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The purpose of this study was to investigate the factors related to temporary mechanical support (tMCS) and surgical approach influencing post-LVAD outcomes in INTERMACS 1 patients. We performed a retrospective review of all INTERMACS 1 patients implanted with the fully magnetically levitated LVAD in our institution from September 2015 through March 2021. Influence of the following factors on in-hospital survival were analyzed: type and time on tMCS; change in the tMCS level (step-up: IABP→ECMO and/or Impella, Impella→ ECMO±Impella; step-down: ECMO+Impella→ ECMO or Impella); heart failure acuity; and surgical approach. Of 287 implanted patients, 102 (35.5%) were INTERMACS profile 1 and included in the study. Full sternotomy (FS) was used in 25 (24.5%) patients and less invasive surgery (LIS) in 77 (75.5%) patients. Patients in the FS group were more frequently bridged with IABP in contrast to LIS patients supported with Impella. Postoperatively, LIS patients bled less, required shorter mechanical ventilation, and had a lower incidence of severe right ventricular failure. In-hospital survival was similar (Table 1). Multivariate analysis demonstrated a positive correlation between IABP and in-hospital survival while FS demonstrated a negative effect (Figure 1). Patients presenting with cardiogenic shock should be expeditiously evaluated for LVAD therapy while supported with adequate tMCS tailored to the patient's requirements. Less invasive LVAD implantation may alleviate some of the perioperative risks. Future trials are required to confirm our data. [ABSTRACT FROM AUTHOR]

Right ventricular failure (RVF) remains one of the major cause of morbidity and mortality after left ventricular assist device (LVAD) surgery. The purpose of this study was to investigate the incidence of RVF after less invasive surgery (LIS) LVAD surgery compared to median sternotomy. The study population comprised of 231 patients who underwent HeartMate 3 LVAD implantation in our institution between September 2015 and June 2020. Patients were compared based on surgical approach: full sternotomy (FS) or LIS. The primary outcome was RVF as defined by INTERMACS. Index hospitalization major complications and survival were secondary outcomes. LIS approach was used in 161 (69.7%) patients and FS approach in 70 (30.3%) of our LVAD patients. Baseline patient characteristics were similar between cohorts apart from LIS patients being younger (54±14 vs 60±11, p= 0.003). Postoperatively, LIS patients had decreased postoperative bleeding (p=0.001) and shorter time on mechanical ventilation (p<0.001) or inotropes (p=0.0042). LIS was associated with a 3-fold reduction in the primary endpoint of RVF (8.7% vs 28.6%; respectively; p<0.001) as well as in the need for Right Ventricular Assist Device support (5 vs 17.1%, p=0.003). Multivariate analysis showed that LIS was associated with a significant reduction in the risk of major postoperative events (Figure 1), including a 76% (p<0.001) reduction in RVF occurrence and a 75% (p=0.004) reduction in the need for RVAD support. Survival at index hospitalization was higher with LIS vs. FS (91.3% vs 78.6%, p=0.0073). Less invasive LVAD implantation is associated with improved perioperative outcomes compared to median sternotomy, including a lower incidence of severe right heart failure and need for temporary mechanical circulatory support. Further research is needed to elucidate the mechanism of the less invasive approach in preserving RV function. [ABSTRACT FROM AUTHOR]

While the feasibility of off-pump HeartMate 3 left ventricular assist device (LVAD) placement has already been demonstrated, the safety of this approach has not been reported to date. We retrospectively reviewed all patients who underwent Heartmate 3 LVAD implantation and identified 19 off-pump patients. These were propensity-matched with 19 on-pump cases using the following variables: age, body mass index, INTERMACS profile, and surgical approach. The study's primary objective was the safety of the off-pump technique compared to the standard on-pump approach. Preoperative characteristics were similar between the groups (Table 1). Most patients presented with the highest acuity INTERMACS Profile 1 (92.1%). A higher frequency of off-pump patients was supported with extracorporeal membrane oxygenation prior to LVAD implantation (31.6 vs. 89.5%, p=0.001). Intraoperatively, a higher proportion of patients in the off-pump group required packed red blood cells administration (47.4% vs. 84.2%, p=0.038). In the immediate postoperative hours, off-pump patients showed trends toward lower vasoactive-inotropic requirements. Postoperative outcomes, including all of the major complications and short-term survival (Figure 1), were comparable between the groups. Results from our retrospective propensity-matched analysis suggest that off-pump LVAD implantation can be offered as a safe alternative for high-risk LVAD candidates. [ABSTRACT FROM AUTHOR]

