Efficacy and Safety of Ferric Carboxymaltose Therapy in Continuous Flow LVAD Patients

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The Journal of Heart and Lung Transplantation, Vol 38, No 4S, April 2019

Conclusion: Anticoagulant therapy without antiplatelet therapy in CFLVAD population may help reduce the incidence of bleeding complications without increasing the risk of TE events. This should be taken into consideration when choosing anticoagulation strategy especially in patients at high risk of bleeding. 941 Short-Term Efficacy and Safety of Tolvaptan in Patients with Left Ventricular Assist Devices T. Fujino, T. Imamura, D. Nitta, G. Kim, A.J. Kanelidis, M. Belkin, B. Chung, B. Smith, A. Nguyen, P. Combs, J. Raikhelkar, C. Juricek, V. Jeevanandam, I. Ebong, N. Narang, L. Holzhauser, G. Sayer and N. Uriel. University of Chicago, Chicago, IL. Purpose: Tolvaptan, an arginine vasopressin type 2 antagonist, is effective for heart failure patients with symptomatic congestion and hyponatremia. The aim of this study is to assess the clinical efficacy and safety of tolvaptan in patients with left ventricular assist devices (LVAD). Methods: We retrospectively reviewed medical records of patients who had undergone LVAD implantation between 1/2014-8/2018. We included all patients who had been treated with tolvaptan following LVAD implantation. Results: Among 217 consecutive LVAD patients, tolvaptan was used in 20 patients (9%). Mean age was 45§14 years old and 14 patients (70%) were male. Tolvaptan was first used at median 15.5 (range 2-519) days following implantation, and in 13 patients (65%) tolvaptan was used during the index hospitalization. The initial dose of tolvaptan was 15 mg in all patients, and increased to 30 mg in 5 (25%) patients. The duration of tolvaptan use during hospitalization was median 4 (range 1-13) days. Urine volume significantly increased from 2646§1073 ml/day just before starting tolvaptan to 4308§1432 ml/day during tolvaptan use (Figure 1A, P<0.01). Serum sodium increased from 127.1§3.1 mEq/l just before starting tolvaptan to 133.5§3.3 mEq/l at the end of tolvaptan use (Figure 1B, P<0.01). Serum creatinine remained unchanged (1.27§0.58 to 1.24§ 0.40 ng/dl, P=0.74). No patients suffered from severe hypernatremia (serum sodium >150 mEq/l). Survival rate after discharge was 92% at 6 months and 76% at 1 year. Heart failure readmission-free survival rate was 70% at 6 months and 61% at 1 year. Conclusion: Short-term use of tolvaptan following LVAD implantation was an effective therapy to augment diuresis and improve hyponatremia.

Purpose: Post-operative pain following left ventricular assist device (LVAD) implantation is commonly managed with opioid analgesics. However, the impact of this particular therapy is unknown. The aim of this study was to compare outcomes of LVAD patients who received opioid therapy and those who did not. Methods: We retrospectively reviewed all patients who underwent VAD implantation from 2014 to 2017. We divided patients into those who received opioids (OP group) and who did not (NOP group) at 3 months post LVAD implantation. At 1 year, we evaluated overall survival, as well as incidence of gastrointestinal bleeding (GIB), stroke, sepsis, driveline infection and pump thrombosis. Results: Among 136 patients, 77 (57%) were in the OP group. At baseline, the OP group was younger (54 vs. 64 years, p=0.001), with a higher BMI (30.8 vs. 28, p=0.023), along with fewer males (60% vs. 81%, p=0.005), and less incidence of atrial fibrillation (23 vs. 28, p=0.018). Survival at 1 year was no different between the two groups (90% vs. 83%, p = 0.27; Figure A). The incidence of overall adverse events, stroke, driveline infection and pump thrombosis were comparable between the two groups. However, incidence of GIB (31% vs. 17%, p = 0.043) and sepsis (30% vs. 13%, p = 0.036) were significantly higher in the OP group (Figure B). Conclusion: This study suggests that opioids do not negatively impact survival of the LVAD patient; however, some AEs may be negatively effected. Further research is needed linking the pathophysiology of higher adverse events with opioid use in LVAD patients.

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Opioid Use in LVAD Patients is Associated with Increased GI Bleed and Sepsis P. Combs, T. Imamura, C. Stonebraker, H.M. Bullard, P. Simone, C. LaBuhn, B. Chung, T. Ota, D. Onsager, T. Song, T. Lammy, G. Kim, B. Smith, S. Kalantari, A. Nguyen, J. Raikhelkar, N. Sarswat, G. Sayer, V. Jeevanandam and N. Uriel. University of Chicago, Chicago, IL.

Efficacy and Safety of Ferric Carboxymaltose Therapy in Continuous Flow LVAD Patients € urk,2 E. Simsek,1 C. Engin,2 T. Yagd{,2 E. Demir,1 S. Nalbantgil,1 P. Ozt€ 2 1 € _ and M. Ozbaran. Cardiology, Ege University Medicine Faculty, Izmir, Turkey; and the 2Cardiovascular Surgery, Ege University Medicine _ Faculty, Izmir, Turkey.

