Left Ventricular Assist Devices Type Research Articles

Associated factors and percentage of cardiac recovery among patients using LVAD: a meta-analysis of 31 studies

Abstract Introduction Patients with advanced heart failure use left ventricular assist devices (LVAD) to improve their outcomes and enhance the reverse remodeling of the heart. There has been no previous meta-analysis on the percentage of cardiac recovery after LVAD. This study aims to find the pooled percentage of cardiac recovery after LVAD. Methods A systematic search was done in PubMed, Scopus, Web of Science, Embase, and Cochrane from inception to December 2023. We used the relevant keywords to include studies that reported the percentage of people who achieved cardiac recovery after LVAD. The percentage of participants using LVAD and achieving cardiac recovery was extracted from the studies. RevMan 5.4 was used for meta-analysis. Results Thirty-two studies totaling 39215 patients were included. Different types of LVAD were used among participants. Across studies, different definitions for cardiac recovery were used, and the most used one is device explant following cardiac recovery and achieving left ventricular ejection fraction (LVEF) ≥ 40% after using LVAD. The pooled percentage of people who achieved cardiac recovery was 5.06%, 95% CI [4.17, 5.95], and the result was heterogeneous (I2 = 94%, p < 0.00001). Shorter duration of heart failure, female gender, younger age, presence of Implantable cardioverter-defibrillator (ICD) and low left ventricular end-diastolic diameter (LVEDD) were the most common mentioned factors associated with cardiac recovery. Conclusion Low cardiac recovery was found in patients using LVAD, and several factors were associated with cardiac recovery. Further action could be taken to improve the recovery among this population.

Optimal anticoagulation strategy for left ventricular assist device patients undergoing thoracentesis: a retrospective study

Abstract Background Left ventricular assist devices (LVADs) are associated with thromboembolic risks necessitating anticoagulation, yet balancing these risks with bleeding concerns remains challenging. Current practice involves warfarin with a target INR of 2-3 alongside anti-platelet therapy. However, consensus on anticoagulation management is lacking, particularly during sub-therapeutic INR or procedural settings. Common strategies include bridging anticoagulation with heparin or enoxaparin, temporary cessation of anticoagulation during the procedure or uninterrupted anticoagulation. Purpose To evaluate and compare the incidence of bleeding and thromboembolic events in LVAD patients undergoing thoracentesis, with a focus on determining the optimal anticoagulation strategy during procedures. Methods Retrospective data was collected over one year from LVAD patients undergoing thoracentesis at a large academic center. Patients were categorized into ‘bridge’ (received intravenous heparin for bridging during thoracentesis) and ‘no-bridge’ (did not receive bridging anticoagulation) groups. Warfarin was paused before procedure and resumed after procedure in both groups. Baseline characteristics, including age, sex, race, BMI, LVAD type, and INTERMACS profile, were recorded. Primary outcomes were major bleeding and thromboembolic events within 30 days of warfarin cessation. Statistical analysis used t-test/Wilcoxon for continuous variables and Chi-square/Fisher exact test for categorical variables. A p-value <0.05 was considered significant. Results During the study, twenty LVAD patients underwent thirty-two thoracenteses (nineteen bridge, thirteen no-bridge). The demographics were similar among the two groups. Warfarin was held for an average of 5.5 ± 4.6 days before and resumed 4.1 ± 4.6 days after the procedure in the bridge group and 3.8± 3.2 days before and 1.7 ± 2.5 days after in the no-bridge group. Major bleeding occurred in 73.7% of bridge group cases versus 30.8% of no-bridge group cases (p=0.059). 63.2% of bridge group patients had a bloody pleural effusion on thoracentesis compared to 46.2% of no-bridge group patients (p value= 0.34). Average transfusion requirements were 2.8 units and 2 units in the bridge and the no-bridge groups respectively (p=0.658). Thromboembolic events included a 10.5% ischemic CVA rate in the bridge group, with none in the no-bridge group. No other arterial thromboembolic events, pump thrombosis or DVT/PE were observed in either group. Conclusion In LVAD patients undergoing thoracentesis, a non-bridging strategy does not appear to elevate the risk of thrombosis compared to a bridging approach. Moreover, the incidence of bleeding, while not statistically significant, trended higher in the bridging group.

Left ventricular assist device in the presence of subcutaneous implantable cardioverter defibrillator: data from a multicenter experience

Abstract Background Left ventricular assist devices (LVADs) are an increasingly used strategy for the management of patients with advanced heart failure (HF).Subcutaneous implantable cardioverter defibrillator (S-ICD) might be a viable alternative to conventional ICDs, with a lower risk of short- and long-term of device-related complications and infections. Purpose:The aim of this multicenter study was to evaluate the outcomes and management of S-ICD recipients who underwent LVAD implantation. Methods:The study population included patients with an S-ICD who underwent LVAD implantation for advanced HF despite optimal medical therapy. Results:The study population included 30 patients (25 male;median age 45 [38-52] years).The HeartMate III was the most common LVAD type. Median follow-up in the setting of concomitant use of S-ICDs and LVADs was 7 months (1-20).There were no reports of inability to interrogate S-ICD systems in this population.Electromagnetic interference (EMI) occurred in 21 (70%) patients.The primary sensing vector was the one most significantly involved in determining EMI.Twenty-seven patients (90%) remained eligible for S-ICD implantation with at least one optimal sensing vector.The remaining 3 patients (10%) were ineligible for S-ICD after attempts of reprogramming of sensing vectors. Six patients (20%) experienced inappropriate shocks due to EMI. Six patients (20%) experienced appropriate shocks.No S-ICD extraction because of need for antitachycardia pacing,ineffective therapy or infection was reported. Conclusions: Concomitant use of LVAD and S-ICD is feasible in most patients. However, the potential risk of EMI oversensing, IS,and undersensing in the post-operative period following LVAD implantation should be considered.Careful screening for EMI should be performed in all sensing vectors after LVAD implantation.

