Surgical Options for Temporary MCS

Michael A. Acker, MDJulian Johnson Professor of SurgeryChief of Cardiovascular SurgeryDirector of Heart and Vascular CenterUniversity of Pennsylvania Health System

Division of Cardiothoracic SurgeryUniversity of Pennsylvania

Goals of Temporary/Percutaneous Mechanical Circulatory Support in Cardiogenic Shock

• Eliminate shock and support end-organ function• Allows neurologic recovery• Relatively inexpensive means of triage• Bridge to revascularization ± mechanical repair• (Limit infarct size-theoretical)• Potential for Recovery• Allows time to optimize for durable long-term

VADs—BTT; DT; heart Transplant• Terminal weaning.Death

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National Trends in the Utilization of Short-Term Mechanical Circulatory Support (STCS)

From 2007 to 2011, use of percutaneous devices for short-term MCS increased by 1,511% compared with a 101% increase in non-percutaneous devices.

J Am Coll Cardiol 2014;64:1407–15

PercTCS

Surgical TCS

LVAD

Acute Refractory Cardiogenic Shock

Temporary VAD/ECMO Support

Recovery/Assessment

Long-term MCS

Bridge to Transplant Destination Therapy Bridge to Recovery

MSOFNeurologic Deficit

MCS Explant

Medical TherapyIABP

Revascularization,surgery

Palliative Care

Rehabilitation

Rapid Deterioration (hrs)

MCS in Cardiogenic Shock: Management Algorythm

Gregoric I, Bermudez C. Braunwald Comp., Mechanical Support 2011

Days -Weeks

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Temporary Devices Available and Characteristics TandemHeartLVAD –RVAD

Impella 2.5-3.5 CP / RP

ECMO Impella 5.0 Temp.VADsSurgical

Bedside Implantation

No No Yes(No in CC)

No No

Flow l/min 3-3.5 2.5-3.5 3-6 4-5 4-6

LV Unloading Yes Yes Partially***(YES in CC)

Yes Yes

RV support No No Yes No Yes

Pulmonary support

No No Yes No no

Duration of support

Days-weeks? Days-week? < 2 weeks weeks Months

Insertion Percut. Percut. Percut. Graft Stern.

Cannula Size 17-21 Fr fLVAD30 Fr for RVAD

9 Fr ,13F Sheath

15-29 Fr 9Fr, 21FRPump (LD)

YES* YES** YES**

* TH-Protek –Duo ** Impella RP *** Peripheral ECMO

Surgical Temporary Mechanical Support Options

Thoratec PVADCentrifugal Pump

(Centrimag, Rotaflow)

• LVAD / RVAD/BiVAD• Membrane Oxygenator • Central Cannulation

- Peripheral Ischemia- LV decompression

Impella 5.0

Inflow: LA, LVRA, RV, Femoral Vein, SVC

Outflow: Aorta, femoral, axillaryPA

Exit sites –Attempt to tunnel cannula/tubingClose sternum with 3 wiresPlan for permanent VAD if possible

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Clinical outcome of mechanical circulatory support for refractory cardiogenic shock in the current era .

Takayam et al ( Columbia)

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44 pts (49%) survived to hospital discharge.

92 % (44 of 48) survived to hospital discharge if reached destination-VAD/OHT/recovery

Overall SV

Entire cohort

(CPR)

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Bridge-to-Decision Therapy With a Continuous-Flow External Ventricular Assist Device in Refractory Cardiogenic Shock of Various Causes

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Circ Heart Fail. 2014;7:799-806

143 pts (148 Cmag)70.6% Intermacs 1

69% (30 day)49%

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Bridge-to-Decision Therapy With a Continuous-Flow External Ventricular Assist Device in Refractory Cardiogenic Shock of Various Causes

Complications Outcomes

Takayama et al .Circ Heart Fail. 2014;7:799-806

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Centrimag® Minimally Invasive Approach

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Novel minimally invasive surgical approach using an external ventricular assist device and extracorporeal membrane oxygenation in refractory cardiogenic shock

Mean Arterial Flow (l/min) 5.3±1.1Mean duration of support 28±14 dProcedure performed off CPB

25 pts in CS ADHG (52%) AMI (48%)

68 % Survival to Discharge

Takeda et al, European Journal of Cardio-Thoracic Surgery 0 (2016) 1–6

Percutaneous Temporary Circulatory Support Options

Tandem Heart-Protek-Duo

RV Support

LV Support

Impella RP ECMO

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Cardiogenic Shock : Limits of percutaneous support ?

