Time Of LVAD Implantation Research Articles

Healthcare consumption of patients with left ventricular assist device: real-world data.

Aleft ventricular assist device (LVAD) is alife-saving but intensive therapy for patients with end-stage heart failure. We evaluated the healthcare consumption in acohort of LVAD patients in our centre over 6years. All patients with aprimary LVAD implantation at the University Medical Centre Utrecht in Utrecht, the Netherlands from 2016 through 2021 were included in this analysis. Subsequent hospital stay, outpatient clinic visits, emergency department visits and readmissions were recorded. During the investigated period, 226 LVADs were implanted, ranging from 32 in 2016 to 45 in 2020. Most LVADs were implanted in patients aged 40-60years, while they were supported by or sliding on inotropes (Interagency Registry for Mechanically Assisted Circulatory Support class2 or3). Around the time of LVAD implantation, the median total hospital stay was 41days. As the size of the LVAD cohort increased over time, the total annual number of outpatient clinic visits also increased, from 124 in 2016 to 812 in 2021 (p = 0.003). The numbers of emergency department visits and readmissions significantly increased in the 6‑year period as well, with atotal number of 553 emergency department visits and 614 readmissions. Over the years, the annual number of outpatient clinic visits decreased by1 per patient-year follow-up, while the annual numbers of emergency department visits and readmissions per patient-year remained stable. The number of patients supported by an LVAD has grown steadily over the last years, requiring amore specialised healthcare in this particular population.

Risk of Infections With Long-Term Left Ventricular Assist Device Support.

We retrospectively reviewed all the patients who underwent new continuous-flow (C-F) LVAD implantation between January 1, 2013, and December 31, 2014, at the University of Nebraska Medical Center. Patients were followed until heart transplant, LVAD explantation, death, or December 31, 2017. We defined LVAD infections as per the International Society of Heart and Lung Transplantation (ISHLT) definition: VAD-specific, VAD-related, and non-VAD infections. The primary outcome was to calculate the incidence of LVAD infections per 1000 days of LVAD support. Secondary outcomes were to assess the cause of death and the effect of bloodstream infections on LVAD thrombosis, stroke, and death. During the study period, a total of 94 patients underwent a C-F LVAD implantation. Five patients were lost in follow-up; 89 patients were included in the study. The mean age at LVAD implantation was 54 (SD+15) years. Out of 89 patients, 67 (75%) were men, and 53/89 (71%) received LVAD as destination therapy (DT). At the time of LVAD implantation,34/89 (38%) patients had ITERMACS (interagency registry for mechanically assisted circulatory support)score 1 (cardiogenic shock). The median duration of LVAD support was 387+493 days, with an interquartile range of 140 to 1083 days. The incidence rate of infections post-LVAD implantation decreased from 3.2 /1000 LVAD days (95% confidence interval [CI] 2.54-4.03) during the first year of LVAD support to 0.78/1000 LVAD days (95% CI, 0.38-1.65) during the following third year of LVAD support. Similarly, the incidence of VAD-specific infections in the first year post-LVAD implantation versus the third-year post LVAD implantation decreased from 0.83/1000 LVAD days (95% CI, 0.53-1.30) to 0.33/1000 LVAD days (95% CI, 0.10-1.04). On univariate survival analysis, an increased risk of death was associated with a one-year increase in age at LVAD implantation (hazard ratio (HR) 1.05 (95% CI, 1.01-1.09), p=0.01), the presence of infection within 30 days before LVAD implantation (HR 2.44 (95% CI, 1.09-5.48), p=0.03), underlying ischemic cardiomyopathy (HR 2.96 (95% CI, 1.28-6.80), p=0.01), and lower ITERMACS profile HR 3.64 (95% CI, 1.09-12.13, p=0.04). Bloodstream infections (BSIs) were not associated with an increased risk of death (HR 1.63 (95% CI, 0.56-4.80, p=0.37). Univariate survival analysis for poor outcomes (LVAD thrombosis, stroke, or death) showed BSIs increased the risk of having a poor outcome (HR 2.39 (95% CI, 1.02-5.57), p=0.04). The incidence rate of post-LVAD infections decreased significantly over time. LVAD implantation may not be contributing to immune suppression as previously suggested. In our study, BSIs were found to have a significantly increased hazard ratio for a poor outcome post-LVAD implantation.