Multicenter evaluation of left ventricular assist device implantation with or without ECMO bridge in cardiogenic shock.

The efficacy of extracorporeal membrane oxygenation (ECMO) as a bridge to left ventricular assist device (LVAD) remains unclear, and recipients of the more contemporary HeartMate 3 (HM3) LVAD are not well represented in previous studies. We therefore undertook a multicenter, retrospective study of this population. INTERMACS 1 LVAD recipients from five U.S. centers were included. In-hospital and one-year outcomes were recorded. The primary outcome was the overall mortality hazard comparing ECMO versus non-ECMO patients by propensity-weighted survival analysis. Secondary outcomes included survival by LVAD type, as well as postoperative and one-year outcomes. One hundred and twenty-seven patients were included; 24 received ECMO as a bridge to LVAD. Mortality was higher in patients bridged with ECMO in the primary analysis (HR 3.22 [95%CI 1.06-9.77], p = 0.039). Right ventricular assist device was more common in the ECMO group (ECMO: 54.2% vs non-ECMO: 11.7%, p < 0.001). Ischemic stroke was higher at one year in the ECMO group (ECMO: 25.0% vs non-ECMO: 4.9%, p = 0.006). Among the study cohort, one-year mortality was lower in HM3 than in HeartMate II (HMII) or HeartWare HVAD (10.5% vs 46.9% vs 31.6%, respectively; p < 0.001) recipients. Pump thrombosis at one year was lower in HM3 than in HMII or HVAD (1.8% vs 16.1% vs 16.2%, respectively; p = 0.026) recipients. Higher mortality was observed with ECMO as a bridge to LVAD, likely due to higher acuity illness, yet acceptable one-year survival was seen compared with historical rates. The receipt of the HM3 was associated with improved survival compared with older generation devices.

Role of Genetic Polymorphisms in the Development of Complications in Patients with Implanted Left Ventricular Assist Devices: HeartWare, HeartMate II, and HeartMate 3

Left ventricular assist device (LVAD) implantation is one of the mechanical circulatory support (MCS) treatments for advanced heart failure (HF) patients. MCS has emerged as a lifesaving therapy that improves patients’ quality of life. However, MCS remains limited by a paradoxical coagulopathy accompanied by thrombosis and bleeding. The mechanisms of MCS thrombosis are increasingly being defined, but MCS-related bleeding, which is related to shear-mediated alteration of platelet function, remains poorly understood. Complications might develop due to the high non-physiological shear stress in the device and as a consequence of individual variability in response to the antithrombotic therapy. Thromboelastography (TEG) and genotyping of gene polymorphisms that are involved in the coagulation cascade and in the metabolism of the antithrombotic therapy might be valuable sources of information for the reduction of complication development. The aim of the study was to identify genetic factors related to the development of device complications according to the implanted LVAD type. We compared the clinical and genetic data of HF patients (n = 98) with/without complications with three types of implanted devices: HeartWare HVAD (HW), HeartMate II (HMII), and HeartMate 3 (HM3). rs9923231 in VKORC1 (95%CI −6.28–0.22, p = 0.04) and rs5918 in ITGB3 genes (95%CI 0.003–4.36, p = 0.05) showed significant association with the TEG coagulation index parameter, which identified hyper- and hypo-coagulation states. The wild genotype of rs5918 in the ITGB3 gene prevailed in patients implanted with HM3 devices, which developed fewer complications than with HMII (p = 0.04). Individual genetic information could be useful in the management of patients with HF and the implantation of MCS to reduce the development of complications.

Abstract 15045: Impact of Left Ventricular Assist Device (LVAD) Type on Arrhythmic Outcomes in Patients With Continuous Flow LVADs

Introduction: Cardiac arrhythmias are common in continuous flow left ventricular assist device (LVAD) recipients. The impact of axial vs. intrapericardial centrifugal LVAD pumps on arrhythmia incidence and associated clinical outcomes is unclear. Hypothesis: This multicenter study evaluated the impact of LVAD type (axial vs. centrifugal) on incidence of atrial and ventricular arrhythmias, ICD shocks and mortality in LVAD patients. Methods: Analysis was done on 536 patients who underwent LVAD implantation at 5 US centers from 2008 to 2016. The groups were divided based on their LVAD type (axial - HeartMate II [HMII, n=433] vs. centrifugal - HeartWare (HW, n=103). Baseline characteristics as well as incidence of post-LVAD atrial arrhythmias (PL-AA), ventricular arrhythmias (PL-VA) and ICD shocks were analyzed in these groups. Multivariable Cox Regression analysis was used to identify predictors of survival. Results: Of 536 patients, 433 had HMII axial LVAD and 103 had HW centrifugal VAD implant. At baseline, HMII group had more males, higher proportion of CRT-D and higher prevalence of AA (Table 1A). Left ventricular dimensions were similar between groups. During a median follow-up of 537 days of LVAD support, incidence of PL-VA and ICD shocks were significantly higher in the HM2 group compared to HW group whereas incidence of PL-AA was not significantly different (Table 1A). In multivariable Cox Regression analysis, LVAD indication was the only variable that predicted survival (Table 1B). Type of LVAD (axial vs. centrifugal) was not associated with survival (HMII vs. HW - HR 1.04, P=0.48). Conclusions: In this multi-center continuous flow LVAD cohort, axial HM2 VAD patients had a higher incidence of PL-VA and ICD shocks. Type of LVAD (axial vs. centrifugal) was not associated with survival.

