II. Indications: Congestive Heart Failure

  1. Criteria
    1. NYHA Class 4 Heart Failure
    2. Ejection Fraction <25%
    3. VO2 Max <15
    4. Poor response to optimal medical management (e.g. Beta Blockers, ACE Inhibitors)
    5. Life Expectancy <2 years
  2. Scenarios (three possible)
    1. Bridge to Heart Transplant
    2. Destination therapy
      1. Primary treatment for those not candidates for Heart Transplant
    3. Reversible disease (e.g. severe Myocarditis)
      1. Bridge to recovery (remodeling of heart allows for LVAD removal)

III. Types: Ventricular Assist Devices

  1. Left Ventricular Assist Device (LVAD)
    1. Shunts blood from inflow cannula at the left ventricle apex via external pump
    2. Transfers blood to outflow cannula in the proximal aorta
  2. Biventricular Assist Device (BiVAD)
    1. Shunts blood from both ventricles via external pump

IV. Mechanism: LVAD

  1. Blood pathway
    1. Blood is shunted from left ventricle to inflow cannula
    2. Inflow cannula to external pump
    3. Pump blood flow capacity up to 10 L/min
    4. External pump to outflow cannula
    5. Outflow cannula to aorta
  2. Controller
    1. Worn externally, and plugs into the implanted pump via drive line protruding from skin
    2. Controller manages speed of pump and monitors patient parameters
    3. Controller will issue audible alarms when problems arise
    4. LED indicators on controller indicate status (e.g. on status)
    5. One button on LVAD indicates battery life
    6. Button on display cycles through alerts (suction event, low battery, driveline disconnected)
    7. LVAD is preprogrammed and can not be modified by controller device without LVAD coordinator assistance
  3. Driveline
    1. Driveline exits implanted pump and is tunneled via skin
    2. Driveline connects to external controller
  4. Power
    1. Controller connects to AC power base unit or to two batteries
    2. Allows for battery to be changed without device interruption
    3. One battery or AC power base unit must be connected at all times
    4. Patient wears batteries on suspenders (one on each side)

V. Precautions

  1. Patients are instructed to carry emergency supplies with them
    1. Backup controller
    2. Charged spare batteries
    3. Cords to connect the battery packs to a charger
    4. Emergency card with device information and VAD treatment team (e.g. VAD coordinator, cardiologist, CV surgeon)

VI. Preparations: LVAD

  1. First Generation LVAD
    1. Pulsatile-flow mechanism
    2. Bulky and less durable
  2. Second Generation LVAD
    1. Continuous-flow mechanism (via centrifugal or axial flow pump)
    2. Smaller, more durable and quieter than first generation pumps
    3. Pump implanted in Abdomen (HeartMate II) or chest (HeartWare)

VII. Symptoms

  1. Maintain a high level of suspicion for serious underlying cause in LVAD patients
  2. Patients with LVAD malfunction may present nonspecifically despite potentially lethal impending decompensation
    1. Weakness
    2. Malaise

VIII. Exam: Continuous Flow LVAD

  1. Signs of adequate perfusion
    1. Intact mental status
    2. Normal Capillary Refill
    3. Warm dista extremities
  2. Auscultation
    1. A working continuous flow LVAD should emit a continuous, low pitched hum (dish washer)
  3. Arterial Pulses are weak or absent and Pulse Pressure is decreased
    1. If pulses present, standard Blood Pressure may be obtained
    2. Pulses are typically absent with normally functioning continuous flow LVADs
  4. Mean arterial pressure (MAP) approximation (in place of standard BP)
    1. Apply manual cuff to arm and apply handheld doppler over brachial artery
    2. Slowly lower cuff pressure
    3. Listen for start of Karotkoff sound (will not be pulsatile with continuous flow LVAD)
    4. Onset of Karotkoff sound approximates mean arterial pressure (MAP)
    5. Goal MAP: 70-90 mmHg
      1. Hypertension (increased Afterload) puts the LVAD patient at risk for pump malfunction and failure
    6. Consider Arterial Line for MAP monitoring
  5. Oxygen Saturation
    1. Typically unreliable with continuous flow LVAD and decreased Pulse Pressure
    2. Consider cerebral oximetry instead