A multicentric observational study of patients affected by advanced heart failure with implantable cardioverter defibrillator and left ventricular assist devices

Abstract Funding Acknowledgements Type of funding sources: None. Background Left ventricular assist device (LVAD) implantation is increasingly used in patients with end-stage heart failure. Most patients already have an implantable defibrillator (ICD) at the time of L-VAD implantation. Studies on this patient population are limited by the small sample size and the short duration of follow-up. Purpose The aim of this study was to retrospectively describe the real-world management of patients implanted with both ICD and LVAD. The main objective was to evaluate the incidence and predictors of appropriate and inappropriate therapies of the ICD and the incidence and predictors of ICD related complications. Methods 212 patients were enrolled in four Centers in the period between July 2006 and November 2020. The inclusion criteria were age> 18 years, advanced heart failure, patients with ICD and concomitant or subsequent continuous flow LVAD implantation. ICD therapy was defined as antitachycardia pacing therapy or shock. The data available at the last visit with a median follow up of 21 months were analyzed. Outcome predictors were assessed by univariate logistic regression and the variables of interest included in a multivariate model. Results The rate of appropriate ICD therapies was 29.7%, while the incidence of inappropriate therapies was 10.4%; in the multivariate analysis the presence of a zone therapy with low detection rate (VT zone with median detection rate of 164.5 bpm) was found to be an independent predictor of the composite of appropriate and inappropriate therapies (OR = 19.05; CI = 2.19-165.21; p = 0.007). Interference between ICD and LVAD occurred in 7.5% of cases; the incidence of infectious complications related to the ICD was 7.1% and bleeding complications of 5.2%; in the multivariate analysis, ICD generator replacement was an independent predictor of total complications related to the ICD (interference, infectious and bleeding; OR = 4.45; IC = 1.60-12.36; p = 0.004). 103 patients had CRT defibrillator (48,6%). At follow up there was no statistically significant difference in the incidence of appropriate therapies between those who had CRT-on (n=74) and those who had CRT-off (n=29; p = 0.61). Conclusions Patients with LVAD implanted with an ICD experience a high rate of appropriate and inappropriate ICD therapies. An active VT zone at low heart rate was found to be an independent predictor of ICD therapies. Of more, ICD generator replacement was found to be an independent predictor of total complications related to the ICD. Our findings suggest the importance of tailoring device programming in order to minimize the incidence of ICD therapies, thus sparing the need for generator replacement in this population.

Surgical Specialization and Standardization of Care Improves Outcomes in Mechanical Circulatory Support: A Single Center Experience

<h3>Purpose</h3> Cardiac surgery continues to transform into areas of sub-specialization and expertise to reduce variability and have superior outcomes. We sought to analyze the impact of surgical sub-specialization and use of protocol and clinical pathways on outcomes with MCS at the time of LVAD implantation. <h3>Methods</h3> A single center retrospective analysis of long term durable MCS patients between 2004-2019 was performed. The analysis was conducted comparing management of patients before (Era 1: 2004-2011) vs. after (Era 2: 2012-2019) based on before and after introduction of MCS sub-specialization. Since 2012, multiple initiatives were introduced namely recruitment of specialized MCS/transplant surgeons, multidisciplinary team rounds, establishment of a shock team, development of clinical care pathways, electronic medical record order sets and clinical practice guidelines. <h3>Results</h3> A total of 542 patients were included. During Era 1, five cardiac surgeons implanted LVADs in 123 patients, while in Era 2, two MCS/transplant trained surgeons implanted LVADs in 419 patients. Era 2 included higher number of INTERMACS 1 and 2 profile patients (41% vs. 63%) reflecting higher-acuity patient population. With implementation of the sub-specialization services, 1-year survival improved from 70% to 90%. Median ICU stay decreased from 13 to 8 days and percent of patients discharged to home increased from 62% to 95%. Standardized protocols for management of high LDH, GI bleeding, and blood pressure management resulted in significant reduction in overall hospital length of stay. With introduction of clinical care pathways, the average time for workup from admission to LVAD implant decreased from 27.6 days to 8.5 days. <h3>Conclusion</h3> Introduction of surgical sub-specialization and standardization of care with the use of clinical pathways and protocols in managing patients with LVADs can help improve survival, reduce variability in medical care, and reduce ICU length of stay.