ECMO

IMPELLA3.5

IABP

IABP-SHOCK II Trial (Thiele et al, NEJM 2012)

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EuroShock Registry: Impella 2.5

Lauten et al. Circ Heart Failure 2013

120 patients with AMI/CS

35% 30d SV

In patients with AMI-CS Impella 2.5 treatment is feasible, reduces lactate however early mortality remains high.

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Outcomes of Patients Receiving Temporary Circulatory Support Before Durable Ventricular Assist Device

Conclusions. Temporary circulatory support restores hemodynamics and reverses end-organ dysfunction. Nevertheless, these patients have high residual risk with postoperative morbidity and mortality that parallels profile 1 patients without TCS.

Shah et al .Ann Thorac Surg 2017;103:106–13

Mechanical Circulatory Support Research Network

TCS pts sicker than Profile 1

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Tandem Heart

Percutaneous left ventricular assist devices vs. IABP for treatment of cardiogenic shock: a meta-analysis of controlled trials

Impella 2.5

Cheng et al. European Heart Journal 2009l doi:10.1093

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IMPELLA CP (3.5) in CS : IMPRESS trial

48 pts with STEMI complicated with CS (MV, SBP <90mmhg 30 min, need of inotropes randomized to Impella CP or IABP

All patients had primary PCI and 92 % had CA before randomization All cause mortality was 50 % in the IMPELLA group vs 46% in the

IABP group (HR 0.96,95%Cl 0.42-2.18). Similar SV at 6 months 50%. Similar CVA rate , 1 major vasc complication in the IMPELLA group, 8

vs. 2 bleeding events in the IMPELLA vs IABP group (3-1 devicedrelated ).

Similar LVEF on follow up 46% IMPELLA and 49% IABP

TCT 2016

IMPELLA CP DOES NOT PROVIDE A SURVIVAL ADVANTAGE OVER IABP IN PATIENTS WITH STEMI-CS AND ITS USE MAY BE ASSOCIATED WITH INCREASING BLEEDING COMPLICATIONS.

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Inadequate unloading LV using Percutaneous Support (Impella CP)

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IMPELLA Registry

CS Patients:2.5 =189CP =1115.0/LD= 24

IMPELLA Registry, Summary of Safety and Effectiveness Data .PMA Appl 2014.

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Short-term mechanical circulatory support with Impella 5.0 for CS

La Pitie

14 patients ,7 STEMI-7 PC 57.2 % SV at 2 years 43% weaning from Imp 5.0 28 % bridge to VAD Average support 8 days

Mastroiani et al , European Heart Journal: Acute CV Care 2016

• 48 patients • 80% Impella 5.0• 72% Recovered LV Fx• 8% Bridge to VAD

* Impella 5.0 patient pictured

AMBULATION WITH IMPELLA 5.0 - AXILLARY APPROACH

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Impella AxillaryApproach Implantable LVAD / Sternotomy

ICU patient

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IMPELLA 5.0 vs ECMO

38% Mortality30 days with

Impella 5.0

44% Mortality30 days withECMO

Lamarche, JTCVS 2011,142:60-5

Pump outflow in PA

Pump Outflow

in IVC

Impella RP: Percutaneous Right Ventricular Assist Device

• Transfemoral venous insertion

• 3D shaped cannula

• 22 Fr motor housing

• Pump mounted on a 11Fr catheter

• Flow: 4 L/min @ 33,000 rpm

• Anticoagulation: ACT ~ 160-180 sec

Approved Sept, 2017

RCT 30 pts completedIn post LVAD and Post MI RVF – FDA Approval – Sept 2017

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Mechanical Circulatory Support for Right Ventricular Failure ( THRIVE Registry) : Surgical and percutaneous RVAD

Kapur et Al J Am Coll Cardiol HF 2013;1:127–34)

• Total mortality 57 % (50% in the PRVAD) and lower in LVAD and AMI group.

• Increased age, biventricular failure, and major bleeding were associated with increased in-hospital mortality.

• Use of the CF-RVSD for RVF is clinically feasible and associated with improved hemodynamic status

• Higher flows with surgical RVADs and better decompression

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• Rapid deployment

• Central or Peripheral

• Right, left, biventricular

• Cardio-pulmonary support

• ? LV decompression

• Inexpensive

Extracorporeal Membrane Oxygenation

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Penn ECMO ContraindicationsVeno-Arterial (VA) ECMO Contraindications• Age > 75 (except failure to wean from CPB)• Active malignancy: with estimated survival<1 yr• Severe peripheral vascular disease • Chronic respiratory failure (COPD on home O2)• Advanced chronic liver disease• Acute aortic dissection• Severe aortic valve regurgitation• Current intracranial hemorrhage• Witnessed CPR > 60 min (in the absence of ROSC)• Unwitnessed arrest > 5 min

Veno-Arterial (VA) ECMO Relative Contraindications• End stage renal disease on hemodialysis or peritoneal

dialysis with acute cardiovascular collapse• Severe baseline disability (significant dementia,

quadriplegia, etc.) which would inhibit ventilator weaning/rehabilitation

• Weight >140kg•

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Percutaneous Technique and Distal Leg Perfusion on VA ECMO to minimize vascular complications.

