herein we present our further results of all 133 patients who underwent AVR with RESILIA™ in Poland.…”

Heart valve tissue engineering: how far is the bedside from the bench?

“…A summary of reported clinical experiences is given in Table 2. It should be noted that this strategy, which is labelled as B in Figure 3, is the one that has gone further of all TEHV approaches concerning clinical trials (Refs 103, 104, 106).…”