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2011 Case Reports in the Sun
2011 Case Reports in the Sun<br />
Relevant Disclosures:<br />
• Will discuss off-label application and use of medical devices<br />
• Have served as a paid consultant for Thoratec Corporation<br />
• Have served as a paid consultant for SynCardia Systems
Implant Profile<br />
CPS/ ECMO<br />
22%<br />
Centrimag VAS<br />
21%<br />
AbioMed Impella<br />
4%<br />
AbioMed BVS<br />
2%<br />
Thoratec VAD<br />
9%<br />
AbioMed AB<br />
4%<br />
HeartWare LVAS<br />
3%<br />
DuraHeart LVAS<br />
1%<br />
CardioWest TAH<br />
10%<br />
HeartMate II<br />
22%<br />
HeartMate XVE<br />
2%
Indication Profile<br />
BT 2nd MCSD<br />
21%<br />
BTT<br />
24%<br />
DT<br />
24%<br />
BTR<br />
31%
44 y/o Native American woman with a 104-day bridge to recovery with<br />
3 mechanical circulatory assist devices<br />
13 days<br />
Fulminant Myocarditis with Cardiogenic<br />
Shock, Circulatory Collapse, CPR & ECMO<br />
33 days<br />
CentriMag BiVAD<br />
RVAD<br />
oxygenator<br />
58 days<br />
PVAD BiVAD<br />
Myocardial Recovery<br />
& Device Explant
Case Report<br />
Vital Signs<br />
HR: 150’s<br />
BP: 62/34<br />
SaO2: 65%<br />
Labs<br />
Echo<br />
BNP: > 3000<br />
EF: 10%<br />
Inotropes<br />
Dobutamine: 5<br />
Milrinone: 0.5<br />
Norepi: 40<br />
Exam<br />
cold distal extremities<br />
pulses not palpable<br />
poor capillary refill<br />
pupils equal and reactive<br />
• 44 y/o Native American woman<br />
• Approx 1-week upper resp infection w/ nausea<br />
• Progressively worsening flu-like symptoms<br />
• Daughter finds her passed out at home<br />
• Emergently transported to nearby county hospital –<br />
further deterioration, intubated<br />
• Transferred to Mayo Clinic 24 hrs later<br />
• History<br />
• NKA, no previous surgeries<br />
• 8 children<br />
• Morbid obesity<br />
• Social alcohol only, never smoked<br />
• No other illnesses, no outside medications
Case Report<br />
Assessment<br />
severe cardiogenic shock<br />
Intra-aortic Balloon Pump<br />
source unknown – likely viral<br />
circulatory collapse<br />
cardiorespiratory arrest<br />
active CPR<br />
Plan<br />
urgent initiation of ECMO<br />
circulatory & pulmonary<br />
stabilization<br />
evaluation for<br />
transplantation<br />
ECMO Circuitry<br />
CentriMag pump<br />
Quadrox-d oxygenator<br />
Terumo x-coated tubing<br />
Cannulation<br />
17 Fr right femoral artery<br />
20 Fr right femoral vein<br />
• ECMO Insertion in ICU<br />
• Cardiorespiratory arrest at start of procedure<br />
• Difficulty locating left femoral artery & vein under<br />
direct dissection<br />
• IABP already in right femoral artery – removed over a<br />
wire and site used for femoral arterial cannula<br />
• Venous access line already in right femoral vein –<br />
removed over a wire and site used for femoral venous<br />
cannula<br />
• Heparin 10,000U given. ACT > 200 seconds.<br />
• Right lower leg ischemia on POD 1.<br />
• 8 Fr cannula inserted into Superficial Femoral Artery<br />
• Connected by ¼ inch tubing and luer connector to<br />
ECMO arterial line
Case Report<br />
Assessment<br />
severe cardiogenic shock<br />
Intra-aortic Balloon Pump<br />
source unknown – likely viral<br />
circulatory collapse<br />
cardiorespiratory arrest<br />
active CPR<br />
Plan<br />
urgent initiation of ECMO<br />
circulatory & pulmonary<br />
stabilization<br />
evaluation for<br />
transplantation<br />
ECMO Circuitry<br />
CentriMag pump<br />
Quadrox-d oxygenator<br />
Terumo x-coated tubing<br />
Cannulation<br />
17 Fr right femoral artery<br />
20 Fr right femoral vein
Case Report<br />
Assessment<br />
severe cardiogenic shock<br />
