HM3 Patients Research Articles

Application of donor predicted heart mass in heart transplant recipients with left ventricular assist device

IntroductionAn association between predicted heart mass (PHM) and post heart transplantation outcomes has been well established; however, there is limited data on the effect of donor PHM on recipients bridged with a durable left ventricular assist device (LVAD). This retrospective observational study seeks to challenge the theoretical benefit of oversizing donor hearts for recipients bridged with LVADs. MethodsAnalysis of the United Network for Organ Sharing (UNOS) database revealed 10,806 adult patients with one of three durable LVADs (HeartMate 2, HeartMate 3 [HM3], HeartWare [HVAD]) between January 1, 2015 and December 31, 2021. Baseline characteristics were compared between seven equally sized groups based on donor-to-recipient PHM. Univariable and multivariable Cox regression analyses were constructed to evaluate the effect of PHM size-matching on the primary outcome of 1-year post-transplant survival. Further analyses were performed specifically on HM3 patients and with PHM as a continuous variable. ResultsMultivariable analysis revealed that severely undersized donor hearts (PHM ratio < 0.86) resulted in worse outcomes with respect to 1-year mortality (HR 1.30; CI 1.03-1.64, p=0.03). There was no significant benefit to oversizing donor hearts. Similar results were found in patients bridged to transplant with HM3. ConclusionSimilar to prior studies on heart transplant recipients, recipients bridged with durable LVAD had worse outcomes when using severely undersized donor hearts. Oversized donor hearts did not significantly improve 1-year mortality, compared to size-matched references. These results were consistent in a subgroup analysis of patients bridged only with HM3 LVADs.

Health status analysis is comparable in HM3 patients with different preoperative grades of mitral regurgitation

BackgroundThe guidelines for mechanical circulatory support of the International Society for Heart and Lung Transplantation do not recommend the routine replacement or repair of the mitral valve at the time point of left ventricular assist device (LVAD) implantation. We investigated different parameters of health status including exercise capacity, anxiety and depression after LVAD implantation in patients with different preoperative grades of mitral regurgitation (MR).MethodsA single-center analysis of health status was performed including 45 patients with HeartMate 3 (HM 3) implantation using the 12-items Short Form Health Survey (SF-12) and the Hospital Anxiety and Depression Score (HADS) questionnaires. The study groups were classified according to echocardiographically defined preoperative grade of MR. The group without severe MR comprised 33 patients; the group with severe MR comprised 12 patients.ResultsDemographic and preclinical characteristics as well as LVAD complications such as thrombosis and bleeding events were comparable between LVAD patients with severe and not severe MR (p > 0.05). Severe MR resolved in all patients after LVAD implantation and improved to moderate, mild or no MR in both groups in a period ranging from 6 months until 2 years. The analyses of SF-12 questionnaire revealed that the physical (p = 0.44) and mental health (p = 0.64) was comparable. The grade of anxiety (p = 0.34) and depression (p = 0.44) was comparable between the groups. Exercise capacity measured by the 6 min walk test correlated positively with the SF-12-determined physical health (p < 0.01, r = 0.518) and negatively with the HADS anxiety (p = 0.01, r = −0.399) and depression (p < 0.01, r = −0.570) scores.ConclusionsOur data showed that the health status is comparable in HM 3 patients with different preoperative MR severities in the post-LVAD period. Preoperative severe MR resolves in the majority of patients early after LVAD implantation and is not associated with concomitant mitral valve repair or replacement at the time of LVAD implantation.

Use of Intracorporeal Durable LVAD Support in Children Using HVAD or HeartMate 3-A EUROMACS Analysis.

