ABSTRACT
PURPOSE: Tolvaptan, a selective vasopressin type-2 antagonist, has been shown to increase serum sodium (Na) and urine output in hyponatremic left ventricular assist device (LVAD) patients in retrospective studies. In this prospective randomized pilot study, we aimed to assess the efficacy of tolvaptan in this population. METHODS: We conducted a prospective, randomized, non-blinded pilot study of LVAD recipients with post-operative hyponatremia (Na < 135 mEq/L) (NCT05408104). Eligible participants were randomized to receive tolvaptan 15 mg daily in addition to usual care versus usual care alone. The primary outcome was a change in Na level and estimated glomerular filtration rate (eGFR), from the first post-operative day of hyponatremia (the day of randomization) to discharge. RESULTS: A total of 33 participants were enrolled, and 28 underwent randomization (median age 55 [IQR 50-62]), 21% women, 54% Black, 32% ischemic cardiomyopathy, median baseline Na 135 (IQR 134-138). Fifteen participants were randomized to tolvaptan (TLV) and 13 were randomized to usual care alone (No-TLV). Mean change in Na from randomization to discharge in the TLV group was 2.7 mEq/L (95%CI 0.7-4.7, p = 0.013) and 1.8 (95%CI 0.5-4.0, p = 0.11) in the No-TLV group, though baseline and final Na levels were similar between groups. The mean change in eGFR was 2.6 ml/min/1.73 m2 (95%CI 10.1-15.3, p = 0.59) in TLV versus 7.5 ml/min/1.73 m2 (95%CI 5.2-20.2, p = 0.15) in No-TLV. TLV participants had significantly more urine output than No-TLV patients during their first 24 h after randomization (3294 vs 2155 ml, p = 0.043). CONCLUSION: TLV significantly increases urine output, with nominal improvement in Na level, in hyponatremic post-operative LVAD patients without adversely impacting renal function.
ABSTRACT
BACKGROUND: A thorough psychosocial assessment is needed during the evaluation of candidacy for ventricular assist device placement to identify potential barriers that would limit success with the device. Ventricular assist device coordinators are generally involved in the psychosocial assessment of the patient, allowing them to provide a more holistic approach to ventricular assist device candidacy during discussions at multidisciplinary meetings. There is a gap in the literature describing the psychological journey of patients after ventricular assist device implantation and the challenges ventricular assist device coordinators face when caring for this complex population. OBJECTIVE: The psychological journey of 3 patients with a ventricular assist device was explored to determine if common themes exist and to describe the experiences faced by the ventricular assist device coordinators with each patient. METHODS: Three patient case scenarios are described, as are the interactions with the patients' ventricular assist device coordinator team members. RESULTS: All 3 case scenarios demonstrate similarities of younger ages, the need of family and social support, and ventricular assist device coordinators who went beyond the call of duty to assist in the successful heart transplantation for 2 cases and the successful decommission of the ventricular assist device in another case. CONCLUSION: The psychosocial needs of patients with a ventricular assist device and ventricular assist device coordinators require ongoing assessment because of the many physical and emotional challenges that arise during the time a patient has an implanted ventricular assist device.