IX. Labs

  1. Basic metabolic panel (Chem8)
    1. Electrolytes
    2. Renal Function tests (BUN and Serum Creatinine)
  2. Complete Blood Count
    1. Evaluate for Anemia and Thrombocytopenia
  3. INR
    1. Typical goal for LVAD: 1.5 to 2.5 (ideally 1.8 to 2.3)
  4. Other labs as indicated
    1. Serum Troponin
    2. Type and Screen
    3. Infection suspected
      1. Serum Lactate
      2. Blood Cultures
    4. Significant Hemolysis suspected
      1. Lactate Dehydrogenase (LDH) increased
      2. Haptoglobin

X. Diagnostics: As Indicated

XI. Imaging: As Indicated

  1. Chest XRay
  2. Echocardiogram (or Bedside Ultrasound)
    1. See Inferior Vena Cava Ultrasound for Volume Status
    2. See Inflow cannula obstruction or malposition (below)

XII. Management: Approach Emergency Department

  1. Contact VAD team on patient arrival (LVAD coordinator or cardiothoracic surgeon)
  2. Evaluate device power (interruption of power even briefly is an emergency)
    1. Check driveline skin exit (for Trauma) and its connection to controller
    2. Check controller connection to batteries
    3. Check for green light on controller (indicates device is powered)
    4. Plug driveline into AC power base unit if available (to conserve battery power)
    5. Feel the controller for excessive heat
      1. Suggests increased circuit resistance
      2. May indicate device malfunction, pump thrombosis or increased Afterload
  3. Evaluate that device is functioning
    1. Check for warning lights or alarms on device
    2. Auscultate for the hum or blender-like sound of an operating LVAD
  4. Evaluate for signs infection
    1. Evaluate skin overlying driveline (or sternal incision if recent implantation)
    2. Consider evaluating pump pocket or device endocarditis with Echocardiogram
    3. Consider other infection sites (e.g. Urinary Tract Infection, Pneumonia) with risk of seeding the device
    4. When empiric antibiotics are indicated in a septic patient cover broadly
      1. See Infection as below
  5. Evaluate for signs of Fluid Overload (e.g. rales, edema, JVD)
  6. Evaluate for Hypertension (MAP >90 mmHg)
    1. MAP over 90 mmHg is a risk of CVA and impaired Cardiac Function
    2. Consider Fluid Overload or missed antihypertensive dose
    3. Consider Beta Blocker or ACE Inhibitor (consult cardiology)
  7. Evaluate for Hypotension (MAP <60 mmHg)
    1. Approach
      1. Consider causes (see each described in detail below under complications)
      2. Obtain Bedside Ultrasound or formal Echocardiogram, CBC and coagulation panel
      3. Initiate fluid bolus 500 to 1000 ml
    2. Dehydration
    3. Gastrointestinal Bleeding
    4. Infection (Sepsis)
    5. Right ventricular dysfunction with Heart Failure exacerbation
    6. Inflow cannula obstruction or malposition
    7. Pump thrombosis (increased risk when MAP <60)
      1. See below
  8. Evaluate for arrhythmia
    1. See Tachyarrhythmia below (VF, VT, a fib with RVR, SVT)
    2. See Cardiac Arrest below
  9. Consider other LVAD complications
    1. Pulmonary Embolism