Feasibility and role of echocontrast evaluation of patients with LVAD

Abstract Background Advanced heart failure is a clinical syndrome characterized by persistent or progressive symptoms of heart failure despite optimal medical therapy. Left ventricular assist device (LVAD) brings survival benefits and improvement in quality of life, compared with conventional medical treatments. Development of Right ventricle failure in patients with LVAD has a direct effect on mortality and hospitalization. Purpose Evaluation of clinical safety and feasibility of echocontrast in patients implanted with 3 different types of LVAD; improvement in the visualization of heart structures; intra and inter-operator agreement of RV assesement with and without contrast. Methods 43 patients were implanted with LVAD, 7 patients (16%) with Jarvik 2000, 31 (72%) with HeartMAte 3, 5 (12%) with (HeartWAre HVAD). Nine patients (21%) had contraindication or refused contrast. In 3 (7%) patients was technically challenging to obtain apical images at all levels. Two (5%) patients lost their follow-up. Our final population was of 29 (67%) patients (mean age 65±7 y; 100% Male). We assessed the reproducibility of these measurements between two different expert blind operators. Results Total 329 (64%) of 516 RV wall segments were available for qualitative analysis without contrast vs 451 (87%) with contrast (p&amp;lt;0.001) with a significant improvement of the evaluability of regional contractility (especially due to the better evaluation of medial and apical segments of lateral and anterior walls) and FAC (41% vs 90%, p&amp;lt;0.001). Evaluation of TAPSE, TR and sPAP was similar with and without contrast (p=NS). All the RV parameters showed little inter-operator variability when measured with contrast. TAPSE, FAC, and RWMA showed an excellent reproducibility (ICC &amp;gt;0.86) while it was good for 2D-baseline derived parameters (ICC = 0.74) showing improvement of inter operator reproducibility in the evaluation of regional contractility in the contrast echocardiography modality. Conclusion EC is safe with all the types of LVAD examined. Accurate and reproducible visualization of RV is imperative for reliability of information, a routine use of EC could play a pivotal role in interpreting RV features. EC improves RV morphologic and functional judgment allowing greater accuracy and precision in the assessment of both global and regional RV functions. This finding may have important clinical improvement, especially in the future for analysis focused in RV prognostic role in LVAD patients. Funding Acknowledgement Type of funding sources: None.

P104 FEASIBILITY AND ROLE OF ECHOCONTRAST EVALUATION IN PATIENTS WITH LVAD

Abstract Background Advanced heart failure is a clinical syndrome characterized by persistent or progressive symptoms of heart failure despite optimal medical therapy. Left ventricular assist device (LVAD) brings survival benefits and improvement in quality of life, compared with conventional medical treatments. Development of Right ventricle failure in patients with LVAD has a direct effect on mortality and hospitalization. Purpose evaluation of clinical safety and feasibility of echocontrast in patients implanted with 3 different types of LVAD; improvement in the visualization of heart structures; intra and inter–operator agreement of RV assesement with and without contrast. Methods 43 patients were implanted with LVAD, 7 patients (16%) with Jarvik 2000, 31 (72%) with HeartMAte 3, 5 (12%) with (HeartWAre HVAD). Nine patients (21%) had contraindication or refused contrast. In 3 (7%) patients was technically challenging to obtain apical images at all levels. Two (5%) patients lost their follow–up. Our final population was of 29 (67%) patients (mean age 65±7 y; 100% Male). We assessed the reproducibility of these measurements between two different expert blind operators Results Total 329 (64%) of 516 RV wall segments were available for qualitative analysis without contrast vs 451 (87%) with contrast (p &amp;lt; 0.001) with a significant improvement of the evaluability of regional contractility (especially due to the better evaluation of medial and apical segments of lateral and anterior walls) and FAC (41% vs 90%, p &amp;lt; 0.001). Evaluation of TAPSE, TR and sPAP was similar with and without contrast (p=NS). All the RV parameters showed little inter–operator variability when measured with contrast. TAPSE, FAC, and RWMA showed an excellent reproducibility (ICC &amp;gt;0.86) while it was good for 2D–baseline derived parameters (ICC = 0.74) showing improvement of inter operator reproducibility in the evaluation of regional contractility in the contrast echocardiography modality. Conclusion EC is safe with all the types of LVAD examined. Accurate and reproducible visualization of RV is imperative for reliability of information, a routine use of EC could play a pivotal role in interpreting RV features. EC improves RV morphologic and functional judgment allowing greater accuracy and precision in the assessment of both global and regional RV functions. This finding may have important clinical improvement, especially in the future for analysis focused in RV prognostic role in LVAD patients.

