Levitronix

Transcription

Levitronix

About Levitronix:
CentriMag® VAS
U.S. Clinical Trials
Patient & System
ICU Management
Levitronix LLC Confidential
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Levitronix is a world leader in magnetically levitated
Bearingless Motor technology, specializing in the
development of “Third Generation” blood pumps.
Copyright Protected (7/05)
®
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CentriMag® Characteristics
CentriMag VAS System
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No bearings, seals, valves, or diaphragms – No wearing parts,
friction, or heat generation in the blood path, reducing the risk for
thrombus formation and hemolysis.
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Elimination of bearings and seals allows uniform washing of the
rotor surface and minimizes areas of blood stagnation and
turbulence in the pump.
and Flow Probe
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Large mechanical gaps in the pump (>0.6mm) allows the shear
forces to be low, greatly reducing hemolysis.
• Cannulae, Tubing
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The system can be used for up to 14 days of continual use.
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The system is capable of providing flow up to 9.9 liters per minute
under normal physiologic conditions.
• CentriMag Blood
Pump and Motor
• Console, Cables
and Connectors
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Example Case - 51 Year Old Male
Objectives of LV/RV support
• AMI requiring hospital admission
• Emergent CABG, IABP
• Day 6: Transfer to VAD/ Transplant Centre
• Ventilator, IABP, inotropic support
• Haemodynamics: C.I. 1.6, mABP 66, EF 8%
• Neurologic status: unknown
• Day 6: LVAD ! BVAD ! BVAD + ECMO
• Day 11: Weaned from ECMO to BVAD
• Day 17: Bridged to HeartMate® VE LVAD
• Day 39: Discharge to Home on HeartMate® VE
• Now: LVAD & Awaiting Heart Transplantation
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Provide essential circulatory support
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Unload and decompress the ventricles
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Reduce myocardial work
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Reduce myocardial oxygen demand
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Reduce myocardial edema
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Regain ventricular function
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Post AMI: Prevent over distention, facilitate solid scar formation,
limit extent of evolving infarction.
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Cannulation for RVAD Support
RVAD Trial Objectives
• To evaluate use of the Levitronix CentriMag®
Ventricular Assist System as an RVAS following
implantation of a commercially approved LVAS.
• Demonstrate safe and effective use for 14 days.
• To serve as a bridge to recovery, bridge to longterm support with a commercially approved
device or bridge to heart transplantation.
• Improvement of the protocols, study design,
training, VAD system, and system components.
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CentriMag Control Panel
CentriMag® Console Control Panel
• Row 1 - Information
• Speed and RPM displays & bars, battery gauge, and power icons
• Row 2 - Alphanumeric Display (4 lines)
• Lines 1 & 2 display system status
• Line 3 displays selected system parameters
• Line 4 displays keypad descriptions
• Row 3 - Keypads
• Alarm Silence, Menu Options, Speed Adjustment, Pump Stop
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Normal Operating Conditions
CentriMagR Control Panel
Alarm Acknowledge - Depressing will silence audio alarm. Message remains
displayed. Alarm messages will be displayed in order of priority.
Menu – Allows user to select system one of three settings to view or modify
e.g. (Adjust RPM, minimum flow alarm level, or audio volume).
Set Pump RPM – When ‘SET RPM’ is displayed depress for speed adjustment.
If ‘EXIT’ is displayed depress to store value. RPM will remain at set rate.
Decrease - Allows user to decrease selected parameter.
Increase - Allows user to increase selected parameter.
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Pump Speed : 3000 – 4000 RPM
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RVAD Flow: 4 – 5 LPM
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CVP / RAP: 10 – 15 mm Hg
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ACT: 190 - 210 by 4th post-op day
Emergency Stop – Depressing for 2 seconds will cause the pump to STOP.
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Management Points
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Potential Early Complications
VAS system has no auto-control
“Similar to other VADs”
Adjustments in flow must be gradual
Periodic flow reduction to wash ventricles
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Bleeding
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Arrhythmias
Avoid conditions that result in line “chatter”
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Tamponade
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Variable volume
Avoid flexing of tubing near the connectors
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Reoperation
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Variable VAS flow
Balance left & right atrial pressure not flows
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“HIT”
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Right ventricular failure
Forces are easily transmitted through tubing
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Adjust VAD RPM For:
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Potential Causes of Low VAD Flow
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Low flow with line chatter/ shaking
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Low volume / low pressure (CVP)
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Periodically (when ordered)