XIII. Complications: Infection

  1. Infection occurs in 18-36% of LVAD implantations
    1. Infection is less common with continuous-flow devices by more than 2.5 fold
    2. May present non-specifically (e.g. weight loss, Fatigue, low-grade fever)
    3. Primary cause of death for LVAD patients
      1. First month: 8.6% of deaths
      2. After the first month: 20.5% of deaths
  2. Sites
    1. Non-LVAD related infections (UTI, Pneumonia, Cellulitis)
    2. Sternal incision infection (mediastinitis)
    3. LVAD pump pocket or pump infection
      1. Presents with vague symptoms (weight loss, malaise and low grade fever)
      2. Consider Echocardiogram or CT to evaluate device or pocket for infection
      3. Pump pocket infection
        1. Introduced in perioperative period (near the time of pump insertion)
      4. LVAD Endocarditis
        1. Pump may be seeded with Bacteria or fungus resulting
    4. Driveline infection
      1. Most common site of infection
      2. Often responds to antibiotics alone (without surgical drainage), covering for organisms listed below
      3. May result if driveline wire fails to adhere well to surrounding tissue (excessive manipulation)
        1. Allows for pocket to form along the driveline, in which infection can develop
      4. Presents with driveline exit site signs of infection
        1. Purulent drainage
        2. Erythema or tenderness or persistent serous drainage
        3. Wound dehiscence
      5. Prevention
        1. Avoid excessive manipulation of the driveline after insertion
        2. Daily cleaning of the driveline skin exit site
  3. Organisms (high risk of nosocomial organisms and Gram Negative infections)
    1. Staphylococcus aureus (including MRSA)
    2. Staphylococcus epidermidis
    3. Enterococcus
    4. Pseudomonas aeruginosa
    5. Klebsiella
    6. Enterobacter
    7. Fungal organisms
  4. Evaluation and Management
    1. Consider CT chest and CT Abdomen if mediastinitis, LVAD pump or pump pocket infection is suspected
    2. Consultation with cardiothoracic surgery
    3. Aim for MAP >65 mmHg in Sepsis via IV fluids
    4. Vasopressors may be needed
    5. Cover for Bacteria listed below with broad spectrum antibiotics
      1. Vancomycin (preferred) or Daptomycin AND
      2. Cefepime (preferred) or Ciprofloxacin or Levofloxacin or Piperacillin-Tazobactam (Zosyn) AND
      3. Fluconazole (preferred) or Voriconazole, Caspofungin, Micafungin, Anidulafungin
  5. References
    1. (2016) Sanford Guide, accessed 4/8/2016
    2. Gordon (2006) Lancet Infect Dis 6(7): 426-37 [PubMed]
    3. Pereda (2011) Cardiol Clin 29(4): 515-27 [PubMed]
    4. Topkara (2010) Ann Thorac Surg 90(4): 1270-7 [PubMed]

XIV. Complications: Bleeding

  1. Anticoagulation
    1. Most patients with LVAD or BiVAD are dual anticoagulated (e.g. Coumadin and Aspirin)
    2. May transiently stop Coumadin for major bleeding without serious risk of Thromboembolism in the short-term
      1. However, risk of pump thrombosis
      2. Reverse Coagulopathy in serious bleeding events (e.g. Vitamin K, Platelet Transfusion, DDAVP)
      3. Avoid Prothrombin Complex Concentrate (PCC)
  2. Small Bowel angiodysplasia (Intestinal arteriovenous malformation)
    1. Unclear etiology, although postulated to result from decreased intestinal mucosal perfusion
    2. Most common cause of Gastrointestinal Bleeding in LVAD patients
  3. Mechanical lysis of blood factors
    1. Acquired Von Willebrand's Disease (mechanical lysis of vwF)
    2. LVAD pump related Hemolysis (mechanical lysis of Red Blood Cells)
  4. Presentations
    1. Gastrointestinal Bleeding is the most common presentation
  5. Management
    1. Keep Mean Arterial Pressure >70 mmHg
    2. Transfuse for Hemoglobin <7 mg/dl (higher Hgb for active bleeding)
      1. Cross-match blood to prevent Antibody formation (risk for future Heart Transplant)

XV. Complications: Pump failure

  1. Presents with a pulseless patient in extremis
  2. Pump failure results in blood backflow into ventricle, and resistance to forward flow
    1. LVAD dependent patients (e.g. severe Aortic Stenosis) will have no forward systemic flow
  3. Auscultate chest (or Abdomen) to confirm that the pump is working (hum or blender-like sound)
  4. Check tubes, cables and controller
  5. Assess if the LVAD controller is over-heating (see above)
  6. Check battery power remaining (press button on battery)
    1. Patient should have extra batteries with the pump
    2. Patient may have power pack that allows for AC plug-in
    3. EMS may also have available AC base power supplies
  7. Evaluate pump output
    1. Obtain mean arterial pressure via doppler Ultrasound
    2. Obtain EKG to assess for acute Myocardial Infarction or arrhythmia
    3. Obtain Echocardiogram to assess for interval changes from prior Echocardiogram
  8. Assess alarms
    1. Red lights or audible alarms suggest impending pump failure (address emergently)
  9. Restarting a stopped pump
    1. Press "Test Select" or "Alarm Reset" buttons may restart the LVAD

XVI. Complications: Inflow cannula obstruction or malposition

  1. Evaluate with Bedside Ultrasound
    1. Evaluate left ventricular and right ventricular function
    2. Small right ventricle and left ventricular collapse may suggest hypovolemia (see below)
  2. Hypovelemia allows left ventricle to collapse over the LVAD inflow cannula (suction event, suck-down phenomenon)
    1. Obstructs blood flow into the pump, reducing Cardiac Output
    2. Fluid bolus may re-expand left ventricle and relieve obstruction
  3. Inflow cannula may also be malpositioned
    1. Urgent cardiovascular surgeon Consultation