Purpose: The withdrawal of HVAD in 2021 created a concern for the pediatric population. The alternative implantable centrifugal blood pump HeartMate 3 has since been used more frequently in children. This paper analyses the outcome of children on LVAD support provided with an HVAD or HM3. Methods: A retrospective analysis of the EUROMACS database on children supported with VAD < 19 years of age from 1 January 2009 to 1 December 2021 was conducted. All patients with an LVAD and either an HVAD or HM3 were included. Patients with missing data on VAD status and/or missing baseline and/or follow up information were excluded. Kaplan-Meier survival analysis was performed to evaluate survival differences. Analyses were performed using Fisher's exact test. Results: The study included 150 implantations in 142 patients with 128 implants using an HVAD compared to 28 implants using an HM3. Nine patients (6%) needed temporary right ventricular mechanical support, which was significantly higher in the HM3 group, with 25% (p: 0.01). Patients in the HVAD group were significantly younger (12.7 vs. 14.5 years, p: 0.01), weighed less (45.7 vs. 60 kg, p: <0.000) and had lower BSA values (1.3 vs. 1.6 m2, p: <0.000). Median support time was 204 days. Overall, 98 patients (69%) were discharged and sent home, while 87% were discharged in group HM3 (p: ns). A total of 123 children (86%) survived to transplantation, recovery or are ongoing, without differences between groups. In the HVAD group, 10 patients (8%) died while on support, whereas in 12% of HM3 patients died (p: 0.7). Conclusions: Survival in children implanted with an HM3 was excellent. Almost 90% were discharged and sent home on the device.

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.

Evaluation of adjusted international normalized ratio goal in patients with HeartMate 3 left ventricular assist devices.

The HeartMate3 left ventricular assist device (HM3 LVAD) has shown a low incidence of thrombosis, but bleeding risk is as high as 43%. We aim to describe the impact of lower international normalization ratio (INR) goal on clinical outcomes. In February 2019, our tertiary care institution lowered INR goal in HM3 patients from manufacturer recommendations to 1.8-2.2 and retrospectively analyzed the data. Two cohorts were compared: patients with lower INR goal upon implant (De novo) and those with subsequently lowered INR goal (Adjusted). The Adjusted group also served as its own historical control. Both groups continued aspirin 81 milligrams daily per manufacturer recommendations. The primary outcomes were incidences of bleed and thrombosis events within 12 months. Secondary outcomes included survival free of disabling stroke or reoperation to remove or replace the device and Rosendaal time in therapeutic range (TTR) over 12 months. Thirty-one patients were evaluated for inclusion with 26 meeting criteria. Within 12 months, incidence of bleeding events was 25% and 28.6% in the De novo and Adjusted groups, respectively. Incidence of thrombotic events within 12 months was 0% in the De novo group and 7.1% in the Adjusted group. Twelve-month survival free of disabling stroke or reoperation to remove or replace the device was higher over 12 months for patients in the De novo group (91.7% vs. 78.6%). Median 12-month TTR was 36%, which was primarily attributable to subtherapeutic deviations. A lower INR goal may be safe when initiated De novo following implantation of the HM3. This study informs the need for larger prospective studies.

Noninvasive finger plethysmography for continuous blood pressure monitoring in patients with left ventricular assist device.

Accurate blood pressure (BP) measurement remains challenging in patients with HeartMate 3™ left ventricular assist devices (HM3 LVADs). The Finapres® NOVA is a promising non-invasive continuous BP monitor that uses the volume clamp method via a finger cuff, so here we aimed to validate the instrument in HM3 patients. In a single-center cohort, BP was monitored in 15 patients within 72 h following HM3 implantation. A radial artery catheter quantified arterial blood pressure (ABP), while the NOVA measured finger arterial pressure (fiAP) and reconstructed brachial artery pressure (reBAP). Waveforms were recorded for 10 min, and mean values were calculated in 15-s intervals. fiAP and ABP were moderately correlated during both the first (ICC 0.61, p = 0.04) and final measurements (ICC 0.66, p = 0.03). reBAP and ABP were strongly correlated during both the first (ICC 0.81, p = 0.002) and final measurements (ICC 0.83, p = 0.001). Both NOVA-derived values may underestimate low BP values while overestimating relatively high BP values. The reBAP was within 5 mm Hg of the ABP in 40% of patients (and within 10 mm Hg in 67%). This pilot represents the first evidence in support of the Finapres® NOVA for non-invasive BP measurement in select patients with HM3 LVADs. The instrument may provide useful data during BP medication adjustments or pump titration, but despite the correlation between the non-invasive reBAP and invasive ABP, individual-level inaccuracy may be clinically meaningful. Further investigation is needed to clarify these limitations and optimize accuracy before widespread adoption in this unique patient population.

