Ventricular Assist Device Outcomes Research Articles

Psychosocial Characteristics and Outcomes in Patients with Ventricular Assist Device

Purpose Patient selection for durable ventricular assist device (VAD) involves a comprehensive medical and psychosocial evaluation. Although there are guidelines for evaluation of medical comorbidities, psychosocial risk assessment remains somewhat subjective. There is ongoing concern that patients may be denied VAD due to perceived high-risk psychosocial characteristics that may not impact survival after VAD implantation. The purpose of this study was to evaluate the patient psychosocial risk profile and its impact on outcomes after VAD implantation. Methods This study was a single center, retrospective analysis of 93 patients who underwent durable VAD implantation at Advocate Christ Medical Center in 2016. Psychosocial factors on outcomes were evaluated using the Student's t-test, Fischer's exact test, and one-way analysis of variance. Results Of 93 patients, mean age was 55 ± 13 years, 73% were males, 46% were African American, 69% had non-ischemic cardiomyopathy, and 60% received destination therapy. Most prevalent psychosocial factors were: 27% had a pre-existing psychiatric diagnosis, 53% were not married, 22% had no children, 11% lived alone, 19% did not complete a high school education, 26% were chronically unemployed, 55% formerly abused tobacco, 13% formerly abused alcohol, and 24% formerly abused illicit drug. Mean days on device was 589 ± 321, mean number of readmissions within the first year was 2.5 ± 2.6, and mean number of days to first readmission was 80 ± 91. Those with less than a high school education were 55% more likely to experience an adverse event (driveline infection, bacteremia, stroke, hemolysis, GI bleed, other bleed) compared to those with a graduate level education (p Conclusion These results suggest that certain psychosocial factors may not influence mortality or adverse event rates after VAD implantation. Although, education level impacted adverse event rates, further delineation is required. A larger sample size is needed to elucidate exactly which psychosocial characteristics affect VAD outcomes.

Sex-Related Differences in Use and Outcomes of Left Ventricular Assist Devices as Bridge to Transplantation

ObjectivesThis study examined sex-related differences in use and outcomes of continuous-flow left ventricular assist devices (CF-LVADs) among individuals awaiting heart transplantation using the United Network for Organ Sharing registry. BackgroundAdvanced therapies for heart failure including CF-LVADs remain underused in women. There have been contradictory results regarding sex-specific outcomes. Many studies have been limited by small sample sizes or included pulsatile-flow devices. MethodsDe-identified patient-level data were obtained from the United Network for Organ Sharing database. The database was queried to identify adult patients (≥18 years of age) who required mechanical circulatory support with HeartWare HVAD (Medtronic, Minneapolis, Minnesota), HeartMate II (Abbott, Lake Bluff, Illinois), or HeartMate 3 (Abbott) as bridge to heart transplantation between 2008 and 2018. Each patient was assigned a propensity score. The primary outcomes of interest were rates of transplantation and death. ResultsA total of 13,305 patients (2,771 women, 20.8%) received support with CF-LVAD in the study period. There were significant sex disparities in CF-LVAD use in listed patients (29.9% men vs. 18.9% women in 2017). Female patients receiving CF-LVAD support had lower chances of heart transplantation (55.1% vs. 67.5%), increased risk of waitlist mortality (7.0% vs. 4.2%), and delisting for worsening clinical status (8.5% vs. 4.7%) at 2 years post-implantation (all p < 0.001). After adjusting for device type, sex was still a significant predictor of waitlist mortality (hazard ratio: 1.51; p < 0.001). ConclusionsDurable mechanical circulatory support with CF-LVADs remains underused in women. When matched with similar male control subjects, women experienced higher mortality and lower rates of heart transplantation.

