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In addition to goal-directed therapies, advanced therapies for heart failure including left ventricular assist devices (LVADs) remain underutilized in women. Sex-specific data in the area of mechanical circulatory support remains sparse and women are often underrepresented in heart failure trials. Even less is known about sex differences in outcomes with the HeartMate 3 LVAD, an FDA approved centrifugal-flow device. Consecutive patients who received HeartMate 3 LVAD as bridge-to-transplant or destination therapy at a single institution were included in the study. Demographics, co-morbidities, device-related factors, and outcomes were comparatively examined between women and men. 175 patients (28 women, 16.0%) were identified. Women were significantly younger than men (53.9 vs. 60.1 years, p=0.023) with smaller body surface area (1.83 vs 2.08, p <0.001). Women were less likely to have hypertension (42.9% vs 64.6%, p=0.030), to use tobacco (35.7% vs 57.5%, p=0.034), and to have an ischemic etiology of HF (21.4% vs 52.4%, p=0.003). There were no differences in the use of temporary mechanical circulatory support and INTERMACS profiles. There were similar rates of RVAD use (35.7% vs. 30.6%, p=0.594) and continuous veno-venous hemofiltration (10.7% vs 8.2%, p=0.659) in women and men. There were no differences in in-hospital mortality (3.7% vs 6.3%, p=0.595) or 90-day mortality (8.7% vs 6.9%, p=0.762) between women and men. There was no difference in post-implant survival (82.8% vs 87.7%, log-rank p=0.944) [Figure], freedom from gastrointestinal bleeding (70.5% vs 69.1%, log-rank p =0.278) or freedom from stroke (96.4% vs 91.4%, log-rank p = 0.471) at 2-year follow-up between women and men. In our single-center experience with HeartMate 3 LVADs, there were no significant differences in early morbidity and mortality between women and men. [ABSTRACT FROM AUTHOR]

MOMENTUM 3 trial excluded patients with planned biventricular support prior to enrollment and 4.2% right ventricular failure requiring RVAD in Heartmate 3 (HM 3) patients. The aim of this study was to assess the use of RVAD in the real-world post-approval era. HM3 implantation at a major academic center were categorized into two era: HM 3 implanted 1) before FDA approval (8/23/2017) [N=67] and 2) after FDA approval [N=107]. Baseline patient characteristics, RVAD utilization patterns, and LVAD complications and mortality were analyzed in the pre- vs. post-approval era. In the post-approval era, HM3 patients were younger (57.5±14.1 vs 61.7±11.2 yrs, p=0.031), more likely to have ischemic etiology of heart failure (55.6% vs 34.3%, p=0.006), to be INTERMACS Class I (21.3% vs. 1.5%, p=0.002), and to have VA-ECMO or paracorporeal VAD support (12.0% vs 0.0%, p=0.012) prior to HM3 implant. 8 (11.9%) patients out of 67 required RVAD in the pre-approval era as opposed to 47 patients out of 108 (43.5%) in the post-approval era (p<0.001). All patients in the pre-approval era received unplanned RVAD (8, 100%) compared to 16 patients (34.0%) in the post-approval era (p<0.001). Despite increased utilization of RVADs, the risk of CVVHD (6.0% vs 10.2%, p=0.413), post-LVAD length of stay (34.3±32.9 vs 41.7±40.0 days), and in-hospital mortality (4.5% vs 6.9%, p=0.741) were comparable in pre- vs. post-approval era. There was no difference in post-implant survival (89.7% vs. 84.7%, log-rank p=0.357), freedom from gastrointestinal bleeding (70.0% vs. 70.4%, log-rank p =0.831) or freedom from stroke (93.2% vs. 92.2% log-rank p = 0.547) at 2-year follow-up in the pre- vs. post- approval period. Level of sickness at the time of device implantation as well as need for RVAD utilization increased substantially in HM3 patients following the FDA approval. However, the change in practice did not adversely affect post-LVAD morbidity or mortality. [ABSTRACT FROM AUTHOR]

