Postoperative tolvaptan use in left ventricular assist device patients: The TOLVAD randomized pilot study.

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.

Physiology and Clinical Utility of HeartMate Pump Parameters.

The HeartMate 3 left ventricular assist device (LVAD) is now the only centrifugal pump intended for durable support being actively manufactured and implanted for adults in the United States. The changes in preload and afterload that accompany common clinical scenarios experienced by patients with an LVAD will cause specific changes to the LVAD pump parameters, namely, the pump power, pulsatility index, and flow. Appropriate care of this unique, and growing, population requires a full understanding of these variables as well as the underlying physiologic principles governing their derivation. The aim of this review is to focus on the updated functionality of the HeartMate 3, specifically in comparison to the HeartMate II, as well as the application of pump parameter interpretation to common clinical scenarios.

Psychological Journey of a Patient With a Ventricular Assist Device: A VAD Coordinator's Perspective.

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.

Winter LVAD implantation is associated with adverse clinical outcomes.

BACKGROUND: The seasonal variation of incidence and severity of heart failure is well known. However, the impact of seasonal variation on clinical outcomes following left ventricular assist device (LVAD) implantation remains unknown. METHODS: We retrospectively reviewed consecutive patients who received LVAD implantation between January 2014 and December 2016 along with their first year of post-implant outcomes. Clinical outcomes were compared between those with winter LVAD implantation (between October and March) and those with non-winter LVAD implantation. RESULTS: 168 patients with a median age of 57 years and 130 males were included. There was no seasonal difference in the number of LVAD implantations. One-year survival free from major adverse events was significantly lower in the winter implant group (n = 88) compared to the non-winter group (n = 80) (44% vs 61%) with an adjusted hazard ratio of 1.81 (95% confidence interval 1.11-2.90, p = 0.014), largely due to a higher rate of heart failure readmission in the winter implant patients (incidence rate ratio 2.29, 95% confidence interval 0.89-5.84). CONCLUSION: Patients who underwent LVAD implantation during the winter season had a higher heart failure readmission rate. A detailed mechanism and therapeutic strategy given our findings warrant further investigation.

Opioid Use and Morbidities during Left Ventricular Assist Device Support.

The use of opioids during left ventricular assist device (LVAD) support is increasing, but the implication remains unknown. We investigated the association between the use of opioid and morbidities during LVAD supports. We retrospectively reviewed the clinical data of patients who received LVAD between 2014 and 2017, which were stratified by the use of opioid at post-LVAD 3 months. Among 136 patients, 77 (57%) were in the opioid group. Hemoglobin and albumin were lower, and C-reactive protein was higher at baseline and 3 months later in the opioid group (P < 0.05 for all). The opioid group displayed worse hemodynamics, with higher pulmonary capillary wedge pressure and central venous pressure (P < 0.05 for both). Furthermore, the opioid group had higher incidences of gastrointestinal bleeding (31% versus 17%, P = 0.043) and sepsis (30% versus 13%, P = 0.036) during the 1 year observational period, whereas survivals were not stratified by the use of opioid (83% versus 90%, P = 0.27). Opioid use was associated with morbidities accompanied by poor hemodynamics during LVAD supports. The detailed causality of opioid use on morbidities remains a future concern.

Longitudinal Trajectories of Hemodynamics Following Left Ventricular Assist Device Implantation.

BACKGROUND: Continuous-flow left ventricular assist devices (LVADs) improve the hemodynamics of patients with advanced heart failure. However, the longitudinal trajectories of hemodynamics in patients after LVAD implantation remain unknown. The aim of this study was to investigate the trends of hemodynamic parameters following LVAD implantation. METHODS AND RESULTS: We retrospectively reviewed patients who underwent LVAD implantation between April 2014 and August 2018. We collected hemodynamic parameters from right heart catheterizations. Of 199 consecutive patients, we enrolled 150 patients who had both pre- and postimplant right heart catheterizations. They had 3 (2, 4) postimplant right heart catheterizations during a follow-up of 2.3 (1.3, 3.1) years. The mean age was 57 ± 13 years, and 102 patients (68%) were male. Following LVAD implantation, pulmonary arterial pressure and pulmonary capillary wedge pressure decreased, and cardiac index increased significantly, then remained unchanged throughout follow-up. Right atrial pressure decreased initially and then gradually increased to preimplant values. The pulmonary artery pulsatility index decreased initially and returned to preimplant values, then progressively decreased over longer follow-up. Subgroup analysis showed significant differences in the trajectories of the pulmonary artery pulsatility index based on gender. CONCLUSIONS: Despite improvement in left-side filling pressures and cardiac index following LVAD implantation, right atrial pressure increased and the pulmonary artery pulsatility index decreased over time, suggesting progressive right ventricular dysfunction.

Effect of tobacco smoking on outcomes after left ventricular assist device implantation.

Despite the well-established correlation between the tobacco use and cardiovascular disease, little is known about postoperative outcomes following the left ventricular assist device (LVAD) implantation. We aimed to elucidate the effect of tobacco smoking on post-LVAD implant outcomes. Patients who received LVADs from 2013 to 2018 were retrospectively characterized as current, former, or never smokers at the time of implant. We examined 1-year survival, total hospital readmissions, and specific hospital readmissions for LVAD-related adverse events based on patient's smoking status. Of the enrolled patients (n = 292), 55% were former smokers, 33% were never smokers, and 11% were current smokers. The majority of patients were African-American (48%) with a median age of 58 years. Never smokers were younger and less likely to be Caucasian compared to former or current smokers (P < .05, for both). The category of former smokers had statistically comparable total readmission rates with never smokers (2.49 vs. 2.13 event/year), whereas current smokers had significantly higher rates compared to never smokers (2.81 events/year, P < .05), with odds ratio 2.12 (95% CI = 1.35-3.32) adjusted for age and Caucasian race for >5 times of total readmissions per year. The rates of driveline infection, stroke, and hemolysis were statistically comparable between the never smokers and former smokers, while current smokers had significantly higher rates compared to never smokers (P < .05 for all).

