Percutaneous Left Ventricular Assist Device Research Articles

Real-time regurgitation estimation in percutaneous left ventricular assist device fully supported condition using an unscented Kalman filter

Objective. Significant aortic regurgitation is a common complication following left ventricular assist device (LVAD) intervention, and existing studies have not attempted to monitor regurgitation signals and undertake preventive measures during full support. Regurgitation is an adverse event that can lead to inadequate left ventricular unloading, insufficient peripheral perfusion, and repeated episodes of heart failure. Moreover, regurgitation occurring during full support due to pump position offset cannot be directly controlled through control algorithms. Therefore, accurate estimation of regurgitation during percutaneous left ventricular assist device (PLVAD) full support is critical for clinical management and patient safety. Approach. An estimation system based on the regurgitation model is built in this paper, and the unscented Kalman filter estimator (UKF) is introduced as an estimation approach. Three offset degrees and three heart failure states are considered in the investigation. Using the mock circulatory loop experimental platform, compare the regurgitation estimated by the UKF algorithm with the actual measured regurgitation; the errors are analyzed using standard confidence intervals of ±2 SDs, and the effectiveness of the mentioned algorithms is thus assessed. The generalization ability of the proposed algorithm is verified by setting different heart failure conditions and different rotational speeds. The root mean square error and correlation coefficient between the estimated and actual values are quantified and the statistical significance of accuracy differences in estimation is illustrated using one-way analysis of variance (One-Way ANOVA), which in turn assessed the accuracy and stability of the UKF algorithm. Main results. The research findings demonstrate that the regurgitation estimation system based on the regurgitation model and UKF can relatively accurately estimate the regurgitation status of patients during PLVAD full support, but the effect of myocardial contractility on the estimation accuracy still needs to be taken into account. Significance. The proposed estimation method in this study provides essential reference information for clinical practitioners, enabling them to promptly manage potential complications arising from regurgitation. By sensitively detecting LVAD adverse events, valuable insights into the performance and reliability of the LVAD device can be obtained, offering crucial feedback and data support for device improvement and optimization.

Bridge-to-transplant temporary mechanical circulatory support and risk of allosensitization.

Since the 2018 change in the US adult heart allocation policy, more patients are bridged-to-transplant on temporary mechanical circulatory support (tMCS). Previous studies indicate that durable left ventricular assist devices (LVAD) may lead to allosensitization. The goal of this study was to assess whether tMCS implantation is associated with changes in sensitization. We included patients evaluated for heart transplants between 2015 and 2022 who had alloantibody measured before and after MCS implantation. Allosensitization was defined as development of new alloantibodies after tMCS implant. A total of 41 patients received tMCS before transplant. Nine (22.0%) patients developed alloantibodies following tMCS implantation: 3 (12.0%) in the intra-aortic balloon pump group (n=25), 2 (28.6%) in the microaxial percutaneous LVAD group (n=7), and 4 (44.4%) in the veno-arterial extra-corporeal membrane oxygenation group (n=9)-p=.039. Sensitized patients were younger (44.7±11.6 years vs. 54.3±12.5 years, p=.044), were more likely to be sensitized at baseline - 3 of 9 (33.3%) compared to 2 out of 32 (6.3%) (p=.028) and received more transfusions with red blood cells (6 (66.6%) vs. 8 (25%), p=.02) and platelets (6 (66.6%) vs. 5 (15.6%), p=.002). There was no significant difference in tMCS median duration of support (4 [3,15] days vs. 8.5 [5,14.5] days, p=.57). Importantly, out of the 11 patients who received a durable LVAD after tMCS, 5 (45.5%) became sensitized, compared to 4 out of 30 patients (13.3%) who only had tMCS-p=.028. Our findings suggest that patients bridged-to-transplant with tMCS, without significant blood product transfusions and a subsequent durable LVAD implant, have a low risk of allosensitization. Further studies are needed to confirm our findings and determine whether risk of sensitization varies by type of tMCS and duration of support.

