Pump Exchange Research Articles

Pump Exchange for Major Device Related Infection in Patients Receiving a Durable Left Ventricular Assist Device

BackgroundDevice-related infection (DRI) remains a cause of morbidity and mortality following durable left ventricular assist device (dLVAD) implantation. We evaluated outcomes following pump exchange (PE) for DRI following dLVAD implantation. MethodsForty-nine patients underwent PE between 1/2007 and 12/2022 for major DRI. Outcomes included survival, incidence of subsequent DRI, and proportion of patients achieving success (freedom from DRI at 1-year following PE). ResultsMedian age was 49 years. Median time from primary implant to DRI diagnosis and from diagnosis to PE was 26 and 4.1 months, respectively. Median time to DRI recurrence was 5.8 months with 76% of patients achieving success. Success was obtained in 23/24 (96%) of patients whose time to PE from DRI diagnosis was ≤ 4 months and 14/25 (56%) if time > 4 months. ConclusionMost patients achieve success following PE for DRI. The risk of subsequent DRI and mortality remains high. Early (≤ 4 months) PE following DRI diagnosis increases the likelihood of success, while reducing the rate of subsequent DRI.

Outflow Graft Tamponade: An Underrecognized Cause of Obstruction

BackgroundLeft ventricular assist device (LVAD) outflow graft obstruction can result in severe clinical deterioration. Underlying mechanisms may vary depending on the location. Outflow graft tamponade due to external compression can be under recognized. Management of this complication varies across institutions and a uniform approach has yet to be elucidated. ObjectivesReport a single center experience with outflow graft tamponade in patients with LVAD with the purpose of developing an optimal algorithm for the diagnosis and treatment of LVAD-related outflow graft tamponade. Methods and ResultsRetrospective chart review between July 2011 and July 2020. A total of 351 LVADs were implanted at our center, with outflow graft tamponade identified in 26 patients with LVAD. Fourteen (53.8%) had HeartMate II™, 8 (30.8%) had HeartMate3™ and 4 (15.4%) had HeartWare™. Individuals presented with heart failure symptoms, an audible precordial murmur and LVAD alarms after a median duration of 862 days of support (IQR 327 - 1455). Of the 26 patients, 15 (57.7%) underwent mini thoracotomy with outflow graft relief, 4 had percutaneous balloon dilatation and stenting, 2 were bridged directly to transplant and 1 had a pump exchange. No intervention was made on the remaining due to mild symptoms (n=4). ConclusionsOutflow graft tamponade is a form outflow graft obstruction with a variable presentation that can result in significant hemodynamic compromise. It is amenable to both surgical and percutaneous interventions that restore LVAD function.

(951) - Effectiveness of Pump Exchange for Major Device Related Infection in Patients Receiving a Durable Left Ventricular Assist Device

(951) - Effectiveness of Pump Exchange for Major Device Related Infection in Patients Receiving a Durable Left Ventricular Assist Device

Remimazolam and Remifentanil Anesthetics for an Adolescent Patient with Stiff-Person Syndrome: A Case Report.

Stiff-person syndrome (SPS) is a rare autoimmune disease characterized by fluctuating rigidity and stiffness of the axial muscles. There are no reports on the use of remimazolam in a patient with SPS. A 16-year-old Japanese woman with SPS was scheduled to undergo intrathecal baclofen pump exchange. General anesthesia was induced and maintained using remimazolam, remifentanil, and intermittent rocuronium bromide. No intraoperative mobility or significant autonomic symptoms were observed. Additionally, electroencephalographic signature showed sufficient anesthetic depth. The patient's emergence from general anesthesia was uneventful. In conclusion, remimazolam could be considered an effective anesthetic drug for patients with SPS.

Repeat left ventricular-assisted device exchange and upgrade from second- to third-generation devices in a high-volume single center.