Does Open Chest After LVAD Surgery Affect Blood Transfusion Rates and PRA

<h3>Purpose</h3> Patients undergoing LVAD placement may experience right ventricular failure (RVF). Treatment strategies for RVF include medications, mechanical support, and inhaled agents. Some centers leave the chest open for first 24 to 48 hrs as a strategy to treat RVF. Open chest however has potential to increase blood transfusion rates. The aim of this study was to understand if open chest after LVAD affects blood transfusion rates and PRA levels at 3 months post implant. <h3>Methods</h3> Patients undergoing primary sternotomy with LVAD implantation between January 2017 and December 2020 were included in the study. 66 patients met those criteria. 45 patients had open chest and 21 had chest closed at the time of LVAD implantation. The Wilcoxon signed-rank test was utilized to find any deference in any blood product utilization and PRA pre and post implant. <h3>Results</h3> Patient baseline characteristics were similar between the two groups. Both groups had similar coagulation parameters, MELD scores and pre implant PRA. The overall amount of blood product utilization perioperatively was similar in the two groups. There was also no difference in PRA pre and post LVAD implant. 2 (4.4%) patients in the open chest group required RVAD implantation whereas 1(4.7%) patient in the closed chest group needed RVAD placement. There was no incidence of mediastinal infection or sternal infections in either of the two groups. <h3>Conclusion</h3> Open chest can be used as an effective treatment option for RVF and does not increase blood transfusion rates or elevated PRA post LVAD at 3 months. Bigger and multicenter studies are needed to better understand the effects of peri-operative blood transfusion on the PRA.

An Integrative Study of Aortic mRNA/miRNA Longitudinal Changes in Long-Term LVAD Support.

Studying the long-term impact of continuous-flow left ventricular assist device (CF-LVAD) offers an opportunity for a complex understanding of the pathophysiology of vascular changes in aortic tissue in response to a nonphysiological blood flow pattern. Our study aimed to analyze aortic mRNA/miRNA expression changes in response to long-term LVAD support. Paired aortic samples obtained at the time of LVAD implantation and at the time of heart transplantation were examined for mRNA/miRNA profiling. The number of differentially expressed genes (Pcorr < 0.05) shared between samples before and after LVAD support was 277. The whole miRNome profile revealed 69 differentially expressed miRNAs (Pcorr < 0.05). Gene ontology (GO) analysis identified that LVAD predominantly influenced genes involved in the extracellular matrix and collagen fibril organization. Integrated mRNA/miRNA analysis revealed that potential targets of miRNAs dysregulated in explanted samples are mainly involved in GO biological process terms related to dendritic spine organization, neuron projection organization, and cell junction assembly and organization. We found differentially expressed genes participating in vascular tissue engineering as a consequence of LVAD duration. Changes in aortic miRNA levels demonstrated an effect on molecular processes involved in angiogenesis.

Exercise capacity in patients implanted with left ventricular assist devices for end-stage heart failure treatment

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Left ventricular assist device (LVAD) is an expanding therapy in end-stage heart failure today. Although LVAD therapy bears the potential to normalize cardiac output, a majority of patients show a severely impaired physical condition at the time of LVAD implantation. To date, no validated standardized training protocol is available, and established practices to effectively improve LVAD patients’ exercise tolerance is lacking. This study sought to investigate exercise capacity quantified by cardiopulmonary exercise testing (CPX) and a standardized six-minute walk test (6MWT) in patients after LVAD implantation. Methods We enrolled 30 end-stage heart failure patients who had received an LVAD implantation 20.7 ± 7.6 days prior to examination, mean age 54.9 ± 7.8 years, 26 males (87 %). Exercise tolerance was assessed using cardiopulmonary exercise testing (CPX) for maximal and submaximal exercise capacity, followed by a standardized (6MWT). Results Patients showed peak oxygen uptake values of 8.3 ± 2.4 ml/min/kg at a mean workload of 46.7 ± 11.3 watts and a mean anaerobic threshold of 6.7 ± 1.7 ml/min/kg at a workload of 32.6 ± 6.9 watts. Mean standardized 6-minute walking distance was at 183.8 ± 71.4 meters. There were no adverse events during exercise testing. Conclusions Cardiopulmonary exercise testing (CPX) and standardized 6MWT show severely impaired cardiopulmonary exercise capacity in patients after LVAD implantation, warranting further studies for dedicated training protocols, specifically focusing on LVAD patients to improve exercise tolerance at an acceptable safety profile.