TCTAP C-150 Simplifying the Procedure for the Complex Patient: Stabilizing Hemodynamics for Safer PCI Using Percutaneous Left Ventricular Assist Device

TCTAP C-150 Simplifying the Procedure for the Complex Patient: Stabilizing Hemodynamics for Safer PCI Using Percutaneous Left Ventricular Assist Device

Predictive value of residual SYNTAX score for clinical outcomes after High-Risk Percutaneous Coronary Intervention (HR-PCI): Evidence from pooled analysis of prospective studies

Abstract Background/Introduction Completeness of revascularisation (CR) after percutaneous coronary intervention (PCI), which is associated with improved long-term patient outcomes, is commonly quantified with the post-PCI residual SYNTAX score (rSS). In High-Risk PCI (HR-PCI), trans-axial percutaneous Left Ventricular Assist Devices (pLVADs) provide higher procedural mechanical circulatory support than intra-aortic balloon pump (IABPs). We hypothesise that pLVADs may contribute to higher CR during HR-PCI. A direct quantitative relationship between revascularisation extent, measured via rSS, and long-term clinical outcomes has not yet been established in HR-PCI. NYHA Class allocation 90-days post-PCI and Ejection Fraction (EF) have been shown strongly predictive of long-term survival, Heart Failure (HF) hospitalization risk and Quality of Life (QoL). Purpose To investigate the relationship between revascularization completeness, NYHA Class and LVEF 90-days in patients undergoing HR-PCI with either pLVAD or IABP support. Methods Individual patient data (IPD) from the PROTECT II and RESTORE-EF prospective studies of pLVADs during HR-PCI were pooled. Using patients with sufficient information, ordinal logistic regressions were performed for NYHA and EF at 90-days post-PCI. All models were refined using stepwise deletion (threshold=0.05) and included treatment group (pLVAD or IABP), baseline age, gender, race, NYHA Class at baseline, LVEF at baseline, SYNTAX Score at baseline and post-procedural rSS. Results NYHA Class utilised 641 patients (484 pLVAD;157 IABP). Baseline SYNTAX, rSS and LVEF at baseline were significant predictors of NYHA Class at 90-days post HR-PCI. Specifically, a single-unit decrease in rSS increases the odds of the patient improving NYHA at 90-days vs. baseline by 2.2%±1.0% (Mean±SE, p=0.021). Utilising solely the subjects with sufficient information enrolled in PROTECT II (178 pLVAD; 157 IABP), post-procedural rSS was the only significant predictor of NYHA Class at 90-days with every single-unit decrease in rSS increasing the odds of NYHA improvement by 3.0%±1.2% (p=0.017). EF examined 622 (405 pLVAD; 217 IABP). Baseline SYNTAX, rSS and baseline LVEF significantly predicted Ejection Fraction at 90-days. A single-unit decrease in rSS leads to an absolute higher LVEF at 90-days of 0.246%±0.05% (p<0.001). Treatment group statistically predicted LVEF at 90-days. For the same level of revascularisation, pLVAD-supported procedures result in an absolute higher LVEF of 4.13%±1.21% (p=0.001). Conclusions Completeness of revascularization, as measured by level of reduction in rSS after a HR-PCI, is significantly predictive of NYHA Class improvement and Ejection Fraction gains at 90-day follow-up. pLVADs were also shown to further increase LVEF at 90-days vs. IABP. These data further support the need for complete revascularization in this patient population and help make additional therapeutic decisions post-PCI.

Abstract 11895: Efficacy of Maintaining Mean Aortic Pressure by Percutaneous Left Ventricular Assist Device for Hemodynamic Support in Ventricular Tachycardia Ablation - Relation to Cycle Length

Introduction: Percutaneous left ventricular assist device (pLVAD) has been used to maintain mean aortic pressure (MAP) during ventricular tachycardia (VT) ablation (ABL) and is a class II recommendation. We sought to assess the ability of pLVAD to maintain MAP and its relationship to VT cycle length (CL). Methods: All patients who underwent CA for VT with pLVAD support within a 3-year period were included. Type of pLVAD was determined by operator. Insertion of device was performed under fluoroscopy via femoral arterial sheath. Acute ablation success was defined as absence of inducible VT at end of procedure. Results: A total of 9 patients were included. Most patients had ischemic cardiomyopathy (Table 1); pLVAD was inserted prophylactically in 66.67% of patients and for refractory VT/VF storm in 22.2%. One patient was had critical AS and underwent balloon valvuloplasty prior to VT ablation. Impella CP was used in 78%, and Impella 2.5 in 22%, mean cardiac output was 2.9 + 0.5 L at mean P flow rate 7.3 + 1.3. CARTO was used in 89% and ESI Navx in 11% for electroanatomic/activation mapping. There were no instances of electromagnetic interference, despite the use of magnetic mapping system in all cases (CARTO in 8, Stereotaxis in 1). Mean PCWP was 17.88 + 10.12 pre-ablation vs 23.57 + 8.30 post-ablation (p=ns). There were 24 VTs, 42% were sustained, with a mean CL 342 + 80 msec, ranging from 223 to 558 msec. Mean MAP pre-ablation was 67.44 + 12.85 mmHg vs 61.86 + 13.27 post-ablation with absent negative correlation to VT CL (p=ns). There was no difference in MAP between VT Cl > 300 msec vs < 300 msec: 66 + 11 vs 59 + 14 mm Hg, (p=ns). Mean dose of phenylephrine was 452 mcg. pLVAD was removed at the end of procedure, there were no femoral site complications. Conclusions: pLVAD utilization maintains stable MAP even with faster VT cycle length in patients undergoing VT ABL under general anesthesia obviating need for high dose pressor support.

