Use Of Ventricular Assist Devices Research Articles

Impact of ventricular assist device use on pediatric heart transplant waitlist mortality: Analysis of the scientific registry of transplant recipients database.

Children awaiting heart transplant (Tx) have a high risk of death due to donor organ scarcity. Historically, ventricular assist devices (VADs) reduced waitlist mortality, prompting increased VAD use. We sought to determine whether the VAD survival benefit persists in the current era. Using the Scientific Registry of Transplant Recipients, we identified patients listed for Tx between 3/22/2016 and 9/1/2020. We compared characteristics of VAD and non-VAD groups at Tx listing. Cox proportional hazards models were used to identify risk factors for 1-year waitlist mortality. Among 5054 patients, 764 (15%) had a VAD at Tx listing. The VAD group was older with more mechanical ventilation and renal impairment. Unadjusted waitlist mortality was similar between groups; the curves crossed ~90 days after listing (p = .55). In multivariable analysis, infant age (HR 2.77, 95%CI 2.13-3.60), Black race (HR 1.57, 95%CI 1.31-1.88), congenital heart disease (HR 1.23, 95%CI 1.04-1.46), renal impairment (HR 2.67, 95%CI 2.19-3.26), inotropes (HR 1.28, 95%CI 1.09-1.52), and mechanical ventilation (HR 2.23, 95%CI 1.84-2.70) were associated with 1-year waitlist mortality. VADs were not associated with mortality in the first 90 waitlist days but were protective for those waiting ≥90 days (HR 0.43, 95%CI 0.26-0.71). In the current era, VADs reduce waitlist mortality, but only for those waitlisted ≥90 days. The differential effect by race, size, and VAD type is less clear. These findings suggest that Tx listing without VAD may be reasonable if a short waitlist time is anticipated, but VADs may benefit those expected to wait >90 days.

Perioperative Left Ventricular Assist Device Use in Patients With Reduced Ejection Fraction Reduces Cardiac Surgery-Associated Acute Kidney Injury.

Background Cardiac surgery may precipitate acute kidney injury (AKI), particularly in patients with poor baseline cardiac function. This is thought to be due to intraoperative renal hypoperfusion, which results in increased morbidity and mortality. This study evaluated the perioperative use of the Impella LD (Abiomed, Danvers, MA) left ventricular assist device (LVAD) in the prevention of postoperative AKI in patients with reduced left ventricular ejection fraction (LVEF) undergoing cardiac surgery. Methods A retrospective analysis was performed at Northwest Medical Center, Tucson, AZ, USA, on patients undergoing valve surgery, coronary arterybypassgrafting(CABG), or both by a single surgeon. Those with preoperative LVEF ≤35% and preoperative serum creatinine ≥1 mg/dL were included and segregated based on intraoperative LVAD implantation. Postoperative renal functionwas assessed using serum creatinine levels and KDIGO (Kidney Disease Improving Global Outcomes) criteria to define AKI. Results Twenty-three patients were enrolled. There were no significant differences in age, demographics, baseline characteristics, or comorbidities between the treatment (n = 12) and the control group (n = 11). In the treatment group, 8% developed AKI by POD#7, while 64% of controls did. The treatment group had a significantly lower mean creatinine change from POD#0-7 (0.07 vs. 0.59, p = 0.02). However, there was no significant difference between groups in the mean creatinine change from baseline to discharge (0.46 vs. 0.42, p = 0.47). Conclusions Our study suggests that intraoperative Impella implantation may reduce the incidence of early postoperative AKI. LVAD implantation is an approach to increase and ensure adequate end-organ (renal) perfusion andcan improve postoperative recovery without dialysis requirements. Additional studies are required to understand its protective effects during the perioperative period fully.

Developments and Challenges in Durable Ventricular Assist Device Technology: A Comprehensive Review with a Focus on Advancements in China.

Heart transplantation is currently the most effective treatment for end-stage heart failure; however, the shortage in donor hearts constrains the undertaking of transplantation. Mechanical circulatory support (MCS) technology has made rapid progress in recent years, providing diverse therapeutic options and alleviating the dilemma of donor heart shortage. The ventricular assist device (VAD), as an important category of MCS, demonstrates promising applications in bridging heart transplantation, destination therapy, and bridge-to-decision. VADs can be categorized as durable VADs (dVADs) and temporary VADs (tVADs), according to the duration of assistance. With the technological advancement and clinical application experience accumulated, VADs have been developed in biocompatible, lightweight, bionic, and intelligent ways. In this review, we summarize the development history of VADs, focusing on the mechanism and application status of dVADs in detail, and further discuss the research progress and use of VADs in China.