Pump exchange is an established strategy to treat LVAD-related complications such as thrombosis, infection, and driveline failure. Pump upgrades with an exchange to newer generation devices are being performed to the advantage of the patient on long-term support. The safety and efficacy of a repeat LVAD exchange with a concomitant upgrade to a third-generation pump have not been reported. We performed a retrospective analysis of all consecutive patients who underwent a repeat LVAD device exchange and upgrade to HeartMate III (HMIII) at Houston Methodist Hospital between December 2018 and December 2020. Five patients underwent exchange and upgrade to HMIII within the specified timeframe. Four patients had already had two prior exchanges (all HMII to HMII), and one patient had one prior exchange (HVAD to HVAD). In all cases, implantation was performed as destination therapy. The surgical exchange was performed via redo median sternotomy on full cardiopulmonary bypass. No unplanned redo surgery of the device component was required. In-hospital mortality was 20% in this very high-risk population. At 1-, 3-, and 6-month follow-up, all discharged patients were on HMIII support, with no major LVAD-related adverse events reported. We report the feasibility and safety of a repeat pump exchange with an upgrade to HMIII in a high-volume center. The decision for medical therapy versus surgical exchange has to be tailored to individual cases based on risk factors and clinical stability but in expert hands, even a re-redo surgical approach grants options for good medium-term outcomes.

Thromboembolic complications following implantation of durable left-ventricular assist devices.

As the utilization of left-ventricular assist devices (LVADs) continues to rise and patients experience extended survival duration with these devices, the overall incidence of adverse events and complications has shown anotable increase. Among the major adverse events, thromboembolic complications are particularly significant. The aim of this study is to present our experience and assess the risk of thromboembolic complications after implantation of durable continuous-flow left-ventricular assist devices (CF-LVAD) in patients with end-stage heart failure. From 2007 to 2022, 169 left ventricular continuous-flow durable mechanical assist devices were implanted at our institute. Three types of devices were employed: HeartMate II (n = 54, 32%), HeartMate 3 (n = 70, 41.4%), and Heart Ware (n = 45, 26.6%). The data were extracted from the EUROMACS register. Thromboembolic complication, pump thrombosis was observed in 11/169 patients (6.5%), with 2patients experiencing stroke after embolism to the central nervous system. Among these cases, 10 patients (90.9%) were equipped with the Heart Ware device while 1 patient (9.1%) had the Heart Mate II device implanted. Nine patients received the durable device as abridge to transplant therapy and two as abridge to candidacy. The overall mean age of the patients was 47.6±10.2 years, with 2 women and 10 men. The pump thrombosis was managed through thrombolytic therapy, high-intensity heparin anticoagulation protocol, pump exchange, pump explantation, and early heart transplant. The combined hospital and long-term mortality rate was 4/11 patients (36.4%). Based on our experience, thromboembolic complications presenting primarily as pump thromboses, were arelatively common phenomenon experienced in association with the second-generation continuous-flow devices, but rarely seen with the third-generation devices. Thrombolysis followed by early heart transplantation proved to be asafe treatment option (Tab. 1, Ref. 14). Text in PDF www.elis.sk Keywords: durable mechanical assist device, durable left ventricular assist devices, outcomes, thromboembolic complications.

Fully magnetically centrifugal left ventricular assist device and long-term outcomes: the ELEVATE registry.

HeartMate 3 (HM3) is a fully magnetically levitated continuous flow left ventricular assist device, which received CE marking in 2015. The ELEVATE Registry was initiated to collect real-world outcomes in patients treated with HM3 post-CE Mark approval. A total of 540 subjects implanted at 26 centres between March 2015 and February 2017 were included in this registry. Of these, 463 received the device as a primary implant (primary implant cohort, PIC), 19 as a pump exchange (pump exchange cohort), and in 58 patients, only anonymized survival data were collected (anonymized cohort, AC). Patients in the PIC contributed to the baseline demographics, survival, adverse events, quality of life (QoL) (EuroQoL-5 Dimensions-5 Levels visual analogue scale), and functional capacity (6 min walk distance) assessments, while patients in the AC contributed only to survival. Primary implant cohort patients had a mean age of 56 years and were predominantly male (89%) with 48% ischaemic aetiology. The majority of subjects was designated bridge to transplant (66%) and had INTERMACS Profiles 1-3 (70%). At baseline, the subjects had poor functional capacity (104 ± 140 m) and impaired QoL (35 ± 19 points). The overall survival rate of the PIC was 63.3% and survival free of stroke was 58.1% at 5 years. Significant improvements in functional capacity and QoL were observed and maintained for 5 years (301 ± 131 m and 64 ± 20 points, respectively). Real-world data from the ELEVATE registry demonstrate an overall survival rate for primary implants of 63.3%. In the PIC, reductions in adverse events for patients in the extended follow-up and improved QoL and functional capacity were observed at 5 years in this patient population with advanced heart failure.