Abstract 12772: In Hospital Outcomes With Extracorporeal Membrane Oxygenation Alone vs Combined With Percutaneous Left Ventricular Assist Device

Background: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is often used to support patients with cardiogenic shock. However, it is associated with an increase in systemic afterload which can lead to worsening cardiac function. The use of a percutaneous left ventricular assist device (pLVAD) plus ECMO has emerged as a strategy to offload the left ventricle, with some studies showing improved outcomes. Hypothesis: The use of ECMO plus pLVAD is associated with improved outcomes compared to the use of EMCO alone. Methods: The National Inpatient Sample was queried from 2011-2018 for relevant ICD-9 and ICD-10 codes to identify patients with cardiogenic shock supported with ECMO or ECMO plus a pLVAD (Ecpella) during the same admission. Baseline characteristics and in-hospital outcomes between groups were compared. Logistic regression was performed to adjust for pre-specified co-variates for outcomes. p-value was considered significant if <0.001. Results: Of 20,171 patients with cardiogenic shock supported with ECMO, 16,064 (79.6%) were treated with only ECMO and 4,107 (20.4%) were treated with ECMO plus pLVAD. Patients in the Ecpella group were more likely to be male (72% vs 66%), have a history of hypertension (50% vs 47%), diabetes (21% vs 15%), chronic kidney disease (27% vs 22%), coronary artery disease (54% vs 44%), myocardial infarction (6% vs 4%, p<0.001 for all). Age (55.6 vs 55.2 years (p = 0.09) and rate of atrial fibrillation and flutter were not significantly different. After adjusting for significant variables, patients in the Ecpella group, had higher rates of mortality (OR 1.2; CI [1.1-1.3]), stroke (OR 1.3; CI [1.2-1.5]), and major bleeding (OR 1.5; CI [1.4-1.7], p < 0.001 for all). The rate of inpatient dialysis was lower in the Ecpella group (OR 0.7; CI 0.7-0.8; p < 0.001). Conclusions: Cardiogenic shock patients treated with ECMO plus pLVAD had worse outcomes compared to patients treated with ECMO alone. Although it is possible that patients treated with ECMO plus pLVAD had a more critical presentation, further studies are needed to evaluate these findings.

Abstract 18575: Impact of Mechanical Circulatory Support on In-Hospital Mortality in Ventricular Tachycardia Ablation: A United States Nationwide Analysis

Background: Mechanical circulatory support (MCS) devices have emerged as a valuable tool in ventricular tachycardia (VT) ablation procedures, offering potential benefits such as improved hemodynamic stability, preserved organ perfusion, and optimized coronary perfusion during prolonged VT induction and mapping. However, the impact of different MCS modalities on in-hospital mortality following VT ablation remains unclear. Objective: This study aimed to investigate the impact of various MCS modalities on in-hospital mortality in those undergoing VT ablation during hospitalization. Method: We analyzed data from the National Inpatient Sample to identify patients who underwent VT ablation and received transient mechanical cardiac support between 2019 and 2020. The primary endpoint was in-hospital mortality, stratified by different MCS modalities. Additionally, we explored independent predictors of in-hospital mortality. Result: A total of 850 patients underwent VT ablation and required MCS from January 2019 to December 2020. Among these patients, extracorporeal membrane oxygenation (ECMO), percutaneous left ventricular assist device (PLVAD), intra-aortic balloon pump (IABP), and a combination of more than one MCS modality were utilized in 5.8%, 64.7%, 18.8%, and 10.5% of cases, respectively. The in-hospital mortality rates for these groups were 40%, 16%, 22%, and 61%, respectively (p<0.01). Notably, the use of multiple MCS modalities, female sex, other races, and self-payment were independent predictors of mortality, with adjusted odds ratios (aOR) of 21.9 (p=0.008; 95% confidence interval [CI]: 2.2-217.1), 9.27 (p=0.045; 95% CI: 1.1-82.1), 27 (p=0.038; 95% CI: 1.1-29.4), and 27.6 (p=0.041; 95% CI: 1.2-660.8), respectively. Conclusion: Our study highlights that the use of multiple MCS modalities, female sex, other races, and self-payment are independent predictors of in-hospital mortality, highlighting the need for careful consideration and selection of MCS for VT ablation patients.

