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American Society of<br />

Extracorporeal Technology<br />

<strong>Perfusion</strong> Safety and Best Practices in<br />

<strong>Perfusion</strong> Meeting<br />

June 24 - 27, 2009<br />

Royal Sonesta Hotel<br />

New Orleans, Louisiana. USA


Session II<br />

<strong>Perfusion</strong> Safety: Case Reports<br />

Session Objective:<br />

To increase patient safety measures<br />

and decrease patient accidents.<br />

Can the Somanetics technology help<br />

us to achieve this goal l?


Cape Cod Hospital<br />

Cardiac Surgery Program<br />

in Partnership with<br />

Brigham & Women’s Hospital


Cape Cod Hospital<br />

Cardiac Surgery Program<br />

• 2002 – 2005<br />

• 355 Primary CABG<br />

• CVA 0.0 0 (0%)<br />

• Mortality 2/355 (0.6%)<br />

• 2002 - 2009<br />

• 659 Primary CABG<br />

• CVA 1/659 (0.015%)<br />

• Mortality 8/659 (1.2%)


Introduction to Cerebral Oximetry


Skull<br />

How the INVOS System Works<br />

Two depths of light penetration are<br />

used to subtract out data from the<br />

skin and skull, resulting in blood<br />

oxygen saturation for deeper tissues<br />

directly underneath the sensor.<br />

Skin<br />

Light<br />

Emitting<br />

Diode<br />

Surface<br />

Photodetector<br />

SomaSensor<br />

Cerebral<br />

Cortex<br />

Deep<br />

Photodetector


Normative Range for rSO2<br />

• Adult cardiac patients 67±10<br />

• Left-Right differences: 5% were >10<br />

• 5% rSO2 baseline values < 50<br />

• 1.6% rSO2 baseline values < 40<br />

• Strong positive correlation with hemoglobin<br />

concentration


Transcranial Cerebral Oximetry<br />

On CPB<br />

Flow Down<br />

Han SH et al: The effect of bloodless pump prime on cerebral oxygenation<br />

in pediatric patients. Acta Anaesthesiol Scand 48:648-652, 2004


Minimal Priming Volume Strategy<br />

Autologus Blood Priming Technique<br />

Priming Volume 800 -1000 ml Normosol


Transcranial Cerebral Oximetry<br />

On CPB


Judging the Adequacy of <strong>Perfusion</strong><br />

Global Measures:<br />

• SVO2 Monitor<br />

• Mean arterial pressure<br />

• Blood flow index (1.8 – 2.4)<br />

• CVP<br />

• Arterial PO2, PCO2<br />

• Venous PO2<br />

• Base Deficit<br />

• Urine output


Transcranial Cerebral Oximetry<br />

Reop. CABG<br />

Kinked Venous Cannula


Determinants of Regional<br />

Cerebral Oxygen Saturation (rSO2)<br />

• Cerebral <strong>Perfusion</strong> Pressure (CPP)<br />

• CPP = MAP – CVP<br />

• Blood flow rate<br />

• PaCO 2<br />

• PaO 2 (FIO 2 )<br />

• Oxygen carrying capacity (HCT)<br />

• Arterial inflow temperature<br />

• Intact cerebral circulation<br />

i


Transcranial Cerebral Oximetry<br />

Taking Venous Return


Transcranial Cerebral Oximetry<br />

EDVH


Transcranial Cerebral Oximetry<br />

EDVH


Transcranial Cerebral Oximetry<br />

Anes Jet Lag


Transcranial Cerebral Oximetry<br />

CCP Jet Lag


Baseline Asymmetry > 10<br />

• Carotid or Intracranial stenosis<br />

• Intracranial space-occupying lesion<br />

• Prior cerebral infarction<br />

• Hemangioma<br />

• Frontal sinus fluid<br />

• Skull defect<br />

• Subclavian steal


Transcranial Cerebral Oximetry<br />

# 614221 Air Embolism<br />

Innominate Art.<br />

90<br />

80<br />

70<br />

60<br />

50<br />

40<br />

30<br />

20<br />

10<br />

0<br />

Left<br />

Right


Transcranial Cerebral Oximetry<br />

• June 16, 2009<br />

• 73 y o Retired University President<br />

• Admit with USA<br />

• Cath; 3VD, AVA < 0.7, 5 CM AAA<br />

• PMH: HTN, IDDM, + Lipids, HB (Pacer)<br />

• Meds: ASA, HCTZ, Lipitor, Insulin<br />

Lisinopril.


