Ventricular Assist Device Outcomes Research Articles

Three-Year Left Ventricular Assist Device Outcomes and Strategy After Heart Transplant Allocation Score Change

BackgroundThe United Network for Organ Sharing (UNOS) adopted new criteria for the heart allocation score on 10/18/2018 to reflect changing trends of candidates’ mortality while awaiting transplant. We examined the impact of these policy changes on rates of left ventricular assist device (LVAD) implantation and outcomes posttransplant from a relatively newer UNOS database. MethodsThe UNOS registry was used to identify first-time adult heart recipients with LVAD at listing or transplant who underwent transplantation between 1/1/2016 and 3/10/2020. Survival data was collected through 3/30/2023. Those listed prior to 10/18/2018 but transplanted after were excluded. Patients were divided into before or after change groups. Demographics and clinical parameters were compared. Survival was analyzed with Kaplan-Meier curves and log-rank tests. A p<0.05 was considered significant. ResultsWe identified 4387 heart recipients with LVAD in the before (n=3606) and after (n=781) score change eras. The after group had a lower rate of LVAD implantation while listed compared to the before group (20.4% vs 34.9%, p<0.0001), and were more likely to be female (25.1% vs 20.2%, p=0.002); in both groups, most recipients (62.8%) were white. There was significantly farther distance from the donor hospital to transplant center in the after group (264.4 NM vs 144.2NM, p<0.0001) and decreased waitlist days (84.9 ± 105.1 vs 369.2 ± 459.5, p<0.0001). Recipients in the after group were more likely to utilize ECMO (3.7% vs 0.5%, p<0.0001) and IV inotropes (19.1% vs 7.5%, p<0.0001), and receive a CDC increased-risk donor organ (37.9% vs 30.5%, p<0.0001). Survival at 3-years was comparable between the two groups. ConclusionsThe allocation score change in 2018 yielded considerable changes in mechanical circulatory support device implantation strategy and outcomes. The rate of LVAD implantation decreased with increased utilization of temporary mechanical circulatory support devices.

(513) - Utilization of Distressed Communities Index to Examine the Impact of Socioeconomic Status on Left Ventricular Assist Device Outcomes

(513) - Utilization of Distressed Communities Index to Examine the Impact of Socioeconomic Status on Left Ventricular Assist Device Outcomes

Preoperative pulmonary function is associated with left ventricular assist device outcomes

IntroductionAlthough left ventricular assist device (LVAD) implantation is associated with improved survival in patients with end-stage heart failure, the impact of preoperative pulmonary function on short-term outcomes is unclear. MethodsWe conducted a retrospective review of all primary LVAD implants at a single institution. Common measures of preoperative pulmonary function were evaluated. Survival was estimated using the Kaplan-Meier method. ResultsFrom 2017–2022, 107 patients underwent primary LVAD implantation. Prior to implantation, 68 (63.6 %) were on room air, 28 (26.4 %) were on nasal cannula, 2 (1.9 %) were on noninvasive positive pressure ventilation, and 9 (8.5 %) were on the ventilator. The average preoperative fraction of inspired oxygen (FiO2) was 25.3 ± 8.2 % while the mean percentage predicted forced expiratory volume in 1 second (FEV1) was 71.4 ± 20.9 %. Overall, 1-year survival was 86.8 %, the median postoperative ventilator time was 20.4 [4.2-77.7] h, and 18 (16.8 %) patients required postoperative tracheostomy. When stratified by pulmonary function, lower FEV1 and increased preoperative FiO2 were associated with decreased 1-year survival ConclusionsIn conclusion, preoperative pulmonary function is associated with short-term LVAD survival, postoperative ventilatory time, and need for tracheostomy. Therefore, rigorous pulmonary function evaluation may help in appropriate preoperative risk stratification.

Outcomes of Intracorporeal Continuous and Paracorporeal Pulsatile Ventricular Assist Devices in Pediatric Patients 10-30 kg.