Heart Transplantation and Thromboembolic Risk In Patients With Percutaneous Aortic Valve Prosthesis and Left Ventricular Assist Device: A Case Report

Transcatheter aortic valve replacements have become a good option for patients with aortic valve disease and high surgical risk. Thromboembolism is reported as a relatively common complication of Transcatheter aortic valve replacement. This risk may be increased in patients who have left ventricular assist devices, as valve motion is drastically reduced. We present the case of a 65-year-old man with a history of alcoholism and valvular cardiomyopathy (severe chronic aortic insufficiency) with severe left ventricular dysfunction. Improvement in ventricular function followed the cessation of alcohol consumption, but still in poor clinical condition. Due to his high surgical risk, it was decided to implant a percutaneous aortic valve to treat the valve deficiency. Two months later, he suffered from a first episode of embolic stroke, which he successfully recovered. Despite the treatment, his clinical status did not improve (INTERMACS 3-4), and he was referred for heart transplantation. A left ventricular assist device was implanted as a bridge to the transplant. While on the waiting list, he suffered from other 3 episodes of stroke, 2 of them requiring mechanical thrombectomy. Finally, his transplant was performed with a favorable postoperative clinical course. Heart transplantation may be feasible in patients with multiple intracardiac devices in left chambers, although we must be aware of the increased thromboembolic risk, especially when used in combination.

Outcome of Patients Managed by Percutaneous Left Ventricular Assist Device Implantation During On-Hours and Off-Hours.

Percutaneous left ventricular assist devices (pVADs) may be used in patients with cardiogenic shock (CS) to stabilize hemodynamics and maintain sufficient end-organ perfusion. Vascular complications are commonly observed in patients with pVAD support. We aimed to assess the relationship between pVAD implantation time and access-site complication rates. This retrospective observational study included all patients who underwent pVAD insertion for the treatment of CS at our university hospital between 2014 and 2021 (n = 224). Depending on the pVAD insertion time, the patients were assigned to the on-hours (n = 120) or off-hours group (n = 104). Both groups had comparable baseline characteristics and comorbidities. The rate of access-site-related complications was higher in the off-hours group than in the on-hours group (26% vs. 10%, p = 0.002). Premature discontinuation of pVAD support to prevent limb ischemia or manage access-site bleeding was required more often in the off-hours group than in the on-hours group (14% vs. 5%, p = 0.016). Pre-existing peripheral artery disease and implantation time off-hours were independent predictors for access-siterelated vascular complications. In conclusion, patients with CS in whom pVAD was inserted during off-hours had higher rates of access-site-related complications and premature discontinuation of pVAD support than those in whom pVAD was inserted during on-hours.

Regurgitation during the fully supported condition of the percutaneous left ventricular assist device

Objective. A percutaneous left ventricular assist device (PLVAD) can be used as a bridge to heart transplantation or as a temporary support for end-stage heart failure. Transvalvularly placed PLVADs may result in aortic regurgitation due to unstable pump position during fully supported operation, which may diminish the pumping effect of forward flow and predispose to complications. Therefore, accurate characterization of aortic regurgitation is essential for proper modeling of heart-pump interactions and validation of control strategies. Approach. In the present study, an improved aortic valve model was used to analyze the severity of regurgitation produced by different pump position offsets. The link between pump position offset degree and regurgitation is validated in the fixed speed mode, and the influence of pump speed on regurgitation is verified in the variable speed mode, using the mock circulatory loop (MCL) experimental platform. Main results. The greater the pump offset and the more severe the regurgitation, the more carefully the pump speed needs to be managed. To avoid over-pumping, the recommended pump speed in this study should not exceed 30 000 rpm. Significance. The modeling approach provide in this study not only makes it easier to comprehend the impact of regurgitation events on the entire interactive system during mechanical assistance, but it also aids in providing timely alerts and suitable management measures.

Clinical Outcomes of Left Ventricular Assist Device Pump Infection.

Few studies have focused on the clinical outcomes and risk factors of left ventricular assist device (LVAD) pump infection, and no standard treatment for LVAD pump infection has been established. Therefore, we used a therapeutic flowchart to manage LVAD pump infections. We retrospectively evaluated 220 patients who underwent continuous-flow LVAD implantation between January 2005 and March 2021 at Osaka University, Japan. First, we performed wound debridement, negative-pressure wound therapy, antibiotic treatment, and omental flap transposition. Subsequently, we administered conservative treatment, scheduled implantable LVAD exchange, or emergent removal of the implantable LVAD and exchange for extracorporeal LVAD or percutaneous LVAD (IMPELLA). Pump infections occurred in 32 patients. The survival rates of patients with pump infections during LVAD support were 93%, 74%, and 61% at 180 days, 1 year, and 2 years after LVAD pump infection, respectively. Fifteen patients underwent successful heart transplantation. Bridge-to-bridge surgery, preoperative use of venoarterial extracorporeal membrane oxygenation or percutaneous LVAD, high lactate dehydrogenase levels, and driveline infection were significantly associated with pump infection. Our study reveals that poor preoperative condition and driveline infection were significant risk factors for LVAD pump infection.

