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Moving Forward in <strong>Perfusion</strong>:<br />

What’s Hot and What’s Evolving<br />

Alfred Stammers<br />

Cody Trowbridge<br />

Nicholas Brindisi<br />

James Pezzuto<br />

Myra Klayman<br />

Kyla Jubach<br />

Joseph Petzold<br />

Sean Fleming<br />

Department of <strong>Perfusion</strong> Services<br />

Division of Cardiothoracic Surgery<br />

Geisinger Health Systems<br />

Danville, PA, USA


Disclosure<br />

No financial relationship with any<br />

<strong>com</strong>pany or entity discussed here within.<br />

No product will be used in an off-label<br />

manner.


What’s Hot<br />

What’s Not<br />

<br />

Evidence – ICEBP<br />

‣ Registries<br />

<br />

Educational decline<br />

‣ Program<br />

<br />

Blood Management<br />

‣ IBBM<br />

<br />

Fragmentation<br />

‣ Societal migration<br />

‣ STS Guidelines<br />

<br />

Strategic Focus<br />

<br />

Quality and Safety<br />

‣ PEMR<br />

‣ No consensus<br />

‣ Eroding caseload


Characteristics for Inclusion<br />

Provocative<br />

Proof of Concept<br />

Recent<br />

Four Letter Maximum<br />

VADS<br />

TAVI<br />

NIRS


United States Heart Failure Statistics<br />

AHA Heart Disease and Stroke Statistics 2010<br />

‣ 5.8 Million Patients with heart failure<br />

‣ 550,000 patients diagnosed each year<br />

‣ 15 million office visits 6.5 million hospital days<br />

‣ Annual # of hospitalizations<br />

> 1 million as 1 o diagnosis > 3 million 1 o or 1 o<br />

‣ Rehospitalization rates<br />

> 25% within 1 month > 50% within 6 months<br />

‣ Total US costs for heart failure 2010 – 39.2 billion


Ventricular Assist Devices


HeartMate II Destination Therapy Trial<br />

HeartMate XVE vs. HeartMate II<br />

• Prospective, randomized, multicenter study<br />

Inclusion Criteria<br />

• LVEF < 25%<br />

• Peak VO2 < 14 mL/kg/min (or 50% age and sex predicted)<br />

and either<br />

• NYHA class IIIb-IV symptoms for at least 45 of the prior 60<br />

days on maximally tolerated oral heart failure medications, or<br />

• Dependence on IV inotropes for at least 14 days, or<br />

• Dependence on an IABP for at least 7 days<br />

• Not a candidate for transplantation<br />

Exclusion Criteria<br />

• Irreversible renal, pulmonary, hepatic dysfunction<br />

• Active Infection


Duration of Support (yrs) Median Longest<br />

CF LVAD 1.7 3.7<br />

PF LVAD 0.6 2.1


FDA Approval of CF DT<br />

1. Increase in number<br />

of centers providing<br />

care to patients in<br />

end-stage heart<br />

failure.<br />

1. Expansion in<br />

utilization of VADs<br />

at non-transplant<br />

centers.


