José Fragata MD, PhD, Agg, FETCS,FESC

University Department of CTS – H Santa Marta

Nova Medical School

Lisbon

November 9th , 2018

ECMO, VAD & PEDIATRIC HEART TX in a setting of limited resources

Disclosures...

None !

background...

• Over past 15 y Pediatric Mechanical Circulatory Support (PMCS) hasbecome an indispensable tool for treating children with advancedHeart Failure, particularly as a bridge to transplantation (BTX).

• Survival rates with VADs have improved markadely as related toECMO’s * and long term TX survival now matches TX without BTX **

• However, and according to Pedimacs “adverse events still continue tobe the major challenge, especially among the young critically illchildren with complex congenital disease” at least one major event in58 % pts - stroke, infection & MOF *** (*) Artif. Organs 2010;34(12):1087-91

(**)Ann Thorac Surg 2016;101:2321–8

(***) J Heart Lung Transplant 2018;37:38-45

agenda...

• Report our approach and outcomes with ECMO & VADs as bridge to Transplantation

• Our numbers a small as are our resources limited, but…• Being “small” does not mean being “minor”, as good

outcomes can still be reached by a thoughtful approach• Volume and quality are certainly associated, though not

necessarily…

Strategy...

V-A ECMO

LVAD - Centrimag

VAD -Berlin Heart

Destination

Bridge DECISIONLung Failure & RVF

Support < 10 dGraft Failure - TX

Support < 1 m

Support > 1 mor bi-ventricular

Transplant

RECOVERY

Rationale...

• Short, or long predicted time for TX bridging: bridging strategy, need to also support lungs, age, blood group…

• Costs Immediate costs Costs from complications while under assist Cost – utility regarding predicted outcome (?)

• CAPITAL COST, MAINTENANCE & CONSUMABLES (pumps & oxygenators)• COST OF ICU STAY

o Personnel o Length of stayo Complications -

We AIM at:• Cheapest system• Easiest to manage• Lesser complications• Smallest possible

duration – earlier TX

Interactive CardioVascular and Thoracic Surgery, 2014; 19, 1:41–48

Costs, ECMO...

1 ECMO specialist for circuit1 :1 dedicated nurse1 respiratory technique ELSO 2014

1 :2 dedicated nurse1 perfusionist (on call)ICU surgeon – available

Keep it SIMPLE !

Costs, VADs...

CONCLUSIONS:

Continuous flow (CentriMag®and PediVas®) blood pumps, asopposed to pulsatile modalities(BH) can lead to significant costsavings to the Health Service,when used for short-term VADor ECLS treatment.

Interactive CardioVascular and Thoracic Surgery, 2014; 19, 1:41–48

the figures...

VAD activity in children expands but implanting hospitals keep the same

Majority of centres in the Registry implant 1 – 5 VAD

type of device...

Para corporeal devices are mostly used below 6 y• 60 % pulsatile• 40 % continuous flow

Implantable – continuous dominate beyond teens

survival...

72 %

• Younger age is linked to worse prognosis • Severe clinical condition affects outcome• Heart Failure Cardiomyopathy shows better outcomes• Type of Device - ? as it confounds with age & severity

Competing outcomes...

• At 6 months after VAD implantation:o Younger age implies less transplanted patientso Higher mortalityo Less patients under assisto More spontaneous recovery

At least one severe Adverse Event occur in 58 % ptsYounger ages more susceptible, MOF and stroke more prevalent

Fate of TX after ECMO or VAD...

Ann Thorac Surg 2016;101:2321–8)

shall MCS be an ECMO, results only level beyond first 4 months

Coagulopathy for PMCS in children

Drews T -ASAIO Journal: 2007;53(5):640-5

PF4ℬ TG

THROMBINTX A2

PATPlatletcount

C

F XII & F X

THROMBUS

VIIXII

• ACCESS RISK OF BLEEDING (IMMEDIATELY PO) hypocoagulation to be

started when bleeding will stop (12 h...)