Comparative Effectiveness of Percutaneous Microaxial Left Ventricular Assist Device vs Intra-Aortic Balloon Pump or No Mechanical Circulatory Support in Patients With Cardiogenic Shock

Recent studies have produced inconsistent findings regarding the outcomes of the percutaneous microaxial left ventricular assist device (LVAD) during acute myocardial infarction with cardiogenic shock (AMICS). To compare the percutaneous microaxial LVAD vs alternative treatments among patients presenting with AMICS using observational analyses of administrative data. This comparative effectiveness research study used Medicare fee-for-service claims of patients admitted with AMICS undergoing percutaneous coronary intervention from October 1, 2015, through December 31, 2019. Treatment strategies were compared using (1) inverse probability of treatment weighting to estimate the effect of different baseline treatments in the overall population; (2) instrumental variable analysis to determine the effectiveness of the percutaneous microaxial LVAD among patients whose treatment was influenced by cross-sectional institutional practice patterns; (3) an instrumented difference-in-differences analysis to determine the effectiveness of treatment among patients whose treatment was influenced by longitudinal changes in institutional practice patterns; and (4) a grace period approach to determine the effectiveness of initiating the percutaneous microaxial LVAD within 2 days of percutaneous coronary intervention. Analysis took place between March 2021 and December 2022. Percutaneous microaxial LVAD vs alternative treatments (including medical therapy and intra-aortic balloon pump). Thirty-day all-cause mortality and readmissions. Of 23 478 patients, 14 264 (60.8%) were male and the mean (SD) age was 73.9 (9.8) years. In the inverse probability of treatment weighting analysis and grace period approaches, treatment with percutaneous microaxial LVAD was associated with a higher risk-adjusted 30-day mortality (risk difference, 14.9%; 95% CI, 12.9%-17.0%). However, patients receiving the percutaneous microaxial LVAD had a higher frequency of factors associated with severe illness, suggesting possible confounding by measures of illness severity not available in the data. In the instrumental variable analysis, 30-day mortality was also higher with percutaneous microaxial LVAD, but patient and hospital characteristics differed across levels of the instrumental variable, suggesting possible confounding by unmeasured variables (risk difference, 13.5%; 95% CI, 3.9%-23.2%). In the instrumented difference-in-differences analysis, the association between the percutaneous microaxial LVAD and mortality was imprecise, and differences in trends in characteristics between hospitals with different percutaneous microaxial LVAD use suggested potential assumption violations. In observational analyses comparing the percutaneous microaxial LVAD to alternative treatments among patients with AMICS, the percutaneous microaxial LVAD was associated with worse outcomes in some analyses, while in other analyses, the association was too imprecise to draw meaningful conclusions. However, the distribution of patient and institutional characteristics between treatment groups or groups defined by institutional differences in treatment use, including changes in use over time, combined with clinical knowledge of illness severity factors not captured in the data, suggested violations of key assumptions that are needed for valid causal inference with different observational analyses. Randomized clinical trials of mechanical support devices will allow valid comparisons across candidate treatment strategies and help resolve ongoing controversies.

CARC3: Simultaneous Transvalvular Percutaneous Left Ventricular Assist Device (LVAD) Exchange: A Reliable Method for Uninterrupted Mechanical Circulatory Support