Transcranial Cerebral Oximetry


AUC – Quantifying Risk<br />

O 2<br />

rSO<br />

90<br />

80<br />

70<br />

Baseline<br />

60<br />

50 25% from Baseline<br />

40<br />

Area Below 25% from Baseline (min%)<br />

30<br />

8:00 8:30 9:00 9:30 10:00 10:30 11:00 11:30<br />

• AUC<br />

(Area Under the Curve)<br />

Quantifies the depth<br />

and duration below<br />

the critical i threshold<br />

h of 25% below baseline<br />

• High AUC has been<br />

correlated with adverse<br />

out<strong>com</strong>es<br />

Murkin JM, et al. Anesth Analg 2007;7(6):515


Common Interventions to Correct<br />

Declining Cerebral Oxygen Saturation*<br />

• Increase blood flow rate (39pts) (67%)<br />

• Increase MAP (42pts) (62%)<br />

• Normalize PaCO 2 (34pts) (50%)<br />

• Deepen Anesthesia (27pts) (48%)<br />

• Increase FIO 2 (28pts) (43%)<br />

• Pulsatile Flow (6pts) (17%)<br />

• Check cannulas<br />

(both arterial & venous)<br />

• Increase oxygen carrying capacity<br />

(Murkin JM, A &A 2007<br />

* Intervention threshold >20% or below 50, Critical threshold > 25% or below 40


STS Database Fields<br />

As of January 1st, 2008 the following Cerebral Oximetry metrics<br />

will be collected by the STS Database:<br />

Pre-Induction Baseline Regional Oxygen Saturation:<br />

Left: ______ (%) Right _______ (%)<br />

Cumulative Saturation Below Threshold:<br />

Left: _____ (minute-%) Right _____ (minute-%)<br />

Cerebral Oximeter Provided The First Indication: Yes No<br />

Skin Closure Regional Oxygen Saturation:<br />

Left: _____ (%) Right _______ (%)


New rSO2 Asymmetry<br />

• Intraoperative Type A Dissection<br />

• Cannulation misadventures (art & ven)<br />

• Axial head rotation<br />

• Heart manipulation<br />

• Gaseous or particulate emboli<br />

• Subclavian steal


Transcranial Cerebral Oximetry<br />

Anemia on CPB<br />

90<br />

80<br />

70<br />

60<br />

50<br />

40<br />

30<br />

20<br />

10<br />

0<br />

Lef t<br />

Right


The Effect of Age on the Brain<br />

• Over age 65<br />

15% carotid stenosis.<br />

> 50%<br />

• 30% “Silent Infarcts”<br />

• HTN- narrows the<br />

deep penetrating<br />

vessels.<br />

• Loss of Cerebral<br />

Autoregulation<br />

Sieber FE, Geriatric Anesthesia; 2007:McGraw Hill Co.


Hour rs<br />

200<br />

Control, Diabetics, n=26<br />

Interventions, Diabetics, n=30<br />

Randomized, prospective, blinded<br />

160<br />

120<br />

80<br />

40 30<br />

0<br />

9<br />

Ventilation*<br />

Study Findings<br />

Bringing g Diabetics in Sync with Non-Diabetics<br />

69<br />

Murkin JM, et al. Anesth Analg 2005;100:SCA101<br />

201.6<br />

Diabetic cardiac surgery patients<br />

monitored with the INVOS System.<br />

Reductions in ventilation time, ICU<br />

time, and LOS were statistically<br />

significant.<br />

132 “Clinical out<strong>com</strong>es were improved to<br />

the point that there were no significant<br />

differences between diabetics i and<br />

non-diabetics, essentially leveling the<br />

playing field for patients who<br />

30 traditionally have had poorer<br />

out<strong>com</strong>es during cardiac surgery.”<br />

ICU Stay* Hospital Stay*<br />

John M. Murkin, MD<br />

Professor of Anesthesiology<br />

University of Western Ontario,<br />

London, Ontario, Canada<br />

Murkin JM, et al. Anesth Analg 2005;100:SCA101.


Study Findings<br />

3% of the rSO2 managed group experienced MOMM<br />

<strong>com</strong>pared to 11% in the control group <strong>com</strong>pared with<br />

13.4% for the STS database<br />

14<br />

13.4%<br />

12<br />

11%<br />

− Death within 30 days<br />

− Permanent stroke<br />

10<br />

− > 48 hours ventilation<br />

8<br />

− Renal failure requiring dialysis<br />

%<br />

6<br />

− Re-operation for any reason<br />

4<br />

3%* − Mediastinitis/deep sternal<br />

infection<br />

2<br />

0<br />

Morbidity<br />

(p


Neonatal l& Pediatric Monitoring


Benefits of Cerebral Oximetry<br />

• Improved Neurocognitive Function<br />

• Shortened ICU/ Hospital Stay<br />

• Decreased Stroke Rate<br />

• Detection of Cerebral Malperfusion<br />

• Early warning of Oxygen Delivery Failure<br />

• Detection of Cerebral Vasospasm<br />

• ? Transfusion Trigger


Session II<br />

<strong>Perfusion</strong> Safety: Case Reports<br />

Session Objective:<br />

To increase patient safety measures<br />

and decrease patient accidents.<br />

Can the Somanetics technology help<br />

us to achieve this goal l?