Ventricular assist devices (VADs) have been increasingly implanted in pediatric patients. Paracorporeal VADs are generally chosen when intracorporeal continuous (IC) devices are too large. Superiority between IC and paracorporeal pulsatile (PP) devices remains unclear in smaller pediatric patients. Our study analyzes outcomes of IC and PP VADs in pediatric patients who could be considered for either of these options. Using the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) database, we identified children between 10 and 30 kg who received a VAD between June 2018 and September 2021. Survival and stroke outcomes were analyzed based on VAD type. There were 41 patients in the IC group and 54 patients in the PP group. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile at the time of implant was higher in the PP cohort ( p < 0.02). The PP cohort was younger ( p < 0.001) and smaller ( p < 0.001) than the IC cohort. The diagnosis was similar between cohorts. Overall survival was similar between groups. Stroke was more common in the PP cohort, but did not reach statistical significance ( p = 0.07). Discharge was possible only in the IC group, but the discharge rate was low (9.5%). Direct comparisons remain challenging given differences in INTERMACS profiles, age, and size.

Surgical Outcomes of Centrifugal Continuous-Flow Implantable Left Ventricular Assist Devices: Heartmate 3 versus Heartware Ventricular Assist Device.

Left ventricular assist devices (LVADs) are widely employed as a therapeutic option for end-stage heart failure. We evaluated the outcomes associated with centrifugal-flow LVAD implantation, comparing 2 device models: the Heartmate 3 (HM3) and the Heartware Ventricular Assist Device (HVAD). Data were collected from patients who underwent LVAD implantation between June 1, 2015 and December 31, 2022. We analyzed overall survival, first rehospitalization, and early, late, and LVAD-related complications. In total, 74 patients underwent LVAD implantation, with 42 receiving the HM3 and 32 the HVAD. A mild Interagency Registry for Mechanically Assisted Circulatory Support score was more common among HM3 than HVAD recipients (p=0.006), and patients receiving the HM3 exhibited lower rates of preoperative ventilator use (p=0.010) and extracorporeal membrane oxygenation (p=0.039). The overall early mortality rate was 5.4% (4 of 74 patients), with no significant difference between groups. Regarding early right ventricular (RV) failure, HM3 implantation was associated with a lower rate (13 of 42 [31.0%]) than HVAD implantation (18 of 32 [56.2%], p=0.051). The median rehospitalization-free period was longer for HM3 recipients (16.9 months) than HVAD recipients (5.3 months, p=0.013). Furthermore, HM3 recipients displayed a lower incidence of late hemorrhagic stroke (p=0.016). In the multivariable analysis, preoperative use of continuous renal replacement therapy (odds ratio, 22.31; p=0.002) was the only significant predictor of postoperative RV failure. The LVAD models (HM3 and HVAD) demonstrated comparable overall survival rates. However, the HM3 was associated with a lower risk of late hemorrhagic stroke.

Discussion to: Preoperative passive venous pressure driven cardiac function determines left ventricular assist device outcomes

Discussion to: Preoperative passive venous pressure driven cardiac function determines left ventricular assist device outcomes

Contemporary Outcomes of Continuous-Flow Left Ventricular Assist Devices: A Systematic Review

End-stage heart failure is a major cause of morbidity and mortality, and its prevalence is expected to rise with the ageing population. For suitable patients, orthotopic heart transplantation remains the gold standard therapy; however, a paucity of donor organs has led to the development of left ventricular assist devices (LVAD). These devices can be utilised as either a bridge to transplant or as an alternative to heart transplantation. While these devices can prolong life and improve quality of life, they are associated with a significant number of adverse events. This study aimed to systematically review the literature to quantify survival and the incidence of adverse events following implantation of continuous flow left ventricular assist devices (cf-LVAD).

Impact of Weight on Ventricular Assist Device Outcomes in Dilated Cardiomyopathy Patients in Pediatric Centers: An ACTION Registry Study.