• HEPARIN BRIDGING (APTT 2 x normal) or 0,3-0,5 U/ml

• KEEP ANTI THROMBIN III > 80 %

• KEEP FIBRINOGEN normal, if too high, ther’s risk of thrombosis

• TEG and ROTEM monitoring, but also measuring ATIII and APTT

• VITAMIN K ANTAGONISTS & PLT ANTI-AGGREGANTS –with feeding

• No ELCO consensus

• SHEAR STRESS & UNCOILING OF VWF FACTOR LEADS TO BEEDING – TIME !!!

• TREAT INDIVIDUALLY:o Not all pMCS systems have same risks (Berlin H Excor is worse)

o Patients react differently – impact of infection, food...

o Hypocoagulation’s needs differ with time – increased peri operatively...

Iki A – 2018 Heart Failure in children and young adults – c 53:707

• Implantable & continuous= BETTER

• Stroke and MOF 1st cause for death in pediatric MCS – 30 %

• Majority of bleeding complications occur early (3 m)

• Bleeding is far more prevalent than Stroke

• Stroke rate is higher in para-corporeal devices, as compared to implantable continuous flow is this device or age related ?

• Younger patients (< 5 years) are more prone to coagulation issues – size of system or immaturity ?

COAGULATION COMPLICATIONS – Thrombus & Bleeding

• Despite “adequate” heart unloading by a wellplaced venous cannula, there will always bereturning blood flow to LA, mainly due to thebronchial circulation.

• Should LV contractility be reduced, LV would thanbecome distended with LVED pressure increasing.Lung congestion and reduced output will result.

• Also, LV distention and wall tension will lead tosubendocardial ischemia and reduce anylikelihood for ventricular recovering:

• “does venting improve recovery and outcome?”

LV decompression during ECMO runs

▪ More usual with AV - ECMO

▪ Possible in LVADs when:o Systemic hypertension

o LA cannula badly draining LV

o LV cannula poorly positioned

o LV cannula thrombosed

o LV cannula or LV flow not superior to Right sided.

Poor LV decompression under ECMO

INDICATIONS LV DECP1. Hearts with no ejection and a

closed aortic valve 2. Refractory pulmonary edema &

hemorrage3. ECHO - Distended left atrium

(LA) and LV4. Significant Ao valve regurg.5. LV thrombus secondary to stasis6. Refractory impaired RV function7. Severe persistent LV dysfunction

Chin S - Adv Interv Cardiol 2017; 13, 1 (47): 1–2

EARLIER DECOMPRESSION SEEMS CRITICAL FOR SUCCESSFULL WEANING

From 8 h to 2,5 days on ECMO*

*Baruteau AE Eur Heart J Acute Cardiovasc Care 2016.

Ways to decompress LV during VA-ECMO ?“Poorly vented LV under ECMO is an independant 30 day mortality factor” *

1. Atrial Septectomy – ballon, blade, stenting

2. Surgically placed vents (LA or LV) by mini-invasive access

(left minithoracotomy or subxiphoid approaches)– LV venting – retrogradely

– Impella 2.5

– ....

S Strunina - Curr Res Cardiol 2016;3(1):5-8.

(*)

“overcirculation” during pCMS

1. Situation when patent systemic-pulmonaryconnections Ductus or BT shunt allowrecirculation of blood through the lungs, withsystemic hypoperfusion and lung overflow.