Evaluation of enoxaparin for bridging of warfarin in outpatients with left ventricular assist devices (LVADs).

Patients with left ventricular assist devices (LVADs) require systemic anticoagulation. The use of enoxaparin for bridging to warfarin remains understudied in this population. This single-center retrospective study was performed to characterize enoxaparin use and associated thrombotic and bleeding outcomes in adult outpatients with LVADs from January 2018 to July 2021. Fifty-four enoxaparin bridging events were evaluated in 49 patients. Most patients with HeartMate II (HM2) and HeartWare (HVAD) devices received enoxaparin dosed 1 mg/kg every 12 h. In patients with HeartMate 3 (HM3) devices, an equal number of patients received 0.5 mg/kg every 12 h and 1 mg/kg every 12 h, with a smaller subset receiving intermediate doses. The median duration of bridging was 6 days (4-8 [IQR]). One major bleeding event required discontinuation of enoxaparin and hospitalization in a patient with an HM3 device. Thrombotic events occurred in four patients with two incidents of pump thrombosis requiring pump exchange and two ischemic strokes. All thrombotic events occurred in patients with HVAD or HM2 devices. These results suggest that enoxaparin bridging in LVAD patients was well-tolerated with low bleeding and thrombotic rates, particularly with the HM3 device.

18F-FDG PET/CT in left ventricular assist device infections: In-depth characterization and clinical implications

BackgroundPrevious retrospective studies suggest a good diagnostic performance of 18F-FDG-PET/CT in left ventricular assist device (LVAD) infections. Our aim was to prospectively evaluate the role of PET/CT in the characterization and impact on clinical management of LVAD infections. Methods40 patients (58[53–62] years) with suspected LVAD infection and 5 controls (69[64–71] years) underwent 18F-FDG-PET/CT. Four LVAD components were evaluated: exit site and subcutaneous driveline (peripheral), pump pocket, and outflow graft. The location with maximal uptake was considered the presumed site of infection. Infection was confirmed by positive culture (exit site or blood) and/or surgical findings. ResultsVisual uptake was present in 40 patients (100%) in the infection group vs 4 (80%) control subjects. For each individual component, presence of uptake was more frequent in the infection than in the control group. The location of maximal uptake was most frequently the pump pocket (48%) in the infection group and the peripheral components (75%) in the control group. SUVmax was higher in the infection than in the control group: SUVmax (average all components):6.9[5.1-8.5] vs 3.8[3.7-4.3], p=0.002; SUVmax (location of maximal uptake):10.6±4.0 vs 5.4±1.9, p=0.01.Pump pocket infections were more frequent in patients with bacteremia than without bacteremia (79% vs 31%, p=0.011). Pseudomonas (32%) and methicillin-susceptible Staphylococcus aureus (29%) were the most frequent pathogens and were associated with pump pocket infections, while Staphylococcus epidermis (11%) was associated with peripheral infections. PET/CT affected the clinical management of 83% of patients with infection, resulting in surgical debridement (8%), pump exchange (13%), and upgrade in the transplant listing status (10%) leading to 8% of urgent transplants. Conclusions18F-FDG-PET/CT enables the diagnosis and characterization of the extent of LVAD infections, which can significantly affect the clinical management of these patients.