Intra-aortic Balloon Pump<br />
source unknown – likely viral<br />
circulatory collapse<br />
cardiorespiratory arrest<br />
active CPR<br />
Plan<br />
urgent initiation of ECMO<br />
circulatory & pulmonary<br />
stabilization<br />
evaluation for<br />
transplantation<br />
ECMO Circuitry<br />
CentriMag pump<br />
Quadrox-d oxygenator<br />
Terumo x-coated tubing<br />
Cannulation<br />
17 Fr right femoral artery<br />
20 Fr right femoral vein
Case Report<br />
Thoratec PVAD Cannulas<br />
Right Atrium – short, beveled tip<br />
with side holes<br />
C/N 10075-2574-001<br />
44 Fr tip<br />
25 cm length<br />
Left Ventricle – long, straight,<br />
beveled tip with side holes<br />
C/N 14111-2571-000<br />
48 Fr tip<br />
25 cm length<br />
Aorta & Pulmonary Artery – long,<br />
straight with sealed graft<br />
C/N 100129<br />
18 mm graft<br />
30 cm length<br />
GISH Connectors<br />
5/8” x 3/8” Reducing Connector<br />
C/N EC2150S<br />
• Patient stabilized over several days on ECMO<br />
• Ongoing renal & hepatic dysfunction<br />
• Ongoing pulmonary edema<br />
• TEE evaluation<br />
• Distended, hypocontractile heart<br />
• No signs of cardiac recovery<br />
• ECMO exchanged for CentriMag BiVAD in OR<br />
• Central Cannulation performed on bypass<br />
▪<br />
140 minutes on CPB<br />
• Using tunneled PVAD cannulas<br />
• RA to PA<br />
• LV to Aorta<br />
• Pulmonary failure weaning from CPB<br />
• Oxygenator in RVAD circuit
Case Report<br />
Thoratec PVAD Cannulas<br />
Right Atrium – short, beveled tip<br />
with side holes<br />
C/N 10075-2574-001<br />
44 Fr tip<br />
25 cm length<br />
Left Ventricle – long, straight,<br />
beveled tip with side holes<br />
C/N 14111-2571-000<br />
48 Fr tip<br />
25 cm length<br />
Aorta & Pulmonary Artery – long,<br />
straight with sealed graft<br />
C/N 100129<br />
18 mm graft<br />
30 cm length<br />
Connectors<br />
5/8” x 3/8” (qty 4)<br />
Tubing<br />
4’ x 3/8” (qty 4)
Case Report<br />
Tubing markings<br />
Colors<br />
Blue colors mark RVAD<br />
Red colors mark LVAD<br />
Single Lines<br />
Signifies directional blood<br />
flow from patient into pump<br />
Double Lines<br />
Signifies directional blood<br />
flow from pump into patient<br />
Proper Nomenclature<br />
Inlet and Outlet confusing<br />
Patient centric<br />
Pump centric<br />
Best Practice<br />
Inlet & Outlet are “forbidden” terms<br />
Name lines for the<br />
anatomical structure to<br />
which they connect (i.e. right<br />
atrium, left ventricle, aorta)
Case Report<br />
Tubing markings<br />
Colors<br />
Blue colors mark RVAD<br />
Red colors mark LVAD<br />
Single Lines<br />
Signifies directional blood<br />
flow from patient into pump<br />
Double Lines<br />
Signifies directional blood<br />
flow from pump into patient<br />
Proper Nomenclature<br />
Inlet and Outlet confusing<br />
Patient centric<br />
Pump centric<br />
Best Practice<br />
Inlet & Outlet are “forbidden” terms<br />
Name lines for the<br />
anatomical structure to<br />
which they connect (i.e. right<br />
atrium, left ventricle, aorta)
Case Report<br />
“Blue Bands”<br />
Simple latex-free, 1-cm polyisoprene<br />
strips of blue band identifiers<br />
Bioseal – Placentia, CA<br />
Used to help prevent extensive<br />
formation of adhesions and<br />
minimize difficulty in dissecting<br />
major vascular structures during<br />
device explant for HTX or recovery<br />
Benefits:<br />
Inexpensive<br />
Easily sterilized<br />
Facilitates identification<br />
Reduced dissection time<br />
Bands are cut to 9 cm length before<br />
gas sterilization<br />
Loosely encircled around IVC, SVC,<br />
PA & Ao and ends clipped together<br />
Ann Thorac Surg 2009; 87: 1623-4.
