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Current Review of Pediatric Mechanical Circulatory Support


Shawn C West, MD, MSc
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, PA, USA
Shawn.West@chp.edu



Mechanical circulatory support with a ventricular assist device (VAD) is often lifesaving in the setting of circulatory collapse. VAD use as a bridge to heart transplant has been shown to decrease waitlist mortality. Pediatric VAD use has increased over the last decade in the US, especially with the FDA approval of the Berlin Heart EXCOR. The Berlin Heart is the first pediatric specific VAD. Next generation adult VADs are also being used for older pediatric patients.

Unlike the adult experience, there are few multicenter studies of pediatric patients. Knowledge in the pediatric VAD field is moving quickly and there have been a number of publications of interest in the last 12 months. Below are synopses of two key articles, the first by Elizabeth Blume and the second publication by Marie Steiner. I have also provided a list interesting articles for further reading.

Article Reviews:

The Pediatric Interagency Registry for Mechanic Circulatory Support is a multicenter registry of pediatric patients requiring temporary and durable mechanical circulatory support. The registry is supported by the NIH. Patient enrollment began in 2012 and now includes over 200 patients. Several articles were published recently using the Pedimacs registry [1,3,4].

From September 2010 through June 2015, 200 patients received 222 durable ventricular assist devices (VAD). 109 patients received continuous flow devices and 91 received pulsatile devices. 15% were under 1 year of age, 34% between 1-10 years of age, and 51% > 10 years of age. 97% of continuous flow devices were implanted in children over 6 years of age; 70% of pulsatile devices were in children less than 6 years of age [1]. Those were received continuous flow devices were older (15 yrs vs 2 yrs; p<0.0001), more like to have a cardiomyopathy (83% vs 62%) less likely congenital heart disease (10% vs 26%; p= 0.0083), less likely to have had previous cardiac surgery (24% vs 55%; p<0.0001), and less likely to have required ECMO (7% vs 24%; p=0.0009) [1].

The most common diagnosis was cardiomyopathy (73%) with only 18% diagnosed as congenital heart disease. 15% of patients required ECMO before VAD.1 Mechanical assist device was LVAD in 81%, Bi-VAD 15%, RVAD 2%, and total artificial heart 3%. 93% of patients were listed as bridge to transplant or bridge to candidacy [1].

The most common adverse events were bleeding, rehospitalization, and infection. Serious adverse events were rate. Neurologic dysfunction occurred at an early event rate of 4.1 per 100 patient months and late event rate of 0.8 per 100 patient months [1,4].

Overall survival was 93% at 1 month, 85% at 3 months, and81% at 6 months and 12 months after VAD [1,3]. The most common cause of death was multisystem organ failure (39%. 6 months after VAD, 58% of patients had undergone heart transplant. At 12 months, 75% of patients had undergone heart transplant.

The Berlin Heart remains the mainstay of pediatric ventricular assist device for young patients. A report from the Berlin EXCOR IDE study investigators reporting the anticoagulation results from the Investigational Device Exemption study. The study included 68 patients at 17 centers in the US and Canada. Cohort 1 was 44 patients had a BSA < 0.7 m2. Cohort 24 patients had a BSA ≥ 0.7 m2 < 1.5 m2. Cohort were older, taller, and weighed more on average than cohort 1. Otherwise, there were no significant differences in regards to demographics between the groups.

Both groups showed wide variability in unfractionated heparin, low molecular weight heparin, and antiplatelet drug doses. Low molecular rate heparin was in target dose ~ 50% and unfractionated heparin was in target range ~ 30% of time. Antiplatelet affect with dipyridamole or aspirin was in target range ~ 30%. By 2 weeks, low molecular rate heparin achieved target dose range ~ 60% of patients.

Adverse event of major bleeding occurred in ~ 40% of patients. ~ 20% Patients with major bleeding had anticoagulation above target range and ~ 25% had antiplatelet affect above target. ~ 28% of patients had a neurologic event. ~ 50% of patients had an episode of major infection. ~50% of patients required pump changes. There were 5 deaths in the study, 4 for which were due to thrombosis. ■

Disclosure Statement: The author has no conflicts of interest to disclose.