Outcomes of modular cable exchange in HeartMate 3 patients versus conventional driveline repair in HeartMate II patients.

Driveline (DL) damages are a common difficulty among ventricular assist devices (VAD). Repairing the electrical fibers inside the DL on a running pump is hazardous and requires technical expertise, which is not easily available on site. A new feature of the HeartMate3 (Abbott, U.S.A.) LVAD is a modular driveline that allows an easy exchange of the DL cord. In this report we analyze our experiences with this feature. We performed a retrospective analysis of 302 patients who underwent either HeartMate II or HeartMate 3 implantation between February 2004 and September 2021. Patients were screened for driveline faults and need for exchange or repair of driveline or VAD exchange. Documented were baseline characteristics, reasons for DL or VAD exchange, and complications. Follow-up was three months after the procedure. We present a cohort of 302 patients who underwent either HMII (n=107;35.4%) or HM 3 (n=195; 64.5%) implantation. Out of those, 40 patients (40/302; 13.2%) required driveline repair (DLRe) or exchange (DLEx). Out of 107 HMII patients, 9 showed severe DL damages (9/107; 8.4%). Six patients (6/9; 66.6%) underwent DLRe, two patients (2/6; 33.3%) required VAD exchange after DLRe, one patient (1/2;50%) experienced emergency VAD exchange after pump stop. The DLRe procedure in the other four patients (4/6; 66.6%) was successful. Due to damage to the internal driveline two patients (2/9; 22.2%) underwent emergency device exchange and one patient (1/9;11.1%) was listed for transplantation. 31 out 195 HM3 patients underwent exchange of the modular DL. In none of the cases, damages of the internal fibers were the reasons for the exchange. In 100% of the cases, damages of the external coating were the reason for DL exchange. In none of the cases, complications occurred after the exchange procedure. Driveline damages are a habitual, recurrent complication in VAD patients. The exchange of the modular driveline cable of the HM3 is feasible and safe compared to the conventional DL repair in HMII patients. Risky repair attempts and surgical LVAD exchange due to major damages of the electrical fibers can be avoided successfully by the new feature of HM3 driveline.

Outcomes in Smaller Body Size Adults After HeartMate 3 Left Ventricular Assist Device Implantation

BackgroundOutcomes in patients with smaller body size after HeartMate 3 left ventricular assist device (HM3) implantation are not well characterized. We sought to evaluate outcomes in smaller vs larger body surface area (BSA) patients in the MOMENTUM 3 pivotal trial and its Continued Access Protocol cohort. MethodsThe analysis cohort included 1015 HM3 patients divided into 2 groups: BSA ≤1.70 m2 (small patients, n = 82) and BSA >1.70 m2 (large patients, n = 933). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or to remove a malfunctioning device. Adverse events were compared between groups. ResultsSmaller patients were more frequently women (56.1% vs 17.7%; P < .001) and had lower prevalence of diabetes (28.1% vs 43.9%; P = .005) and hypertension (51.2% vs 71.9%; P < .001), larger median indexed LVEDD (normalized by BSA, 40 vs 33 mm/m2; P < .001), and lower median serum creatinine concentration (1.1 vs 1.3 mg/dL; P < .001). The proportion of patients achieving the composite end point at 2 years was 77% in both groups (adjusted hazard ratio, 1.14; 95% CI, 0.68-1.91; P = .62). Two-year adverse event rates were also similar between groups except for sepsis (6.1% vs 14.9%; P = .029) and cardiac arrhythmias (24.4% vs 35.3%; P = .005), which were higher in the larger patients. ConclusionsOutcomes after HM3 implantation were comparable between small and large patients. Smaller body size should not be used to deny HM3 implantation in patients who are otherwise suitable candidates for durable mechanical circulatory support.