Case Report<br />
CentriMag BiVAD Pump Exchange<br />
Prime & de-bubble two new CMag<br />
pump sets with tubing<br />
Label LVAD & RVAD inlet and<br />
outlet with proper tapes<br />
Clamp all 4 cannula sites above and<br />
below the 5/8” x 3/8” connectors<br />
Disconnect lines on 3/8” end<br />
Briefly bleed each connector<br />
to clean loose fibrin deposits<br />
Make sterile wet-to-wet connections<br />
between cannulas and new pumps<br />
Set & secure new pumps in<br />
proper LVAD/RVAD motors<br />
Verify proper connections according<br />
to red/blue and single/double tapes<br />
Turn on pumps & release all clamps<br />
Return to previous pump<br />
speed & flow alarm settings<br />
• RVAD oxygenator removed s/p BiVAD CMag day 7<br />
• Pumps exchanged s/p BiVAD CMag day 12<br />
• Loose fibrin stranding found at 3/8” tubing<br />
connection of both LVAD and RVAD pump outlets<br />
• No fibrin depositions found at 5/8” x 3/8” connectors<br />
• Successful chest closure s/p BiVAD CMag day 18<br />
• 9 mediastinal explorations for control of bleeding<br />
• 6 in ICU, 3 in OR<br />
• Awake, alert & extubated s/p BiVAD CMag day 22<br />
• Patient participated in bed-side rehabilitation<br />
including standing but was too weak for walking<br />
• TEE evaluation s/p BiVAD CMag day 30<br />
• Distended, hypocontractile heart<br />
• Slight signs of cardiac recovery<br />
• PVAD exchange in OR s/p BiVAD CMag day 33
Switch Procedure<br />
The patient has had an opportunity to wake, be evaluated for cardiac recovery or<br />
transplant, and hopefully has begun recovering end-organ function,<br />
rehabilitating and returning to an anabolic state.<br />
Additionally, the patient’s chest has likely been closed since being place on<br />
CentriMag support.<br />
Switching to PVAD for long-term support is a non-invasive procedure but still<br />
with risk and should be conducted in the OR with the full cardiac surgery team.<br />
CPB stand-by is highly re<strong>com</strong>mended.