Cluster analysis of preoperative echocardiographic findings and outcomes following left ventricular device implantation

ObjectiveTo investigate whether preoperative echocardiography findings determine postoperative continuous-flow left ventricular assist device outcomes. MethodsFrom January 2003 to June 2017, 490 patients received a durable, continuous-flow left ventricular assist device. Two-step clustering of parameters including heart rate and preoperative echocardiographic findings (ie, left ventricular [LV] ejection fraction, right ventricular [RV] function, aortic insufficiency, mitral regurgitation [MR], tricuspid regurgitation [TR]) was performed and identified 5 distinct clusters associated with LV failure: group 1: moderate right ventricular dysfunction (RVD), severe MR and mild TR (n = 110); group 2: severe RVD, severe MR and TR (n = 64); group 3: moderate RVD and severe aortic insufficiency (n = 16); group 4: mild RVD and mild valvular pathology (n = 163); and group 5: moderate-severe RVD and mild valvular pathology (n = 137). Silhouette measure of cohesion and separation demonstrated satisfactory separation at 0.6. ResultsGroup 2 had the greatest Interagency Registry for Mechanically Assisted Circulatory Support Level 1 (25%, P = .010), preoperative right atrial pressure (11 ± 5 mm Hg, P < .001), incidence of postoperative right ventricular failure (RVF; 20%, P = .001), delayed closure of the sternum (61%, P = .002), postoperative permanent dialysis (6%, P = .04), rate of tricuspid valve repair (n = 52; 81%, P < .001), and lowest RV stroke work index (489 ± 228 cc mm Hg/m2/beat, P < .001). RVF in groups 1, 3, 4, and 5 was 6%, 0%, 4%, and 9%, respectively. No differences in incidence of heart transplantation (P = .400) or survival (P = .535) were found. Severe TR predicted RVF in those with moderate-severe preoperative RVD (P = .001, odds ratio 3.9). ConclusionsClustering demonstrated the importance of preoperative TR in predicting RVF. Combined severe LV and RV failure with severe MR and TR portends the worse prognosis.

Effects of socioeconomic status on clinical outcomes with ventricular assist devices.

Lower socioeconomic status (SES) is a known risk factor for worse outcomes after major cardiovascular interventions. Furthermore, individuals with lower SES face barriers to evaluation for advanced heart failure therapies, including ventricular assist device (VAD) implantation. Examination of the effects of individual determinants of SES on VAD outcomes will show similar survival benefit in patients with lower compared with higher SES. All VAD implants at the University of Florida from January 2008 to December 2015 were reviewed. Patient-level determinants of SES included place of residence, education level, marital status, insurance status, and financial resources stratified by percent federal poverty level. Survival or transplantation at 1 year, 30-day readmission, implant length of stay (LOS), and an aggregate of VAD-related complications were assessed in univariate fashion and multivariable regression modeling. A total of 111 patients were included (mean age at the time of implant 57.6 years, 82.8% men). More than half received destination therapy. At 1 year, 78.3% were alive on device support or had undergone successful transplantation. There were no differences in survival, 30-day readmission, or aggregate VAD complications by the SES category. Although patients with lower levels of education had longer LOS in univariate analysis, on multivariable ordinal regression modeling, this relationship was no longer seen. Patients with lower SES receive the same survival benefit from VAD implantation and are not more likely to have 30-day readmissions, complications of device support, or prolonged implant LOS. Therefore, VAD implantation should not be withheld based on these parameters alone.

Outcomes of children with congenital heart disease implanted with ventricular assist devices: An analysis of the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs).

The reported ventricular assist device (VAD) experience in the pediatric congenital heart disease (CHD) population is limited. We sought to describe contemporary use and outcomes of VADs in children with CHD and compare these outcomes to those of non-CHD children. Patients enrolled in the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) between September 19, 2012 through June 30, 2017 were included. CHD was classified as biventricular vs single ventricle (Stages 1, 2, or 3). Outcomes were compared between groups and multivariable analysis was used to identify factors associated with mortality on the device. Among the 471 patients enrolled, 108 (24%) had CHD (45 biventricular and 63 single ventricle). CHD patients were younger (5.7 ± 5.7 years vs 9.8 ± 6.5 years; p < 0.0001) and smaller (0.8 ± 0.5 m2 vs 1.2 ± 0.7 m2; p < 0.0001) compared with non-CHD patients. CHD patients were more likely to receive a paracorporeal continuous-flow VAD (36.1% vs 12.9%; p < 0.0001) and less likely to receive an implantable continuous-flow VAD (27.8% vs 55.0%; p < 0.0001) compared with non-CHD patients. After 6 months on a VAD, CHD patients had higher mortality (36.4% vs 12.1%) and a lower transplantation rate (29.1% vs 59.9%) than non-CHD patients (p < 0.0001). In the multivariable analysis, CHD was the factor most strongly associated with mortality on VAD (hazard ratio [HR] = 2.9; p < 0.0001), whereas the factors implantable continuous-flow device and high-volume center were protective (HR = 0.3, p < 0.0001, and HR = 0.6, respectively; p = 0.02). VAD use in children with CHD is associated with increased mortality and decreased transplant rates compared to children without CHD. For the subgroup of children with CHD who received implantable continuous-flow VADs, survival rates were higher and comparable to those of children without CHD. Increased experience correlated with better survival in pediatric VADs.