References:

  1. Elizabeth D. Blume, MD, David N. Rosenthal, MD, Joseph W. Rossano, MD, J. Timothy Baldwin, PhD, Pirooz Eghtesady, MD, PhD,?David L.S. Morales, MD, Ryan S. Cantor, MSPH, Jennifer Conway, MD, Angela Lorts, MD, Christopher S. Almond, MD, MPH, David C. Naftel, PhD, James K. Kirklin, MD and for the PediMACS Investigators. Outcomes of children implanted with ventricular assist devices in the United States: First analysis of the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS). J Heart Lung Transplant 2016; 35:578-584.
  2. Marie E. Steiner, Lisa R. Bomgaar, and M Patricia Massicotte, for the Berlin heart EXCOR Pediatric VAD IDE study investigators. Antithrombotic Therapy in a Prospective Trial of a Pediatric Ventricular Assist Device. ASAIO Journal 2016; 62:719-727.
  3. Joseph W. Rossano, MD, Angela Lorts, MD, Christina J. VanderPluym, MD, Aamir Jeewa, MD, Kristine J. Guleserian, MD, Mark S. Bleiweis, MD,?Olaf Reinhartz, MD, Elizabeth D. Blume, MD, David N. Rosenthal, MD, David C. Naftel, PhD, Ryan S. Cantor, MSPH and James K. Kirklin, MD. Outcomes of pediatric patients supported with continuous-flow ventricular assist devices: A report from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS). J Heart Lung Transplant. 2016;35:585-590
  4. David N. Rosenthal, MD, Christopher S. Almond, MD, MPH,?Robert D. Jaquiss, MD, Christine E. Peyton, BSN, MS, Scott R. Auerbach, MD, David R. Morales, MD, Deirdre J. Epstein, RN, Ryan S. Cantor, MSPH, Robert L. Kormos, MD, David C. Naftel, PhD, Ryan J. Butts, MD,?Nancy S. Ghanayem, MD, James K. Kirklin, MD, and Elizabeth D. Blume, MD. Adverse events in children implanted with ventricular assist devices in the United States: Data from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS). J Heart Lung Transplant. 2016;35:569-577.

Additional Articles:

  1. Stulak JM, Dunlay SM, Sharma S, Haglund NA, Davis MB, Cowger J, Shah P ,Masood F, Aaronson KD, Pagani FD, Maltais S. Treatment of device thrombus in the HeartWare HVAD: Success and outcomes depend significantly on the initial treatment strategy. J Heart Lung Transplant. 2015 Dec;34(12):1535-41.
  2. May LJ, Montez-Rath ME, Yeh J, Axelrod DM, Chen S, Maeda K, Almond CS, Rosenthal DN, Hollander SA, Sutherland SM. Impact of ventricular assist device placement on longitudinal renal function in children with end-stage heart failure. J Heart Lung Transplant. 2016 Apr;35(4):449-56.
  3. Healy AH, Stehlik J, Edwards LB, McKellar SH, Drakos SG, Selzman CH. Predictors of 30-day post-transplant mortality in patients bridged to transplantation with continuous-flow left ventricular assist devices--An analysis of the International Society for Heart and Lung Transplantation Transplant Registry. J Heart Lung Transplant. 2016 Jan;35(1):34-9.
  4. Seth A. Hollander, David M. Axelrod, Daniel Bernstein, Harvey J. Cohen, Barbara Sourkes, Sushma Reddy, David Magnus, David N. Rosenthal, Beth D. Kaufman. Compassionate deactivation of ventricular assist devices in pediatric patients. J Heart Lung Transplant 2016;35:564-567.
  5. Jennifer Conway, Mohammed Al-Aklabi, Don Granoski, Sunjidatul Islam, Lyndsey Ryerson, Vijay Anand, Gonzalo Guerra, Andrew S. Mackie, Ivan Rebeyka, Holger Buchholz. Supporting pediatric patients with short-term continuous-flow devices. J Heart Lung Transplant 2016;35:603-609.
  6. Lindsay J. May, Maria E. Montez-Rath, Justin Yeh, David M. Axelrod, Sharon Chen, Katsuhide Maeda, Christopher S.D. Almond, David N. Rosenthal, Seth A. Hollander, Scott M. Sutherland. Impact of ventricular assist device placement on longitudinal renal function in children with end-stage heart failure. J Heart Lung Transplant 2016;35:449-456.
  7. Mary Lynette Stein, Duy T. Dao, Lan N. Doan, Olaf Reinhartz, Katsuhide Maeda, Seth A. Hollander, Justin Yeh, Beth D. Kaufman, Christopher S. Almond, David N. Rosenthal. Ventricular assist devices in a contemporary pediatric cohort: Morbidity, functional recovery, and survival. J Heart Lung Transplant. 2016; 35 (1): 92-98.
  8. Ferro G, Murthy R, Williams D, Sebastian VA, Forbess JM, Guleserian KJ. Early Outcomes With HeartWare HVAD as Bridge to Transplant in Children: A Single Institution Experience. Artif Organs. 2016 Jan;40(1):85-9.
  9. Luigi Adamo, Yuanyuan Tang, Michael E. Nassif, Eric Novak, Philip G. Jones, Shane LaRue, John A. Spertus, Douglas L.Mann. The HeartMate Risk Score Identifies Patients With Similar Mortality Risk Across All INTERMACS Profiles in a Large Multicenter Analysis. J Am Coll Cardiol HF. 2016;4:950-8)



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