BeneMACS Study:HeartMate 2 (HM2)Left Ventricular Assist Device (LVAD) Survival in Non Transplant Patients is Equal/Better Than Results in Medical Literature (BeneMACs)

This is an interventional treatment trial for Heart Failure focused on measuring HeartMate II, BeneMACS, LVAD, Thoratec Corporation Read More

Inclusion Criteria:

• Patient or their legal representative has signed an informed consent. > 18 years of age.
• BSA > 1.3m2.
• Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient must meet one of the following) On optimal medical management, including dietary salt restriction, diuretics, beta-blockers, spironolactone and ACE inhibitors, for at least 45 out of the last 60 days and are failing to respond; or In Class III or Class IV heart failure for at least 14 days, and dependent on intra aortic balloon pump (IABP) for 5 days and/or inotropes for at least 10 days; or Treated with ACE inhibitors or beta-blockers for at least 30 days and found to be intolerant.
• Female patients of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study.
• Ineligible for cardiac transplant.
• VO2max < 14 ml/kg/min or <50% of predicted VO2max with attainment of anaerobic threshold (AT), if not contra-indicated due to IV inotropes, angina or physical disability.
• LVEF is < 25%.

Exclusion Criteria:

• Etiology of heart failure is due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy.
• Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator.
• Body Mass Index (BMI) > 40 kg/m2.
• Positive pregnancy test if female of childbearing age.
• Presence of mechanical aortic valve that will not be converted to a bioprosthesis at time of LVAD implant.
• History of cardiac transplant or cardiomyoplasty.
• Platelet count < 50,000.
• Evidence of an untreated aortic aneurysm > 5cm.
• Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAD management.
• Presence of active, uncontrolled infection.
• Intolerance to anticoagulant or antiplatelet therapies or any other peri/post operative therapy the investigator will require based upon the patient's health status.
• INR > 2.5, which is not due to anti-coagulant therapy, or Plavix administration within 5 days.
• Evidence of intrinsic hepatic disease as defined by liver enzyme values (AST or ALT or total bilirubin) that are > 5 times the upper limit of normal, or biopsy proven liver cirrhosis.
• History of severe COPD or severe restrictive lung disease.
• Fixed pulmonary hypertension with a PVR > 8 Wood units that is unresponsive to pharmacological intervention.
• History of a stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (> 80%) extra cranial stenosis.
• Serum creatinine > 3.5 mg/dl or the need for chronic renal replacement therapy (e.g. chronic dialysis).
• Significant peripheral vascular disease accompanied by rest pain or extremity ulceration.
• The patient has moderate to severe aortic insufficiency without plans for correction during pump implantation surgery.
• Participation in any other clinical investigation that is likely to confound study results or affect study outcome.
• Any condition, other than heart failure, that is likely to limit survival to less than 3 years.