Ventricular assist device (VAD) options vary for children in different weight groups. This study evaluates contemporary device usage and outcomes for children based on weight. Data from the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry were examined for patients with dilated cardiomyopathy (DCM) in 4 weight cohorts: <8 kg, 8-20 kg, 21-40 kg, and >40 kg, for devices implanted 3/2013-10/2020. Adverse event rates and ultimate outcome (deceased, alive on device, transplanted, or ventricular recovery) were analyzed. 222 DCM patients were identified with 24% in cohort 1, 23% in cohort 2, 15% in cohort 3, and 38% in cohort 4. Of 272 total implants, paracorporeal pulsatile devices were most common (95%) in cohorts 1 and 2 and intracorporeal continuous devices (81%) in cohorts 3 and 4. Stroke was noted in 17%, 12%, 6%, and 4% of cohorts, respectively (Cohort 1 vs. 4 and 2 vs. 4 - p = 0.01; other comparisons - not significant). Incidences of major bleeding, device malfunction, and infection was not different. All cohorts had >90% positive outcomes. Stroke incidence was higher in smaller cohorts, but other outcomes were similar. Positive outcomes were attained in over 90% across all weight groups, demonstrating excellent outcomes using current VADs in this DCM population.

(290) Comparison of Patient Characteristics and Outcomes of Left Ventricular Assist Devices before and after the Heart Transplant Allocation Change

(290) Comparison of Patient Characteristics and Outcomes of Left Ventricular Assist Devices before and after the Heart Transplant Allocation Change

High Acuity Elderly Patients Have Similar Left Ventricular Assist Device Outcomes As Younger Patients

High Acuity Elderly Patients Have Similar Left Ventricular Assist Device Outcomes As Younger Patients

Association Of The Stanford Integrated Psychosocial Assessment Score With Short-term Post-left Ventricular Assist Device Outcomes

Association Of The Stanford Integrated Psychosocial Assessment Score With Short-term Post-left Ventricular Assist Device Outcomes

(965) Preoperative Pulmonary Function is Associated with Left Ventricular Assist Device Outcomes

(965) Preoperative Pulmonary Function is Associated with Left Ventricular Assist Device Outcomes

The Impact of MOMENTUM 3 Trial Eligibility on Left Ventricular Assist Device Outcomes: A Real-World Experience

IntroductionAlthough the landmark MOMENTUM 3 trial was associated with excellent short-term left ventricular assist device (LVAD) outcomes, many end-stage heart failure patients would not have met the trial eligibility criteria. Moreover, the outcomes of trial ineligible patients are poorly characterized. Therefore, we undertook this study to compare MOMENTUM 3 eligible and ineligible patients. MethodsWe conducted a retrospective review of all primary LVAD implants from 2017 to 2022. Primary stratification was according to MOMENTUM 3 inclusion and exclusion criteria. Primary outcome was survival. Secondary outcomes included complications and length of stay. Multivariable Cox proportional hazards regression models were constructed to further characterize outcomes. ResultsFrom 2017 to 2022, 96 patients underwent primary LVAD implantation. Thirty-seven (38.54%) patients were trial eligible while 59 (61.46%) were ineligible. When stratified by trial eligibility, patients who were trial eligible had higher 1-year (80.15% versus 94.52%, P = 0.04) and 2-year survival (70.17% versus 94.52%, P = 0.02). Multivariable analysis showed that trial eligibility was protective of mortality at both 1 y (HR: 0.19 [0.04-0.99], P = 0.049) and 2 y (HR: 0.17 [0.03-0.81], P = 0.03). Although the groups had similar rates of bleeding, stroke, and right ventricular failure, trial ineligibility was associated with a longer periprocedural length of stay. ConclusionsIn conclusion, the majority of contemporary LVAD patients would not have been eligible for the MOMENTUM 3 trial. Ineligible patients have decreased but acceptable short-term survival. Our findings suggest that a simply reductionist approach to short-term mortality may improve outcomes but fail to capture the majority of patients who could benefit from therapy.

