HM3 SWIFT

This study is looking at patients who will be receiving the HeartMate3 Left ventricular assist device and its insertion based off of an incision technique aside from full median sternotomy.

Inclusion Criteria

• Subject is NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV
• LVEF ≤ 25%
• Subject is:
  • Inotrope dependent OR
  • Has a CI < 2.2 L/min/m2, while not on inotropes and meets one of the following criteria: 
    • On optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond to therapy or
    • Advanced heart failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) for at least 7 days

Exclusion Criteria

• Subject has a planned concomitant procedure at time of implant (e.g. valve repair, CABG, ASD repair, etc.)
• Subject has greater than mild aortic insufficiency
• Subject has ongoing mechanical circulatory support (MCS) at the time of LVAD surgery other than IABP

Study Requirements

• Medical History, including cardiovascular history with etiology of HF and duration of HF
• Physical Exam, including height, weight and vital signs
• Current Medications (total daily dose): anticoagulation/anti platelet, antibiotics, and cardiovascular medications including ACE inhibitors, ARBs, beta blockers, statins, nitrates, allopurinol, aldosterone blockers, and diuretics including metolazone, hydrochlorothiazide and furosemide
• Laboratory Assessments: a. Hematology: hemoglobin, hematocrit, PHgb, WBC, Bleeding/Coagulation: INR;Chemistry: Blood Urea Nitrogen (BUN), creatinine, eGFR (calculated); Liver Enzymes: LDH, AST, ALT, total bilirubin
• Hemodynamic Measurements: Pulmonary Capillary Wedge Pressure, Pulmonary Arterial Systolic Pressure, Pulmonary Arterial Diastolic Pressure, Pulmonary Arterial Mean Pressure, Central Venous Pressure, Cardiac Index, Cardiac Output, Pulmonary Vascular Resistance, Right Atrial pressure, and Left Atrial pressure (LAP only if available)
• Echocardiogram: LVEF, LVEDD, LVESD, AV opening, AI, MR, TR including severity and/or grade
• Chest x-ray: AP and Lateral, submitted to sponsor; DICOM format should be uploaded (if standard of care)
• 6 Minute Walk Test (6MWT) (if Subject is able; reason must be provided if not performed)
• EQ-5D-5L
• Kansas City Cardiomyopathy Questionnaire (KCCQ)
• Modified Rankin Score (as determined by an independent assessor; defined as an independent, trained, and certified clinician)
• NYHA Classification (as determined by an independent assessor; defined as an advanced practice practitioner other than the treating investigator)
• INTERMACS Patient Profile (to be assessed immediately prior to implantation; refer to Appendix 2 for definitions)