Switch Procedure<br />
Participants in the procedure should all be VAD-trained members of the<br />
cardiac surgery team:<br />
• CT Surgeon<br />
• 1 st Assistant<br />
• Surgical Scrub<br />
• Cardiac Anesthesia<br />
• Cardiology or other TEE operator<br />
• VAD Operator<br />
• <strong>Perfusion</strong>ist on CPB stand-by<br />
• Circulating Nurses
CentriMag to PVAD<br />
switch procedure<br />
Second Procedural Pause<br />
Identify the players and their<br />
roles. All others in the room<br />
will be silent during the switch.<br />
Talk out every step and assign<br />
who will be doing what.<br />
Confirm LVAD & RVAD<br />
cannulas. Mark the direction of<br />
blood flow.<br />
Verify PVAD pump orientation.<br />
Will the LVAD be right-side up<br />
or up-side down? RVAD?<br />
Note the current CentriMag<br />
blood flow. This will be the<br />
target PVAD blood flow.<br />
• Preparation<br />
• Prep & drape the patient for median sternotomy and<br />
possible groin access<br />
• Using TEE, evaluate cardiac function & look for<br />
ventricular & valvular clots<br />
• Hang and connect inotropes & pressors (Epinephrine,<br />
Dobutamine, Milrinone, Norepi, Vasopressin) and<br />
have blood products in the room checked for use<br />
• Conduct your standard time-out<br />
• Set up the DDC, prime the PVADs, and connect the<br />
pneumatic & electrical leads to the pump & console<br />
• Start sufficient inotropic support so patient can selfsustain<br />
for up to 5-10 minutes<br />
• Give ½ CPB table dose heparin bolus<br />
• Conduct 2 nd procedural pause while waiting for ACT
CentriMag to PVAD<br />
switch procedure<br />
Important Points<br />
Verify correct direction of<br />
blood flow before AND after<br />
connecting pump to cannulas<br />
Thoratec Cannula Connection<br />
Tool can speed the process but<br />
requires prior practice using<br />
Briefly rotate and turn pump to<br />
look for signs of gross air within<br />
pump chamber, on valves or<br />
inside cannulas and repeat deairing<br />
procedure if necessary<br />
Slide metal collet and white nut<br />
down cannula onto pump and<br />
hand-tighten only<br />
• Clamp and Go!<br />
1. Patient in Trendelenburg position<br />
2. Place a tubing clamp on each PVAD cannula as close<br />
to the velour as possible w/o bending the wire<br />
reinforcements (4 clamps used)<br />
3. Place a tubing clamp on each CMag line near the<br />
5/8”x3/8” connectors (4 add’l clamps used)<br />
4. CMag consoles OFF<br />
5. Trim PVAD cannulas as close to 5/8” connectors as<br />
possible to leave room for connecting to PVAD<br />
pump<br />
6. Scrub pulls away CMag lines while Surgeon &<br />
Assistant slide white nut & metal collet on cannulas<br />
7. Scrub brings LVAD PVAD pump to field for surgeon<br />
to slip into LVAD cannulas while Assistant fills gaps<br />
with saline for a bubble-free wet-to-wet connection
CentriMag to PVAD<br />
switch procedure<br />
Important Points<br />
Verify correct direction of<br />
blood flow before AND after<br />
connecting pump to cannulas<br />
Thoratec Cannula Connection<br />
Tool can speed the process but<br />
requires prior practice using<br />
Briefly rotate and turn pump to<br />
look for signs of gross air within<br />
pump chamber, on valves or<br />
inside cannulas and repeat deairing<br />
procedure if necessary<br />
Slide metal collet and white nut<br />
down cannula onto pump and<br />
hand-tighten only
CentriMag to PVAD<br />
switch procedure<br />
Important Points<br />
Verify correct direction of<br />
blood flow before AND after<br />
connecting pump to cannulas<br />
Thoratec Cannula Connection<br />
Tool can speed the process but<br />
requires prior practice using<br />
Briefly rotate and turn pump to<br />
look for signs of gross air within<br />
pump chamber, on valves or<br />
inside cannulas and repeat deairing<br />
procedure if necessary<br />
Slide metal collet and white nut<br />
down cannula onto pump and<br />
hand-tighten only<br />
• Consider starting LVAD if patient is unstable<br />
8. Scrub brings RVAD PVAD pump to field for surgeon<br />