The INTERMACS profiles are established as important selection and prognostic criteria for Left Ventricular Assist Devices (LVAD) implantation. We sought to investigate the correlation of higher acuity INTERMACS profile and post-LVAD implantation outcomes in carefully selected and optimized patients. We conducted a retrospective analysis of all HeartMate 3 LVAD (HM3) implantations in our institution between September 2015 and April 2021. Baseline characteristics and clinical outcomes were compared based on pre-implantation INTERMACS profiles: 1 and 2 (IP1-2) vs. 3 and 4 (IP3-4). Our primary study endpoint was the composite of stroke events and death from time of HM3 implantation through late follow-up. Of 234 patients implanted with a HM3 during the study period, 116 (49.6%) presented in cardiogenic shock IP1-2, while 118 (50.4%) were less acute IP3-4 (Table 1). Patients in IP1-2 at time of LVAD implantation were younger with de-novo heart failure and worse end-organ function. Postoperatively, patients in the IP1-2 group experienced higher rates of early adverse events including severe right ventricular failure (9% vs. 3%, p=0.025) and prolonged hospital length of stay. There was no statistically significant difference in the Kaplan-Meier estimator (Figure 1.) for the composite end-point of death and stroke between IP groups. INTERMACS 1/2 patients implanted with HM3 LVAD were younger, had longer intubation times, and longer ICU and hospital lengths of stay. Clinical outcomes were similar between the groups with INTERMACS 3/4 patients showing a trend toward a lower composite event rate of stroke and death. [ABSTRACT FROM AUTHOR]

Smaller body surface area (BSA) frequently precludes patients for Left Ventricular Assist Device (LVAD) therapy. We sought to investigate the clinical outcomes in patients with small BSA undergoing less invasive LVAD implantation. We conducted a retrospective review of 216 patients implanted with HeartMate 3 LVAD via less invasive surgery (LIS) at our institution. Patients were dichotomized and compared based on their pre-implant BSA: small BSA (BSA≤1.8 m2) and normal/large BSA (BSA>1.8 m2). We analyzed patients' perioperative characteristics and outcomes. In our study, small BSA was found in 32 (14.8%) patients, while 184 (85.2%) had normal/large BSA (Table 1). Women were more prevalent in the small BSA group (50.0% vs. 13.0%, p<0.001). Preoperative and intraoperative data showed comparable results. Major complications and hospital length of stay did not differ by BSA group. Patients with smaller BSAs had significantly decreased pump parameters at discharge, this includes LVAD flow (4.11±0.49 vs.4.60±0.54, L/min, p<0.001) and pump speed (5200 vs. 5400, rpm, p<0.001). Survival to discharge and within 6 post-implantation months were similar between the groups (Figure 1). Our study results suggest that less invasive HeartMate 3 implantation can be safely performed and demonstrates equivalent outcomes in patients with smaller body habitus. Randomized trials are required to confirm our data. [ABSTRACT FROM AUTHOR]

We evaluated outcomes in patients with third-generation Heartmate (HM3) left ventricular assist devices (LVAD), stratified by international normalized ratio (INR) values. The objective of our study was to assess thrombotic and hemorrhagic complications with varying anticoagulation intensity. We retrospectively reviewed patients receiving a HM3 LVAD between 2015 and 2020 at a major heart failure center. INR data available on each patient post-implantation was extracted. INR values were categorized by subtherapeutic (INR <2.0), therapeutic (2.0-3.0), or supratherapeutic (>3.0). A linear interpolation was performed between points to establish percent time within each anticoagulation intensity. Thrombotic (ischemic stroke, suspected pump thrombosis) and hemorrhagic (gastrointestinal (GI) bleeding, hemorrhagic stroke) outcomes of interest were compared with these groups. A total of 232 patients received a HM3-CF LVAD. 204 (87.9%) patients were discharged and 184 (79.3%) were alive at last known follow-up to date. A total of 24 thrombotic events occurred: 2 pump thrombosis events and 22 ischemic strokes. A total of 70 hemorrhagic end points was recorded: 63 GI Bleeding events from 43 patients and 7 hemorrhagic strokes (4 intraparenchymal hemorrhage, 2 subarachnoid hemorrhage, 1 subdural hematoma). The percentage of time spent in the subtherapeutic anticoagulation range was not significantly different between patients with and without ischemic strokes. However, patients with hemorrhagic stroke spent a larger portion in the supratherapeutic range. A binary logistic regression was conducted revealing an INR 1.8 to 2.2 had no significant effect on the odds of observing a ischemic stroke or GI bleeding events however a model evaluating therapeutic INR (2-3) with ischemic stroke and GI bleeding were both found to be significant. The ideal anticoagulation intensity for preventing thrombotic and hemorrhagic strokes in HM3 LVAD has not yet been elucidated. Our results suggest that patients with greater time spent in subtherapeutic ranges may experience less adverse thrombotic or hemorrhagic events following implantation. Additional studies are warranted to more clearly understand and define the ideal anticoagulation intensity in this cohort. [ABSTRACT FROM AUTHOR]