Background: Impella CP and Impella 5.5 are commonly used catheter-based percutaneous transvalvular LVADs with differing flow support capacities and sites of placement. Impella exchanges are indicated for escalation of therapy, in cases of vascular or renal complications, and for mobility enhancement and improvement of physical conditioning. During conventional exchange, flow interruption occurs as the old device is pulled into the thoracic aorta prior to advancing the new device into the left ventricle (LV), threatening hemodynamic collapse in device-dependent cardiogenic shock patients. While “double device” uninterrupted Impella exchange has been reported, concerns remain with respect to valve damage, stroke, and entanglement with two devices concurrently in the LV. We present the largest institutional experience of simultaneous transvalvular Impella placement reported to date, demonstrating the feasibility, reproducibility and safety of the uninterrupted percutaneous LVAD exchange. Methods: 22 consecutive cardiogenic shock patients supported by an Impella (CP, 5.0 or 5.5) and requiring LVAD device replacement underwent a simultaneous transvalvular exchange procedure. The new device was advanced into the LV under transesophageal echocardiographic (TEE) and fluoroscopic guidance with the old device still in position. Flow was started on the new device as the old device was weaned, powered down and removed from the ventricle. Demographic data, etiology of illness, indication for device exchange, details of that exchange, and any postoperative complications were analyzed. Results: 95.5% (21/22) of patients were male, with average age of 54 years (32-71). 68.2% (15/22) had ischemic, whereas 31.8% (7/22) had nonischemic cardiomyopathy. Initial Impella location was the femoral artery in 90.9% (20/22) of patients. Replacement device was inserted via the right axillary artery in 90.9% (20/22) of patients. Using intraoperative TEE, 95.5% (21/22) showed no postoperative aortic insufficiency (AI), whereas 4.5% (1/22) had trace AI. No patients suffered vascular complications or suffered cardiac arrest during device exchange. One patient (4.5%) developed a hemorrhagic stroke 3 days post exchange. 59.1% (13/22) survived, with 3 patients recovering, 8 progressing to heart transplant, and 2 to durable LVAD. The ECMO-Impella patients had a survival rate of 35.7% (5/14), while the Impella-only survival was 100% (8/8). Conclusion: Based on our institutional experience, this technique is safe and reliable for escalating percutaneous LVAD device support in patients who are critically ill and cannot tolerate flow interruption. The severity of illness in this cohort is reflected in the incidence of pre-existing end-organ injury and overall mortality. By our evaluation, this “double barrel” exchange technique carries a significant advantage and minimal risk; however, larger studies will be needed to demonstrate statistical equivalency of this approach.Figure 1. Fluoroscopy demonstrating both percutaneous LVAD devices within the LV simultaneouslyFigure 2. Simultaneous Transvalvular Percutaneous LVAD Exchange

CARC1: Impella 5.5 Percutaneous Left Ventricular Assist Device (LVAD) Bridge to Orthotopic Heart Transplant (OHT): A Case Series

Background: Limited donor organ availability necessitates the use of mechanical circulatory support (MCS) as a bridge to transplant for patients in medically refractory end-stage heart failure. The increasing availability, flow capability and durability of the Impella 5.5 percutaneous LVAD has benefitted patients with its minimally invasive nature. We present a single-center case series of patients supported with Impella 5.5 to OHT, demonstrating the safety and feasibility of this approach in what is, to our knowledge, the largest reported series to date. Methods: From January 2021 to present, 31 consecutive patients supported by Impella 5.5 underwent OHT at our institution. Demographic data, etiology of illness, details of procedures, duration of support, postoperative complications, and outcomes were analyzed. We additionally report two different methods of complete device removal during OHT – via device transection in the field versus removal from the axillary insertion site. Results: Of 31 patients, 80.7% (25/31) were male and the average age was 49.5 (21-70) years. The etiology of cardiomyopathy was predominantly nonischemic in 77.4% (24/31) of patients. Average length of stay was 78.2 days (27-229) with an average 53.1 days (19-133) in the intensive care unit. 27 patients (87.1%) had device placed in the right axillary artery, with 3 being on the left. Average Impella 5.5 duration was 29.6 days (2-97). During OHT, 67.7% (21/31) had device transected in the aorta and sent off the field, while the remaining 32.3% had device removal via axillary site. 8 patients (25.8%) underwent multiple organ transplant (7 kidney, 1 liver). Two patients (6.5%) suffered neurological insult. Notably, in both cases, the device was removed via the second method. There was 1 vascular complication, requiring axillary artery repair. Three patients (9.7%) had postoperative acute kidney injury or renal failure. Average days from OHT to discharge were 26.0 (7-80). There was 1 death in a patient who developed mixed septic and cardiogenic shock, and another death in a patient who developed a mediastinal infection several months postoperatively. The 30-day survival rate was 96.8% (30/31). 6.5% (2/31) patients had concern for rejection. Eleven patients (35.5%) were alive at 1 year, while another 18 (58.0%) were alive but had not yet reached 1 year post-transplant. Conclusion: Based on our institutional experience, Impella 5.5 is safe and reliable for prolonged bridge to OHT, as demonstrated in the high 30-day and 1-year survival rates. Complication rates were relatively low while offering a minimally invasive approach and avoiding resternotomy at time of OHT. We speculate that device removal via transection in the ascending aorta poses a lower stroke risk than the more established alternative, but further work will need to demonstrate superiority of either technique. Finally, further studies are needed urgently to determine the optimal MCS approach in patients awaiting OHT. Table 1. Prolonged Impella 5.5 Support as Bridge to Transplant

