Dr. Holger BuchholzClinical Assistant Professor Division of Cardiac Surgery

Director Pediatric Artificial Heart ProgramUniversity of Alberta, Stollery Children's Hospital and Mazankowski Alberta Heart Institute

Mechanical Support in the Pediatric Population

AATS/STS Congenital Heart Disease Skills

Disclosure

PI HeartWare MVAD StudyI will discuss of label use

Pediatric Implants by Device Type Fiscal Year: 2005 – 2014

Limitations of Donor Availability

2006 2007 2008 2009 2010 2011 20120

1

2

3

4

5

Average time on the wait list (months)

% of Patients Bridged with Mechanical Circulatory Support* by Year (Jan 2005 – Dec 2012)

2005 2006 2007 2008 2009 2010 2011 20120

5

10

15

20

25

30

35

22.121.1

22.7 22.0

29.1

25.2 25.7

28.8

Any

ECMO

VAD + ECMO

% o

f P

ati

en

ts

* LVAD, RVAD, TAH, ECMO2014JHLT. 2014 Oct; 33(10): 985-995

The Fifth INTERMACS Annual Report:James K. Kirklin, et al, The Journal of Heart and Lung Transplantation (February 2013)

VAD support in Pediatric Patients

Pulsatile FlowBerlin Heart EXCOR®Syncardia TAH

Continuous FlowThoratec CentriMag®HeartWare and HeartMate II

Mechanical Circulatory Support

- Short–term support - (ECMO)

- Mid-term support

- (Bridge to Decision device)

- Long-term support- (Implantable VAD)

The Fifth INTERMACS Annual Report:James K. Kirklin, et al, The Journal of Heart and Lung Transplantation (February 2013)

HeartMate II patient

Inpatient Technology

Outpatient Technology

Home Communities of Our Patients

ISHLT Abstracts 2014

M. Schweiger . Outpatient Experience with Heartware® Ventricular Assist Device System in Children: A Multicenter Experience

Multicenter, retrospective study (1 Australia, 3 Europe, 4 US)

11 patients 6 males; Median age 12.3 (8-15) BSA 1.3m2 (0.76-1.9); wt range 18-81Kg Indications: DT (1); BTR (1); BTT (9) Inpatient duration 53 d (19-95) Mean outpatient support: 234 d(42-736) No adverse events requiring EMS or ER; 8 back at school

Considered for Implantation of a VAD

• inotrope-dependency

(worsening signs/symptoms of heart failure when inotropic support is weaned or withdrawn)

AND…

• evidence of compromise to at least one other organ system:

– respiratory failure (e.g., requiring mechanical ventilation)

– worsening renal function (e.g., rise in serum creatinine by at least 0.3 mg/dL)

– hepatic dysfunction (e.g., AST >50 U/mL, conjugated bilirubin >1.0 or INR >1.5)

– inability to tolerate enteral feeds– impaired mobility due to heart failure symptoms

resulting in confinement to bed

AND……

• the patient is in cardiogenic shock or impending cardiogenic shock

• ECMO

OR……

Methods

• 17 centers across North America• Compared to historical ECMO control group• 2 Cohorts: <0.7 m2 and 0.7-1.5m2

• Primary Outcome:– VAD: Time to death or wean with poor neurological outcomes

– ECMO: Time to death

Cohort 1(BSA<0.7 m2 ; n=24):

174 days88% Transplanted

12% died

Cohort 2 (BSA 0.7-1.5m2;n=24):

192 days92% Transplanted

8% died

Adverse Events

Cohort 1(BSA<0.7 m2 ; n=24)

Cohort 2(BSA 0.7-1.5m2;n=24)

Bleeding 42% 50%Infection 63% 50%Stroke 29% 29%Hypertension 50% 33%Pump exchanges

46 exchanges with 43 for thrombus

RESULTS:• 204 children implanted with the EXCOR• Median age was 19 months; the median weight was 10 kilograms• 30% had congenital heart disease (CHD)• 41% were supported on ECMO, and 27% had renal dysfunction• Overall survival at 12 months was 75% including 64% who survived to

transplant, 6% who recovered, and 5% who were alive with the device in place

• Median duration of EXCOR support was 45 days • Early mortality was associated with smaller weight, BIVAD support, and

elevated bilirubin• Late mortality was associated with elevated bilirubin and renal

dysfunction• Neurological dysfunction occurred in 29% across both cohorts and

was the leading cause of deathCirculation. 2013 Mar 28. [Epub ahead of print]The Berlin Heart EXCOR(R) Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children.Almond CS, Buchholz H et al

Unpublished Literature

To date there are ~ 250 implants worldwide in children <18 yrsAges 3-17yrs

Pedi MACSPatiens >5 y. 80% continus flow pumps

Heartware® in Pediatricsn Age

Wt. Ranges

Complications Outcomes

Padalino et al. 3 11-15 yrs26-65 Kg

1)Splenic and renal infarcts2) Bleeding (mediastinal)3) Nosebleeds, driveline infxn

Tx 2/3

Miera et al. 7 6-16 yrs17-19 Kg

1 Pericardial tamponadeNo infection or TE events

Tx 6/7On support 1

D’Alessandro et al.

1 13 yrs15.5 Kg

None Tx at 11 days

Kirklin et al. 1 9 yrs42.8Kg

None Tx at 60 days

Crews et al. 1 9 yrsBSA 1.29

None (126 days) Tx

ISHLT Abstracts 2014

R. K. Singh et al. Wait List Outcomes of Pediatric Patients Bridged to Heart Transplantation on Continuous Flow Left Ventricular Assist Devices

41 HM II vs. 18 HVAD Age: 14.2 vs. 12.7 yrs (p=0.02) BSA: 1.8m2 vs. 1.5m2 (p=0.034) 1 death in HM II group (98% success) vs. 0 deaths in HVAD (100%

success) No CVA or pump exchanges 95% Tx (Median 89 days) vs. 72% Tx (Median 58d) Avg. duration of support for those still on waitlist

435 days for 1 HM II patients 255 +/- 64 days in 4 HW patients

Edmonton Pediatric VAD Program

• Bridge to bridge or decision

• Bridge to recovery

Bridge to Decision - Levitronix

Multi Organ Failure• Levitronix LVAD / BVAD plus/minus Oxigenator, Prisma• Implantation off pump

Unclear Neuro status• Levitronix with Berlin Heart cannula

Edmonton CentriMag® Outcomes 33 runs

• 21.1% (n=7) weaned for recovery• 42.0% (n=14) converted to a long term VAD• 12.1% (n=4) resulted in direct transplant• 9.0% (n=3) were converted to ECMO cannulation

15.0% (n=5) resulted in death 64% (18/28) hospital discharge

• Bridge to transplant• Bridge to candidacy• Destination Therapy

Edmonton Pediatric VAD Program

Bridge to transplant

2 kg – 15 kg• Berlin Heart

>15 kg• Heart Ware

>40 kgHeartMate II

Pediatric VAD’s

• 27 x Centrimag• 65% survival

• 39 x Berlin Heart • 2x weaned• 2x diseased• 1x ongoing• 34x transplanted

• 3x HeartMate II • 2x ongoing• 1x diseased

• 7x HeartWare • 5x < 20kg• 6x transplanted• 1x ongoing

Conclusion

• In children the use of a VAD as a BTT results in improved waitlist morality with no adverse events effects on the post transplant outcomes

• There are a number of devices that can be choosen and careful planning for each patients will assist in choosing the right pump for the right patient

• In the future, VAD therapy as a destination might be an alternative choice to a high risk transplant