Elderly Patients With Higher Acuity Have Similar Left Ventricular Assist Device Outcomes as Younger Patients at a Nontransplant Center

Although left ventricular assist device (LVAD) implantation is associated with acceptable survival, previous reports have demonstrated that advanced age is associated with increased short-term mortality. Because age is a relative contraindication to transplantation, nontransplant centers tend to implant a disproportionate number of elderly patients. We undertook this study to evaluate the impact of advanced age on LVAD outcomes at a nontransplant center. We conducted a retrospective review of all LVAD implants at our center from 2017 to 2022. Primary stratification was by age >70 years. The primary outcome was survival as assessed by the Kaplan-Meier method. The risk of 1-year mortality was further evaluated using multivariable Cox proportional hazards regression modeling. From 2017 to 2022, 93 patients underwent LVAD implantation. The mean age was 65.03 ± 11.28 years, with a median age of 68 (60 to 73) years. Most patients were INTERMACS 1 or 2 (71 patients; 76.34%). When stratified by age, 41 patients (44.09%) were aged ≥70 years. Patients aged ≥70 years had similar 30-day (96.15% vs 100.00%, p=0.213), 1-year (90.05% vs 84.00%, p=0.444), and 2-year survival (82.03% vs 84.00%, p=0.870). When only the INTERMACS 1 and 2 patients with higher acuity were included, there was still no difference in 30-day, 1-year, or 2-year survival. On multivariable analysis, age >70 years was not associated with an increased hazard of 1-year mortality (0.90 [0.22 to 3.67], p=0.878). In conclusion, in carefully selected patients, age >70 years is not associated with increased short-term mortality. Age alone should not be a contraindication to LVAD therapy.

Care fragmentation predicts 90-day durable ventricular assist device outcomes.

To examine whether fragmentation of care is associated with worse in-hospital and 90-day outcomes following durable ventricular assist device (VAD) implant. Cohort study. This study was conducted using Medicare claims linked to the Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) among patients undergoing VAD implant between July 2009 and April 2017. Medicare data were used to measure fragmentation of the multidisciplinary care delivery network for the treating hospital, based on providers' history of shared patients within the previous year. STS Intermacs data were used for risk adjustment and outcomes ascertainment. Hospitals were sorted into terciles based on the degree of network fragmentation, measured as the mean number of links separating providers in the network. Multivariable regression was used to associate network fragmentation with 90-day death or infection risk. The cohort included 5159 patients who underwent VAD implant, with 11.2% dying and 27.6% experiencing an infection within 90 days after implant. After adjustment, a 1-unit increase in network fragmentation was associated with an increase of 0.179 in the probability of in-hospital infection and an increase of 0.183 in the probability of 90-day infection (both P < .05). Similar results were observed in models of the numbers of in-hospital and 90-day infections. Network fragmentation was predictive of the probability of 90-day mortality, although this relationship was not significant after adjustment. Care delivery network fragmentation is associated with higher in-hospital and 90-day infection rates following durable VAD implant. These networks may serve as novel targets for enhancing outcomes for patients undergoing VAD implant.

Novel Estimates of Renal Function are Associated with Short-Term Left Ventricular Assist Device Outcomes

