Download HeartWare Ventricular Assist System Instructions for Use

HeartWare® Ventricular Assist System Instructions for Use
*Infection Control Guidelines and Driveline Care based on recommendations from “Multicenter
Experience: Prevention and Management of Left Ventricular Assist Device Infections”. Chinn et al.
ASAIO Journal 2005; 51:461–470
CAUTION: ALWAYS examine the driveline for evidence of tears, punctures or breakdown of
any of the material during exit site dressing changes. Driveline damage may affect
HeartWare® System performance.
5. Perform exit site care every 24-48 hours using an antiseptic cleansing agent, such as a diluted
chlorhexidine scrub solution. Following aseptic cleansing, rinse and dry the site to avoid tissue
injury. Aseptic technique should be followed anytime the dressing is removed and the exit site is
exposed, inspected, dressed or handled. When performing exit site care, be sure to wear a cap,
mask and sterile gloves.
CAUTION: AVOID the use of prophylactic topical antibiotic ointments such as silver
sulfadiazine, betadine or polymyxin-neomycin-bacitracin on the tissue around the driveline
exit site as these ointments can injure the tissue.
6. Immobilize the percutaneous lead with occlusive dressing and if necessary, a Hollister clip,
Montgomery strap, or a custom-made percutaneous lead immobilization binder or belt. Keep the
extra external length of the driveline under a binder or clothing.
7. Complicated, non-routine driveline dressing changes that involve exit site infections may require
assistance/supervision from a health care professional.
8. For wounds/incisions other than the driveline exit site that require dressing changes and/or other
care, the ability of the patient and caregiver to provide that care will be evaluated by the
implanting center. Treatment plans will be dependent upon this evaluation.
18.6 Arrhythmias
The HVAD® Pump functions most effectively when adequate and stable amounts of preload are
available. A stable supraventricular rhythm helps to optimize right heart performance and provide the
HVAD® Pump with preload. Many heart failure patients will have permanent pacemakers and internal
defibrillators in place by the time an LVAD is implanted. These devices are often needed in the early
postoperative period.
18.7 Right Heart Failure
Right heart failure is common in patients receiving LVADs. Right heart failure usually develops within
the first 24 hours after LVAD implant. Warning signs include increasing right atrial pressure (RAP) with
concurrent decreases in the pulmonary capillary wedge pressure (PCWP) and LVAD flow. Systemic
hypotension, tachycardia and a decrease in urine output soon follow. Volume should be given to
increase the RAP to 15-18mmHg. This can be accomplished quickly and easily in the operating room
while the patient is on cardiopulmonary bypass. Increasing the RAP to >20mmHg is usually ineffective.
After optimizing intravascular volume, increasing inotropic drug support in conjunction with
pulmonary vasodilators such as nitric oxide is usually effective. If volume and pharmacological therapy
fail, a right ventricular assist device (RVAD) should be considered. Late right heart failure (weeks to
months) post LVAD implant is unusual but would manifest itself with similar but less acute symptoms.
The etiology of late right heart failure may be a progression of chronic heart disease such as coronary
artery disease and/or right ventricular infarction. The cause of the right heart dysfunction should be
identified and treated appropriately.
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