Mechanical circulatory support challenges in pediatric and (adult) congenital heart disease.

Increased miniaturization of ventricular assist devices (VADs) and new mechanical support strategies (MCS) has increased the use of MCS in the pediatric and congenital heart disease (CHD) population. This comes with the need for care providers specialized in this field to determine optimal patient and device selection, and to improve outcomes and decrease complication rates for new innovative strategies. A review of the published literature in this field is timely and relevant. There has been a rapid evolution of using adult designed continuous flow VADS to support children and adults with CHD (ACHD). Patient selection for patients with CHD is complex because of patient size and anatomical diversity and, therefore, makes decision-making complex and unique when compared to general adult practice. Outcomes for children depend on size and diagnosis with neonates with single ventricle physiology being the highest risk candidates. This also holds true for ACHD, in which VAD outcomes in patients with two ventricle physiology are comparable to non-ACHD patients. In children, there is an increased use of continuous flow devices and a growing experience with outpatient management. Patients with CHD especially when associated with single ventricle physiologies, remain a challenge when it comes to MCS/VAD placement but successful durable VAD implantation with discharge home has been reported.

Outcomes of Continuous Flow Left Ventricular Assist Devices: A Single Institutional 18-Year Experience with Over 850 Devices

Outcomes of Continuous Flow Left Ventricular Assist Devices: A Single Institutional 18-Year Experience with Over 850 Devices

Left ventricular assist device outcomes based on flow configuration and pre-operative left ventricular dimension: An Interagency Registry for Mechanically Assisted Circulatory Support Analysis

Axial configuration (AC) and centrifugal configuration (CC) left ventricular assist devices (LVAD) have different flow characteristics, and whether the interaction between device flow configuration and the pre-operative left ventricular internal diastolic diameter (LVIDD) mediates adverse events after LVAD implantation is unknown. We queried 9,424 continuous-flow LVAD recipients who received LVADs from April 2008 to June of 2015 in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). The pre-operative LVIDD * flow configuration interaction term was tested in multivariable models to determine its relationship to adverse events. The pre-operative LVIDD * flow configuration interaction was a significant predictor of device thrombosis. As the LVIDD increased, the risk of AC device thrombosis increased compared with CC devices (p = 0.0099). At 7.0 cm, the hazard ratio (HR) for AC device thrombosis compared with the CC device was 1.61 (95% confidence interval [CI], 1.17-2.22; p = 0.004) and continued to rise as the LVIDD increased. The LVIDD * flow configuration interaction did not predict stroke, gastrointestinal bleeding, or patient survival. In multivariable models, the hazard of stroke was higher with the CC device regardless of the LVIDD (HR, 1.96; 95% CI, 1.64-2.36; p < 0.0001). Adjusted analyses showed LVAD implantation into a larger left ventricle was associated with a lower risk of death (HR, 0.90; 95% CI, 0.85-0.95; p = 0.0004) per centimeter of LVIDD. Our study suggests that the pre-operative LVIDD, flow configuration, and interaction terms should be considered individually when choosing the appropriate LVAD to mitigate the rates of device thrombosis, stroke, and death.