Hemodynamic Optimization Of Left Ventricular Assist Devices During Right Heart Catheterization Ramp Studies

Background : Studies have shown that the hemodynamic measurements taken during a Left Ventricular Assist Device (LVAD) ramp study can be used to optimize LVAD speed and improve clinical outcomes, yet these studies lack external validation. Methods : 470 patients, including 3 LVAD subtypes, were retrospectively analyzed at Penn State Hershey Medical Center from January 2015 to September 2020 and 53 ramp studies were identified. Measurements (RA, mean PA, PCWP, and CI) were taken at speeds +/- 20% of manufacturer recommended set speed for HM2, HM3, and HVAD devices. Primary outcomes were all-cause and heart failure (HF) hospitalizations in the 6-month period pre- and post-ramp study. Secondary outcomes included final LVAD speed and hemodynamic measurements following ramp study. Subgroup analysis was performed on LVAD type and subjects who underwent LVAD speed change. Time to first hospitalization and cumulative incidence rate of all-cause and HF hospitalization were reported. Results : 53 ramp studies were analyzed. Baseline characteristics included: mean age of 60.1 (+/- 10.9), 84.9% male, 56.6% ischemic etiology, 71.7% destination therapy, and average NYHA class and INTERMACS of 2.5 (+/- 0.7) and 5.9 (+/- 1), respectively. 38 of 53 studies (71.7%) showed PCWP decompression >20%, with average PCWP decompression of 51.2% (+/- 21.0%), and CI increase of 22.5% (+/- 18.7%). Optimal LVAD speeds were chosen to maintain CI > 2.2, PCWP < 15 and minimize RAP, in the absence of suction events. 31 (58.5%) of studies resulted in an LVAD speed change and 16 (30.2%) of studies resulted in diuretic change. All-cause and HF hospitalizations were significantly decreased in the 6-months following ramp studies compared the 6-months pre-ramp (total days hospitalized for all causes: 12.0 vs 26.6, p=0.0002; total days hospitalized for HF, 4.8 vs 22.1, p=0.00003). Time to first hospitalization was decreased in the subgroup of studies who underwent a speed change during ramp procedure, yet these differences were not statistically significant. Conclusion : This data externally validates previous work showing that LVAD hemodynamic ramp studies decrease hospitalizations. Future, prospective studies with a larger patient cohort and longer follow up time may elucidate specific hemodynamic targets to improve mortality and further reduce rehospitalizations. : Studies have shown that the hemodynamic measurements taken during a Left Ventricular Assist Device (LVAD) ramp study can be used to optimize LVAD speed and improve clinical outcomes, yet these studies lack external validation. : 470 patients, including 3 LVAD subtypes, were retrospectively analyzed at Penn State Hershey Medical Center from January 2015 to September 2020 and 53 ramp studies were identified. Measurements (RA, mean PA, PCWP, and CI) were taken at speeds +/- 20% of manufacturer recommended set speed for HM2, HM3, and HVAD devices. Primary outcomes were all-cause and heart failure (HF) hospitalizations in the 6-month period pre- and post-ramp study. Secondary outcomes included final LVAD speed and hemodynamic measurements following ramp study. Subgroup analysis was performed on LVAD type and subjects who underwent LVAD speed change. Time to first hospitalization and cumulative incidence rate of all-cause and HF hospitalization were reported. : 53 ramp studies were analyzed. Baseline characteristics included: mean age of 60.1 (+/- 10.9), 84.9% male, 56.6% ischemic etiology, 71.7% destination therapy, and average NYHA class and INTERMACS of 2.5 (+/- 0.7) and 5.9 (+/- 1), respectively. 38 of 53 studies (71.7%) showed PCWP decompression >20%, with average PCWP decompression of 51.2% (+/- 21.0%), and CI increase of 22.5% (+/- 18.7%). Optimal LVAD speeds were chosen to maintain CI > 2.2, PCWP < 15 and minimize RAP, in the absence of suction events. 31 (58.5%) of studies resulted in an LVAD speed change and 16 (30.2%) of studies resulted in diuretic change. All-cause and HF hospitalizations were significantly decreased in the 6-months following ramp studies compared the 6-months pre-ramp (total days hospitalized for all causes: 12.0 vs 26.6, p=0.0002; total days hospitalized for HF, 4.8 vs 22.1, p=0.00003). Time to first hospitalization was decreased in the subgroup of studies who underwent a speed change during ramp procedure, yet these differences were not statistically significant. : This data externally validates previous work showing that LVAD hemodynamic ramp studies decrease hospitalizations. Future, prospective studies with a larger patient cohort and longer follow up time may elucidate specific hemodynamic targets to improve mortality and further reduce rehospitalizations.

Gastrointestinal Bleeding After LVAD Implantation: Is It Predictable?