Abstract 15424: Phase-to-Phase Short Phenomenon in a Left Ventricular Assist Device: Navigating Through Clinical and Ethical Challenges

Description of Case A 59-year-old male with an axial continuous-flow left ventricular assist device (CF-LVAD) presented asymptomatically after noticing low-flow alarms. He reported extensive external driveline damage that accumulated over one year. The CF-LVAD was connected to an ungrounded cable and the driveline was repaired by the manufacturer. However, low-flow alarms continued. Log files revealed pump stoppages on all modes of power which was compatible with phase-to-phase short phenomenon (PtPSP). The patient was cannulated in case of emergent need for ECMO and upgraded to UNOS status 1 for heart transplant. Because PtPSP was considered unrepairable, the patient underwent emergent cardiac transplantation. Discussion The CF-LVAD driveline consists of three phases, each of which is formed by two electrical wires, connected to six motor stators. PtPSP causes driveline dysfunction due to a loss of insulation between the three phases owing to multiple breaches of the insulator, causing the pump to lose power when the damaged phases come into contact. Pump stoppages are likely and unpredictable even on batteries or an ungrounded cable. Patients may notice alarms associated with low flow, pump speed drops, or pump arrest. PtPSP is unrepairable, and pump exchange or urgent heart transplantation are the only viable treatment options.This case highlights the ethical complexity of the care of patients with advanced heart failure, whereby subjective treatment decisions often translate to objectively different levels of priority on the heart transplantation waiting list without intrinsic measures of disease severity, which may incentivize more aggressive care. Conclusions: CF-LVAD driveline dysfunction due to PtPSP is a clinically asymptomatic ominous scenario often uncovered by pump-controller alarms. Given the high risk of abrupt pump stoppage, a diagnosis of PtPSP necessitates emergent device exchange or explant with an orthotopic heart transplantation.

Abstract 16276: Complex Corynebacterium Case: Management of Recurrent Corynebacterium Bacteremia in a Patient With Cardiac Implanted Electronic Device and Left Ventricular Assist Device

Background Cardiac implantable electronic device (CIED) infections are morbid and costly. Atypical organisms are increasingly recognized as a cause of CIED infections. We present a case of recurrent Corynebacterium striatum bacteremia requiring CIED and left ventricular assist device (LVAD) extraction. Case Presentation A 54-year-old female dialysis patient with diabetes, ischemic cardiomyopathy, primary prevention single chamber transvenous defibrillator (ICD) 8 years prior, and destination LVAD presented with chronic C. striatum driveline site infection and relapsing and remitting bacteremia. Over the prior two years, she suffered from chronic driveline infections requiring wound care, driveline washouts, and antibiotics, although not seen by the electrophysiology (EP) team. After a fourth episode of bacteremia, she underwent ICD extraction and LVAD pump exchange, followed by 6 weeks of vancomycin and 3 months of rifampin. She then remained free of bacteremia for 19 months, though continued to demonstrate evidence of driveline infection despite pump exchange. Ultimately, C. striatum bacteremia recurred. Given unrelenting soft tissue infection and recurrent bacteremia, redo LVAD exchange was deferred and she was treated with lifelong suppressive antibiotics. Discussion Corynebacterium species have historically been considered skin flora, but more recently have been identified as pathogens, both as a cause of endocarditis, and a common organism in LVAD associated soft tissue infections. There are few reports of CIED infection. Source control is difficult in bacteremia patients with both CIED and LVAD. In this case, recurrent bacteremia could be attributed to recurrent driveline-soft tissue infection. However, the prolonged freedom from bacteremia off antibiotics after CIED extraction, despite ongoing soft tissue and driveline infection, argues that her transvenous ICD may have been seeded. This case highlights the growing spectrum of bacteria implicated in CIED-related infection, that early extraction may be a critical intervention regardless of infectious source, and importance of multidisciplinary discussions including heart failure, surgery, infectious disease, and EP to improve outcomes in this complex population.