IntroductionAlthough preoperative kidney function has been associated with left ventricular assist device (LVAD) outcomes, most previous estimates of glomerular filtration rates (eGFRs) have utilized race in the calculation. Recently, novel eGFR equations independent of race have been suggested and validated. Therefore, we undertook this study to evaluate the predictive value of a novel, non–race-based eGFR calculation on short-term LVAD outcomes. MethodsWe conducted a retrospective review of all primary LVAD implants from 2017 to 2022 at our institution. eGFR was calculated using the novel Chronic Kidney Disease Epidemiology Collaboration 2021 formula (CKD-EPI 2021). eGFR was also calculated according to the Modification of Diet in Renal Disease equation for historical reference. Primary stratification was by eGFR: ≥60, 30-60, and <30. The primary outcome was 1-y survival. Multivariable Cox proportional hazards regression modeling was used to further evaluate the impact of kidney function on 1-y mortality. ResultsFrom 2017 to 2022, 91 patients underwent LVAD implantation with a HeartMate 3 device. The average age was 65.20 ± 11.08, 77 (84.62%) were male, and 14 (15.38%) were Black. The mean CKD-EPI 2021 eGFR was 56.07 ± 23.55 compared with 54.72 ± 26.37 as calculated by Modification of Diet in Renal Disease (P = 0.719). Overall, 30-d and 1-y survival was 96.7% and 85.0%, respectively. When stratified by eGFR, there was a significant difference in 1-y survival (≥60, 93.46%; 30-60, 87.36%; <30, 62.75%; P = 0.016). On multivariable analysis, a preoperative eGFR <30 was associated with an increased hazard of 1-y mortality (5.58 [1.06-29.17], P = 0.043). ConclusionsIn conclusion, non–race-based estimates of renal function are predictive of short-term LVAD outcomes. Further investigation of this phenomenon is warranted.

Ventricular Assist Device Outcomes in Infants and Children With Stage 1 Single Ventricle Palliation.

Data on ventricular assist device (VAD) outcomes in infants with stage 1 single ventricle (SV) palliation are limited. We examined the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry for outcomes of pre/poststage 1 SV patients undergoing VAD implantation between March 2018 and October 2020. Data are collected from 32 centers and major adverse events undergo central adjudication. During the study period, 30 stage 1 SV patients underwent VAD implant with median age of 0.9 months (range 0.1-25) and weight 3.7 kg (2.4-17). Preimplant illness severity was high: ventilator support (90%), ECMO (30%), prior cerebral vascular accident (CVA, 23%), and dialysis (13%). Devices used included paracorporeal pulsatile (50%), paracorporeal continuous-flow (37%), and multiple devices (13%). Median support duration was 56 days (range 3-246). A positive clinical outcome (transplanted or weaned) was attained in 63% (63% transplanted, 37% mortality, 0% weaned). VAD adverse events included: major infection (43%), neurologic dysfunction (any = 30%; CVA = 20%), major bleeding (17%), renal dysfunction (13%), and device malfunction (3%). In conclusion, stage 1 SV patients undergoing VAD support have high preimplant illness severity and complexity, as well as significant morbidity and mortality postimplant. A variety of devices and strategies are employed by centers to support this challenging population.

Impact of preoperative Impella support on destination left ventricular assist device outcomes.

Although left ventricular assist device (LVAD) implantation is associated with improved heart failure survival, the impact of pre-implantation Impella support on outcomes is unknown. We undertook this study to evaluate the impact of preoperative Impella support on LVAD outcomes. We conducted a retrospective review of all Heartmate 3 LVAD implants. Primary stratification was by the need for preoperative Impella support with the 5.0/5.5 device. Longitudinal survival was assessed by the Kaplan-Meier method. Multivariable Cox proportional hazards regression models were developed to evaluate mortality. Secondary outcomes included changes in laboratory values during Impella support. From 2017 to 2021, 87 patients underwent LVAD implantation. Sixteen were supported with a single inotrope, 36 with dual inotropes, 27 with Impella, and 3 with extracorporeal membrane oxygenation (ECMO). When stratified by the need for Impella, there was no difference in survival at 30-days (98.3 [88.2-99.8]% vs. 96.3 [76.5-99.5]%, p = .59), 1-year (91.0 [79.8-96.2] vs. 74.9 [51.7-88.2], p = .10), or at 2 years (87.9 [74.3-94.5] vs. 74.9 [51.7-88.2], p = .15). On multivariable modeling, the need for preoperative Impella was not associated with an increased hazard of 1-year (1.24 [0.23-6.73], p = .81) or 2-year mortality (1.05 [0.21-5.19], p = .95). After 7 (5-10) days of Impella support, recipient creatinine (p < .01), creatinine clearance (p = .02), and total bilirubin (p = .053) improved and lactic acidosis resolved (p < .01). Preoperative Impella support is not associated with increased short or long-term mortality but is associated with improved renal and hepatic function as well as total body perfusion before LVAD implantation.