Right Ventricular Failure and Left Ventricular Transmural Pressure as Predictors of Successful Left Ventricular Unloading in Patients with HM 3 CF-LVAD

<h3>Purpose</h3> To investigate whether right ventricular failure was associated with impaired left ventricular (LV) unloading during Left Ventricular Assist Device (LVAD) speed optimization. <h3>Methods</h3> Patients with Heartmate (HM) 3 LVADs implanted between January 2016 and April 2021 who had undergone speed optimization using right heart catheterization within one year from the implant were identified. We included patients with inadequate LV unloading as demonstrated by a pulmonary capillary wedge pressure (PCWP) above 12mmHg. We grouped patients based on the presence of right ventricular (RV) failure, defined as a right atrial pressure (RAP) to PCWP ratio >0.8. We also studied the impact of left ventricular transmural pressure (LVTMP) as a surrogate for true LV preload. Mean changes with increased pump speed (per 100 RPM) in PCWP were determined by the generalized linear mixed model. Line plots were used to present the slope of PCWP. All the analyses were performed on Stata version 17.0 (StataCorp LLC, College Station, TX, USA). A p-value of <0.05 was considered statistically significant. <h3>Results</h3> Thirty-six patients were included in this study. The median age was 52.5±11.8, 86.1% were male, 77.8% were implanted as destination therapy, and the median number of RPM changes was 3.5. Patients with RA/PCWP>0.8 had a trend towards lower decrease in PCWP with pump speed increase compared to RA/PCWP ≤0.8 (-0.57 vs -0.72, P=0.06, Figure 1A). Reduced LVTMP, defined as PCWP-RAP ≤4 mmHg, was significantly associated with a decreased slope of PCWP reduction with LVAD speed (-0.44 vs -0.96, p=0.02, Figure 1B). <h3>Conclusion</h3> In patients with RV failure the unloading of the LV is impaired, likely due to reduced LVTMP which is a surrogate for true LV preload. The presence of RV failure should be taken into account in the optimization of the LV pressures with speed optimization in HM3 patients.

Adverse Events in HVAD vs. HM3 Patients under Outpatient Bridging with Low-Molecular Weight Heparin for Subtherapeutic Anticoagulation

<h3>Purpose</h3> The standard of care in patients with durable left-ventricular assist devices combines antiplatelet with anticoagulation therapy. Current guidelines recommend use of intravenous (IV) unfractionated heparin as bridge to therapeutic INR-values in the postoperative period. However, management of subtherapeutic INR in the ambulatory setting is not yet clearly defined by guidelines. The protocol at our center proposes the use of unfractionated heparin perioperatively and low-molecular weight heparin in outpatients. Therefore, we aimed to analyse outcomes in patients with continuous-flow LVAD (CF-LVAD). <h3>Methods</h3> In this single-center retrospective trial all patients after CF-LVAD implantation at our center were included between 1/2015 and 12/2020 (n=110 patients; HVAD n=80, HM3 n=30). Patients were followed up from initial discharge after LVAD implantation until death, heart transplantation or end of the observation period (9/2021). Bridging for subtherapeutic INR (≤ 0.4 below target INR) were provided with enoxaparin in a therapeutic dose adapted to weight and renal function. Only patients with an INR > 0.4 below target INR were admitted to hospital for bridging with IV unfractionated heparin. Bleeding events leading to hospital admission, cerebrovascular events and pump thromboses were evaluated and provided in percent of study population and/or events per patient year (eppy). <h3>Results</h3> Follow-up covers a total of 214.2 patient years. Overall mortality was 18.2 %. Bleeding events occurred in 42.7 %, of which GI bleeding constituted the largest group with 21.8 % (HVAD: 0.25 eppy; HM3: 0.05 eppy). Stroke/TIA/PRIND occurred in 5.5 % of the patients (HVAD: 0.07 eppy; HM3: 0.01 eppy; in total: 0.03 eppy). Intracerebral hemorrhage (overall 0.04 eppy) occurred 6.3 times more often in HVAD patients. Pump thrombosis occurred in 8.2 % of all CF-LVAD patients and was limited to HVAD (0.13 eppy). <h3>Conclusion</h3> Current studies tend to promote the use of low molecular weight heparins, especially enoxaparin for outpatient anticoagulation bridging in case of subtherapeutic INRs. However, in most cases old generation CF-LVADs were studied. Our study includes a relevant number of HM3 devices. Overall, the adverse event rates presented herein suggest feasibility of low-molecular weight heparin bridging in patients with HM3 devices.