Oil Subsidy, Corruption Risk, Midstream and Downstream Oil Revenue in Nigeria: Problem, Prospects and Methodology

The exploratory research identified the problem and prospects on the oil subsidy corruption risk and downstream oil revenue in Nigeria. The study focused mainly on the revenue generated from oil refining, storing, marketing, distribution and sale of petroleum products with the purpose of investigating Nigeria’s oil subsidy payments and its effects on the growth of downstream oil revenue and finding out if the level of corruption affects the downstream oil revenue sustainability in Nigeria. It is revealed that the following factors could explain downstream oil revenue and models are conceptualized that landing cost of PMS, poverty index, demand for local consumption, refining capacity and official pump price global oil price and exchange rate variation are probable significant variables in determining the volume of oil revenue in the downstream sector in Nigeria. A quantitative study and methodology are recommended to evaluate the impact of fuel oil subsidy and corruption indices on the dependent variable (downstream oil revenue) with a view to predicting and forecasting a sustainable and dependable oil revenue in refining, storing, marketing and distribution of petroleum products in Nigeria

P59: Treatment of Impella 5.5 Purge Dysfunction with Tissue Plasminogen Activator Prevents Subsequent Pump Exchanges

Background: The Impella 5.5 is a temporary, percutaneous left ventricular assist device (VAD) that contains a purge system to prevent blood from entering the motor housing. Acute pump failure can occur if purge flow is significantly disrupted and can be predicted by changes in purge pressure or flow rate. The use of alteplase (tPA) in a temporary purge solution is one intervention used to salvage pumps at risk of failure. We share our center’s experience using tPA to treat purge dysfunction in the Impella 5.5 population. Methods: We retrospectively reviewed all Impella 5.5 patients implanted at a single academic center from November 2020 to January 2023 (n=90). Cases were identified by tPA use in the purge system and purge dysfunction was verified by EMR documentation of a notable change in purge pressure or flow rate. Results: tPA was used to treat purge system dysfunction in 10 patients (11.1%) supported for an average of 25 days (Table 1). Nine patients (90%) had dextrose and sodium bicarbonate purge solution with systemic bivalirudin anticoagulation, and one patient had dextrose and heparin purge solution with systemic heparin anticoagulation. On average, purge dysfunction requiring tPA use occurred on post-operative day 13 and required 10 ± 9 mg of tPA in solution. Nine patients (90%) had successful restoration of baseline purge pressure and flow following tPA administration, while the other patient was transitioned to comfort measures shortly after and success could not be determined. No patients required a pump exchange for continued purge dysfunction. Of those treated with tPA, 6 patients (55%) survived to discharge. Other than an incidental finding in one patient questionable for subarachnoid hemorrhage that not impacting clinical care, there were no other major bleeding events or strokes within 48 hours of tPA administration. Conclusion: In cases of identified purge dysfunction prior to pump failure, tPA is an effective intervention for resolution and return to baseline purge function in the Impella 5.5 device preventing the need for surgical pump exchange.

CARC9: Validation of HeartMate 3 Risk Score as a Survival Predictor Calculator

Purpose: Recently, a patient-specific HeartMate 3 Survival Risk Score (HM3RS) was developed to predict 1-year and 2-year survival after implantation based on age, prior cardiac surgery, sodium level, blood urea nitrogen (BUN) level, left ventricular end diastolic diameter, and right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) ratio. We sought to validate the HM3RS using recent data from our referral center. Methods: Through a retrospective review of 101 HM3 patients implanted between 2017-2021, baseline characteristics, complete hemodynamic profiles, and significant outcomes were collected. Patients were stratified into 3 groups by HM3RS: higher-than-average expected survival (HM3RS <2.41), average expected survival (2.41-2.97), and lower-than-average expected survival (>2.97). Kaplan Meier (KM) curves stratified by HM3RS grouping were plotted and survival was compared with log-rank tests. Time-varying receiver operating characteristic (ROC) curves were also constructed to evaluate survival predictions. Results: Patients with lower-than-average expected survival (n=43) were older (mean age 65±7.6 years), had higher BUN before LVAD (45.3±20.1 mg/dl), were more likely to have had prior coronary artery bypass surgery (41.8%), and RAP/PCWP ratio > 0.6 (56%) (all P < 0.05) (table 1). KM plots showed lower survival in this group at 1-year, 2-years, and during the entire follow-up of 2±1.2 years censored at time of transplant, death or pump exchange (figure 1). However, these results did not reach statistical significance, possibly owing to small sample size. Area under the ROC curve was 0.622 and 0.676 at 1 and 2 year follow-up, respectively (figure 2). Summary: In this study, observed survival was consistent with predictions derived from HM3RS score. The HM3RS appears to be a valid tool to predict survival after LVAD implantation in the real-world and to aid in decision-making. Larger prospective trials are needed to independently validate this tool in clinical practice.Figure 1. Kaplan Meier curves for survival by HM3RS groups through (A) entire follow-up, (B) 1-year of follow-up, (C) 2-years of follow-up.Figure 2. Time dependent receiver operating curve (ROC) to determine survival prediction (A) at 1 year, and (B) at 2 years.

