Improved outcomes with pulsatile paracorporeal ventricular assist device support in children: A single-center experience
Single-center cohort published in JTCVS Open (2025)
Abstract
OBJECTIVE: The Berlin Heart EXCOR (BHE) remains the only long-term mechanical circulatory support option for small children, yet it carries a high risk of morbidity and mortality, most notably from cerebrovascular accidents (CVAs). This study evaluates how the outcomes of children supported with BHE changed with evolving management. METHODS: All consecutive patients receiving BHE at our institution from 2009 to 2024 were included. RESULTS: BHE support was used in 75 patients (median age 1 year). Median support duration was 128 days. Transplantation was achieved in 64% (48/75) of patients. BHE was removed because of recovery in 13.3% (10/75), and 21.3% (16/75) died while on BHE support. Overall survival was 87.7%, 80.9%, and 65.9% at 1, 6, and 12 months, respectively. Survival improved significantly after 2019 (hazard ratio, 0.14; 95% confidence interval, 0.03-0.72; P = .02), whereas the risk of death was greater in patients with CVA (hazard ratio, 3.08; 95% confidence interval, 0.99-9.47; P = .05). A total of 36 CVAs occurred in 23 patients (31%). Freedom from CVA at 1, 6, and 9 months was 81.8%, 67.5%, and 59.1%, respectively. Overall CVA incidence and freedom from CVA did not differ between eras, but fatal CVA incidence decreased (54% vs 10%, P = .03), coinciding with increased rate of successful outcomes (transplantation and explantation: 70.8% vs 92.6%, P = .03). Key differences between eras included the introduction of bivalirudin, decreased threshold for cannula/pump interventions (1.4 vs 5.8 per patient, P < .001), and more proactive timing of support, with fewer patients progressing to preimplantation cardiogenic shock (P = .02) and reduced pre-BHE extracorporeal membrane oxygenation (P = .04) and pre-BHE centrifugal pump support (P = .007). CONCLUSIONS: Modern BHE management significantly reduces incidence of fatal strokes and improves survival, despite increased duration of support.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
In 75 children supported with Berlin Heart EXCOR, survival improved significantly after 2019 and fatal stroke incidence fell from 54% to 10%, an era that also included introducing bivalirudin and more proactive support timing.
Why This Matters for Hirudotherapy
This study evaluated how outcomes of children supported with the Berlin Heart EXCOR (BHE) changed with evolving management at one institution from 2009 to 2024, including 75 patients with a median age of 1 year and median support duration of 128 days. Survival improved significantly after 2019 (hazard ratio 0.14), and fatal cerebrovascular accident incidence decreased (54% vs 10%, P=.03), coinciding with multiple management changes including the introduction of bivalirudin, more aggressive cannula/pump interventions, earlier timing of support initiation, and reduced pre-BHE ECMO or centrifugal pump support. The abstract mentions bivalirudin by name as one of several concurrent management changes but provides no pharmacological detail about it and no mention of hirudin, leech saliva, leech therapy, or the leech secretome. Bivalirudin's individual contribution cannot be isolated from the other concurrent changes. Bivalirudin (formerly Hirulog) is a synthetic peptide anticoagulant designed partly on the C-terminal sequence of hirudin, the anticoagulant of the medicinal leech (Maraganore et al., 1990); this paper studies the drug, not leech therapy.
Citation
Reference (Vancouver style)
Iaprintsev V, Fricke TA, Buratto E, Zubritskiy A, Perrier S, Eastaugh L, et al. Improved outcomes with pulsatile paracorporeal ventricular assist device support in children: A single-center experience. JTCVS Open. 2026;29:101507. doi:10.1016/j.xjon.2025.10.027. PMID: 41960081
Bibliographic details (authors, volume, pages, DOI) are taken from the PubMed record.
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