(99) - Utilization and Outcomes of Temporary Ventricular Assist Devices in Children: A Report from the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs)

(99) - Utilization and Outcomes of Temporary Ventricular Assist Devices in Children: A Report from the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs)

Abstract 169: Contemporary Trends in Utilization and Outcomes of Percutaneous Ventricular Assist Devices in Cardiogenic Shock Complicating ST-Elevation Myocardial Infarction in the United States

Background: Percutaneous ventricular assist devices (pVAD) can be rapidly deployed in cardiac catheterization laboratory and have emerged as an effective modality for short-term hemodynamic support in patients with cardiogenic shock. There are limited data on contemporary trends in utilization and outcomes of pVAD in patients with cardiogenic shock complicating ST-elevation myocardial infarction (STEMI). Objectives: To determine the temporal trends in utilization and outcomes of pVAD in patients with cardiogenic shock complicating STEMI. Methods: We queried the 2007-2011 Nationwide Inpatient Sample databases to identify all patients aged ≥ 18 years with STEMI and cardiogenic shock. Patients who underwent pVAD implantation were then identified using ICD-9 procedure code 37.68. Temporal trends in utilization of pVAD in STEMI patients with cardiogenic shock and in-hospital outcomes in these patients were analyzed. Results: From 2007-2011, of 1,053,161 patients with STEMI, 100,881 (9.6%) had cardiogenic shock. The in-hospital mortality in patients with cardiogenic shock decreased from 39.2% in 2007 to 33.9% in 2011 (P trend &lt;0.001, adjusted OR [per year] 0.98, 95% CI 0.97-0.99). Of the STEMI patients with cardiogenic shock, a total of 1,068 (1.1%) patients underwent pVAD implantation. The use of pVAD in STEMI patients with cardiogenic shock increased from 0.1% in 2007 to 2.6% in 2011 (P trend &lt;0.001). The incidence of acute cerebrovascular accident in patients with pVAD was 6.7% with no significant temporal change in incidence (P trend =0.99). The incidence of acute gastrointestinal bleeding in these patients was 14.3% with no significant temporal change in incidence (P trend =0.52). The overall in-hospital mortality in patients who received pVAD was 49.6% with an increase in in-hospital mortality during the study period (P trend =0.03, adjusted OR [per year] 1.22, 95% CI 1.02-1.47). The average length of stay in these patients increased from 12 days to 15 days (P trend &lt;0.001), whereas the average total hospital charges increased from $180,849 to $361,050 (P trend &lt;0.001). Conclusion: In recent years, there has been an increase in utilization of pVAD in patients with cardiogenic shock complicating STEMI. However, this trend was not accompanied with a decrease in overall in-hospital mortality among patients who underwent pVAD implantation. There were also adverse temporal trends in the average length of stay and average hospital cost in STEMI patients with cardiogenic shock undergoing pVAD implantation.

(111) - Outcomes of Implantable Left Ventricular Assist Devices in a South East Asian Population

(111) - Outcomes of Implantable Left Ventricular Assist Devices in a South East Asian Population

(259) - Utilization and Outcomes of Continuous-Flow Ventricular Assist Devices in Pediatric: Patients: A Report From the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS)

(259) - Utilization and Outcomes of Continuous-Flow Ventricular Assist Devices in Pediatric: Patients: A Report From the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS)

(508) - Substance Abuse and Left Ventricular Assist Device Outcomes: Does a History and Type of Use Matter?

(508) - Substance Abuse and Left Ventricular Assist Device Outcomes: Does a History and Type of Use Matter?

(132) - Does Indication for Destination Therapy Affect Left Ventricular Assist Device Outcomes?

s S57 Conclusion: Patients requiring LVAD insertion typically have associated cardiac defects which are often regurgitant valvular lesions. Repairing, replacing or closing insufficient valves is associated with a longer CBP time but does not result in increased operative mortality or decreased survival at 2 years as observed in registry data. Patient informed consent should be based upon treatment center’s specific results and not multicenter registry data.

(627) - Prior Sternotomy Does Not Affect Short and Long-Term Ventricular Assist Device Outcomes

(627) - Prior Sternotomy Does Not Affect Short and Long-Term Ventricular Assist Device Outcomes

Impact of Hypertension on Continuous Flow-Left Ventricular Assist Device Outcomes

Older Women Benefit from Early Mechanical Support: An Update from the USPella Registry Susan M. Joseph, Meredith A. Brisco, Mary N. Walsh, Monica Colvin, Kathleen L. Grady, Maria Mountis, Jennifer L. Peura; Washington University School of Medicine, St. Louis, MO; Medical University of South Carolina, Charleston, SC; St. Vincent Heart Center of Indiana, Indianapolis, IN; University of Minnesota, St. Louis, MN; Northwestern University, Chicagot, IL; Cleveland Clinic, Cleveland, OH

Four-year outcomes with third-generation centrifugal left ventricular assist devices in an era of restricted transplantation.