Reduced Anticoagulation Strategy with HeartMate 3

<h3>Purpose</h3> The use of anticoagulation is the standard of care for management of patients with a Heartmate 3 LVAD (Abbott; Chicago, IL).With the advanced magnetically levitated design of the HM3, there is more flexibility for patients unable to tolerate traditional anticoagulation regimens. We review the clinical outcomes of our single center experience with HM3 patients off anticoagulation or with reduced INR goals. <h3>Methods</h3> All patients implanted at our center with a Heartmate 3 VAD from January 2018 to August 2021 were retrospectively reviewed. Patients off anticoagulation or reduced INR goals were included in this study. <h3>Results</h3> There were a total of 27 patients implanted with a HM3 at our center from 2018-2021 with a mean age 65.4 years, 85.2% (n=23) were male. Thirty-seven percent of patients (n=10) were taken off of anticoagulation entirely or had a reduced INR goal. due to concerns for tolerance of traditional INR goals. Ten percent of these patients (n=1) were not started on any anticoagulation due to severe postoperative bleeding, while 20% (n=2) were stopped within 6 months of VAD implantation and 50% (n=5) stopped within two years due to adverse events. Twenty percent (n=2) of patients had a reduced INR goal of 1.5-2. The most common reason for discontinuation of anticoagulation or reduction of INR goals included persistent gastrointestinal bleeding (40% n=4). Remainder of etiologies included subdural hematoma, noncompliance, and presence of TTR amyloid. Nintey percent (n=9) of patients who were managed off anticoagulation or with reduced INR goals survived greater than one year without clinical signs of device thrombosis or malfunction, including significant fluctuations of device parameters, LDH or echocardiographic abnormalities. Additionally this population remained free from adverse events including stroke or thromboembolism. Sixty percent (n=6) of patients remained event free for 2 years. <h3>Conclusion</h3> THis single center real world retrospective analysis, suggests that, similar to published data, it is reasonable to conclude that HM3 patients canminimal to no anticoagulation without significant adverse events. Patients should continue to have judicious montioring for signs of adverse events and detection of hemolysis and pump thrombosis.

Systematic Evaluation of HeartMate 3 Inflow Cannula at Transplant and the Association with Reduced Anticoagulation

<h3>Purpose</h3> Pumps inflow cannula design considerably impacts thrombus formation proclivity that translates to a risk of thrombotic events. Long-term performance of the HeartMate3 (HM3; Abbott, USA) fully textured conic infundibulum cannula is incompletely understood given limited systematic analysis at time of transplant. Evidence of reduced anticoagulation impact on cannula thromboresistance absents completely. <h3>Methods</h3> Consecutive HM3 patients (n= 46) undergoing transplant (2017-2021) were subject to comprehensive apical area analysis of explanted native heart. Makro- and detailed microscopic examination of the tissue surrounding the inflow cannula was performed. <h3>Results</h3> Mean time on support was 586 ±297 days (144-1351). Cut-then-sew technique was used in 13 pts while sew-then-cut dominated in 33 pts (71.7 %). One HM3 was implanted off-pump. Nine patients were till transplant on pre-specified long-term modified anticoagulation given dedicated study participation (6 pts INR range 1.5-1.9; complete warfarin withdrawal 3 pts; mean duration 504 (229-1028) days and 257 (73-526) days respectively). No pump thrombosis or thromboembolic events were revealed on support. Of 46 pts, we confirmed on histology only one (2.2 %) small spheric thrombus firmly adherent to the base of the cannula in sew-then-cut off-pump implanted pt with complete warfarin withdrawal for 73 days pre-transplant (see photo below). <h3>Conclusion</h3> Our analysis suggests consistent pattern of mitigated thrombus formation with HM3 cannula contributing its hemocompatibility. The effect persists irrespective of the implant technique. Observations may signal preserved thromboresistant profile even in long-term low-intensity anticoagulation domain. However, complete withdrawal of warfarin and off-pump strategy mandate extreme caution.