to slip into RVAD cannulas while Assistant fills gaps<br />
with saline for a bubble-free wet-to-wet connection<br />
9. Release all remaining tubing clamps<br />
10. Start both LVAD & RVAD at rate of 40 b/min while<br />
monitoring for signs of air with TEE<br />
11. Increase fixed rate to minimum level and switch DDC<br />
to Volume Mode when full-fill signals are consistent<br />
12. Use DDC Vacuum adjustment and blood product<br />
infusions to help achieve baseline CMag blood flows<br />
13. Begin weaning inotropic support as tolerated<br />
14. Reverse heparin<br />
• Patient may require higher CVP with PVAD than<br />
baseline with CMag due to mechanics of PF vs. CF
Case Report
Case Report<br />
Not a Good Candidate for<br />
Heart Transplantation<br />
Morbid obesity<br />
(BMI > 40)<br />
High Antibody Sensitivity<br />
(PRA > 85%)<br />
Psych/Social & family support<br />
concerns<br />
BTR Deemed Best Option<br />
LVEF 65% by TEE exams both 1<br />
week & 2 days before device<br />
removal<br />
• Patient out of bed and participating in rehab<br />
sessions twice daily s/p BiVAD PVAD day 3<br />
• Patient moved from ICU to telemetry ward s/p<br />
BiVAD PVAD day 10<br />
• Ongoing rehabilitation with functional improvement<br />
• Serial echocardiography over next month<br />
• Gradual recovery of Left Ventricle<br />
• Trailing recovery of Right Ventricle<br />
• Initiated a methodical and slow wean of VAD<br />
support s/p BiVAD PVAD day 40<br />
• Taken to OR s/p BiVAD PVAD day 58<br />
• Redo sternotomy<br />
• Removal of BiVAD on CPB (pump time 67 min)<br />
• Closure of left ventriculotomy<br />
• Removal of right atrial / left ventricular thrombus
Case Report<br />
BiVAD PVAD Weaning Process<br />
Confirm native heart tolerance of all<br />
adjustments with echo exam<br />
Always ensure LV flow > RV flow<br />
• Alternative weaning method<br />
Beginning with patient on full<br />
support in volume (auto) mode<br />
Reduce L & R vacuum<br />
settings in 20% increments<br />
When vacuum at Zero, switch to<br />
async (fixed) mode at same rate<br />
Return vacuum to ensure<br />
adequate blood pump filling<br />
Reduce L & R fixed rate<br />
settings in 20% increments<br />
At fixed rate 40 b/min (~2.6 l/min)<br />
Place a continuous flow right<br />
heart catheter in patient<br />
Quick temporary trials of<br />
VADs off under echo exam<br />
Ann Thorac Surg 2001; 71: 215–8.
Case Report<br />
Discharge Medications<br />
Atrovent inhaler<br />
Furosemide (2x day)<br />
Prilosec (daily)<br />
Spironolactone (daily)<br />
K-Dur (2x day)<br />
Norco<br />
Zestril (daily)<br />
Coreg (2x day)<br />
Aspirin (daily)<br />
Loratadine (daily)<br />
PRN<br />
40 mg<br />
20 mg<br />
25 mg<br />
20 mEq<br />
PRN<br />
5 mg<br />
3.125 mg<br />
81 mg<br />
10 mg<br />
• Patient weaned from CPB with no <strong>com</strong>plications<br />
on low dose dobutamine & milrinone<br />
• Extubated s/p BiVAD explant day 1<br />
• Patient moved from ICU to telemetry ward s/p<br />
BiVAD explant day 3<br />
• Dobutamine & milrinone weaned s/p BiVAD<br />
explant day 6<br />
• Echo exam s/p BiVAD explant day 7<br />
• LVEF 40-50%<br />
• Mild tricuspid valve regurgitation<br />
• Patient discharged home s/p BiVAD explant day 11<br />
• Total Days on Device = 104<br />
• Total Days in Hospital = 115
There are cheaper and quicker ways to provide circulatory support for<br />
patients in cardiogenic shock.<br />
Why use this technique? What are the benefits?<br />
• Can extubate and rehabilitate<br />
• Chest is closed and the cannulas are secure at the heart, vessels, and<br />
skin exit sites = safe for ambulation<br />
• Tissue growth into the velour means less bleeding & infection<br />
• Still have options<br />
• Setup for PVAD if longer BTR or if BTT is required<br />
▪ Is he/she a HTX candidate? Is the disease process recoverable?<br />
• Setup for ECMO if pulmonary failure occurs or returns<br />
▪ Splice oxygenator into RVAD pump outlet line<br />
J Heart Lung Transplant 2009; 28: 984-986. Interact CardioVasc Thorac Surg 2011; 12: 110-111.