Outcomes of Intracorporeal Continuous, Paracorporeal Continuous, and Paracorporeal Pulsatile Ventricular Assist Devices in Pediatric Patients 10-30 kg

<h3>Purpose</h3> In the past decade, ventricular assist devices (VADs) have been increasingly implanted in pediatric patients. Although no definitive size standards exist, paracorporeal VADs are generally chosen when intracorporeal continuous (IC) devices are deemed too large for smaller patients. Superiority between IC, paracorporeal continuous (PC) and paracorporeal pulsatile (PP) devices remains unclear in smaller pediatric patients. Our study analyzes outcomes of IC, PC and PP VADs in pediatric patients who could be considered for any of these options. <h3>Methods</h3> Using the Advanced Cardiac Therapies Improving Outcomes Network(ACTION) database, we identified children between 10 and 30 kg who were supported on a VAD between June 2018 and September 2021. Survival and stroke outcomes were analyzed based on VAD type. <h3>Results</h3> Patient demographics, survival outcomes and stroke rates are displayed in Table 1. Patient diagnosis was similar amongst all three cohorts. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile at time of implant was similar in all groups except when comparing the IC vs PP cohorts (p = 0.03). The PP and PC cohorts were younger (p<0.001) and smaller (p<0.001) than the IC cohort. The number of device days was highest in the IC cohort. Overall survival was similar between groups. Stroke rate was higher in the PP group, but without statistical significance. Discharge was possible only in the IC group, but the discharge rate was low (9.5%). <h3>Conclusion</h3> There was difference in overall survival rates between the IC, PC and PP cohorts. Rates of stroke were highest in the PP cohort, but without statistical significance. Diagnosis and INTERMACS profile were similar with the exception of the IC vs PP cohorts, but direct comparisons remain challenging given differences in age and size. Future studies are needed to compare outcomes in these devices especially given size constraints in smaller pediatric patients.

Left Ventricular Assist Device Outcomes In Patients With Chronic Kidney Disease And End-stage Renal Disease

<h3>Background</h3> There is paucity of data regarding Left ventricular Assist Device (LVAD) outcomes in patients with advanced Chronic kidney disease (CKD) and End Stage Renal Disease (ESRD). <h3>Methods</h3> We conducted a retrospective study utilizing United States Renal Database (2006-2016) to compare 1-year outcomes between Medicare beneficiaries with ESRD to 5% sample of Medicare beneficiaries with CKD among LVAD patients. Comorbidities and outcomes were identified using appropriate ICD9 or ICD-10 codes. Patients who underwent heart transplant in follow up were excluded prior to obtaining outcomes. Subgroup analysis of CKD patients with available staging information [n=181(41.2%)] was explored to study CKD stage impact on outcomes. <h3>Results</h3> There were 482 patients with CKD and 192 patients with ESRD who underwent LVAD implantation. The ESRD group were 5 years younger and had more females compared to CKD group. Non-ischemic cardiomyopathy was more common in CKD vs ESRD (45.2% vs 23.9%, p <0.001). The details of baseline characteristics are shown in Table 1. The 1-year mortality is higher in ESRD when compared to CKD group (68.3% vs 35.5%, p <0.001). Median time to mortality in ESRD was 22 days (IQR; 6-55) and 46 days (IQR; 19-153) in CKD group. Out of patients with available baseline CKD staging, 91.2% had advanced CKD (stage III and above). Subgroup analysis in this cohort showed trend of increase in mortality from III (33.9%) to IV/V (40.9%). There were no significant differences in bleeding, pump thrombosis, stroke and sepsis/infection between two groups. <h3>Conclusions</h3> The patients with ESRD who receive LVAD have worse survival when compared to CKD group. There is also trend of gradual increase in mortality with worsening renal function. This information will help in shared decision making while considering advance heart failure therapies in CKD or ESRD patients.