Apixaban: Alternative Anticoagulation for HeartMate 3 Ventricular Assist Device.

Patients with left ventricular assist devices currently require long-term anticoagulation with warfarin. Warfarin requires frequent blood tests and is associated with adverse events when not in the therapeutic range. Apixaban is a possible alternative that is potentially better for compliance and requires no additional testing. The purpose of this study was to compare adverse events in patients with a HeartMate 3 LVAD receiving apixaban versus warfarin. Thirty-five patients underwent HM3 implantation between January 01, 2016 to January 31, 2021. The groups compared were apixaban (n = 15, 43%) and warfarin (n = 20, 57%). All patients received 325 mg aspirin daily. Stroke, bleeding, and death were identified as primary outcomes after LVAD implant. Univariate nonparametric statistical analysis was performed. The median duration of treatment with apixaban was 148 days (37-606 days). The groups were comparable in terms of age (56 vs. 54 years), gender (male, 85% vs. 75%), and renal function (Cr 1.5 vs. 1.4). The apixaban group had significantly higher mean pulmonary artery pressure (41 vs. 34, p = 0.03) and there were more (p < 0.05) ischemic cardiomyopathy and INTERMACS profile >3 in the warfarin group. At 6 months, thrombotic complications and death were not different between the groups. The two deaths in the apixaban group were from right heart failure. The apixaban group had clinically lower rates of bleeding complications (5% vs. 30%). The adverse events of bleeding, stroke, and death were similar in HM3 patients receiving warfarin or apixaban. Apixaban may be a safe alternative anticoagulant therapy in HM 3 LVAD patients.

The ever-changing field of mechanical circulatory support: new challenges at the advent of the 'single device era'.

The ever-changing field of mechanical circulatory support: new challenges at the advent of the 'single device era'.

Role of Left Atrial Appendage Occlusion in Patients with HeartMate 3

<h3>Purpose</h3> Left atrial appendage occlusion (LAAO) at time of implantation was previously shown to reduce thromboembolic events (TEs) in continuous flow left ventricular assist devices (LVADs); however, the efficacy of LAAO in HM3 recipients is unknown. This study aims to assess the clinical impact of LAAO in HM 3 patients. <h3>Methods</h3> Adults receiving first HM3 implantation from November 2014 through December 2019 at our center were retrospectively reviewed. TEs included device thrombosis and ischemic strokes. Patients were classified by whether they received LAAO or not. Incidence of TEs was compared between groups using cumulative incidence curves with competing risks (death and heart transplant) and risk factors for TEs were assessed with Fine and Gray competing risk regression. <h3>Results</h3> 182 patients received HM 3s during the study period. Ninety-nine HM3 patients (54%) received LAAO versus 83 (46%) who did not. Zero LAAO patients (0%) had prior coronary artery bypass grafting, compared to 35 patients (42%) who did not receive LAAO (p < 0.001). Forty-six LAAO patients (48%) had a past medical history of atrial fibrillation, which was similar to the 45 patients (55%) who did not receive LAAO (p = 0.48). There were 14 thromboembolic events, including 13 strokes (7%) and one pump thrombosis (0.5%). Cumulative incidence of TEs was similar in both groups (less than 10% at three years). LAAO was not associated with TEs (p = 0.35) in Fine and Gray competing risk regression and no statistically significant risk factors for TEs were identified. <h3>Conclusion</h3> A low number of TEs was observed in HM3 recipients. LAAO did not further reduce the rate of TEs in this patient population.