XVII. Complications: Pump thrombosis

  1. Occurs in up to 10% of LVAD patients
  2. Pump may become clogged with clot, impeding forward flow
  3. Emergent condition typically presenting with MAP <60 mmHg
  4. Evaluate pump parameters
    1. Pump parameters are available when the pump is on external power
    2. High pump power, high pump speed despite decreased flow may suggest pump thrombosis
    3. Pump may sound choppy, instead of typical constant hum
    4. Controller display may show alert "low flow alarm"
  5. Bedside Ultrasound or Echocardiogram
    1. Left ventricle small and right ventricle large
  6. Exam
    1. Paradoxically increased palpable pulse
    2. Findings suggestive of right ventricular Heart Failure
  7. Labs
    1. Lactate Dehydrogenase (LDH) may be increased (esp. if LDH>1000)
      1. Increases due to Hemolysis
    2. Hemoglobuniuria may occur
  8. Management
    1. Consider intravenous Thrombolytics

XVIII. Complications: Heart Failure exacerbation despite pump operating

  1. Right ventricular dysfunction is common after LVAD insertion
    1. LVAD patients depend on the right ventricle for Preload
  2. Obtain Bedside Ultrasound or Echocardiogram to evaluate right ventricle
  3. Consider Endotracheal Intubation
    1. May decrease Pulmonary Hypertension
    2. May improve Respiratory Acidosis and Metabolic Acidosis
  4. Consider Vasopressors

XIX. Complications: Tachyarrhythmia

  1. Common arrhythmias
    1. Ventricular Tachycardia or Ventricular Fibrillation
      1. Sustained VT or VF occurs in up to 52% of LVAD patients
      2. May be asymptomatic for days in some LVAD patients
      3. Those with AICD may fire repeatedly
    2. Atrial Fibrillation or Atrial Flutter
    3. Supraventricular Tachycardia
  2. Presentation
    1. Right-sided Heart Failure
      1. Decreased left Ventricular Preload
      2. Results in Syncope, light headedness or weakness
  3. Management
    1. AICD may fire repeatedly if present
    2. Consult with VAD team when able
    3. Cardioversion is critical if this affects the right ventricle and Preload of the left ventricle
      1. Attempt chemical cardioversion (e.g. Procainamide, Amiodarone) in stable patients
      2. Electrical cardioversion if unstable or refractory tachyarrhythmia
        1. Avoid overlapping conductor pads over the LVAD (or AICD) if possible

XX. Complications: Cardiac Arrest

  1. Precautions
    1. Absent pulse or Blood Pressure does not equate to Cardiac Arrest in the LVAD patient (see exam above)
    2. Chest Compressions may dislodge left ventricle LVAD inflow cannula
      1. Start Chest Compressions as a last resort, but do not withhold if indicated
      2. Abdominal only CPR has been suggested as possible option (experimental only)
      3. Some studies have demonstrated safety of CPR in LVAD patients
        1. Shinar (2014) Resuscitation 85(5):702-4 +PMID:24472494 [PubMed]
    3. Avoid overlapping electrical Defibrillation conductor pads over the LVAD (or AICD) if possible
  2. Diagnostics
    1. Auscultate the chest for hum, and if present, measure mean arterial pressure
    2. Bedside Echocardiogram to evaluate assess left and right ventricles
    3. Confirm that LVAD is operational (see above under pump failure)
      1. Pump disconnected from driveline, battery disconnected or discharged
  3. Management
    1. Follow ACLS protocol (including electrical Defibrillation)
    2. Address pump failure, pump thrombosis, and inflow cannula obstruction (see above)
    3. Consider Intravenous FluidResuscitation if left ventricular collapse suspect (with inflow cannula obstruction)
  4. References
    1. Shinar (2014) Resuscitation 85(5): 702-4 [PubMed]

XXI. Efficacy

  1. Survival rates (continuous flow devices)
    1. Year 1: 80% (compared with 25% on medical therapy)
    2. Year 2: 70% (compared with 8% on medical therapy)
    3. Kirklin (2013) J Heart Lung Transplant 32(2):141-56 [PubMed]