P2: Impella Smart Assist Technology and Hemodynamics Management in Cardiogenic Shock Management

Background: Smart Assist Impella pumps provide enhanced hemodynamic metrics via real-time assessment of aortic pressure (AoP), left ventricular pressure (LVP), cardiac output (CO) and cardiac power output (CPO). These data can constitute powerful management tools for clinicians yet information on the Smart Assist Technology algorithms and calculations remains scarce. This case reports illustrates the importance of an in-depth understanding of this newer technology to effectively manage cardiogenic shock patients on Impella support. Method: A 64yo man with cardiogenic shock supported with Impella 5.5 as a bridge to transplant had been on support for 27 days, with stable hemodynamics on P8, flowing 4.5 LPM. On day 28 patient experienced suction alarms and LVDP <-40mmHg prompting the team to reduce P level, administer fluid and attempt Impella repositioning. None of the interventions resolved the issue and consideration was given to reducing support to P2 and weaning or exchanging the Impella. The pump appeared correctly positioned by echo and hemolysis markers were negative. Careful review of patients’ data demonstrated a discrepancy between the transduced radial artery MAP at 73 mmHg and the aortic pressure measured by the Impella fiber optic sensor at 42 mmHg. This prompted a review of the LVP metric. The Impella Left ventricular pressure is calculated in real time by subtracting from the AoP the differential pressure gradient between pump outlet and inlet as derived from the motor current. An erroneous Ao signal input will result in an inaccurate LVP. Furthermore, the Impella suction alarm algorithm utilizes a sustained low LVDP as a trigger and can thus be triggered erroneously if the Ao signal is inaccurate. The suctions alarms and the low LVP were determined to be caused by drifting data feed from the Impella aortic fiber optic sensor. An Impella Ao signal bedside recalibration based on transduced MAP resolved the suction alarms. Result A drifting AoP signal resulted in an erroneous LVP measurements and subsequent suction alarms. Fiber optic technology does not require periodic calibrations once in vivo. Per IFU, the accuracy of the Ao is 1.9mmHg and the accuracy of the LV is 8.8 mmHg. In this case, the recalibration of the AO signal resolved the suction alarms and low LVP. Decision was made to not undertake an invasive pump exchange and continue supporting the patient on the implanted pump managing the metrics with daily manual recalibration. The patient was supported for an additional 17 days demonstrating optimal perfusion pressure and LV unloading and successfully underwent orthotopic heart transplant on Impella day 45. Conclusion: Impella Smart Assist technology is a powerful tool to manage patients’ hemodynamics. An in-depth understanding of the technology and its algorithms is crucial in delivering optimal patient care and preventing erroneous data feed from guiding hemodynamic management.Figure 1. Impella Smart Assist metrics. A. Stable on P8. B. Suction alarm generated by low LVDP. C. Persistent alarms despite fluid bolus and lower P level. D. Suction alarm resolved by Ao recalibrationFigure 2. LVP Calculation