A Less Than 81mg of Aspirin in Heart Mate 3 is Safe Irrespective of Amount of Platelet Inhibition

Purpose Optimal dose of aspirin for Heartmate 3 (HM 3) LVAD patients is still not known. Recently low dose aspirin (81mg compared to 325mg) has shown to be efficacious. Randomized control trial with no dose aspirin is underway. However, platelet inhibition can be still achieved with less than low dose aspirin. So we looked into safety and efficacy of a very low dose aspirin ( Methods We did retrospective analysis of HM3 patients implanted in our institution (2015- 2020). Patients who were on less than 81mg of aspirin/day were identified. Thromboelastogram (TEG) was used to assess response to aspirin. We compared the number of thromboembolic events, bleeding events, LDH, and hematocrit before and after the dose change, with the patients being their own controls, using paired t test. Results In our program, we follow 35 patients on HM3. Most of them 24(68.6%) receive > 81 mg of aspirin daily. We Identified 11 patients on less than 81mg of aspirin. The mean age of this cohort was 51.18 years, 7 were Male. Out of the 11, 3 patients were on aspirin 40.5 mg every other day, 3 on 40.5 mg every day, 4 on 81mg every other day and one patient was not on any aspirin. Reason for dose alteration was adequate inhibition noted on TEG in 5 patients and bleeding in 6 patients (4 out of 6 for gastrointestinal bleed). Mean duration of follow up was 22.57±18months. Six patients in this cohort were on standard warfarin protocol with the INR goal 2-3 and one patient was not on any warfarin. The follow-up on a very low ASA dose was 13.7±8.6 months. There were no pump thrombosis or other thromboembolic events either before or after the dose change. There was no significant difference in LDH levels before (225.2±24.3) or after (220.1±27.8) p=0.7, hematocrit before 33.6+/-9.9 or after 35.0+/-8.1, P=0.08, aspirin dose change. Arachidonic Acid inhibition on thromboelastogram was less than 80% in 7 patients and 5 of them had inhibition less than 50%. Conclusion A very low dose of aspirin (

Accuracy of Noninvasive Blood Pressure Versus Central Aortic Pressure in Patients Supported on Left Ventricular Assist Device Therapy.

Accuracy of Noninvasive Blood Pressure Versus Central Aortic Pressure in Patients Supported on Left Ventricular Assist Device Therapy.

Continuous-flow LVAD exchange to a different pump model: Systematic review and meta-analysis of the outcomes.

Despite improved outcomes of modern continuous-flow left ventricular assist devices (CF-LVADs), device exchange is still needed for various indications. While the majority of CF-LVADs are exchanged to the same model, exchange to a different pump model is occasionally warranted. In this meta-analysis, we sought to consolidate the existing evidence to better elucidate the indications and outcomes in these cases. A comprehensive systematic search of adult patient cohorts who underwent CF-LVAD exchange to a different CF-LVAD model was performed. Study-level data from 10 studies comprising 98 patients were extracted and pooled for analysis. Mean patient age was 58 (95% CI: 48-65) and 81% were male. Indication for initial CF-LVAD was ischemic cardiomyopathy in 45% (34-57). Initial device was HeartMate II LVAD (HMII) in 93 (94.9%) and HeartWare HVAD (HW) in 5 (5.1%) patients. After mean CF-LVAD support time of 18.8 (15.2-22.4) months, exchange indications included thrombosis in 71% (43-89), infection in 21% (8-47) and device malfunction in 12% (7-21). HMII to HW exchange occurred in 53 (54.1%) patients, HMII to HeartMate III (HM3) in 32 (32.7%), and HM II to either HW or HM3 in 13 (13.2%) patients. Postoperatively, right ventricular assist device was required in 16% (8-32). Overall, 20% (8-40) of patients experienced a stroke, while HW patients had a significantly higher stroke incidence than HM3 patients (HW: 21% (8-47) vs. HM3: 5% (1-24), P < .01). Overall 30-day mortality was 10% (6-17), while HW had a significantly worse 30-day mortality than HM3 (HW: 13% (7-24) vs. HM3: 5% (1-24), P = .03). Following device exchange from a different CF-LVAD model, HM3 is associated with lower stroke and higher survival when compared to HW.