Purpose Non-surgical bleeding (NSB) is one of the major clinical complications in patients under continuous-flow left ventricular assist device (LVAD) support. Previous studies showed an altered platelet receptor composition in response to increased shear stress and bleeding events in LVAD patients. We investigated if the platelet receptor composition of patients with bleeding complications differs from patients without bleeding complications prior to LVAD implantation. Methods Blood samples were obtained prior to LVAD implantation and at regular follow up-visits after LVAD implantation. The bleeder group consisted of 18 consecutive LVAD patients with postoperative NSB that were matched by age and gender with LVAD patients without NSB (non-bleeder group, n=18). Platelet receptor expression of GPIbα, GPIIb/IIIa, P-selectin and CD63 as well as intra-platelet oxidative stress levels were quantified by flow cytometry. Further we documented clinical characteristics, aggregation capacity and von Willebrand factor (vWF) diagnostic of all patients. Results Bleeders and non-bleeders were comparable regarding their age at study begin, gender, LVAD type, vWF antigen, vWF activity, vWF collagen-binding activity, and the aggregation capacity before and after LVAD implantation (p>0.05). LVAD patients in the bleeder group suffered from gastrointestinal bleeding (44%; n=8), epistaxis (28%; n=5), hematuria (28%; n=5), and from cerebral bleeding (11%; n=2). The analysis of platelet receptor expression showed that the percentage of P-selectin-positive platelets and the relative quantity of GPIIb/IIIa molecules on platelets were decreased in bleeders (GPIIb/IIIa: 26.900 ± 13.608 U; P-selectin: 7.2 ± 2.6%) compared to non-bleeders (GPIIb/IIIa: 36.259 ± 9.914 U; p = 0.024; P-selectin: 12.4 ± 8.1%; p = 0.016) prior to LVAD implantation. Conclusion In this pilot study, we observed a restricted surface expression of the two platelet receptors P-selectin and GPIIb/IIIa prior to LVAD implantation in patients who suffer from NSB during LVAD support. We hypothesized that P-selectin and GPIIb/IIIa may be suitable markers to identify patients at risk for LVAD-related NSB prior to LVAD implantation. Non-surgical bleeding (NSB) is one of the major clinical complications in patients under continuous-flow left ventricular assist device (LVAD) support. Previous studies showed an altered platelet receptor composition in response to increased shear stress and bleeding events in LVAD patients. We investigated if the platelet receptor composition of patients with bleeding complications differs from patients without bleeding complications prior to LVAD implantation. Blood samples were obtained prior to LVAD implantation and at regular follow up-visits after LVAD implantation. The bleeder group consisted of 18 consecutive LVAD patients with postoperative NSB that were matched by age and gender with LVAD patients without NSB (non-bleeder group, n=18). Platelet receptor expression of GPIbα, GPIIb/IIIa, P-selectin and CD63 as well as intra-platelet oxidative stress levels were quantified by flow cytometry. Further we documented clinical characteristics, aggregation capacity and von Willebrand factor (vWF) diagnostic of all patients. Bleeders and non-bleeders were comparable regarding their age at study begin, gender, LVAD type, vWF antigen, vWF activity, vWF collagen-binding activity, and the aggregation capacity before and after LVAD implantation (p>0.05). LVAD patients in the bleeder group suffered from gastrointestinal bleeding (44%; n=8), epistaxis (28%; n=5), hematuria (28%; n=5), and from cerebral bleeding (11%; n=2). The analysis of platelet receptor expression showed that the percentage of P-selectin-positive platelets and the relative quantity of GPIIb/IIIa molecules on platelets were decreased in bleeders (GPIIb/IIIa: 26.900 ± 13.608 U; P-selectin: 7.2 ± 2.6%) compared to non-bleeders (GPIIb/IIIa: 36.259 ± 9.914 U; p = 0.024; P-selectin: 12.4 ± 8.1%; p = 0.016) prior to LVAD implantation. In this pilot study, we observed a restricted surface expression of the two platelet receptors P-selectin and GPIIb/IIIa prior to LVAD implantation in patients who suffer from NSB during LVAD support. We hypothesized that P-selectin and GPIIb/IIIa may be suitable markers to identify patients at risk for LVAD-related NSB prior to LVAD implantation.

Progression of aortic valve insufficiency during centrifugal versus axial flow left ventricular assist device support.

Long-term left ventricular assist device (LVAD) support can cause accelerated progression of aortic insufficiency (AI). The MOMENTUM trial has led to increased use of the HeartMate 3 (HM3) LVAD, due to greater hemocompatibility. However, the differential effect on the rate of progression of AI during HM3 support versus HeartMate 2 (HM2) has not been extensively studied. This analysis compares the rates of progression to moderate or severe AI (MSAI) comparing a cohort of patients supported with the HM2 versus HM3. A retrospective review was performed on all consecutive patients implanted with HM2 or HM3 between May 2005 and June 2020. Follow-up time was limited to the first 6 years after LVAD implantation. Demographics and 4005 echocardiograms were assessed for 536 HM2 and 300 HM3 patients. The primary end point was progression to MSAI. Univariable and multivariable Cox proportional hazard regression and landmark analyses were performed. Progression to MSAI was greater in the HM2 (17%) versus HM3 (9.9%) cohort. On the univariable analysis, the hazard ratio for HM3 was 0.581 (95% confidence interval 0.370-0.909, P = 0.02) whereas on multivariable analysis hazard ratio was 0.624 (95% confidence interval 0.386-1.008, P = 0.0537). Preoperative AI, female sex and body surface area <2 were significantly associated with progression to MSAI. Landmark analysis suggests that LVAD type has the most significant effect on progression to MSAI between 1 and 2 years post-implantation. Current practice strategies achieved low rates of progression to MSAI. Preoperative AI, female sex and body surface area <2 were the most important predictors of progression to MSAI. Pump type appears to be of secondary importance.