Disparities by Sex, Race, and Ethnicity in Use of Left Ventricular Assist Devices and Heart Transplants Among Patients With Heart Failure With Reduced Ejection Fraction.

The extent to which sex, racial, and ethnic groups receive advanced heart therapies equitably is unclear. We estimated the population rate of left ventricular assist device (LVAD) and heart transplant (HT) use among (non-Hispanic) White, Hispanic, and (non-Hispanic) Black men and women who have heart failure with reduced ejection fraction (HFrEF). We used a retrospective cohort design combining counts of LVAD and HT procedures from 19 state inpatient discharge databases from 2010 to 2018 with counts of adults with HFrEF. Our primary outcome measures were the number of LVAD and HT procedures per 1000 adults with HFrEF. The main exposures were sex, race, ethnicity, and age. We used Poisson regression models to estimate procedure rates adjusted for differences in age, sex, race, and ethnicity. In 2018, the estimated population of adults aged 35 to 84 years with HFrEF was 69 736, of whom 44% were women. Among men, the LVAD rate was 45.6, and the HT rate was 26.9. Relative to men, LVAD and HT rates were 72% and 62% lower among women (P<0.001). Relative to White men, LVAD and HT rates were 25% and 46% lower (P<0.001) among Black men. Among Hispanic men and women and Black women, LVAD and HT rates were similar (P>0.05) or higher (P<0.01) than among their White counterparts. Among adults with HFrEF, the use of LVAD and HT is lower among women and Black men. Health systems and policymakers should identify and ameliorate sources of sex and racial inequities.

Efficacy of Decision Aids in The Use of Left Ventricular Assist Device in Patients With Advanced Heart Failure: A Systematic Review and Meta-Analysis of Randomized Control Trials

Although left ventricular assist device (LVAD) implantation can improve survival in patients with end-stage heart failure, it is not without risk. Numerous complications are possible, and durable support requires substantial lifestyle changes. The use of various knowledge-assessment tools may allow for more informed patient decisions. To synthesize the totality of the evidence, we conducted a systematic review and meta-analysis to summarize the efficacy of decision aid (DA) use in patients with advanced heart failure who are eligible for LVAD. Any randomized controlled trial (RCT) evaluating the efficacy of DAs in patients considering LVAD was eligible for inclusion. A complete search of EMBASE and PubMed was conducted from the start until June 8, 2023. The primary outcome was patients' LVAD knowledge. Data extraction was performed independently by 2 reviewers. Data were pooled using a random-effects model. Of the 575 references, 2 RCTs randomizing 490 patients were included in this study. DAs were associated with no significant change in LVAD knowledge (standardized mean difference 0.07, 95% confidence interval -0.24 to 0.39, p=0.64) or decisional conflict (mean difference -1.48, 95% confidence interval -5.28 to 2.32, p=0.45). The certainty of the evidence ranged from moderate to very low. The use of DAs in LVAD-eligible patients with advanced heart failure resulted in no difference in patients' knowledge of LVAD after LVAD education. The findings from this study will aid in the power analysis of a well-designed RCT to evaluate and encourage further investigation into the efficacy and relevance of DAs in preparing patients for a life with LVAD.

Outcomes of pediatric ventricular assist device in the United States: an analysis of the national inpatient sample database