Left ventricular assist device driveline infections in three contemporary devices.

Driveline infections (DLI) are common adverse events in left ventricular assist devices (LVADs), leading to severe complications and readmissions. The study aims to characterize risk factors for DLI readmission 2 years postimplant. This single‐center study included 183 LVAD patients (43 HeartMate II [HMII], 29 HeartMate 3 [HM3], 111 HVAD) following hospital discharge between 2013 and 2017. Demographics, clinical parameters, and outcomes were retrospectively analyzed and 12.6% of patients were readmitted for DLI, 14.8% experienced DLI but were treated in the outpatient setting, and 72.7% had no DLI. Mean C‐reactive protein (CRP), leukocytes and fibrinogen were higher in patients with DLI readmission (P < .02) than in outpatient DLI and patients without DLI, as early as 60 days before readmission. Freedom from DLI readmission was comparable for HMII and HVAD (98% vs. 87%; HR, 4.52; 95% CI, 0.58‐35.02; P = .15) but significantly lower for HM3 (72%; HR, 10.82; 95% CI, 1.26‐92.68; P = .03). DLI (HR, 1.001; 95% CI, 0.999‐1.002; P = .16) or device type had no effect on mortality. DLI readmission remains a serious problem following LVAD implantation, where CRP, leukocytes, and fibrinogen might serve as risk factors already 60 days before. HM3 patients had a higher risk for DLI readmissions compared to HVAD or HMII, possibly because of device‐specific driveline differences.

De-Novo Human Leukocyte Antigen Allosensitization on HeartMate 3 versus HeartMate II Left Ventricular Assist Device Recipients

MOMENTUM 3 trial demonstrated superiority of Heartmate 3 (HM 3) compared to Heartmate II (HM 2) with regards to hemocompatibility, however, their differential effects on de-novo HLA allosensitization, which may create a challenge for future transplantation, remains unknown. Patients who underwent HM2 or HM3 implantation and had no prior HLA antibodies by solid-phase assay (Luminex) testing at a major academic center were included for the study. Complement dependent cytotoxicity (CDC) panel reactive antibody (PRA) levels as well as Luminex antibody profiles were followed until cardiac transplantation, device explantation, or death. 34 HM3 and 34 HM2 patients with no HLA antibodies by Luminex testing prior to LVAD implant were identified with a mean follow-up duration of 1.71 ± 1.1 years on device support. HM3 and HM2 groups had similar age at implant (56.1±8.6 vs 54.7±12.0, p=0.575), female gender (11.8% vs. 14.7%, p=0.720), ischemic HF etiology (38.2% vs 35.3%, p=0.801), and bridge strategy at implant (44.1% vs 58.8%, p=0.225). Over the follow-up period, 41.2% of HM3 and 47.1% of HM2 patients had detectable HLA antibodies by Luminex testing (p=0.625). Development of high level (MFI>10, 000) Class I HLA antibodies were significantly lower in HM3 patients (2.9% vs 17.9%, p=0.046) compared to high-level Class II HLA antibodies which were similar in two device groups (2.9% vs 5.9%, p=0.555). CDC PRA testing showed lower proportion of HM3 patients with a positive result (PRA >0%) for T cell (32.4% vs. 55.9%, p=0.050) compared to positive B cell panel which was comparable in two groups (32.4% vs 47.1%, p=0.215). Peak PRA levels in patients who turned positive was comparable for T cell (5.8% vs 6.5%, p=0.775) and B cell (10.2% vs. 12.4%, p=0.568) in HM3 vs. HM2 patients. Our findings suggest that HM3 is associated with a lower likelihood of de-novo HLA sensitization than HM2 specifically against Class I antigens.