Feasibility and role of echocontrast evaluation of patients with LVAD

Abstract Funding Acknowledgements Type of funding sources: None. Background In patients with Advanced heart failure (AHF) long-term support with durable mechanical circulatory support (MCS) devices such as left ventricular assist device (LVAD) brings survival benefits and improvement in quality of life, compared with conventional medical treatments. Development of RVF in patients with LVAD has a direct effect on mortality and is associated with prolonged length of stay in intensive care unit and in-hospital stay and with poor quality of life. Purpose: the evaluation of clinical safety and feasibility of echocontrast (EC) in patients implanted with 3 different types of LVAD (HeartWAre HVAD, Jarvik 2000, HeartMate 3); the assessment of the improvement in the visualization of heart structures; the intra and inter-operator agreement of RV measurements (FAC, TAPSE, sPAP, TR, regional wall motion abnormalities) with and without contrast. Methods: Between 2014 and 2019, 43 patients were implanted with LVAD, in particular 7 (16%) patients were implanted with Jarvik 2000, 31 (72%) with HeartMAte 3, 5 (12%) pts with HeartWAre HVAD. Nine patients (21%) either had contraindication or refused contrast injection. In 3 (7%) patients, it was technically challenging to obtain apical images at all levels. Two (5%) patients lost their follow-up. Our final population was of 29 (67%) patients. We also assessed the reproducibility of these measurements between two different expert operators (blind analysis). Results: We observed no allergic reaction to EC. Total 329 (64%) of 516 RV wall segments were available for qualitative analysis without contrast vs 451 (87%) with contrast (p &amp;lt; 0.001) with a significant improvement of the evaluability of regional contractility and FAC (41% vs 90%, p &amp;lt; 0.001). Evaluation of TAPSE, TR and sPAP was similar with and without contrast (p = NS) All the RV parameters showed little inter-operator variability when measured with contrast. TAPSE, FAC, and RWMA showed an excellent reproducibility (ICC &amp;gt;0.86) while it was good for 2D-baseline derived parameters (ICC = 0.74) showing improvement of inter operator reproducibility in the evaluation of regional contractility in the contrast echocardiography modality. Conclusion: EC is safe with all the types of LVAD we examined. Accurate and reproducible visualization of RV is imperative for reliability of information, a routine use of EC could play a pivotal role in interpreting RV features. EC improves RV morphologic and functional judgment; allowing greater accuracy and precision in the assessment of both global and regional RV functions. This finding may have important clinical improvement, especially in the future for analysis focused in RV prognostic role in LVAD patients

A Flow Sensor-Based Suction-Index Control Strategy for Rotary Left Ventricular Assist Devices.

Rotary left ventricular assist devices (LVAD) have emerged as a long-term treatment option for patients with advanced heart failure. LVADs need to maintain sufficient physiological perfusion while avoiding left ventricular myocardial damage due to suction at the LVAD inlet. To achieve these objectives, a control algorithm that utilizes a calculated suction index from measured pump flow (SIMPF) is proposed. This algorithm maintained a reference, user-defined SIMPF value, and was evaluated using an in silico model of the human circulatory system coupled to an axial or mixed flow LVAD with 5–10% uniformly distributed measurement noise added to flow sensors. Efficacy of the SIMPF algorithm was compared to a constant pump speed control strategy currently used clinically, and control algorithms proposed in the literature including differential pump speed control, left ventricular end-diastolic pressure control, mean aortic pressure control, and differential pressure control during (1) rest and exercise states; (2) rapid, eight-fold augmentation of pulmonary vascular resistance for (1); and (3) rapid change in physiologic states between rest and exercise. Maintaining SIMPF simultaneously provided sufficient physiological perfusion and avoided ventricular suction. Performance of the SIMPF algorithm was superior to the compared control strategies for both types of LVAD, demonstrating pump independence of the SIMPF algorithm.

Cognition predicts days-alive-out-of-hospital after LVAD implantation.

Cognition influences hospitalization rates for a variety of patient groups but this association has not been examined in heart failure (HF) patients undergoing left ventricular assist device (LVAD) implantation. We used cognition to predict days-alive-out-of-hospital (DAOH) in patients after LVAD surgery. We retrospectively identified 59 HF patients with cognitive assessment prior to LVAD. Cognitive tests of attention, memory, language, and visual motor speed were averaged into one score. DAOH was converted to a percentage based on total days from LVAD surgery to either heart transplant or 900 days post-LVAD. Variables significantly associated with DAOH in univariate analyses were included in a linear regression model to predict DAOH. A linear regression model including LVAD type (continuous or pulsatile flow) and cognition significantly predicted DAOH (F(2,54) = 6.44, p = 0.003, R2 = .19). Inspection of each variable revealed that cognition was a significant predictor in the model (β = .11, SE = .04, p = 0.007) but LVAD type was not (p = 0.08). Cognitive performance assessed prior to LVAD implantation predicted how much time patients spent out of the hospital following surgery. Further studies are warranted to identify the impact of pre-LVAD cognition on post-LVAD hospitalization.

Carotid artery duplex velocity criteria might be equivocal after left ventricular assist device implantation