Heartmate II risk score (HMRS) and MELD-Xi score are validated mortality risk predictors in Heartmate II left ventricular assist device (LVAD) patients. Prognostic utility of these risk scores remains unknown in patients considered for Heartmate 3 (HM3) LVAD therapy. HMRS were calculated for 175 consecutive patients who underwent HM3 LVAD implantation at a single academic institution. Receiver operating characteristic (ROC) curve and logistic- and cox-regression models were developed to assess the impact of HMRS and MELD-Xi scores on short- and long-term outcomes in HM3 patients. Mean HMRS and MELD-Xi scores in HM3 population was 1.38±0.57 and 14.4±0.28, respectively. Pre-implant HMRS was not predictive of RVAD use (OR 1.25, p=0.392), CVVHD (OR 1.16, p=0.722), in-hospital mortality (OR 1.52, p=0.409), or 90-day mortality (OR 1.44, p=0.457). Pre-implant MELD-Xi score showed trend towards increased RVAD use (OR 1.09, p=0.056) and need for CVVH (OR 1.14, p=0.064), however was not predictive of in-hospital mortality (OR 1.02, p=0.836), or 90-day post-LVAD mortality (OR 0.958, p=0.636). Area under curve (AUC) for in-hospital mortality was 0.531 for HMRS and 0.525 for MELD-Xi score (Figure). There was no difference in post-implant survival (88.6% vs. 85.7%, log-rank p=0.569), freedom from GI bleeding (73.5% vs. 65.1%, log-rank p =0.257) or freedom from stroke (93.3% vs. 90.8% log-rank p = 0.478) at 2-year follow-up in patients with below average vs. above average HMRS. Similarly, There was no difference in post-implant survival (91.3% vs. 82.3%, log-rank p=0.121), freedom from gastrointestinal bleeding (72.2% vs. 65.2%, log-rank p =0.257) or freedom from stroke (92.0% vs. 92.4% log-rank p = 0.820) at 2-year follow-up in patients with below average vs. above average MELD-Xi score. HMRS and MELD-Xi scores do not predict mortality in patients undergoing HM3 implantation. New prediction models are required to optimize patient selection and outcomes in HM3 patients. [ABSTRACT FROM AUTHOR]

C-reactive protein (CRP) emerged as a biomarker of inflammation in heart failure patients and associated with increased morbidity and mortality. We hypothesized that higher serum CRP level prior to Heartmate 3 LVAD implantation is associated with increased risk of post-implant adverse events and mortality. 123 patients who underwent Heartmate 3 LVAD implantation at a tertiary care center and had a CRP level measured prior to device implant were included in the analysis. Optimal CRP cut-off was determined used ROC curve and patients were categorized into high vs. low CRP groups accordingly. Study end-points included RVAD use, need for CVVH, in-hospital mortality, and 2-year survival. Mean and median pre-implant CRP levels in HM3 patients were 35.5±43.6 mg/L and 15.0 mg/L respectively. Patients with an elevated pre-implant CRP (≥12 mg/L) were more likely to be in INTERMACS Class I or II (78.4% vs. 46.6%), to have temporary MCS (49.2% vs. 27.5%), and elevated WBC count (9.1 vs. 7.5) compared to those with a pre-implant CRP less than 12 mg/L (all p <0.05). High CRP group had significantly higher RVAD use (32.3% vs. 15.5%, p=0.030), need for CVVHD (13.8% vs. 3.4%), and in-hospital mortality (14.0% vs. 1.8%, p=0.028). Patients with elevated pre-implant CRP had significantly lower survival compared to those with lower pre-implant CRP (74.2% vs. %96.1, log-rank p =0.020) and a trend-towards lower freedom from post-implant stroke (%89.2 vs. %98.3, log-rank p =0.072) at 2-year follow-up (Figure). After adjustment for age, ischemic etiology, creatinine, bilirubin, albumin, and INTERMACS Class, high CRP (≥ 12 mg/L) remained as an independent predictor of survival on LVAD support (HR 3.81 [1.35 - 10.75], p=0.011). Pre-implant CRP is a strong predictor of morbidity and mortality in patients undergoing HM3 implantation. Routine assessment of CRP prior to implant may improve patient selection and outcomes in this population. [ABSTRACT FROM AUTHOR]