OBJECTIVESThird-generation ventricular assist devices (VADs) are associated with improved outcomes, though in recent clinical trials bridge-to-transplant (BTT) rates are ∼30% at 6 months, so that transplantation can be used as a ‘bail out’ for serious complications. In the UK, there was a significant reduction in heart transplantation rates over the last decade, so that transplantation from VADs is much less frequent. The objective of this study was to determine outcomes and their predictors in this situation of low BTT rates, and as patients were exposed to long-term support, the incidence and outcomes of VAD thrombosis.METHODSWe analysed outcomes for 102 consecutive patients between 2009 and 2013 (mean age 47 ± 13; VentrAssist n = 6 and HeartWare n = 96). The median duration of support was 462 ± 426 days.RESULTSSurvival rates on the device were 75 and 66% at 1 and 2 years, respectively. Older age and more acute INTERMACS groups were significantly related to reduced survival within the first 90 days (P = 0.030 and 0.010, respectively). Poor preoperative right ventricular (RV) function had a negative effect on survival after 1 year (P = 0.009), though not earlier. VAD thrombosis (n = 24 HeartWare and n = 1 VentrAssist) occurred at 0.18 events per patient-year for HeartWare and 0.07 for VentrAssist devices at a median time of onset at 404 ± 281 days. There was no significant effect of VAD thrombosis on survival. Only 14 of 102 patients were transplanted at a median of 334 ± 347 days, and only 3 were transplanted within the first 6 months.CONCLUSIONSThird-generation left ventricular assist device implants with a low rate of transplantation have similar survival to destination therapy, and are susceptible to long-term complications of VAD thrombosis and right heart failure.

(138) - Favorable Outcomes of Left Ventricular Assist Device as Bridge to Simultaneous Heart Kidney Transplantation

(138) - Favorable Outcomes of Left Ventricular Assist Device as Bridge to Simultaneous Heart Kidney Transplantation

(184) - Regional Differences in Utilization and Outcomes of Left Ventricular Assist Devices: Insights from the INTERMACS Registry

Background We sought to examine whether characteristics, implant strategy, and outcomes in patients who receive continuous-flow left ventricular assist devices (CF-LVAD) differ across geographic regions in the United States (US).

Abstract T P332: Despite Differences in Device Design, Anticoagulation, and Duration of Use, Pulsatile- and Continuous-Flow Left Ventricular Assist Devices Share Similar Stroke Rates and Outcomes

Background: Stroke is the primary adverse outcome in Left Ventricular Assist Devices (LVADs), not well-described in current literature. We hypothesized that pulsatile-flow devices would have worse stroke rates and outcomes than continuous devices. Methods: This is a single-center retrospective study of all adult LVADs from 1999-2013 at the University of Utah utilizing the internal LVAD and Stroke Center databases. Complete chart review included review of all relevant outside records with no case loss. Categorical variables were computed using a χ 2 test; ordinal variables via the Mann-Whitney U test. Results: Among 52 pulsatile (47 patients) and 91 continuous (81 patients) devices, 17.3% of pulsatile and 18.7% of continuous devices had at least one stroke/TIA (p=0.84). Stroke subtypes and LVAD-specific outcomes did not vary by device. Stroke severity was higher at first stroke/TIA with a median (IQR) NIHSS of 4 (2, 11) vs. 1 (1, 2) in continuous vs. pulsatile devices (p=0.03). Despite continuous devices having nearly twice the number of overall days on device (DOD), there was no difference in median DOD until first stroke/TIA: 170 in pulsatile; 165 in continuous; p=0.56. Stroke outcomes by device were good with mRS≤2 in 71% of pulsatile and 53% of continuous devices (p=0.42). All-cause 1-year mortality was high but with only the minority due to stroke (Table 1). Neither sepsis nor pump thrombus were associated with stroke/TIA. Conclusions: Continuous devices provide longer DOD without increased stroke risk or significantly worse outcomes. First AIS/TIA events were more severe in continuous devices, with non-significantly worse mRS scores. In this study, we did not replicate previous findings of infection predisposing to stroke.