BackgroundAlthough conventional angiography remains the reference standard for the grading of carotid stenosis, carotid duplex ultrasound (CDUS) is the most commonly used modality for determining the degree of carotid stenosis. The validity of CDUS findings for patients after left ventricular assist device (LVAD) implantation is questionable, because the velocities are often altered secondary to the continuous flow nature of the devices. MethodsA retrospective review was performed of all patients who had undergone LVAD implantation from January 2007 to December 2019. All patients who had undergone CDUS before and after LVAD implantation were included. Patients receiving extracorporeal membrane oxygenation, those with unusable carotid imaging studies, and those with internal carotid artery (ICA) occlusion were excluded. The peak systolic velocity (PSV) and end-diastolic velocity (EDV) in the ICA and common carotid artery (CCA) and the ICA/CCA ratios were compared before and after LVAD implantation. ResultsA total of 36 patients (mean age 59 years; 30 men; 6 women) had undergone CDUS both before and after LVAD implantation (mean, 647 days between imaging studies). A total of 61 ICAs had met the criteria for inclusion. Before LVAD, 7 carotid arteries (13%) had had >50% carotid stenosis and 53 (87%) had had 0% to 50% stenosis. The mean changes in the velocities after LVAD were as follows. The ICA PSV had decreased by 6.12 ± 4.34 cm/s, and the ICA EDV had increased by 13.44 ± 4.23 cm/s. The CCA PSV had decreased by 17.22 ± 4.95 cm/s, and the CCA EDV had increased by 10.83 ± 2.59 cm/s. The mean ICA/CCA ratio had increased by 0.18 ± 0.05. All the mean changes in velocity were significant (P < .01), except for the ICA PSV (P = .167). Among four patients with known stenosis of 60% to 69%, the degree of increase in the ICA and CCA EDVs (75.8 and 13.3 cm/s, respectively) was significantly greater than that for patients with <50% or no stenosis. Carotid artery laterality did not significantly affect the differences in mean velocity. Centrifugal LVADs resulted in a significantly larger increase in the ICA EDV compared with axial LVADs (26.0 vs 6.3 cm/s; P < .01). ConclusionsLVADs were associated with significant changes in CCA PSV, ICA and CCA EDV, and ICA/CCA ratios. However, the magnitude of these changes in patients with <50% stenosis was minimal and might not be clinically significant. The LVAD type might only have an effect on EDV measurements in the CCA, and the left and right carotid arteries did not appear to have different degrees of change in velocity. The currently used criteria for determining carotid stenosis might result in an under- or overestimation of carotid stenosis in patients with an LVAD.

Survival Outcomes with Regards to Implant Strategies in Heart Transplantation

Purpose Strategies underlying the use of Left ventricular assist devices (LVAD) for patients with end-stage heart failure include its use as bridge to transplant (BTT) or as destination therapies (DT). Survival outcomes of patients undergoing these LVAD implant strategies were evaluated and compared. Methods A retrospective analysis of single center database heart transplant patients that received LVADs from Nov. 2009 to Sep. 2020 (n=137). Patients were placed into the following cohorts based on the implant strategy: 1) BTT (n=31), 2) DT (n=106). Demographics were compared between groups for significance. Kaplan Meier curves were calculated and compared via log rank tests, and Cox Regression Analysis was performed. P-values Results Demographics between the groups were: diagnosis (p=0.257), CPB time (p=0.957), XC time (p=0.763), ischemic time (p=0.478), warm ischemic time (p=0.332), age (p=0.323), race (p=0.067), length of stay (p=0.355) and PRA (p=0.701). Of 137 patients that received LVADs used for BTT or DT prior to heart transplant, the BTT group had better survival outcomes than DT (p=0.0467). Median survival time for DT group was 2554 days, and median survival time for BTT group was 3030 days. The type of LVADs used between the two groups were significantly different (p=0.0009), therefore cox regression was run to control for statistically significant variables, with device showing no significant effect on survival. In cox regression BTT had a protective effect over DT with a hazard ratio of 1.439, p=0.0364. Conclusion Implant strategies for LVAD as BTT or DT show a difference in survival outcomes for end-stage heart failure patients, however both had reasonable outcomes. This paper supports the current literature in that LVADs are viable for use in patients of all types, with slightly better effects in BTT patients.

Mean Arterial Pressure is Not Associated with Hemocompatibility-Related Outcomes in LVAD Patients

<h3>Purpose</h3> Elevated mean arterial pressure (MAP) is associated with stroke in patients with HeartMate II and Heartware HVAD left ventricular assist devices (LVADs). We assessed the relationship between mean arterial pressure (MAP) and hemocompatibility-related clinical adverse events (HRAE) in patients with LVADs. <h3>Methods</h3> Prospectively collected hemodynamic data from LVAD patients who had undergone invasive hemodynamic ramp study at our institution between 4/2014-7/2018 were analyzed. ROC analysis was performed to determine optimal cutoff value for MAP, and patients were divided into two groups: high MAP (≥90mmHg) and low MAP (<90mmHg). Hemocompatibility scores (HCS) were calculated based on HRAE. Univariate and multivariate logistic regression analyses were performed to determine the association between MAP with primary endpoints of HRAE, HCS, heart failure readmissions, and mortality. <h3>Results</h3> 91 patients (average age 61 ± 11 years, 34% women, 40% Black, 38% ischemic cardiomyopathy) were included in the analysis. Of all patients, 29% had HeartWare HVADs, 57% HeartMate II, and 14% HeartMate 3 LVADs. MAP was not significantly associated with HRAE, HR 1.53 (95% CI 0.88-2.64, p=0.13), even when adjusted for LVAD type, HR 1.65 (95% CI 0.95-2.87, p=0.076). Similarly, MAP was not significantly associated with HCS. Low MAP was, however, significantly associated with higher mortality, HR 2.47 (95% CI 1.13-5.39, p=0.024, Figure 1A), and higher rates of heart failure readmission, HR 2.05 (95% CI 1.06-3.99, p=0.034) (figure 1B). <h3>Conclusion</h3> MAP was not significantly associated with HRAE in this population of LVAD patients. However, low MAP was significantly associated with mortality and heart failure readmission.

