Long-term paracorporeal pulsatile mechanical circulatory support in adolescent and adult patients

Abstract

Objectives Our study objective was to analyse adverse events in adolescent and adult Berlin Heart EXCOR patients and to assess outcome of subsequent heart transplantation (HTX) Methods From 2006 to 2020, 58 patients (12–64 years) received a biventricular assist device (BIVAD) at our institution and were included in this study. Results Causes of biventricular heart failure were non-ischaemic cardiomyopathy (62.1%), ischaemic cardiomyopathy (22.4%) and myocarditis (15.5%). Median INTERMACS score was I (I—III). Median age was 49 years (IQR 34–55 years) and 82.8% were male. Causes of death were: multi-organ failure (25.0%), septic shock (17.9%), cerebral haemorrhage (14.3%), bleeding (14.3%) and embolic events (14.3%). Major bleedings were more frequent in the group who died on BIVAD (60.7 vs 6.7%, p < 0.001). Wound infections were more prevalent in HTX recipients (n = 21, 70.0%). After BIVAD thrombosis, 104 chamber exchanges were performed in 28 patients (48.3%). HTX was performed in 52.6% of the patients after BIVAD support time 316 ± 240 days. Mean time to follow-up of 30 HTX recipients was 1722 ± 1368 days. One-, 6- and 12-month-survival after heart transplantation were 96.7%, 90.0% and 76.7% respectively. Long-term survival after 5 and 10 years was 69.7%. Conclusions Pump thrombosis, infections and bleeding after BIVAD did not preclude successful HTX. Although only 50% of BIVAD patients were successfully transplanted, long-term survival after HTX in BIVAD patients was non-inferior when compared to other recipients.

Wound Infections in Adult Patients after Berlin Heart® EXCOR Biventricular Assist Device Implantation

“…Many countries, including Germany, struggle with a shortage of organ donors, while the number of patients in need of HTx due to acute or chronic heart failure is increasing. Therefore, MCS is suitable for long support times as BTT becomes more important in the clinical routine [ 1 , 5 , 17 ]. Occurring in increasing numbers in VAD-supported patients, related complications present a major problem in aftercare.…”

“…Data regarding the usage of Berlin Heart ® EXCOR devices, especially in a biventricular configuration, is limited [ 5 ]. Although VAD infections have been the focus of several pediatric studies, their impact on adolescent and adult patients, who carry different etiologies, comorbidities, and characteristics, is still not well documented.…”

“…It can provide durable support to the left ventricle (LV), right ventricle (RV), or both ventricles and can be used as BTR or BTT. It is the only system worldwide that is officially designed and licensed for pediatric patients [ 3 , 4 , 5 ]. Pump chambers are available in six different sizes.…”

Prediction, prevention, and management of right ventricular failure after left ventricular assist device implantation: A comprehensive review

“…Excor is a paracorporeal pulsatile mechanical ventricle of different sizes that can be used exclusively as RVAD or combined with an LVAD. A common Excor R complications include thrombosis of the mechanical ventricle, which is risky on the right side, high rates of bleeding and wound infections (294,295). However, approximately 50% of carefully selected patients receiving an upgrade to Excor support following a failed temporary RVAD wean could be successfully bridged to OHT, with similar survival after OHT as other recipients (294)(295)(296).…”