A Simplified Temporary Right Ventricular Assist Device (RVAD) during LVAD Implantation - Low Risk, Easy to Do and Ideal for Patient Rehabilitation

Purpose Management of RV failure at the time of LVAD implantation is often difficult, and institution of emergency RVAD support leads to poor outcomes in these patients. We want to share our experience of a simplified, less traumatic temporary surgical RVAD support during LVAD implant, which allows safe post-operative care and rehabilitation, as well as allow an easy removal under local anaesthetic (LA). Methods Between 2012-2020, we identified 178 patients undergoing LVAD implantation in our unit. In 41 patients (23%), temporary RVAD support was needed due to failure to wean from CPB. Patients who required delayed RVAD support were excluded (n=12). The RVAD implant consisted of a 8 mm outflow graft onto the main pulmonary artery, and tunnelled via the left chest. The venous inflow via the sapheno-femoral junction. This technique allowed safe mobilization of the patient during their post-operative rehabilitation. The decannulation is performed under LA without resternotomy. Results A total of 29 patients were included in this study. There were 23 males and 6 females with a mean age of 51.1 years (range 12-68). Pre-operative diagnosis was DCM in 17 (58.6%), ICM in 8 (27.6%), giant cell myocarditis in 2 (6.9%) and others in 4 (13.7%). The median INTERMACS class was 2. 22/29 patients (75.8%) were successfully weaned from RVAD support. In those that failed to wean, five (17.2%) were transplanted super-urgently while another two patients (6.9%) died of multi-organ failure. Median RVAD support was 7 days (range 3-28). Post-operative complications occurred in 20/29 patients (68.9%). Bleeding/tamponade occured in 11/29 (37.9%) - six patients required re-exploration. One patient (3.4%) had bleeding from the PA graft - he was reopened after his RVAD was weaned off. RVAD support was reinstituted for a further 13 days. Median ICU LOS was 12 days (range 5-33) and median hospital LOS was 40 days (range 5-149). 25/29 patients (86.2%) were discharged home and the 30-day survival was 89.6%. Conclusion Our simplified temporary RVAD technique is a safe and less invasive surgical approach to allow for successful LVAD implant in patients with severe RV failure. This allows significant improvement in perioperative management including rehabilitation on ICU. The rate of complications is low and the explant procedure easy with minimal trauma.

Higher Body Mass Index is Associated with End Stage Renal Failure after Left Ventricular Assist Device Implantation

Elevated body mass index (BMI) is a well-established risk factor for post-operative adverse events. We hypothesized that patients with higher BMI are more likely to develop end stage renal failure (ESRD) after LVAD implantation, a complication regarded as a strong negative prognostic marker for survival. A single center continuous flow LVAD cohort (n=456) was queried for BMI at the time of LVAD implantation. To determine the relationship between BMI and the probability of ESRD, a multivariable Cox regression analysis was performed. Patients were stratified into 3 groups by BMI (<25, 25-30, >30 kg/m2) for analysis. The mean age of the cohort was 57±14 years. 80% were male, 54% had ischemic cardiomyopathy, 57% were designated as bridge to transplant and the median pre-implant creatinine was 1.2. The median follow-up time on LVAD support was 1.3 years. 25 of the 456 patients in our cohort (5.5%) developed ESRD. BMI >30 kg/m2 was associated with a significantly increased risk for renal failure (adjusted HR: 6.5, CI: 1.4-29.4; p=0.015). While there was a trend, the risk for the intermediate BMI group did not reach statistical significance (p=0.079) when compared to BMI<25 kg/m2. The model was adjusted for age, sex, INTERMACS profile, bridge to transplant status and pre-implant renal function. BMI above 30 kg/m2 at the time of LVAD implantation was associated with a significantly increased post-operative risk for renal failure in our cohort. Further studies are warranted to determine the pathophysiology and to develop strategies to mitigate this risk.