2. Following TAH implantation, patients may developpulmonary edema, the mechanism of which is not yetcompletely understood and is likely to be multi-factorialin nature: transient inability of the pulmonarymicrovasculature, which is accustomed to severe lowflow states, to adjust to the “normal” right ventricularoutput flow and pressure of a TAH. May require VVECMO*

*The International Journal of Artificial Organs - 2018, Vol. 41(1) 66–68

• ECMO for Norwoods– Classical BT shunt:

• keep systemic flow• minimize SVR • Increase ECMO flow (> 150 ml/Kg)• Restrict BT flow by surgical cliping

– Sano Shunt • maintain adequate systemic flow• adequate decompression of ventricle• Monitor for conduit patency

• Manage Qp/Qs – potential run-off via BTS to lungscausing over-circulation and inadequate systemicperfusion

Di Nardo M. Front. Pediatr., 07 October 2016

Clinical Case – we should never give up !

• 13 y old Brazilian boy• Dilated Cardiomyopathy after viral infection• Acute Heart Failure, inotropes, Levosimendan…• VAD Centrimag (LA / Aorta) – improving, but...• Complications – reoperation for bleeding – 3rd POD

– stroke (ischaemic) – 18th POD• Emergent thrombectomy – clot removal from MCA• Uneventful Heart TX, 6 days after thrombectomy• FUP – 15 months, active and well – no sequalae

Total PMCS = 10

• Continuous (Levitronix) – 3

• Pulsatile (Berlin Heart & Thoratec) – 7

Total ECMO = 10

Our results Pediatric Cardiac ECMO & VADP

age 1m – 13 y

weight 3,5 – 33 Kg

duration 7 d – 124 d

BiVAD

LVAD

5

2

ADV EV

N = 11

Infection

Thrombus

Local Infect

TX4 (OK) / 7

3 died - CS

100 %OK - TX

58 %OK - TX

age 7– 15 y

weight 25 - 62 Kg

duration 6 – 19 d

TX - OK Yes – all 3 !

ADV EVBleeding 2

Thrombus 2

2005-2018 – 20 pcms – 12 survived to weaning / TX – 60 % survival

Our results - cardiac VA ECMO

10 ECMO runs – 5 weaned (50 %)

# 1 Dilated Cardiomyopathy – ECMO bridge to Centrimag – 1 TX (WELL)# 2 POST PUMP JET – ECMO

1 – weaned1 – dead

# 5 POST PUMP FAILURE TO WEAN - ECMO 2 - weaned3 – died

# 1 FAILING FONTAN 1 – died# 1 POS TX GRAFT FAILURE – ECMO 1 - weaned

35%

15%

50%

BERLIN H CENTRIMAG VA ECMO

System of PMCS

0% 20% 40% 60% 80% 100%

VADs

TOTAL

CENTRIMAG

BERLIN H

VA ECMO

Survival / System

alive dead

Global RESULTS

• Number of TX - 18

• Number listed kids – 28

❤ dilated cardiomyopathy – 13

❤ congenital heart disease – 3

❤ restrictive cardiomyopathy – 2

❤ Successfully bridged from MCS – 8

Paediatric Cardiac Transplantation – 2005 till 2018

Data

76 d – 19 y

13 d - 2,6 yMean Age TX 6 y

Mean WLT 6 m

0

5

9

14

18

23

0. 30. 60. 90. 120. 150.

Nº

tota

l

Meses

Survival

Mean FUP 3,5 y (20d-9.9y)

5 y – 74 % survival

Cardiac TX - resultsI was 4 days

on ECMO

I spent 3 months on a BERLIN HEART

Transplanted at 2 months 16 months after TX

In conclusion...

• CMS in children is expanding as a most valuable tool, but stillcarries a significant rate of complications, particularly in the veryyoung, as thrombosis & bleeding, stroke and infection.

• Clear strategies regarding candidate selection, complicationprophylaxis & management are needed, namely:– Strictly individualizing of hypocoagulation,

– Aggressive LV decompression (+++ AV ECMO)

– Attentive management of overcirculation

• Allow for results within the expectable range, even in scenariosof cost containment and also for small pt series. CENTRIMAGdoes look favourable, on cost – effectiveness & pt outcomes.

jigfragata@gmail.com

Ευχαριστώ!Obrigado!

Thank you!