Trans Aortic Valve Implantation (TAVI)<br />

1. 50,000 AVR in US per year<br />

2. AVR increase life expectancy over 4-fold<br />

3. AVR <strong>com</strong>plications: 4-18% risk of mortality<br />

4. Increasing population will increase AVR<br />

Edwards Sapien THV<br />

Medtronic CoreValve


Transcatheter Valve Implantation (TAVI)<br />

Risk Benefit Analysis Assumptions<br />

Transcatheter valves will be more effective, but have<br />

more risks, than medical therapy<br />

Transcatheter valves might be less effective, but less<br />

risky, than surgery<br />

?????<br />

Transcatheter valves will be more effective than<br />

medical therapy and less risky than surgery<br />

Julie Swain, MD<br />

Division of Cardiovascular Devices, FDA<br />

STS Transcatheter Valve Symposium


TAVI<br />

Access<br />

Transfemoral<br />

Transapical<br />

Trans-Subclavian or Trans-Carotid<br />

Intervention Location<br />

Off-site – catheterization laboratory<br />

Hybrid OR – endovascular room


TAVI<br />

Complications<br />

Valvuloplasty<br />

Valve Implantation<br />

Aortic instrumentation<br />

1. Ascending aorta dissection<br />

2. Embolic debris liberation<br />

3. Valve embolization<br />

4. Coronary artery obstruction<br />

5. Mitral valve interference<br />

6. LV rupture or hemorrhage<br />

7. Vascular access injury<br />

8. Post-implant instability<br />

9. Distal/Proximal dislocation<br />

of prosthesis


TAVI<br />

Patient Management<br />

Anesthesia<br />

General anesthesia with ET intubation<br />

Heparinization with ACTs > 250 s<br />

Clopidogrel 300 mg<br />

Rapid ventricular pacing<br />

Vasopressors to maintain MAP


TAVI<br />

Patient Management<br />

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

Emergent CPB Plan (planning and drills)<br />

Pump in-room with dedicated perfusionist<br />

Intraoperative Autotransfusion (cell salvage)<br />

Rapid deployment precautions<br />

Considerations<br />

Hybrid room (C-arm and table movement)<br />

Extra-personnel – non-cardiac surgical team??<br />

NIRS monitoring


TAVI<br />

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

Conventional <strong>Perfusion</strong> CPB<br />

1. Ascending 1. CPS aorta vs. Conventional dissection CPS-MMLSS-MECC<br />

CPB<br />

2. LV rupture central or hemorrhage vs. percutaneous 1. Post-implant cannulation instability<br />

3. Coronary 2. Carotid artery or obstruction Subclavian 2. Valve – bifurcated embolization graft<br />

4. Mitral 3. Mini-ECMO<br />

valve interference<br />

4. TandemHeart


CPS-MMLSP-MECC<br />

Benefits<br />

1. Portability and thumbprint<br />

2. Rapid deployment<br />

3. Self-contained - ECMO<br />

Detriments<br />

1. Flexibility - cardioplegia<br />

2. Limited aspiration<br />

3. Absent PEMR interface


Conventional CPB<br />

Benefits<br />

1. Familiarity - <strong>com</strong>plete<br />

2. Intact safety systems<br />

3. Cardioplegia<br />

Detriments<br />

1. Limited flexibility<br />

2. Incapable of ECMO<br />

3. Location of procedure


Intraoperative Neuromonitoring<br />

NIRS<br />

Non-invasive technique used to monitor regional<br />

oxygenation in cerebral or somatic tissue, measuring<br />

oxygen saturation of hemoglobin in venous capillaries.<br />

Utility<br />

Although assessment is at specific site, variation in<br />

saturation has been shown to act as surrogate marker to<br />

end-organ, or global, perfusion.


CasMed ® Fore-Sight ®<br />

Covidien INVOS


NIRS<br />

Intervention Guidelines<br />

1. Head positioning for cannula placement and/or<br />

decreasing CVP during CPB<br />

2. Depth of anesthesia (CMRO 2 , SMRO 2 )<br />

3. Increase PaO 2 through FiO 2<br />

4. Increase perfusion pressure (CPB MAP)<br />

5. Increased perfusion (CO or Q b Pump)<br />

6. Acid-Base manipulation (hypercarbia)<br />

7. Increased red blood cell volume<br />

hemoconcentration vs. transfusion


NIRS<br />

Critical Values or Threshold<br />

IFU: Greater than 20% from resting baseline or<br />

nadir of 40%<br />

Casati:<br />

Murkin:<br />

Maintain ScTO 2 greater than 75% of resting<br />

baseline<br />

Maintain rSO 2 greater than 75% of resting<br />

baseline.<br />

Derived parameters:


Cerebral<br />

Hepatic<br />

Renal<br />

Muscular


Summary Opportunities for <strong>Perfusion</strong>ists<br />

The efficacy of continuous flow VADs for<br />

destination therapy will expand the role of<br />

perfusionists.<br />

Transcatheter valve implantation techniques<br />

will present perfusionists with new challenges<br />

and opportunities.<br />

Neuromonitoring with NIRS will provide<br />

perfusionists with a modality for measurement<br />

and statistical analysis to improve out<strong>com</strong>es.

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