End-stage Heart Failure Awaiting VAD Implantation Clinical Trial
Official title:
A Controlled, Single-Center Clinical Pilot Study to Evaluate the Performance of CoSeal as a Barrier for Adhesion Prevention in Patients Submitted to Ventricular Assist Device VAD)
The objective of this controlled, non-randomized, single-center pilot study (CoSeal arm prospective)study is to evaluate the efficacy of the synthetic surgical hydrogel CoSeal® in the prevention of cardiac adhesion formation in patients submitted to VAD procedures.
In the past decade the use of ventricular assist devices) (VADs) for bridging to heart
transplantation (HTx) or, in some cases, to recovery of the ventricular function has
increased and, during the same time, the duration of the implantation period has lengthened
dramatically. When removing VADs after a long period, surgeons face severe pericardial
adhesions at the mediastinum level and of the surrounding tissue due to the inflammatory
response. During resternotomy, dissection of these adhesions increases surgical time and can
be a source of lesions on the cardiac or vascular structures and of severe bleeding at the
moment of transplantation or when the device is removed.
Many products have been used to prevent or reduce adhesions but an ideal antiadhesive
treatment has remained elusive. CoSeal®, a licensed synthetic hydrogel (Baxter, USA) has
been shown to reduce pericardial adhesions in a limited series of reoperations.
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Observational Model: Case Control, Time Perspective: Prospective