Abstract Background Infants and children with advanced heart failure, refractory to medications, are frequently supported with ventricular assist devices (VAD). Purpose To describe the patient characteristics of those who were supported with VADs and describe the factors associated with mortality with use of VAD in the USA. Methods We conducted a retrospective analysis of a large administrative database, the National Inpatient Sample (NIS) dataset for the years 2010 to 2018. We identified pediatric patients (0–18 years of age) who had implantation of VAD during the hospitalization. Patient characteristics and outcomes were compared between survivors and those who died during the hospitalization. Results We identified 1620 patients with VAD procedure in the years we studied. Of them, 324 patients (20%) died during the hospitalization. The trend of utilizing VAD was increasing during the years of the study (Fig. 1). Mortality trend over the study years is presented in figure 2. In multivariable regression analysis, patients with VAD who died were more likely to be less than 1 year of age (OR=4.14, 95% CI:2.29–7.50, p &amp;lt; 0.001), on mechanical ventilation for more than 96 hours (OR=10.71, 95% CI: 6.69–17.14=5, p &amp;lt; 0.001), had liver failure (OR 19.88, 95% CI:10.15-38.95, p&amp;lt;0.001). Those who survived to hospital discharge were more likely to have orthotopic heart transplantation (OR=19.08, 95% CI: 8.12-44.81, p&amp;lt;0.001) and were diagnosed with dilated cardiomyopathy (OR=5.08, 95% CI: 3.38-7.63, p&amp;lt;0.001). Conclusion VAD in pediatric population is increasingly being used in the United States as a bridge to recovery or transplantation. During study period, in hospital mortality trended down significantly. Younger patient's age; less than one year, liver failure and &amp;gt;96 hours mechanical ventilation are considerable risk factors for mortality. Prospective studies are needed to account for confounders, and further classify risk factors based on underlying structural heart disease and clinical status at time of hospital admission.

Abstract 16289: Functional Status Improves Following Heart Transplantation for Most Patients and Functional Status at One Year Predicts Five-Year Survival

Introduction: Heart transplantation is a critical treatment for end-stage heart disease, with the goal of improving both length and quality of life. We investigated predictors of functional status improvement following transplant and the impact of functional status at 1 year on survival. Methods: We used data from the Scientific Registry of Transplant Recipients on 34,649 U.S. adults who received a heart transplant from Jan. 2006 - Jul. 2020. Functional status was measured using the Karnofsky Performance Scale (KPS; 0-100%). Linear regression with stepwise selection was used to identify predictors of change in KPS from listing to transplant, and from transplant to 1 and 5 years post-transplant. Kaplan Meier curves with log-rank testing was used to compare 5-year survival between patients with poor (≤50%) versus non-poor (&gt;50%) KPS at 1 year. Results: Mean KPS was low at listing (47.9%, SD 22.4%) and discharge following transplant (45.6%, SD 24.1%). At 1-year post-transplant, the mean KPS increased to 85.8% (SD 17.7%), which was stable at 5 years (Figure). There was a small difference in KPS at 1 and 5 years based upon KPS at listing (p&lt;0.0001). After adjusting for KPS at transplant and transplant center, predictors of the magnitude of KPS change from transplant to 1 year included insurance type, diabetes, hypertension, prior cardiac surgery, smoking, “1A” waitlist priority, and hospitalization status. Predictors of KPS change from transplant to 5 years included insurance type, diabetes, ventricular assist device use, prior cardiac surgery, sex, and age. Only 5.5% of patients had poor KPS (≤50%) at 1 year. Of these patients, 5-year survival was significantly lower at 72.9% compared to 88.3% among patients with KPS&gt;50% at 1 year (p&lt;0.0001). Conclusions: Functional status is an important outcome following heart transplant and impacts survival. Most patients alive at 1 year have excellent KPS but clinical and social interventions may help optimize KPS among at-risk patients.

Left Ventricular Assist Device Use in Minorities: An Analysis of the National Inpatient Sample.

Minorities are less likely to receive a left ventricular assist device (LVAD). This, however, is based on total implant data. By examining rates of LVAD implant among patients admitted with heart failure complicated by cardiogenic shock, we sought to further elucidate LVAD utilization rates and racial disparities. Utilizing the National Inpatient Sample from 2013 to 2019, all patients admitted with a primary diagnosis of heart failure complicated by cardiogenic shock were included for analysis. Those who then received an LVAD during that hospitalization defined the LVAD utilization which was examined for any racial disparities. Left ventricular assist device utilization was low across all racial groups with no significant difference noted in univariate analysis. Non-Hispanic Blacks had the highest length of stay (LOS), the highest proportion of discharge to home (71.52%), and the lowest inpatient mortality (6.33%). Multivariable modeling confirmed the relationship between race and LOS; however, no differences were noted in mortality. Non-Hispanic Blacks were found to be less likely to receive an LVAD; however, when controlling for payer, median household income, and comorbidities, this relationship was no longer seen. Left ventricular assist devices remain an underutilized therapy in cardiogenic shock. When using a multivariable model, race does not appear to affect LVAD utilization.