Low Left Ventricular Stroke Work Index is Associated with a Poor Prognosis in LVAD Patients

<h3>Purpose</h3> Hemocompatibility-related adverse events (HRAE) are thought to be largely driven by the pump-patient interaction. We hypothesized that patients with left ventricular assist devices (LVADs) with low left ventricular stroke work index (LVSWI), and thus less native contribution to total flow, would have more adverse clinical outcomes. <h3>Methods</h3> Hemodynamic data was prospectively collected from LVAD patients who had undergone a right heart catheterization with ramp study at our institution between April 2014 and July 2018. LVSWI was calculated as 0.0136 * ((cardiac index/heart rate) * 1000) * (mean arterial pressure - pulmonary capillary wedge pressure). We used a previously identified cutoff point of 31.73 for LVSWI to separate patients into low and high LVSWI groups. Univariate and multivariate logistic regression analyses were performed to determine the association between LVSWI and HRAE, heart failure (HF) readmission, and mortality. <h3>Results</h3> A total of 93 patients were included in this analysis - average age 61 +/- 11 years, 34% women, 40% Black, and 38% ischemic cardiomyopathy. Low LVSWI was not significantly associated with HRAE (HR 1.65, 95% CI 0.93-2.91, p = 0.081) in univariate analysis, but was statistically significant (HR 1.81, 95% CI 1.02-3.22, p = 0.042) when adjusted for LVAD type (HeartWare HVAD, Heartmate II, and Heartmate 3). Low LVSWI was significantly associated with HF readmission (HR 3.02, 95% CI 1.46-6.24, p = 0.0029) and mortality (HR 2.97, 95% CI 1.29-6.85, p = 0.011), even when adjusted for LVAD type (HR 3.15, 95% CI 1.52-6.54, p = 0.0021 and HR 3.13, 95% CI 1.36-7.21, p = 0.0074, respectively). <h3>Conclusion</h3> Low LVSWI in LVAD patients is associated with poor prognosis and worse clinical outcomes such as increased HF readmission and mortality.

Cardiac Power Output and Cardiac Power Efficiency Show Prognostic Value in LVAD Patients

<h3>Purpose</h3> Hemocompatibility-related clinical adverse events (HRAE) are thought to be driven by the pump-patient interaction. We hypothesized that the hemodynamic variables cardiac power output (CPO) and cardiac power efficiency (CPE), which reflect underlying ventricular contribution, have prognostic value in patients with left ventricular assist devices (LVADs). <h3>Methods</h3> Prospectively collected hemodynamic data from patients with LVADs who had undergone invasive hemodynamic ramp study at our institution between 4/2014-7/2018 were analyzed. CPO [(mean arterial pressure x cardiac output)/451], cardiac power index (CPI) (CPO/body surface area), and CPE (CPI/ pulmonary capillary wedge pressure) were calculated. Patients were divided into groups of high and low CPO and CPE using ROC-derived cutoff values of 0.847W and 0.0552 WmmHg/m² respectively. Hemocompatibility scores (HCS) were also calculated for each patient based on their HRAE. Univariate and multivariate logistic regression analyses were performed to determine the association between CPO and CPE with primary endpoints of HRAE, HCS, heart failure readmissions, and mortality. <h3>Results</h3> 91 patients (average age 61 ± 11 years, 34% women, 40% Black, 38% ischemic cardiomyopathy) were included in the analysis. Low CPO was significantly associated with higher rates of HRAE, HR 2.02 (95% CI 1.12-3.66, p=0.02, Figure 1A). CPO was not significantly associated with mortality or heart failure readmission, HR 1.84 (95% CI 0.68-3.32, p=0.31) and HR 1.84 (95% CI 0.92-3.68, p=0.083), respectively. Low CPE was significantly associated with higher rates of HRAE, heart failure readmission (Figure 1B), and mortality (Figure 1C) when adjusted for LVAD type: HR 1.97 (95% CI 1.02-3.81, p=0.043), HR 3.11 (95% CI 1.28-7.58, p=0.012), and HR 3.41 (95% CI 1.18-9.88, p=0.024), respectively. <h3>Conclusion</h3> CPO and CPE demonstrate prognostic value in patients with LVADs, showing significant associations with HRAE, heart failure readmissions, and mortality.

Impact of Type of Left Ventricular Assist Device (LVAD) on Health-Related Quality of Life during Prolonged LVAD Support

Purpose Left ventricular assist devices (LVADs) have emerged as an important treatment option for bridging patients with heart failure to transplant. LVADs have shown improved survival; however, the impact of LVAD type on the quality of life (QoL) while on long-term LVAD support is unknown. We aimed to evaluate the QoL of patients while supported with a LVAD in Japan. Methods 299 patients enrolled in the Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS), who were listed for transplant or likely to be listed, received a LVAD from 2010 to 2018 and had full QoL data, were enrolled. QoL data, such as visual analogue scale (VAS) and EQ-5D-3L by 5 dimensions (5D: mobility, self-care, usual activities, pain/discomfort and anxiety/depression) before and at 3- and 12-months after implantation of a LVAD were obtained from the J-MACS Registry. These patients were divided into 3 groups; primary implantable LVAD (iLVAD) (N=263), primary paracorporeal LVAD (pLVAD) (N=9) and bridge from paracorporeal to implantable LVAD (BTB) (N=27). Results VAS in all groups significantly increased from before to 3- and 12-months after LVAD implantation(p Conclusion QoL as VAS and 5D were significantly improved after implantation of any LVAD type. However, VAS and 5D except anxiety/depression in patients with pLVAD were significantly lower and more problems than those in patients with iLVAD. These differences were eliminated by converting from pLVAD to iLVAD. BTB might be a beneficial treatment option to improve QoL as well as patient's survival.