Predictors of Late Tricuspid Regurgitation in Patients with Left Ventricular Assist Devices

Moderate and severe tricuspid regurgitation (TR) at the time of LVAD-Implantation is associated with poor survival. Therefore the benefit of Tricuspid repair at the time of LVAD implantation is subject of intensive discussion. The aim of this study was to evaluate predictors of moderate to severe and severe TR (ms-sTR) 6 months after Implantation. All patients that were able to present at our center 6 months after LVAD-Implantation underwent clinical assessment and echocardiography. We divided patients in two groups regarding postoperative TR (no to moderate TR vs. ms-sTR) and retrospectively analyzed preoperative-, operative data and the results of the 6 months follow up. 121 adult patients underwent LVAD-Implantation between 3/2018 and 2/2019. 51% were classified as INTERMACS profile 1 or 2. 31 patients died during first 6 months. Patients who were lost in follow up (n=4), with congenital heart disease (n=2) and patients who underwent Tricuspid repair (n=4) were excluded. Therefore 80 patients presented between 6.24 months (IQR: [5.8, 7.1]) supported with HeartWare HVAD 79 (n=63), HeartMate 3 (n=17). The patients were 56±11 years old, 68 were male, 12 female. 32 had dilative cardiomyopathy, 42 had ischemic cardiomyopathy, 6 other causes. All received optimal medical therapy (27 ACE-Inhibitor or angiogensine II receptor blockers, 51 Sacubitril-Valsartan, 69 aldosterone antagonist, 67 beta blockers). 10 patients showed late ms-sTR while 70 had no to moderate TR. There was no significant difference in preoperative clinical parameters (age, Body mass index, duration of heart failure, INTERMACS level, atrial fibrillation, implantable cardiovascular electric device) between the groups. There was also no significant difference in preoperative echocardiographic parameters (grade of TR, grade of mitral regurgitation, left ventricular enddiastolic diameter, left ventricular ejection fraction, right ventricular diameters, right ventricular ejection fraction, TAPSE, TK annulus diameter, systolic pulmonary artery pressure) between the two groups. 15 patients with preoperative ms-sTR showed spontaneous improvement and 7 patients with preoperative mild or moderate TR developed ms-sTR after six months. Late TR after LVAD-implantation may develop independent from preoperative right ventricular function and preoperative TR.

Clinical Implications of Concomitant Surgical Intervention for Aortic Insufficiency with Left Ventricular Assist Device Implantation

Aortic insufficiency (AI) is a common problem in advanced heart failure and progression after left ventricular assist device implantation is well described. Patterns of care for AVP at the time of LVAD implantation and the associated outcomes remain poorly described. We included all patients in the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who received a continuous-flow LVADs and at least mild AI from 2008 to 2017. AI was stratified by mild, moderate, or severe disease. Patients undergoing any AVP were compared to those of identical severity without intervention. Descriptive, Cox regression, and Kaplan-Meier analysis were performed to identify associations between intervention and clinical outcomes. Of 6,492 patients identified with any degree of AI, 5,457 (84.1%) had mild, 814 (12.5%) had moderate, and 221 (3.4%) had severe insufficiency. AVP rate increased with AI severity, from 3.7% of mild to 55.2% of severe insufficiency. AVP was not associated with a survival difference for moderate or severe AI. In mild AI, AVP was associated with decreased survival compared to mild without AVP (median 57.8 vs 58.9 months, log-rank test: P=0.0089, Hazard Ratio 1.5 [95% confidence, 1.1-2.2]). AVP was not associated with decreased adverse event rates, nor was AVP associated with improved quality of life metrics at 24 months follow-up for any degree of AI severity. AVP at time of LVAD implantation was not associated with improved survival for end-stage heart failure patients with mild, moderate, or severe AI and was not associated with improved quality of life. Additional evidence to define a role for AVP among patients receiving LVAD is needed.

