Page 14 - VAD Guidelines
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Pediatric Ventricular Assist Device (VAD) Guidelines

               VAD Adverse Events


               Major Bleeding Episodes
               Bleeding events while requiring device support have long been one of the most frequently encountered
               adverse events in pediatric VADs. Though management has improved from the time of the Berlin IDE
               trial when 40% of patients suffered from major bleeding episodes, the rate of bleeding events in
               pediatrics remains over two-fold that is seen in adults.  Major bleeding episodes are explicitly defined as
               internal or external bleeding episodes with a single PRBC transfusion requirement within the first post-
               operative week of >20 ml/kg (4 units for adult sized patients) or any transfusion related to a confirmed
               or suspected bleed after 1 week post implant.

               Early Bleeding
               Bleeding risk relates to multiple factors including time from implant with very early (<2 weeks) events
               predominating, patient characteristics with younger age increasing risk, and type of device with
               paracorporeal devices carrying the highest risk.  However, the single most effective predictor of early
               post-operative bleeding is intra-operative hemostasis.

               Risks of Inadequate Perioperative Hemostasis
                   •  Need for reoperation
                   •  Acute increase in PVR with frequent/high volume transfusion (risk of RV dysfunction and failure)
                   •  Delay in initiation of systemic anticoagulation (risk of device thrombosis and stroke)

               Management of Early Perioperative bleeding
                   •  Correction of perioperative coagulopathy via factor replacement
                   •  Delayed initiation of anticoagulation until hemostasis achieved
                   •  Slow infusion of blood products

               Late Bleeding
               Though early bleeding predominates in pediatric patients, bleeding risk never approaches zero for the
               duration of device support related to on-going need for anticoagulation. Adult data in continuous flow
               devices shows GI bleeding predominates long-term risk with etiologies relating to acquired Von
               Willebrand Factor (aVWFD) and resultant GI vascular malformations and thus bleeding risk. Though
               aVWFD has been shown to exist in both pediatric pulsatile and continuous flow devices, little is known
               regarding how this relates to risk. Late bleeding in pediatrics presents most frequently as mucosal
               bleeding, and in the setting of intrapericardial devices as pericardial effusion.  Development of late
               bleeding, however, correlates most frequently to changes in anticoagulation or antiplatelet therapy.

               Cardiac Tamponade
               Any VAD patient in whom there is concern for tamponade should have an immediate echo and the
               surgeon advised of the concern. Note that evidence of tamponade with the HeartWare® or Heartmate 3
               patient includes loss of pulsatility on device monitoring. Echo surveillance is important as clinical
               evidence may be lacking.

               Hemolysis in the setting of VAD support relates to increases in shear stress to which red blood cells are
               exposed.  Though current device technology limits the amount of turbulence within the pump

               Updated 3/24/2019                                                                      page 14
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