Short-Term Efficacy and Safety of Tolvaptan in Patients with Left Ventricular Assist Devices.

Tolvaptan is an effective therapy for heart failure patients with symptomatic congestion and hyponatremia. The efficacy of its use in patients with continuous-flow left ventricular assist devices (LVADs) is unknown. The aim of this study was to assess the clinical efficacy and safety of tolvaptan in LVAD patients. We retrospectively reviewed medical records of patients who underwent LVAD implantation between January 2014 and August 2018. Among 217 consecutive LVAD patients, tolvaptan was used in 20 patients. Mean age was 46 ± 14 years old and 14 patients were males. The duration of tolvaptan therapy was 4 (interquartile range 1-8) days. Urine volume significantly increased from 2,623 ± 1,109 ml/day before tolvaptan to 4,308 ± 1,432 ml/day during tolvaptan therapy (p < 0.001). Serum sodium increased from 127 ± 3 to 133 ± 3 mEq/L at the end of tolvaptan therapy (p < 0.001). No patients developed hypernatremia (serum sodium >150 mEq/L). The 90-day overall survival following tolvaptan therapy was 89% in both the tolvaptan group and a propensity score-matched non-tolvaptan group (p = 0.918). Survival free of heart failure readmissions was also comparable between the groups (p = 0.751). In conclusion, short-term use of tolvaptan following LVAD implantation is a safe and effective therapy to augment diuresis and improve hyponatremia.

Metabolic Dysfunction in Continuous-Flow Left Ventricular Assist Devices Patients and Outcomes.

Background Metabolic impairment is common in heart failure patients. Continuous-flow left ventricular assist devices (CF-LVADs) improve hemodynamics and outcomes in patients with advanced heart failure; however, the effect of CF-LVADs on metabolic status is unknown. This study aims to evaluate the changes in metabolic status following CF-LVAD implantation and measure the correlation of metabolic status with outcomes. Methods and Results Prospective data on CF-LVAD patients were obtained. Metabolic evaluation, including hemoglobin A1C, free and total testosterone, thyroid-stimulating hormone (TSH), and free T4, was obtained before and at multiple time points following implantation. Patients with nonelevated thyroid-stimulating hormone and normal hemoglobin A1C and testosterone levels were defined as having normal metabolic status. Baseline characteristics, hemodynamics, and outcomes were collected. One hundred six patients were studied, of which 56 had paired data at baseline and 1- to 3-month follow-up. Before implantation, 75% of patients had insulin resistance, 86% of men and 39% of women had low free testosterone, and 44% of patients had abnormal thyroid function. There was a significant improvement in hemoglobin A1C, free testosterone, and thyroid-stimulating hormone following implantation (P<0.001 for all). Patients with normal hemoglobin A1C (<5.7%) following implantation had higher 1-year survival free of heart failure readmissions (78% versus 23%; P<0.001). Patients with normal metabolic status following implantation also had higher 1-year survival free of heart failure readmissions (92% versus 54%; P=0.04). Conclusions Metabolic dysfunction is highly prevalent in advanced heart failure patients and improves after CF-LVAD implantation. Normal metabolic status is associated with a significantly higher rate of 1-year survival free of heart failure readmissions.

The first-in-human experience with a minimally invasive, ambulatory, counterpulsation heart assist system for advanced congestive heart failure.

BACKGROUND: The intravascular ventricular assist system (iVAS) is a new, minimally invasive, ambulatory counterpulsation heart assist system delivered via the subclavian artery and powered by a portable driver. It is designed for recovery, bridge to transplantation (BTT) or for prolonging medical therapy. We report the first-in-human (FIH) experience with iVAS. METHODS: This is a prospective, non-randomized single arm, U.S. Food and Drug Administration (FDA)-approved early feasibility trial in patients listed for cardiac transplantation. The primary end-point was survival to transplant or stroke-free survival at 30 days. RESULTS: Fourteen patients were enrolled and 13 (92.8%) were treated with iVAS. At time of implant, the average age was 58 ± 6.7 years; 85% were male; 28% had ischemic cardiomyopathy; and 3 were Interagency Registry for Mechanically Assisted Devices (INTERMACS) Level 2, 9 were Level 3, and 1 was Level 4. The mean left ventricular ejection fraction was 22%, left ventricular internal diameter diastole was 7.13 mm, and 69% had moderate or severe mitral regurgitation. There were no intra-operative complications. Intensive care unit stay after implant was 6 ± 6 days. All patients were transplanted after 32 ± 21 days. There were no deaths or thromboembolic events: 1 patient required escalation of mechanical support, and post-implant complications included pleuritis/pericarditis (n = 1) and neuropathy (n = 2). No intra-operative blood transfusions were required. CONCLUSIONS: This study demonstrates a high rate of successful outcomes with an excellent risk-to-benefit profile. This FIH experience reveals that the iVAS can be successfully inserted in a standardized approach, provide hemodynamic support, can be interrupted for short periods, and allows for ambulation. A multicenter trial to investigate effectiveness and safety is warranted.