Abstracts Purpose: Iron deficiency (ID) is common in heart failure patients and is associated with reduced exercise capacity, fatigue, worsening heart failure and increased rate of heart failure hospitalization. Intravenous iron therapy allows restoration of iron deficiency, increasing hemoglobin levels and ameliorates functional capacity. In this study, we aimed to determine the efficacy and safety of ferric carboxymaltose (FCM) treatment in continuous flow LVAD patients Methods: In the study, we retrospectively analysed 29 patients treated with 1000 mg IV iron (FCM) due to ID between June 2018 and October 2018. We evaluated the effect of therapy on functional capacity, six-minute walking distance(6MWD), and laboratory findings. Results: Mean age of the population was 51.6 § 13.4 years, and 69% of the patients were male. Mean body mass index(BMI) was 26.8 § 5.47kg/m2. The mean follow-up period after FCM infusion was 97.8 § 21.2 days. NYHA functional class decreased from 1.83 § 0.46 to 1.39 § 0.49. 6MWD increased from 371 § 75 meters to 395 § 60 meters, mean change was 13.7 § 35 meters. Hematological parameters (hemoglobin, hematocrit, blood iron level, ferritin, TSAT) improved. Mean NT pro-BNP value decreased from 1520 § 1429 pg/ml to 1513 § 1817 pg/ml, mean change was 6.7 pg/ml. The number of thrombocytes decreased (276 § 97 to 220 § 49.8, mean change 56.1 § 87.7), mean platelet volume increased (10.25 § 1.01 to 10.43 § 0.92, mean change 0.188§0.55) and platecrit decreased (0.28 § 0.071 to 0.23 § 0.047, mean change -0.048 § 0.074) In the follow up period four patients developed pump thrombosis (PT) and treated with iv thrombolytic therapy. When we compare the iron treated patients with the ones who were not treated there was an increase in the rate of pump thrombosis although it did not reach significance (PT rates were respetively, 13.7% - 6.3%, p=0.239). The variables associated with pump thrombosis were BMI (PT:50.7 § 13.7 kg/m2- nonPT:57.25 § 10.6 kg/m2 p=0.001), increase in mean platelet volume (PT: 10.3 § 0.94 fl - nonPT: 11.15 § 0.17 fl, p=0.001) and increase in platecrit (PT: 0.225 § 0.039 % nonPT:0.282 § 0.063%, p= 0.023) after therapy. Conclusion: FCM therapy increased functional class and 6MWD in LVAD patients with ID. Natriuretic peptid levels decreased after therapy. However there was a trend in pump thrombosis after therapy. Further studies are needed to establish the safety of FCM therapy in this population.

S375 ST-T segment changes and prolongation of the QT interval can be used to predict the type of HFrEF with satisfactory sensitivity and specificity.

945 944 Deep Learning for Diagnosing Heart Failure from ECG Signals K. Kim, and J. Kwon. Sejong General Hospital, Kyunggi do, Republic of Korea. Purpose: The aim of this study is to present the state-of-the-art of the machine learning methodologies applied for the assessment of heart failure from ECG signals. Methods: We performed a multicenter retrospective cohort study in 2 hospitals. The subjects were admitted adult (age≥18 years) heart failure patients who underwent echocardiography and ECG. We performed a cross-sectional study analyzing ECG and echocardiographic data from 2209 subjects with chronic HFrEF (n=1006) HFmidEF (n=1103) compared with normal EF patients ECG (n=18196). HFrEF and HFmidEF were defined as an ejection fraction (EF) ≤ 40% and 40 80, QRS duration > 110 ms, right bundle branch block (RBBB), ST-T segment changes and prolongation of the QT interval (>410ms). Based on receiver operating characteristic (ROC) curve analysis, we obtained a score for HFpEF of -1 to +3, while HFrEF had a score of +4 to +6 with 98% specificity, a 95% positive predictive value. Conclusion: In this study, we developed and validated a deep-learningbased model for predicting HF in ECG. Through validation, this study confirmed that the accurate performance of the deep-learning-based model was excellent for predicting heart failure and showed better accuracy than random forest model. QRS duration > 110 ms, RBBB,

Cardiac Surgical Procedures with Concomitant vs. Staged Orthotopic Liver Transplant H.G. Reddy, J. Choi, E.J. Maynes, L.A. Carlson, J. Gordon, D.P. Horan, J. Khan, M.P. Weber, R.J. Morris, H.T. Massey and V. Tchantchaleishvili. Division of Cardiac Surgery, Thomas Jefferson University, Philadelphia, PA. Purpose: In patients who require orthotopic liver transplant (OLT), cardiac surgery may be needed to optimize preoperative cardiac status for OLT. The aim of this systematic review was to evaluate patient characteristics and outcomes undergoing staged versus concomitant cardiac procedures with OLT. Methods: An electronic search was performed to identify all case reports and series, from which patient-level data was extracted regarding cardiac procedures associated with OLT. After assessment for inclusion and exclusion criteria, 26 articles were pooled for systematic review. Results: Overall, 49 patients were included in the analysis, of whom 12 (24%) underwent staged procedures and 37 (76%) underwent concomitant procedures. The median age was lower in the staged group [staged: 51.0 (IQR, 43.8-59.2) years vs. concomitant: 60.0 (IQR, 55.0-64.0) years, p=0.02]. Other baseline characteristics were comparable between the two groups. For staged procedures, the median time between heart procedures and OLT was 2 months. The most commonly reported cardiac procedures were coronary artery bypass graft (CABG) [staged: 4/ 12 (33.3%) vs. concomitant: 21/37 (56.8%), p=0.28], aortic valve replacement (AVR) [staged: 3/12 (25.0%) vs. concomitant: 19/37 (51.2%), p=0.21], and transcatheter aortic valve replacement (TAVR) [staged: 4/12 (33.3%) vs. concomitant: 0/37 (0%), p=0.002]. There was