Bridging patients in cardiogenic shock with a paracorporeal pulsatile biventricular assist device to heart transplantation—a single-centre experience

Abstract

OBJECTIVES We evaluated the outcome of patients in cardiogenic shock receiving a paracorporeal pulsatile biventricular assist device as a bridge to transplantation. METHODS We performed a retrospective single-centre analysis of all patients who received a Berlin Heart Excor® at our institution between 2004 and 2019. RESULTS A total of 97 patients (90 adults, 7 paediatric) were analysed. Eighty-four patients were in Interagency Registry for Mechanically Assisted Circulatory Support level 1 (80 adults, 4 paediatric). Diagnoses were dilated cardiomyopathy (n = 41), ischaemic cardiomyopathy (n = 17) or myocardial infarction (n = 4), myocarditis (n = 15), restrictive cardiomyopathy (n = 2), graft failure after heart transplant (n = 7), postcardiotomy heart failure (n = 5), postpartum cardiomyopathy (n = 3), congenital heart disease (n = 1), valvular cardiomyopathy (n = 1) and toxic cardiomyopathy (n = 1). All patients were in biventricular heart failure and had secondary organ dysfunction. The mean duration of support was 63 days (0–487 days). There was a significant decrease in creatinine values after assist device implantation (from 1.83 ± 0.79 to 1.12 ± 0.67 mg/dl, P = 0.001) as well as a decrease in bilirubin values (from 3.94 ± 4.58 to 2.65 ± 3.61 mg/dl, P = 0.084). Cerebral stroke occurred in 16 patients, bleeding in 15 and infection in 13 patients. Forty-eight patients died on support, while 49 patients could be successfully bridged to transplantation. Thirty-day survival and 1-year survival were 70.1% and 41.2%, respectively. CONCLUSIONS A pulsatile biventricular assist device is a reasonable therapeutic option in cardiogenic shock, when immediate high cardiac output is necessary to rescue the already impaired kidney and liver function of the patient.

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

“…The results with biventricular Berlin Heart EXCOR support presented here shed light on the feasibility of this surgical approach and the noninferior survival rate post-HTX in patients with a BIVAD compared to HTX patients with an HTX without previous VAD therapy [ 7 , 8 ]. Between 2006 and 2020, we implanted 250 permanent MCS devices in patients seen at our centre (BIVAD = 58, HeartWare ventricular assist device = 83, HeartMate II = 5, HeartMate 3 = 104).…”

“…Pump thrombosis, wound infections and bleeding are the main complications while the patient is on VAD support [ 13 ]. The most recent studies on BIVAD in adults included 80 patients on the Berlin Heart EXCOR [ 7 , 8 ]. Wound infections in patients who have the Berlin Heart EXCOR are discussed mainly in paediatric subpopulations.…”

“…None of the patients with pump thrombosis died, and the patients all underwent successful pump chamber exchanges. Bartfay et al reported that 14% of their group needed intervention for pump thrombosis; about 40% needed pump replacements due to thrombotic deposits in the study by Michel et al [ 8 , 19 ]. In the latter study, the first pump replacement was indicated after 35.5 days, with a median support time of only 37 days [ 8 ].…”

“…The European Registry for Patients with Mechanical Circulatory Support report on primary biventricular support from 2019 included only 5 adult patients with the Berlin Heart EXCOR [ 6 ]. Recently, 2 larger studies of adults support by a paracorporeal pulsatile BIVAD showed good survival rates and highlighted the challenges of long-term support [ 7 , 8 ]. One study focuses on allosensitization in adults before an HTX without further description of adverse events [ 7 ].…”

“…One study focuses on allosensitization in adults before an HTX without further description of adverse events [ 7 ]. The second study by Michel et al presents an outcome evaluation of patients in beginning cardiogenic shock who were bridged to an HTX with the Berlin Heart EXCOR [ 8 ].…”