Advanced Kidney Disease in the Left Ventricular Assist Device Population: Impact on Disease Progression, Morbidity and Mortality

Purpose Advanced kidney disease is often considered a relative contraindication to LVAD implantation and many implanting centers view stage 4 and 5 chronic kidney disease (CKD) as an absolute contraindication. We sought to analyze the impact of CKD at the time of LVAD implant on outcomes. Methods All LVAD patients between September 2007 and September 2017 with CKD at the time of LVAD implantation from a single institution were analyzed. Patients were stratified by CKD stage (CKD 1 through 5) at the time of implant and rates of worsening renal function, need for renal replacement therapy (RRT), hospitalizations, LVAD-related complications and death were analyzed. Results Of the 405 total patients, 191 patients (59% centrifugal, 80% male, average age 59 ± 11 years) had varying degrees of renal dysfunction at the time of LVAD implantation (17% CKD 1 or 2, 35% CKD 3a, 34% CKD 3b and 15% CKD 4 or 5). Patients with CKD 4 or 5 were more likely to require RRT than lesser CKD Stages 3b, 3a, and 1 or 2 (37.9% vs. 3.1%, vs. 7.6% vs. 0%, p trend Conclusion Patients with advanced CKD at the time of LVAD implant were more likely to have persistent renal dysfunction and require RRT thereafter. However, there were no statistically significantly differences in LVAD-related morbidity and mortality across the stages of CKD.

Resolution of Right Atrial Congestion before LVAD Implantation is Associated with Improved Outcomes

Purpose Increased right atrial pressure is known to be a predictor of poor outcomes after LVAD implantation. Whether resolution of right heart congestion prior to LVAD implantation is associated with more favorable outcomes is not well understood. Methods We analyzed LVAD recipients from our institution from 1/1/2015 to 2/28/2018. We excluded patients bridged to LVAD with ECMO support. Patients with admission right atrial pressure (RAPadmit) and implant RAP (RAPimplant) ≥ 14 mmHg were defined as having persistent congestion, while patients with RAPadmit ≥ 14 mmHg and RAPimplant unpaired t-tests . Time to death or RVAD was compared between groups using Cox proportional hazards models . Results Of 57 LVAD recipients with RAPadmit ≥ 14 mmHg, 14 (25%) had persistent congestion at the time of LVAD implantation. While there were no statistically significant differences between groups, patients with persistent congestion were more likely to be INTERMACS profile 1 (21.4% vs 9.5%), less likely to have a destination therapy device strategy (28.6% vs 34.9%), less likely to have moderate or severe right ventricular (RV) dysfunction (64.3% vs 83.7%), and had similar RAPadmit (20.4 mmHg vs 18.9 mmHg) compared to patients with resolved congestion. Median follow up was 307 days. Patients with persistent congestion had a higher frequency of death or RVAD implantation compared to those with resolved congestion (50% vs 14%, HR 3.75, 95% CI 1.25-11.25, p=0.02, Figure). Conclusion Among patients with elevated RAP at admission, patients with persistently elevated RAP at the time of LVAD implantation had worse outcomes than patients who were able to be decongested prior to surgery. These data support optimization of RV filling pressures prior to LVAD surgery.

Argatroban Bridging in the Immediate Post-Operative Period in Recipients of Durable Left Ventricular Assist Devices

Purpose In recipients of durable LVADs, the development of heparin induced thrombocytopenia threatens the integrity of the pump circuit and thus the life of the patient. In hospitalized HF patients, the exposure to heparin is frequent and often prolonged. We set out to change our immediate bridging protocol post-LVAD to decrease heparin exposure and evaluate the bleeding and thromboembolic consequences of these 2 different bridging strategies. Methods This is a single center retrospective study of consecutive patients implanted with a durable LVAD. Heparin (HEP) bridging was utilized in patients from Jan 2016 to June 2017 (n=30) and argatroban (ARG) bridging was utilized in patients from July 2017 through June 2018. Patients that received an RVAD at time of LVAD implantation were excluded from the analysis. Patients were started on intravenous anticoagulation the morning of POD#1 and were titrated to goal (heparin anti-factor Xa levels 0.3 to 0.5; argatroban PTT 50-70 s.) Aspirin and warfarin were also initiated on POD#1. Events were tracked 6 months post-implant. Results Device selection between the two groups was different with the following breakdown; HEP group with 27 HM2 and 3 HVADs compared to the ARG group with 11 HM2, 15 HVADs and 3 HM3. The need to return to the OR from bleeding was lower in the ARG group (6.4% vs 23.3%, p=0.27). The mean number of red blood cell transfusions was statistically lower in the ARG group (1.5 vs 2.7 units, p=0.02). There was no difference observed between the platelet counts on POD#3 or POD#7. A nonsignificant reduction in major hemolysis between the two groups was noted (HEP 20.0% vs ARG 3.2%, p=0.10). There was 1 patient with pump thrombosis in the ARG group compared to 2 patients in the HEP group. A nonsignificant increase in strokes was observed in the ARG group (overall 25.8% - 19.3% ischemic stroke; 6.5% hemorrhagic stroke) compared to the HEP group (overall 16.6% - 13.3% ischemic; 3.3 hemorrhagic stroke; p=0.58) Conclusion Argatroban bridging in the immediate post-operative period is safe in recipients of durable LVADs. There were fewer bleeding events in the ARG bridged group. Though not meeting statistical significance, there were numerically more episodes of major hemolysis and pump thrombosis in the HEP group which contrasted with more stroke events in the ARG group.