(545) Frankenstein &amp; Beyond: IPP Fixes with Pump Exchange and Fluid Addition

Abstract Introduction We report outcomes for patients in which the IPP became unusable by the patient because of pump difficulties or inadequate fluid volume in the IPP system. Objective We sought to assess outcomes of penile implant single component exchange or fluid instillation in a cohort of patients, challenging the entire device replacement dogma. Methods 17 patients underwent single component exchange by a single surgeon. CT scan was obtained to ensure device integrity, assess for air in the system, and to delineate device details. In cases of pump difficulties, the old pump was removed and replaced with a “classic” Genesis Coloplast pump regardless of initial device brand (“Frankenstein” if brands are mixed). Patients are taught pump rocking techniques and have &amp;gt; 6 months of difficulty before exchange. Patients are warned of auto-inflation as there is no lock out valve in the Genesis pump. For fluid addition to the system, the two old connector collars are separated and sometimes re-used after saline is added to only the cylinders. We never add fluid to the reservoir using a piston syringe for fear of reservoir capsule rupture into adjacent structures. Revisions were copiously irrigated, as of 2022, with Irrisept. Results Pump exchange: 14 patients underwent single component pump exchange secondary to inability for the patient to be able to adequately cycle the device (11 AMS MS, 1 Coloplast Touch). Remarkable differences were noted in pump cycling between office exam (difficult), exam under anesthesia prior to incision (sometimes difficult), and once the pump is removed from its capsule (universally easy). Complications of these 14 patients include 1 fungal infection requiring replacement with a malleable device and one repeat pump exchange (AMS MS - AMS MS - Genesis). Two patients noted non-bothersome minor auto-inflation. The single Coloplast case had a remarkably thickened capsule after a likely low grade infection. All patients can successfully use their devices now. Fluid Addition: Three patients underwent fluid addition to the system. One had a significant proximal aneurysm for which we added 35 ml. A different case had both a pump exchange and 30 ml added to the system as the initial reservoir appeared to have folded cordoning off fluid. The final fluid addition occurred 18 months after initial Coloplast 22+2 cm placement in which the patient very aggressively cycled the device and could not obtain 10/10 erection. 30 ml was added to the system totaling 140 cc. All patients have done well with fluid addition with mean time since surgery of 1 year. Conclusions Pump exchange with genesis pump or simple fluid addition to the system are safe and feasible and successfully restores IPP functionality. The Frankenstein strategy is a viable alternative, although patients must be counseled that auto-inflation may occur. With modern day irrigation techniques and CT confirmation of fluid system integrity, the dogma to replace the entire device may actually carry higher morbidity in some patients. Disclosure No

Our Single Center Experiences with Left Ventricular Assist Device Exchange

Mechanical circulatory support technology continues to evolve to satisfy the needs of advanced heart failure patients. Despite improvements, various problems occur frequently, and surgical exchange of the pump can be a feasible treatment option. Optimal patient selection is key to success in exchange operations. Using a retrospective observational cohort design, this study aims to evaluate preoperative profiles and clinical courses of patients' undergoing a device exchange operation and identified possible contributors to in-hospital mortality. Currently, 155 left ventricular assist device (LVAD) patients are being followed up in our program. In total, 15 of 155 patients underwent a pump exchange operation. Baseline characteristics, clinical features, and laboratory results were evaluated. The primary outcome was all-cause in-hospital mortality. Of the 15 patients who underwent a pump exchange operation, thrombosis was the primary cause in 12. Five patients experienced in-hospital mortality within 30 days of LVAD exchange. The international normalized ratio (INR) was higher in patients who experienced in-hospital mortality (2.4 [±0.6] vs 1.2 [±0.4], P=.005) than in patients who survived to discharge. In addition, preoperative lactate levels were significantly higher in patients who died within 30 days (2.9 [±2.6] vs 0.9 [±0.4], P=.019). Higher INR and lactate levels could possibly contribute to in-hospital mortality, which underlines the importance of right ventricular function in this patient population. Careful evaluation of the right heart function is of great importance before exchange operations, and preoperative hemodynamic stability is crucial for better postoperative outcomes.