P5: Red Blood Cell Distribution Width in Patients with Cardiogenic Shock Supported with Impella 5.5 Temporary Percutaneous Microaxial Left Ventricular Assist Device

Background: Severe cardiogenic shock with metabolic derangement can preclude candidacy to durable left ventricular assist device (LVAD) or cardiac transplant, but may be reversed with temporary mechanical circulatory support. Our primary aim was to determine if red cell distribution width- coefficient of variation (RDW-CV) differed among survivors and non-survivors during their admission with temporary circulatory support. Methods: A series of 27 consecutive patients supported with Impella 5.5 percutaneous microaxial LVAD were reviewed retrospectively. All implants were performed via a tunneled vascular graft anastomosed to the right subclavian artery to allow ambulation. RDW-CV was recorded at admission and at the end of circulatory support. The series was divided into survivors and non-survivors. Groups were compared using Student’s t-test. Results: Surviving patients had a lower percentage of males (79% vs 88%), their cardiomyopathy was more likely to be non-ischemic (58% vs 25%), and were slightly younger (62 vs 69.5 years old) than non-survivors. RDW-CV at the end of Impella support was significantly different between those that survived [median RDW-CV 16.8], and those that did not [median RDW-CV 19.98] (p=0.04). Conclusion: In patients supported with temporary circulatory support with Impella 5.5, RDW-CV is significantly lower among patients that survive to discharge when compared to non-survivors.

Use of Percutaneous Left Ventricular Assist Device Before Durable Device Implantation in Patients With Cardiac Cachexia: Case Series.

Frailty and malnutrition in patients with heart failure are barriers to durable left ventricular assist device (D-LVAD) support and heart transplantation. Moreover, cachexia in patients with advanced heart failure carries a high mortality risk. There are no guidelines for these patients other than increased caloric intake and rehabilitation. Patients suffering from cardiac cachexia and heart failure may benefit from temporary, percutaneous assist device support to improve the underlying heart disease and reverse the catabolic state. We retrospectively reviewed patients from January 2017 to January 2022. All patients who received Impella support (5.0 or 5.5, Abiomed) before D-LVAD implantation were screened. Those who met the criteria for cardiac cachexia were included. Patient demographics, nutritional and biochemical markers, and survival data were collected. A total of 14 patients were included. The majority of patients were male (85.7%) with ischemic cardiomyopathy (64.3%). Caloric intake, physical strength, and ambulation improved. Prealbumin levels improved from a median of 13.7-18.0 mg/dl ( p < 0.006) while on Impella 5.0 or 5.5 support. All patients survived to discharge and the 6 month follow-up. In conclusion, use of the Impella device improves cardiogenic shock symptoms and, consequently, may improve cachexia status prior to D-LVAD implantation.

Outcomes of heart transplant recipients bridged with percutaneous versus durable left ventricular assist devices.

The new United Network for Organ Sharing (UNOS) heart allocation policy prioritizes temporary percutaneous over durable left ventricular assist devices (LVAD) as bridge to transplant. We sought to examine 1-year outcomes of heart transplant recipients bridged with Impella versus durable LVADs. All primary adult orthotopic heart transplant recipients registered in UNOS between January 2016 and June 2021 were analyzed. Recipients were identified as being bridged with isolated durable or percutaneous LVAD at the time of transplant. Baseline characteristics were compared and 1-year survival was examined using the Kaplan Meier method and multivariable Cox proportional hazards regression. During our study period, heart transplant recipients bridged with LVADs were divided between 5422(94%) durable and 324(6%) percutaneous options. Impella-bridged recipients were more likely to be status 1A under the old allocation system (98% vs. 70%, p<.01) and status 2 or higher under the new allocation system (99% vs. 24%, p<.01). Impella-bridged recipients were less likely to be obese (27% vs. 42%, p<.01), have ischemic cardiomyopathy (27% vs. 34%, p<.01), and were more likely to be on inotropic agents at the time of transplant (68% vs. 6%, p<.01). One-year post-transplant survival was not significantly different between the two groups on univariable (HR .87, 95% CI .56-1.37) or multivariable analysis (aHR .63, 95% CI .37-1.07). Following the UNOS allocation policy change, Impella utilization has increased with no significant difference in 1-year survival compared to bridge with durable LVADs. Impella may be a reasonable alternative to durable LVADs in select patients.