Cape Cod Hospital<br />

Cardiac Surgery Program


Adoption to Date<br />

• 645 Centers (adult &<br />

pediatric) nationwide<br />

• 185 ,000 procedures<br />

annually<br />

• 500+ Clinical<br />

references that speak<br />

to its clinical value<br />

• Supported by direct<br />

sales and clinical<br />

specialists coast-tocoast<br />

– International distributors<br />

Tyco Healthcare and<br />

Edwards LifeSciences


Intra-Operative Strategies to Avoid<br />

Adverse Neurologic Out<strong>com</strong>es<br />

Minimize the number<br />

of Cerebral Emboli<br />

Avoid Cerebral<br />

Hypo-<strong>Perfusion</strong><br />

Attenuate the Whole Body<br />

Inflammatory Response<br />

Epi-Aotic Scanning<br />

CPB Filtration.<br />

Single Cross Clamp<br />

Min. Card. Suction<br />

Thermal Management<br />

Acid Base Mgt.<br />

Neurologic Monitoring<br />

VAVD<br />

Surface Coatings<br />

Min Cardiotomy Suction<br />

Pharmacological Mgt.<br />

Anti-coagulation Mgt.<br />

Murkin JM, et al. Attenuation of Neurologic Injury During Cardiac Surgery.<br />

Ann Thorac Surg 2001;72: S1838-S1844<br />

Lill KJ t l O ti d P f i St t t Att t Ad<br />

Lilly KJ, et al. Operative and <strong>Perfusion</strong> Strategy to Attenuate Adverse<br />

Neurologic Out<strong>com</strong>es. <strong>Perfusion</strong> 2006; 21:1-7


Study Findings<br />

• ICU Length Of Stay for the intervention group was significantly shorter<br />

• Standard Deviation was also tighter, indicating fewer outlier patients<br />

5<br />

4<br />

Monitored<br />

Unmonitored<br />

±2.7<br />

Da ays<br />

3<br />

2<br />

1<br />

0<br />

±0.8<br />

1.25 1.87<br />

ICU Length of Stay<br />

(p


Study Design - Murkin<br />

Study Design and Hypothesis<br />

• Prospective, Randomized, Blinded, Cardiac Surgery Study<br />

• n = 200, (100 Control, 100 Intervention)<br />

• Data collected by an independent, blinded observer in an<br />

autonomous, protocol driven, “closed”, ICU<br />

Control Group<br />

n = 100, Blinded rSO2 Data Collection<br />

No Interventions<br />

R<br />

Intervention Group<br />

n = 100, rSO2 Data Collection<br />

Interventions per Protocol<br />

Murkin JM, et al. Anesth Analg 2007;7(6):515


Data Summary Page<br />

Data Base Summary in Run Mode


Judging the Adequacy of f<strong>Perfusion</strong>


INVOS:IN VIVO OPTICAL<br />

SPECTROSCOPY<br />

• LIGHT: NEAR- INFRARED LIGHT (NIRS)<br />

• WAVELENGTH 730+810 nm<br />

• 3 cm.depth DURA MATER+CSF<br />

• 4 cm. depth GRAY MATTER<br />

• PLACEMENT MID- FOREHEAD<br />

• VENOUS/ARTERIAL 75% VENOUS<br />

25% ART.


Post - Operative<br />

• Day 1, awoke with extreme agitation,<br />

treated with sedation (Propofol)<br />

• Day 3, Neuro Consult, Head CT & EEG<br />

Diagnosis: Metabolic Encephalopathy<br />

• Day 7, Propofol weaned agitation returned,<br />

Precedex started (1500 hrs)<br />

• Day 8, Woke up,followed <strong>com</strong>mands, weaning<br />

initiated, extubated by noon, Precedex D/C 1300<br />

• Day 16, Discharged to rehabilitation hospital.


<strong>Perfusion</strong> Management of Acute<br />

Ascending Aortic Dissection:<br />

Does Brain Monitoring Help?<br />

Kevin J. Lilly CCP, Paul A. Pirudini MD, Douglas Shook MD,<br />

Michaela A. Smith CCP, Pam DeVellis NP, Brian Gorsach PAC,<br />

Bruce Campbell RPh, Pauline Philie RN , Robert J. Rizzo MD<br />

Division of Cardiac Surgery<br />

Brigham & Women’s Hospital and Cape Cod Hospital<br />

Harvard Medical School


AAAD<br />

• October 19, 2005<br />

• 64 yo male admitted from Falmouth Hosp to OR.<br />

• PMH: HTN, Hyperlipidemia, Remote Tob.<br />

• Pt retired 5 days PTA from Biotech. Ind. (PhD)<br />

• CP while building walkway, relieved with rest.<br />

• CP returned next day along with leg numbness,<br />

• Leg weakness and ataxia, drove to local ER<br />

• Collapsed on presentation.