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To wash ventricles and valves
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Respiratory therapy (if necessary)
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Interstitial edema
Cardiac tamponade
Pulmonary vascular resistance
Cannulae selection and position
Operating at too high of an RPM
Ventricular function/ dysfunction
Hypovolemia (Bleeding, Fluid Balance)
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Anticoagulation Guidelines*
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More Aggressive Anticoagulation
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Short or no cardiopulmonary bypass
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Normal of hypercoaguable profile
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Clot formation in circuit or pump
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Low flow (<4 LPM) or high RPMs
Target PTT 1.3-1.6 (eg. 39 – 48 sec) times normal
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Circuit Design (connectors, Leur, etc…)
Increase Target ACT & PTT approx. 5% each day
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Oxygenator or heat exchanger
Target ACT of 190-210 by 4th post op day
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Infection or inflammatory process
Target PTT 1.5-1.8 times normal by 4th post op day
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High platelet count (>100k)
Add platelet anti-aggregant by the 4th postop day
(eg. 81- 325 mg aspirin per day) by the 4th postop day
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High fibrin level
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Prosthetic valve, patch, or ring.
CentriMag VAD flow > 4.0 LPM
No anticoag. for 6-12 hrs unless no CPB for implant
Start heparin infusion if CT < 50 cc/hr for 2-3 hrs
Target ACT 160-180 sec
(Hemochron Celite ACT)
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History of “bleeding”.
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Hepatic and/or renal dysfunction
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Patient temperature – hypothermia
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Abnormal platelet function
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Hemostasis Management
Less Aggressive Anticoagulation
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LABORATORY STUDIES:
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TREATMENT OPTIONS:
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ACT, PT, INR, PTT
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Platelets
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Fibrinogen
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FFP, Cryoprecipitate
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Platelet count and function
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Protamine Sulfate
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Amicar, Aprotinin
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Vitamin K
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Study Daily Data Requirements
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CentriMag® System Checks (Q 1-2°)
Hemodynamics
• HR, TEMP, CVP, PAP, PCWP, ABP, CO
• RVAD RPM & LPM, LVAD RPM & LPM
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Laboratory
• CBC, Chem13, LDH, PFHgb, Coags, ACT
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Neurologic
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ACT within target range?
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Record VAD flow and RPMs with VS
Line chattering or shaking?
Color of urine for hemolysis?
Reduce VAD flows to wash valves
aortic root, and ventricles.
• Glascow Coma Scale
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CentriMag® System Checks (Q Shift)
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Tubing secured to patient?
Circuit bends wide and smooth?
On AC power and battery fully charged?
Air circulation around motor & console?
Two tubing clamps near each blood pump?
Backup console ready with battery charged?
Low flow alarm set 1.0 LPM less than target?
Review “Emergency Switch to Backup” ref. card
Practice pump “Switch” with the backup console
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CentriMag® System Checks (Q Day)
Move flow probe ~1 cm
Study GCS, labs and hemodynamics recorded?
Pump properly mounted with screw in notch?
Strain relief (sleeve) on the pump connectors?
Inspect circuit and connectors with flashlight
Minimal or no tubing movement during inspection
Emergency supplies (pump, tubing, etc.) present?
Motor and motor clamp out of harms way & secure?
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Patient Movement & Transport
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Risk of decannulation is greater
during transport of the patient
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Continuously monitor patient’s
hemodynamics and VAD flows
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Assign one individual to monitor
VAD consoles and blood pumps
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Place blood pump and motor on
the bed between the patients legs
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Insure pumps are not covered
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Each console has approximately
1 hr of battery power
EMERGENCY SWITCH TO BACKUP
Backup console and clamps must
always be with the patient
RPM > 1000
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Review Questions:
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Typical battery life for each console?
Action to take for low flow or line shaking?
Target CVP? Must L. and R. flow be equal?
What value should the flow alarm be set at?
Expected RPM and LPM values on console?
Indicators that the pump is mounted correctly?
Backup items required with patient at all times?
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Levitronix

Transcription

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