XXII. References

  1. Lo and Devine (2014) Crit Dec Emerg Med 28(7): 2-9
  2. Mallemat, Swaminathan and Egan in Herbert (2014) EM:Rap 14(10): 3-5
  3. Swadron and Shinar in Majoewsky (2012) EM:RAP 12(4): 4-5
  4. Vanlandingham (2015) Crit Dec Emerg Med 29(10): 2-14
  5. Klein (2012) Cardiol Clin 30(4): 673-82 [PubMed]

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Ontology: Artificial Ventricle (C0085842)

Definition (UMD) Circulatory assist units designed to assist one of the ventricles (most frequently, the left ventricle) of a damaged or weakened heart in pumping blood. These units typically consist of a mechanism that includes a pump, cannulae to draw venous blood to the pump and deliver it back to the aorta or pulmonary artery (according to left or right ventricle assistance, respectively), valves, and a unit that controls pump operation. Ventricular assist units are used to improve blood circulation in patients with a debilitated heart; the main components of these devices work external to the body, but some components, such as cannulae and/or balloons, are inserted in the circulatory system. Ventricular assist units are intended for temporary use either while the heart is healing or as a bridge to a heart transplant.
Concepts Medical Device (T074)
MSH D006353
SnomedCT 360064003
LNC LA16769-4
English Artificial Heart Ventricle, Artificial Heart Ventricles, Artificial Ventricles, Device, Ventricle-Assist, Devices, Ventricle-Assist, Heart Ventricle, Artificial, Heart Ventricles, Artificial, Ventricle Assist Device, Ventricle, Artificial, Ventricle, Artificial Heart, Ventricle-Assist Device, Ventricle-Assist Devices, Ventricles, Artificial, Ventricles, Artificial Heart, Circulatory Assist Units, Ventricular, Circulatory Assist Units, Cardiac, Ventricular, VADs, Ventricular Assist Devices, ventricular assist device (treatment), ventricular assist device, ventricular assist devices, assisted device ventricular, assist device ventricular, Assist Device, Ventricular, Devices, Ventricular Assist, Ventricular Assist Device, Assist Devices, Ventricular, Device, Ventricular Assist, Ventricular assist device (physical object), Ventricular assist device, Artificial Ventricle
Portuguese Ventrículo Artificial, Dispositivo para Suporte Ventricular, Ventrículo Cardíaco Artificial
Spanish Ventrículo Artificial, dispositivo de asistencia ventricular (objeto físico), dispositivo de asistencia ventricular, Dispositivo de Ayuda Ventricular, Ventrículo Cardíaco Artificial
German Künstlicher Ventrikel, Herzventrikel, künstlicher, Ventrikelunterstützende Vorrichtungen
French Appareil d'assistance ventriculaire, Dispositif d'assistance ventriculaire, Ventricule artificiel
Czech podpora srdeční komory, podpora srdečních komor
Norwegian Venstre ventrikkelassistanse, Ventrikkelassistanse, Hjelpehjerter
Italian Dispositivo di assistenza ventricolare, Ventricoli artificiali
Dutch Voorzieningen, ventrikelondersteunende, Hartventrikel, artificiële, Ventrikel, artificiële

Ontology: Biventricular assist device (C0179322)

Concepts Medical Device (T074)
SnomedCT 360057000
English Biventricular Assist Devices, Biventricular assist device (physical object), Biventricular assist device
Spanish dispositivo de asistencia biventricular (objeto físico), dispositivo de asistencia biventricular

Ontology: Left ventricular assist device (C0181598)

Definition (NCI_CDISC) A procedure involving a mechanical cardiac pump which receives blood from the left ventricle and delivers it to the aorta.
Definition (NCI) A mechanical pump which also includes a control system and an energy supply. It receives blood from the left ventricle and delivers it to the aorta, thus helping the heart to pump sufficient blood to the body.
Concepts Medical Device (T074)
SnomedCT 360066001
English Left Ventricular Assist Devices, Left Ventricular Assist Device, assist devices left ventricular, assisted device left ventricular, left ventricular assist devices, assist device left ventricular, left ventricular assist device, LVAD, LEFT VENTRICULAR ASSIST DEVICE, Left ventricular assist device (physical object), Left ventricular assist device
Spanish dispositivo de asistencia para el ventrículo izquierdo (objeto físico), dispositivo de asistencia para el ventrículo izquierdo