Description
- The proposed indications include:
- * Patients requiring aortic or pulmonary valve replacement.
- * Pediatric patients 30 days or older and \< 18 years, and adult patients 18-50 yrs.
- o Particularly patients with significant growth potential
- * Insufficient options are available for valve replacement
- o Patients at risk of immunogenic bio-prosthetic valve failure
- * Discussion with patient /family - option for durable valve rather than traditional prosthesis
- * ABO compatible
- * Patient and family able to travel to BCH within 48 hour time frame or within our organ procurement organization
- * Patients that are able to maintain follow-up at BCH during the duration of the study
- * Patients that are able to provide medical record authorization for 5 year follow-up
- The proposed contraindications include:
- * Age \< 30 days
- * Irreversible multisystem organ failure; or additive effects of the multiple systems affected making transplant survival unlikely
- * Progressive systemic disease with early mortality (genetic/metabolic, idiopathic, syndromic)
- * Morbid obesity (BMI\>35)
- * Diabetes mellitus with evidence of end-organ damage
- * Severe chromosomal, neurologic or syndromic abnormalities
- * Immunocompromised condition (DiGeorge, SCID etc.)
- * Active infection
- * History of endocarditis
- * HIV or chronic hepatitis B or C infection
- * Malignancy within 5 years prior to transplant
- * Severe renal or liver failure
- * Inadequate social support for post-transplant management
- * Recent history of illicit drug, tobacco or alcohol abuse despite trials/assistance to stop behavior
- * Evidence of large stroke with high risk for hemorrhagic conversion
- * Heart transplant recipient
- * Patients that are unable to follow-up during the initial 6 month window
- * Patients that are unable to provide medical record authorization for 5 years
Ages Eligible for Study:
30 Days to 50 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No