What Happens to Right Ventricular Strain and Function Following Tricuspid Valve Repair in Patients Undergoing Implantation of a Left Ventricular Assist Device?

Purpose Pre- and post-operative RV function were analyzed by echocardiography, including RV longitudinal strain in 80 patients with moderate or higher pre-implant TR to evaluate the impact of concomitant tricuspid valve repair during LVAD implantation on post-operative RV function. Methods Between 2008 and 2017, 100 patients with moderate (Mod), moderate-severe (M/S), or severe (Sev) TR underwent LVAD implantation at our institution. Forty-four (44) patients had concomitant TV repair (TVR) and 56 did not have TV repair (No-TVR). Preoperative and postoperative clinical, echocardiographic and hemodynamic parameters were recorded in 80 of the patients and included right ventricular (RV) freewall longitudinal strain (FLS) and RV Fractional Area Change (FAC) calculated retrospectively using speckle-tracking echocardiography. Results Preoperatively, 41% of patients in the TVR group and 77% in the No-TVR group had Mod TR (p Conclusion RV strain analysis tracks hemodynamic and echocardiographic parameters and does not add to the assessment of RV function in patients undergoing LVAD implantation with or without TVR. Repairing moderate TV regurgitation at the time of LVAD implantation is not associated with improved outcomes and emphasizes the need for a definitive prospective trial.

Presence of Left Atrial or Left Ventricular Thrombus at the Time of CF-LVAD Implantation is Associated with Increased Post-Operative Risk of Stroke or Death

Purpose Patients with advanced HF are at increased risk for intra-cardiac thrombus formation. The impact of pre-existing left atrial (LA) or left ventricular (LV) thrombi on post-operative outcomes in LVAD patients is unknown. Methods We retrospectively reviewed 376 patients who underwent HeartMate II LVAD implantation from February 2009 through August 2018 at a single large volume center. Transthoracic echocardiography (TTE) within 1 month of implant, intra-operative transesophageal echocardiography (TEE), and operative reports were reviewed to identify patients with pre-existing LA (including appendage) or LV thrombus at the time of LVAD implantation. We assessed the composite endpoint of stroke and death at 6 months and 2 years. Results Of the 376 patients (age 57±13 years, 81% male, 47% ICM), 26 (6.9%) had a pre-existing thrombus (13 in LA and 15 in LV). Incidence of stroke at 6 months was 23% in patients with intracardiac thrombi and 9% in patients without intracardiac thrombi (p=0.02). Incidence of stroke at 2 years was 23% in patients with intracardiac thrombi and 14% in patients without intracardiac thrombi (p=0.22). Notably all strokes occurred in the first 6 months of device support in patients with intra-cardiac thrombi. Patients were significantly more likely to die or have a stroke in the first 6 months of device support if they had pre-existing intracardiac thrombi (HR (95%CI): 2.7 (1.4, 5.2), p Conclusion Pre-existing LA or LV thrombus is associated with decreased survival free of stroke following CF-LVAD implantation which may have important implications for patient selection and management.