There are cheaper and quicker ways to provide circulatory support for<br />
patients in cardiogenic shock.<br />
Why use this technique? What are the benefits?<br />
• Cheaper than alternative systems<br />
• AB5000 not BTT or discharge approved<br />
▪ Complete pump & cannula change required for BTT<br />
• Direct to PVAD more costly if patient does not survive<br />
▪ PVAD > $100,000 vs. CMag < $40,000<br />
• Physiologic Advantages<br />
• Reduced shear stress on blood = lower hemolysis<br />
• No diastolic “filling” time = no stagnant blood = lower thrombosis<br />
• 30-day survival up to 75% w/ CMag used in acute cardiogenic shock<br />
J Thorac Cardiovasc Surg 2011; 141: 932-9. J Thorac Cardiovasc Surg. 2007; 134: 351-8.
Physiologic<br />
Advantages of CF<br />
pumps vs. PF pumps<br />
Patients presenting in<br />
circulatory failure will share<br />
some <strong>com</strong>mon characteristics.<br />
The result is patients quickly<br />
deteriorate into Multi-System<br />
Organ Failure (MSOF).<br />
An increase in CVP with a<br />
decrease in MAP results in a<br />
lower trans-organ perfusion<br />
pressure and the tissues<br />
be<strong>com</strong>e congested from an<br />
absence of venous<br />
de<strong>com</strong>pression.<br />
Decreased CO<br />
Lower MAP<br />
Higher PCWP<br />
Higher CVP<br />
Reduced tissue perfusion<br />
The organs begin to fail<br />
without adequate blood flow.<br />
End-organ dysfunction
Outflow (L/min)<br />
Outflow (L/min)<br />
CONTINUOUS FLOW PUMP<br />
PULSATILE FLOW PUMP<br />
30<br />
25<br />
20<br />
15<br />
Pump speed = 10,000 RPM<br />
30<br />
25<br />
20<br />
15<br />
10<br />
5<br />
0<br />
-5<br />
-10<br />
10<br />
5<br />
0<br />
-5<br />
-10<br />
Flow Waveforms for Continuous Flow and Pulsatile Flow Pumps<br />
(Both have average flow between 4-5 L/min)
CONTINUOUS FLOW PUMP<br />
• Lower CVP & PCWP<br />
• Pump inlet always diastolic<br />
• Pump outlet always<br />
systolic<br />
• Example:<br />
• Pump Flow 5.5 l/min<br />
• MAP 80<br />
• CVP 8<br />
• <strong>Perfusion</strong> Pressure 72<br />
PULSATILE FLOW PUMP<br />
• Higher CVP & PCWP<br />
• Shorter diastolic time to<br />
maintain higher rate for<br />
adequate blood flow<br />
• Example:<br />
• Pump Flow 5.5 l/min<br />
• MAP 70<br />
• CVP 20<br />
• <strong>Perfusion</strong> Pressure 50
J Heart Lung Transplant 2011; 30: 862–9.
Physiologic<br />
Advantages of CF<br />
pumps vs. PF pumps<br />
Application of intermediate CF<br />
BiVAD support to improve<br />
long-term PF BiVAD out<strong>com</strong>e<br />
Patients can be diuresed to low<br />
RA & LA filling pressures w/o<br />
adverse drop in pump flow<br />
Improved trans-organ tissue<br />
perfusion pressures by venous<br />
de<strong>com</strong>pression<br />
Promotes pulmonary, renal,<br />
hepatic decongestion and<br />
recovery<br />
Higher<br />
MAP<br />
Lower<br />
PCWP<br />
Lower<br />
CVP<br />
Improved<br />
tissue<br />
perfusion<br />
Patients in circulatory shock &<br />
MSOF can be optimized for<br />
pulsatile BiVAD support<br />
Increased<br />
CO
Cardiogenic<br />
Shock<br />
On ECMO<br />
Recovery<br />
possible?<br />
No recovery<br />
possible?<br />
CentriMag w/<br />
PVAD cannulas<br />
Transplant<br />
Evaluation<br />
Recovery<br />
within weeks?<br />
Recovery over<br />
a few months?<br />
Yes.<br />
No.<br />
Continue<br />
CentriMag<br />
Consider<br />
switch to PVAD<br />
Implant BTT<br />
approved<br />
device<br />
Consider DT<br />
device or<br />
hospice
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