Distal LE perfusion using cannulamay be superior to sheath introd.

15-19 Fr

25-29 Fr

8Fr

RhinoDilator

FA

FV Near –Infrared Spectroscopy

Artificial Organs 2014, 38(11):940–944

Artificial Organs 2012, 36(8):659–667

The incidences of limb ischemia and limb ischemia requiring surgical intervention were significantly higher for the introducer sheath compared with the cannula (30.6 vs. 15.6% and 15.4 vs. 6.25%, respectively). 6/17 (30%) pts patients had persistent unilateral

lower limb oximetry events, which resolved upon placement or replacement of a distal perfusion cannula.

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Concomitant implantation of Impella® on top of veno-arterial extracorporeal membrane oxygenation may improve survival of patients with cardiogenic shock.

Pappalardo et al European Journal of Heart Failure (2016) doi:10.1002/

Concomitant treatment with VA-ECMO and Impella may improve outcome in patients with cardiogenic shock compared with VA-ECMO only.

Prospective match cohort

(Propensity Matched)

ECMO

• Conceived as a therapy for respiratory failure

• Provides a temporary cardiac output in Veno-Arterial configuration

Promoter of LV Recovery VA-ECMO

Direct Ventricular Mechanical Unloading Ventricular Afterload Increased

Termination of systemic shock Normally effective at terminating shock

Low inflammation Inflammatory insult

Preload optimisation Little direct preload control

Improved Coronary Perfusion Marginal effect on coronary perfusion

Reverse Remodeling No evidence of VA-ECMO induced reverse remodeling

• Investigators from Cardiac Surgery, HF and Interventional Cardiology and Critical Care at HUP, PPMC, LGH

96 patients over 3 sites

Balanced for aetiology, sex

and age

48 VA-ECMO

48 VA-ECMO + Impella

Randomised within 12 hours of VA-ECMO when screening criteria metImpella inserted within 12 hours of randomisation, maximum of 24 hours since ECMO institution

A PROSPECTIVE RANDOMISED TRIAL OF EARLY LV VENTING USING IMPELLA CP FOR RECOVERY IN PATIENTS WITH

CARDIOGENIC SHOCK MANAGED WITH VA ECMO (REVERSE)

ECMO

Percutaneous Surgical HeartMate IIIHeartMate III

Impella Centrimag HeartWareTandem RotoFlow SynCardia

TemporaryExtracorporeal

Heart Assist Devices Heart Assist Devices

PermanentIntracorporeal

MCS Overview

ECMO anomaly:lower cost but higher

revenue vs. temporary

devices

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Hospital Cost

Hospital Revenue

Three primary cost factors

1. Device cost ─ can vary widely• SynCardia ≅ $130K

• Heartmate II, III & Heartware ≅ $70–$100K per kit

• Impella 2.5 / 5.0 ≅ $25K / $28K

• Tandem ≅ $20K (plus equipment rental)

• Centrimag ≅ $9K

• Rotoflow ≅ $2K (plus capital investment)

2. Length of Stay ─ varies widely3. Site of Stay ─ ICU days versus Med/Surg days

• SICU days are twice as costly

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ECMO

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Summary

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TMCS are increasingly used as a bridge to decision in patients with CS .

The technical simplicity and lack of definite guidelines has favored the use of percutaneous technologies, without evidence supporting their superiority over surgically implanted devices.

The limitations of flow and LV unloading of percutaneous TCS leads frequently to the need to combine devices increasing vascular complications and hemolysis, with unclear effects on clinical outcomes and recovery.

Surgically implanted devices provide longer and more stable support with adequate flow and LV unloading, with the potential to facilitate recovery and second destination and should be considered as first option in patients where percutaneous support may not be sufficient or may be contraindicated.

As the indications and type of support needed may vary, the use of TMCS should be directed by an experienced team (Shock Team) capable of defining the correct candidate and destination alternatives, but also with the experience to identify futile support .

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Percutaneous (non-surgical) vs Surgical approach in CS.

VAD/ECMO SurgeonInterventional Cadiologist

When things get rough… who do we call ?

SHOCK TEAM