(134) Lysis Therapy vs. Pump Exchange for Intra-Pump Thrombosis of Left Ventricular Assist Devices

(134) Lysis Therapy vs. Pump Exchange for Intra-Pump Thrombosis of Left Ventricular Assist Devices

2025. Outcomes of Pseudomonas aeruginosa Ventricular Assist Device Infection

Abstract Background Ventricular assist device (VAD) infections caused Pseudomonas aeruginosa (PA) are difficult to treat given limited antibiotic options, development of resistance and biofilm formation in the presence of retained hardware. We looked at outcomes of patients who developed Pseudomonas aeruginosa LVAD infection (PA-LVADI) Methods Single center retrospective study of patients older than 18 years who received LVAD from 7/1/2007 to 2/1/2021 and subsequently developed PA-LVADI. Patients with proven or probable VAD-specific infections: driveline infection (DLI), pump pocket, and pump/cannula infections were included. The cumulative incidences of death, transplant, and LVAD explant, following Pseudomonas aeruginosa infection, were evaluated as competing outcomes. Fig 1:Classification of Pseudomonas aeruginosa LVAD Infections at diagnosisFigure 3:Cumulative incidence of death, transplant, or explant following Pseudomonas aeruginosa LVAD infection Results 51 patients with VAD-specific PA-LVADI were identified (Fig 1). Median age at the time of first LVAD placement was 55 years (23 – 74). Of the 28 patients ever listed for transplant, 13 (46%) received heart transplant, 8 (29%) were delisted, 7 (25%) were alive on transplant list (Fig 2). The median number of days from LVAD placement to first PA infection was 587 (54 – 3389). 30 (59%) had PA as the first causative organism. The extent of first PA-LVADI was superficial DLI in 43(84%), deep DLI in 5 (10%), pump pocket in 2(4%) and pump/cannula in 1(2%). 46 (90%) of patients received intravenous (IV) therapy with median duration of 84 (2 – 525) total IV antibiotic days. Antibiotic resistance emerged in 25/51 (49%) patients, with 32% being multi-drug resistant (MDR). Surgery was performed in 30 (58%). 12/13 who received heart transplants were followed for at least 1 year post-transplant and all were alive. 5 of the remaining 38 patients underwent pump exchange or explant. 20/38 (53%) of patients who were not transplanted died (Fig 3). Conclusion This is the largest study on PA-LVADI to date. We noted significant morbidity and mortality, with 90% of patients requiring prolonged IV antibiotics and over half requiring surgical treatment. Drug resistance emerged in a significant proportion of patients. Survival after transplant was excellent, but by 2 years of infection over half of the patients have been transplanted, explanted, or died. Disclosures All Authors: No reported disclosures.

Mechanical Device Malfunction of the HeartMate II Versus the HeartMate 3 Left Ventricular Assist Device: The Rotterdam Experience.

Mechanical device malfunction remains a known issue in left ventricular assist devices (LVADs). We investigated the incidence of mechanical device malfunction in the HeartMate II and HeartMate 3 LVADs. We conducted a retrospective study of all HeartMate II and HeartMate 3 LVADs implanted in our center. We evaluated major malfunction, potential major malfunction, minor malfunction, and need of device exchange. In total, 163 patients received an LVAD; in 63 (39%) a HeartMate II, and in 100 (61%) a HeartMate 3, median support time of respectively 24.6 months (interquartile range [IQR]: 32.4) and 21.1 months [IQR: 27.2]. Mechanical device malfunction, consisting of both major and potential major malfunction, occurred significantly less in the HeartMate 3 patients with a hazard ratio (HR) of 0.37 (95% Confidence Interval [CI]: 0.15-0.87, p = 0.022). Major malfunction alone occurred significantly less in HeartMate 3 patients with a HR of 0.18 (95% CI: 0.05-0.66, p = 0.009). HeartMate 3 patients had a significantly decreased hazard of a pump or outflow graft exchange (HR 0.13, 95% CI: 0.08-0.81, p = 0.008). System controller defects occurred significantly less in HM 3 patients (p = 0.007), but battery-clips defects occurred significantly more in HM 3 patients (p = 0.039). Major device malfunction including pump or outflow graft exchange occurred significantly less in HeartMate 3 compared to HeartMate II, while minor malfunctions were similar. Periodical assessment of the technical integrity of the device remains necessary during long-term LVAD support.