Our group previously reported the safety and feasibility of the off-pump HeartMate 3 left ventricular assist device in a small cohort of high-risk patients. We now present a larger cohort who underwent off-pump HeartMate 3 LVAD placement, the majority via a less invasive approach. The study's primary objective was the safety and feasibility of the off-pump technique compared to the standard on-pump approach with an emphasis on the less invasive technique. We retrospectively reviewed all patients who underwent HeartMate 3 LVAD implantation at our institution since June of 2019. One hundred and sixty-one of these patients underwent on-pump implantation while 52 underwent off-pump implantation with 49 of them (94%) undergoing a less invasive approach which includes bilateral thoracotomies and thoracotomy with hemi-sternotomy. Preoperative characteristics were similar between groups. More patients in the off-pump group were categorized as INTERMACS Profile 1 at the time of implant (67% vs 29% in the on-pump group, p<0.0001). There was no significant difference between total length of stay and in-hospital mortality between the two groups. Postoperative outcomes, including all major complications and short-term survival, were comparable between groups. Results from our single-center, retrospective analysis suggest that off-pump, less invasive LVAD implantation can be offered as a safe alternative for LVAD candidates in critical cardiogenic shock. [ABSTRACT FROM AUTHOR]

Data on home-based exercise rehabilitation (HER), using a wearable activity monitor and smartphone app, are limited in LVAD recipients. The purpose of the MOVE-LVAD study is to evaluate the feasibility, safety, and effects of HER on activity levels and healthcare utilization in newly implanted HeartMate 3 (HM3) LVAD patients. MOVE-LVAD is a randomized study conducted at a single center. We aim to enroll 30 subjects, and here we provide data on the first 14 patients. Subjects in the HER and usual care (UC) groups wear an activity watch to monitor steps. In the HER group, patients also use a smartphone app to rate perceived exertion on the Borg scale and complete video calls with an exercise physiologist. Borg rating and daily steps are used to titrate exercise prescriptions. Endpoints include mean steps and rehospitalization. Mean daily steps are calculated for individual patients during weeks 1, 4, 8, and 12, and averages at each timepoint for the HER and UC groups are calculated separately. We provide data for the first 14 subjects during 3-month follow-up. 6 patients (mean age 60 years, 83% male) were randomized to HER and 8 (mean age 56 years, 88% male) to UC. During week 1, mean daily steps were 1595 ± 1579 in the HER group and 1436 ± 1031 in the UC group (Figure). During week 12, mean daily steps were 3705 ± 2628 in the HER group and 1669 ± 991 in the UC group. From week 1 to week 12, the average increase in daily steps was 1711 ± 1106 in the HER group and 587 ± 923 in the UC group. HER was not associated with any adverse events. There were 0 rehospitalizations in the HER group and 7 rehospitalizations in the UC group in 4 separate patients. Initial data from the MOVE-LVAD study suggest that HER with remote monitoring is feasible, safe, and may be associated with a greater increase in daily activity levels and lower rehospitalization rate compared to UC in newly implanted HM3 LVAD patients. Larger studies are needed to determine the effects of HER on long-term outcomes. [ABSTRACT FROM AUTHOR]

We sought to develop and implement a comprehensive enhanced recovery after surgery protocol for patients implanted with left ventricular assist device. Our approach to the development and phased implementation of the ERAS protocol were described (Figure 1). We retrospectively reviewed prospectively collected LVAD implant data at our institution between February 2019 and August 2020. Patients were divided into 6-months period cohorts: Pre-ERAS cohort (which covered 6 months prior to ERAS initiation) and ERAS cohort. A time gap of 6 months between the cohorts was used to appreciate initial outcomes after implementing most of the protocol phases. Of the 115 LVAD implants, 38 patients were classified in pre-ERAS cohort and 46 in ERAS cohort. We reduced transfusions and discharge on opioids and show a trend towards reduced intubation times, ICU and overall length of stay (Table 1). ERAS for advanced heart failure patients deemed candidates for LVAD therapy is a novel, evidence-based, interdisciplinary approach to care with multiple potential benefits. We described details of the protocol, challenges faced as well as early positive changes in clinical outcomes. Further studies are needed to both assess provider satisfaction and evaluate benefits of an ERAS protocol in reduction of adverse events. [ABSTRACT FROM AUTHOR]