Dr. Holger Buchholz Clinical Assistant Professor Division of Cardiac Surgery Director Pediatric...
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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(worsening signs/symptoms of heart failure when inotropic support is weaned or withdrawn)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