AAAD<br />

• Admitted R/O MI,<br />

?TIA<br />

• TEE: flap ascending<br />

aorta.<br />

• 4+AI


Classification of Aortic Dissections<br />

Cohn LC, Edmunds LH: Cardiac Surgery in the Adult.


AAAD – Otb October 192005 19, Type I Aortic Dissection


Acute Ascending Aortic<br />

Dissection<br />

Dec 30, 2005 - 10 weeks post discharge


Cape Cod Hospital<br />

Cardiac Surgery Program


The Future of Cardiac Surgery


Effect of Age on Neurologic<br />

Out<strong>com</strong>e in CABG Surgery<br />

Neurologic Events<br />

• < 65 yrs (0.9%)<br />

• < 74 yrs (3.6%)<br />

• > 75 yrs (8.9%) 10X<br />

N = 2000<br />

Tuman KJ et al, Differential effects of age on neurologic and cardiac risks of<br />

coronary artery operations. J Thorac Cardiovasc Surg. 1992 Dec; 104(6): 1510-7


Risk Factors Associated with<br />

Adverse Neurological Events<br />

Type I (Focal)<br />

• Advanced age<br />

• Aortic Atherosclerosis<br />

• Previous Stroke<br />

• Diabetes<br />

Type II (Non-Focal)<br />

• Advanced Age<br />

• HTN<br />

• COPD<br />

• ETOH


Incidence of Type I & Type II<br />

Adverse Neurological Events<br />

• Type I,( CVA, Focal<br />

Injury; Coma). 31% 3.1%<br />

Mortality = 21% vs 2%<br />

LOS = 25 days vs 10 days<br />

• Type II, Cognitive<br />

Dysfunction 30% 3.0%<br />

LOS = 21 days<br />

• N = 2108


The Effect of Aging on the Brain<br />

• Diminuation of Brain Mass<br />

• Decreased Neuronal Density<br />

• Decreased in <strong>com</strong>plexity of Neuronal<br />

Interconnections.<br />

• Increased Cerebrospinal Fluid (Hydrocephalus)<br />

• Reduced d production & function of<br />

Neurotransmitters<br />

Peters A, Structural changes in the normally aging cerebral cortex of primates.<br />

Prog Brain Res.2002;136:455-465


The Effect of Aging on the Brain<br />

Physiologic changes can result in:<br />

• Deterioration of gait, mobility & reflexes<br />

• Impairment of memory, intellect & executive<br />

function<br />

• Altered sleep patterns<br />

• Diminished vision, hearing, taste and smell.<br />

Sieber FE, Geriatric Anesthesia; 2007:McGraw Hill Co.


The Effect of Aging on the Brain<br />

The reduced production of Neurotransmitters:<br />

Acetylcholine<br />

Dopamine<br />

Norepinephrine<br />

Serotonin<br />

May be related to the development of Alzheimer’s<br />

Dementia, Parkinson's and may alter the brain’s<br />

sensitivity to volatile anesthetics


Cape Cod Hospital<br />

Cardiac Surgery Program


Cardiac Surgery Program<br />

CABG Results: CVA<br />

Year 2002 2003 2004 2005 2006<br />

STS 1.9% 1.9% 2.2% 1.8% 1.65%<br />

Predicted<br />

CVA Rate<br />

Actual<br />

CVA Rate<br />

0% 0% 0% 0% 0%


Cardiac Surgery Program<br />

CABG Results: Mortality<br />

Year 2002 2003 2004 2005 2006<br />

STS 2.53% 3.24% 3.43% 2.7% 3.64%<br />

Predicted<br />

Mortality<br />

Actual<br />

Mortality<br />

0% 0% 0% 1.9%<br />

(2)<br />

2.3%<br />

(2)


CCH Cardiac Surgery Program<br />

August 15, 2002 - August 31, 2007<br />

Isolated CABG 489<br />

Valve (all) 311<br />

Program<br />

mortality:<br />

16 / 844<br />

= 1.9%<br />

CABG/Other 19<br />

Aorta w/o CABG or Valve 7<br />

Tumor (+1) 5<br />

Other Cardiac Surgery 8<br />

Non pump OR cases 5<br />

Total lPump cases 843<br />

CPB assisted PCI 3<br />

TOTAL Cardiac surgery<br />

patients<br />

844


Cannulation Misadventures<br />

Cohn LC, Edmunds LH: Cardiac Surgery in the Adult.

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