Early experience with the HeartMate 3 continuous-flow ventricular assist device in pediatric patients and patients with congenital heart disease: A multicenter registry analysis
O’Connor MJ, Lorts A, Davies RR, Fynn-Thompson F, Joong A, Maeda K, Mascio CE, McConnell PI, Mongé MC, Nandi D, Peng DM, Rosenthal DN, Si MS, Sutcliffe DL, VanderPluym CJ, Viegas M, Zafar F, Zinn M, Morales DLS.
J Heart Lung Transplant. 2020 Feb 13. pii: S1053-2498(20)31393-0. doi: 10.1016/j.healun.2020.02.007. [Epub ahead of print]
Select item 32089389
- This is a collaborative, retrospective study from ACTION compiling current experience with the novel use of the Heartmate 3 (HM3) ventricular assist device in older pediatric and adolescent patients.
- Overall, the HM3 demonstrated a very good safety profile, and most patients successfully underwent heart transplantation during the study period.
- The data are mostly summary in nature, and further details regarding management decisions will be needed in the future to help guide patient selection and post-implantation management.
Commentary from Dr. Jeremy Herrmann (Indianapolis), section editor of Congenital Heart Surgery Journal Watch: This study is a collaborative effort through the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) and is the largest report of the use of the HeartMate 3 (HM3) LVAD in pediatric and adult patients with congenital heart disease. From 9 centers, the HM3 was implanted in 35 patients between December 12, 2017, and September 19, 2019. The median patient age was 15.7 years, median weight 65.7 kg, and median BSA 1.74 (range, 0.78-2.36) m2 (Table 1). Patients who underwent planned biventricular support device placement were excluded. Data were collected with a focus on quality improvement and are presented as summary statistics.
Dilated cardiomyopathy with or without neuromuscular disease was the most common pre-implantation diagnosis (83%), and 72% of patients were INTERMACS category 2 or 3 (Table 1). Of the HM3 implantations, 54% were bridge to transplantation, 29% were bridge to decision, 6% were bridge to recovery, and 11% were for chronic/destination therapy. Five Fontan patients received a HM3, though this was likely a very select group as none exhibited protein-losing enteropathy and likely were supported for atrioventricular valve regurgitation and/or systolic dysfunction.
The median follow-up period was 78 days (range, 2-646 days). Thromboembolic complications were infrequent with one occurrence of fatal global hypoxic-ischemic encephalopathy (the only mortality in the cohort). Bleeding requiring reoperation occurred in only one patient. Right heart failure (CVP > 16 mm Hg) occurred in 20% of patients, though biventricular support was needed in only 1 patient. The authors observed significant variation in anticoagulation management, though nearly all patients received warfarin and aspirin. At the time of the study, 13 patients were alive with the device, 20 underwent heart transplantation, and 1 underwent device explantation after recovery. Of the 21 patients transplanted or explanted for recovery, the median duration of support was 40 days (range, 2-310 days). Forty percent of patients weighed <60 kg with a BSE ranging from 0.78 to 1.72 m2. Five patients weighed less than 45 kg. There were no mortalities in this group while 11 of the 14 patients underwent transplantation. Other adverse events were relatively infrequent throughout the cohort.
While the results of the study are descriptive in nature, they demonstrate the ability of ACTION to rapidly assimilate information about new or evolving management techniques across multiple centers. It appears the HM3 LVAD may be a viable option for older pediatric and adolescent patients, though this is merely the start of potentially a larger discussion of how best to mechanically support this patient age group. The HM3 exhibited a favorable safety profile in this group, but how would it compare with other implantable devices? The HM3 has a larger extracardiac profile but shorter inflow cannula compared with the HeartWare device, and do these characteristics make the HM3 a better option for certain patient sizes or myocardial pathology? Variation in institutional practices was significant though expected given this novel application. It would be interesting to glean deeper information about how institutions chose this option and how long they waited to proceed with transplantation to permit recovery from the sequelae of end-stage heart failure. Finally, what is the discharge-to-home potential for patients with the HM3 device? Hopefully, ongoing work by ACTION will help clarify these issues in the near future.