3154 Resolution of right atrial congestion before LVAD implantation is associated with improved outcomes

OBJECTIVES/SPECIFIC AIMS: Increased right atrial pressure is known to be a predictor of poor outcomes after LVAD implantation. Whether resolution of right heart congestion prior to LVAD implantation is associated with more favorable outcomes is not well understood. METHODS/STUDY POPULATION: We analyzed LVAD recipients from our institution from 1/1/2015 to 2/28/2018. We excluded patients bridged to LVAD with ECMO support. Patients with admission right atrial pressure (RAPadmit) and implant RAP (RAPimplant) ≥ 14 mmHg were defined as having persistent congestion, while patients with RAPadmit ≥ 14 mmHg and RAPimplant &lt; 14 mmHg were defined as having resolved congestion. Baseline characteristics between groups were compared using the Chi-square and unpaired t-tests. Time to death or RVAD was compared between groups using Cox proportional hazards models. RESULTS/ANTICIPATED RESULTS: Of 57 LVAD recipients with RAPadmit ≥ 14 mmHg, 14 (25%) had persistent congestion at the time of LVAD implantation. While there were no statistically significant differences between groups, patients with persistent congestion were more likely to be INTERMACS profile 1 (21.4% vs 9.5%), less likely to have a destination therapy device strategy (28.6% vs 34.9%), less likely to have moderate or severe right ventricular (RV) dysfunction (64.3% vs 83.7%), and had similar RAPadmit (20.4 mmHg vs 18.9 mmHg) compared to patients with resolved congestion. Median follow up was 307 days. Patients with persistent congestion had a higher frequency of death or RVAD implantation compared to those with resolved congestion (50% vs 14%, HR 3.75, 95% CI 1.25–11.25, p=0.02). DISCUSSION/SIGNIFICANCE OF IMPACT: Among patients with elevated RAP at admission, patients with persistently elevated RAP at the time of LVAD implantation had worse outcomes than patients who were able to be decongested prior to surgery. These data support optimization of RV filling pressures prior to LVAD surgery.

OC56 OUTCOMES IN VAD-PATIENTS: A SINGLE CENTER EXPERIENCE

Abstract Objectives: we report our single-center experience with implantable ventricular assist devices. Methods: From March 2005 to December 2017, 89 consecutive patients underwent implantation of long-term ventricular assist devices (VADs). The mean age was 53.8 ± 10.3 with a clear prevalence of females (92.4%). Ischemic cardiomiopathy was the main etiological diagnosis (51.7%) and bridge to transplant represented the major indication to implant. The mean INTERMACS level was 2.4 ± 1. We implanted n = 3 Heartmate I XVE (3.4%), n = 51 Heartmate II (57.3%), n = 8 Heartware HVAD (9%), n = 3 HVAD as BIVAD (3.4%) and n = 24 Heartmate 3 (26.9%). Results: the overall in-hospital mortality was 13.5% (12 patients). Twelve patients (14.0%) needed temporary RVAD (Centrimag Levitronix) at the time of LVAD implantation. The mean VAD support time was 16.9 ± 14.0 months in group of patients who received transplantation (n = 35) and 16.4 ± 16.2 in group with no following transplantation (n = 54). The most common adverse events were driveline exit site or VAD infection (18%), gastrointestinal bleeding (9.1%), stroke (10.4%), late RVF requiring re-hospitalization (5.2%). Device malfunction (pump thrombosis or other) was observed in 9.1% (n = 7) of patients. The overall survival in VADs patient were 78.3%, 63.8% and 53.9% at 12, 24 and 72 months, respectively. Conclusion: our analysis on a single-center cohort of patients confirms utility and relative safety of VAD-therapy in advanced heart failure.

Pathological Correlation Between Apical Core Biopsies at the Time of Left Ventricular Assist Device Implantation and Excised Heart at Time of Transplant or Autopsy

The diagnostic yield of endomyocardial biopsy is low, a possible explanation is the small sample size. At the time of LVAD implantation, core tissue biopsies may prove to be useful but some reports suggest pathological findings are non-specific. In this study, we aim to compare core biopsy findings at the time of LVAD implantation with those of the explanted heart at the time of heart transplantation (HT) or autopsy

(195) - Impact of Evaluation of Left Ventricular Apical Core Pathology Obtained at Time of LVAD Implantation

(195) - Impact of Evaluation of Left Ventricular Apical Core Pathology Obtained at Time of LVAD Implantation