Right ventricular adaptation to isolated temporary left ventricular support for cardiogenic shock

Abstract Background Acute right ventricular (RV) failure is a well-described, yet not completely understood, complication of durable left ventricular assist device (LVAD) implantation. Although temporary percutaneous LVAD may have a similar hemodynamic impact on the RV, evidence in this setting is minimal. Purpose This study aims to assess the acute adaptation of the RV to isolated left side support with the Impella device in cardiogenic shock (CS). Methods Consecutive patients assisted with an Impella device and monitored with a pulmonary artery catheter in two tertiary centres between September 2018 and November 2021 were included. Clinical and hemodynamic data were retrospectively recorded at the baseline and up to 72 hours after the implantation of the pLVAD and analysed. Two subgroups analysis were performed to test the chance of a different trend on the basis of baseline RV hemodynamics and of the cause of CS. Results Forty-eight consecutive patients were included; median age was 61 (51.5–70.5) years, 83.3% were male. 54.2% presented with SCAI (Society for Cardiovascular Angiography and Interventions) stage D cardiogenic shock [1], mostly due to myocardial infarction (AMI-CS 56.3%). Impella support was associated with a relevant improvement of the systemic perfusion and left ventricular (LV) loading condition (Table 1). At 24 hours, cardiac output improved from 3.4 (2.6–4.2) to 4.0 (3.0–5.5) L/min, p&amp;lt;0.01; lactate decreased from 3.2 (1.65–6.3) to 1.55 (1.25–2.35) mmol/L, p&amp;lt;0.01. An improvement of RV afterload, reflected by a mean pulmonary arterial pressure dropping from 31.5 (25–38.5) to 25.5 (22–32.5) mmHg, p&amp;lt;0.01, was associated with a trend toward an improvement of the right atrial pressure (RAP, from 15.8±7.3 to 13.3±5.9 mmHg, p=0.05) and a stability of the pulmonary artery pulsatility index (PAPi) from 1.08 (0.72–1.5) to 1.19 (0.83–1.64), p=0.11. When stratifying patients by RV hemodynamic parameters at baseline [2], a significantly more pronounced improvement of RAP, RAP/pulmonary capillary wedge pressure (PCWP) and PAPi in the first 24 and 48 hours was seen in those who had poor RV hemodynamics at the baseline (Table 2). Thus, at 24 and 48-hours no differences were detectable anymore in RV hemodynamic parameters between the subgroup with and without RV dysfunction at the baseline evaluation. When stratifying patients by CS aetiology, those with a non-ischemic cause of CS showed a trend toward progressively better parameters of RV function than patients with AMI-CS [median PAPi at 48 hours 1.55 (0.85–2.89) versus 1 (0.73–1.47) in AMI-CS, p=0.1; median RAP/PCWP at 48 hours 0.68 (0.55–0.81) versus 0.89 (0.77–0.92) in AMI-CS, p=0.01]. Conclusion In this cohort of patients with cardiogenic shock undergoing isolated LV support a significant improvement of systemic perfusion and LV loading condition was followed by a tendency towards an improvement of right ventricular function, even in patients with compromised RV hemodynamic profiles at baseline. Funding Acknowledgement Type of funding sources: None.

MT3 Completeness and Concordance between Electronic Medical Records (EMR) and Submitted Insurance Claims in German Hospitals Utilizing Percutaneous Left Ventricular Assist Devices (PLVADS): Considerations for Outcomes Research

Real-World Evidence (RWE) are being used to assess medical technologies. Within the context of complex conditions that challenge traditional research designs, RWE research supports the safety, efficacy, and long-term effectiveness of innovations. Nevertheless, little is known on exactly how many and how well various covariates are captured in systems designed originally for financial needs instead of clinical research. Failure to appropriately differentiate records can lead analyses to inappropriate conclusions.

Analogue Mean Systemic Filling Pressure: a New Volume Management Approach During Percutaneous Left Ventricular Assist Device Therapy

The absence of an accepted gold standard to estimate volume status is an obstacle for optimal management of left ventricular assist devices (LVADs). The applicability of the analogue mean systemic filling pressure (Pmsa) as a surrogate of the mean circulatory pressure to estimate volume status for patients with LVADs has not been investigated. Variability of flows generated by the Impella CP, a temporary LVAD, should have no physiological impact on fluid status. This translational interventional ovine study demonstrated that Pmsa did not change with variable circulatory flows induced by a continuous flow LVAD (the average dynamic increase in Pmsa of 0.20 ± 0.95 mmHg from zero to maximal Impella flow was not significant (p = 0.68)), confirming applicability of the human Pmsa equation for an ovine LVAD model. The study opens new directions for future translational and human investigations of fluid management using Pmsa for patients with temporary LVADs.