Berlin Heart EXCOR Pediatric VAD, Руководство пользователя

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Chapter 3 Summary of Clinical Studies
who met critical eligibility criteria. The dataset for the ELSO registry included baseline
and outcomes data comparable to the EXCOR dataset. The control group was then
created by matching the EXCOR subjects to the patients in the subset using a
propensity score analysis (PSA).
3.6.3 Inclusion/Exclusion Criteria
Subjects of both genders who satisfy all inclusion and exclusion criteria were eligible
for entrance into the primary cohorts of the clinical study.
Inclusion Criteria
1. Severe NYHA Functional Class IV (or Ross Functional Class IV for subjects
≤
6
years) heart failure refractory to optimal medical therapy, and has met at least
one of the following criteria:
a.
INTERMACS
™
profile status 1 or 1A, i.e. critical cardiogenic shock (low BP
unresponsive to support, compromised end organ perfusion, < 24 hour
survival expected without mechanical support; may be due to VT/VF (1A)
b. INTERMACS profile status 2 or 2A (i.e. progressive decline): not in imminent
danger, but worsening despite optimal inotropic therapy; may be due to VT/
VF (2A) AND at least one of the following criteria:
a.
Decline in renal function as defined by a 50 % reduction in estimated
GFR despite optimization of subject volume status
b. Decline in nutritional status as defined by a sustained (
≥
7 days) inability
to tolerate an enteral nutritional intake sufficient to provide at least 75 %
of the prescribed caloric needs for the subject, or signs of nutritional
compromise (cachexia, nutritional weight loss) despite appropriate
intervention
c. Decline in mobility/ambulation as defined by sustained bed confinement
(
≥
7 days without prospect for improvement) attributable to heart failure
symptoms or its treatment (e.g. intubation for pulmonary edema)
c. Support with extra-corporeal membrane oxygenation (ECMO) or other
mechanical circulatory support device OR
d. Unable to separate from cardiopulmonary bypass (must be listed for heart
transplantation at time of transfer to the operating room)
2. Listed (UNOS status 1A or equivalent) for cardiac transplantation
3. Two-ventricle circulation, including cardiomyopathy, repaired structural heart
disease (e.g. ALCAPA, aortic stenosis) or acquired heart disease (e.g.
myocarditis, Kawasaki disease)
4. Age 0 to 16 years; corrected gestational (CGA) at least 37 weeks
5. Weight
≥
3 kg and
≤
60 kg
6. Legal guardian (and subject if age-appropriate) understands the nature of the
procedure, are willing to comply with associated follow-up evaluations, and
provide written informed consent and assent prior to the procedure
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