Intelligent embedded system for physiological control of ventricular assist devices in health 4.0 Background

The use of Left Ventricular Assist Devices (LVADs) has proven to be an effective treatment option for Congestive Heart Failure (CHF) patients who are not eligible for heart transplantation. These devices can serve as a bridge to heart transplantation (BTT) or as destination therapy (DT). While LVADs operate at a constant flow, this can affect the patient's quality of life and survival rate. To address this issue, Health 4.0 (H4) has developed new technological resources to personalize control systems and integrate medical devices into treatment. In this effort, a Physiological Control of LVAD (PC-LVAD) system was implemented within the H4 platform, using an Intelligent Embedded System (IES). The IES was developed using the MyRIO® development platform and tools such as LabVIEW® FPGA and RT, Quartus II® EDA, and MATLAB®. To evaluate its performance, preliminary criteria were assessed in experimental tests, analyzing the Internet of Things (IoT) characterization and applying best practices for information security. The results of the experimental tests showed that the IES could store and transmitting data in real-time to a graphical interface, and the data were found to be consistent with external measuring instruments.

Impact of new allocation system on length of stay following heart transplantation in the United States.

United Network for Organ Sharing (UNOS) allocation criteria changed in 2018 to accommodate the increased prevalence of ventricular assist device use as a bridge to heart transplant, which consequently prioritized sicker patients. We aimed to assess the impact of this new allocation policy on the length of stay following heart transplantation. Secondary outcomes include other risk factors for prolonged hospitalization and its effect on mortality and postoperative complications. The UNOS Registry was queried to identify patients who underwent isolated heart transplants in the United States between 2001 and 2023. Patients were divided into quartiles according to their respective length of stay. A total of 57020 patients were included, 15357 of which were allocated with the new system. The median hospital length of stay was 15 days (mean 22.7 days). Length of stay was longer in the new allocation era (25±30vs. 22±27 days, p<.001). The longer length of stay was associated with increased 5-year mortality in the new allocation system (aHR: 1.18; 95% CI: 1.15, 1.20; p-value:<.001). Longer hospital stays and associated observed increased risk for mortality in the era after the allocation criteria change reflect the rationale of this shift which was to prioritize heart transplants for sicker patients. Further studies are needed to track the progress of surgical and perioperative management of these studies over time.

The prevalence of osteopenia and osteoporosis after heart transplantation assessed using CT

Osteoporosis is frequently observed in patients after heart transplantation (HT), although the prevalence long-term post-HT is unknown. Most studies investigating bone mineral density (BD) after HT were performed using dual-energy X-ray absorptiometry. In this study BD, including the prevalence of osteopenia and osteoporosis, was investigated using coronary computed tomography (CCT) long-term post-HT. Moreover, risk factors for abnormal BD were investigated. All first CCT scans between February 2018 and June 2020 used for the annual screening for cardiac allograft vasculopathy were included. Retransplantations and scans with not fully imaged vertebrae were excluded. BD was measured as a mean of the BD of three consecutive thoracic vertebrae and categorized into normal BD, osteopenia or osteoporosis. Binary logistic regression was used to find determinants for an abnormal BD. Linear regression was used to explore determinants for the mean Hounsfield unit (HU) value of the BD. In total, 140 patients were included (median age 55.2 [42.9-64.9] years, 51 (36%) female). Time between HT and CT scan was 11.0 [7.3-16.1] years. In total, 80 (57%), 43 (31%), and 17 (12%) patients had a normal BD, osteopenia, or osteoporosis, respectively. Osteoporotic fracture or vertebrae fractures was seen in 11 (8%) patients. Determinants for an abnormal BD were recipient age (OR 1.10 (1.06-1.14), p<0.001) and prednisolone use (OR 3.75 (1.27-11.01), p=0.016). In linear regression, left ventricular assist device use pre-HT (p=0.024) and time since HT (p=0.046) were additional BD determinants. Osteopenia and osteoporosis are frequently seen on CCT post-HT. More investigation on appropriate measures to maintain a normal BD in these patients are needed.

Testing radiofrequency energy delivery and catheter entrapment in three left ventricular assist device models in mock circulation

Abstract Funding Acknowledgements Type of funding sources: None. Background The use of Left Ventricular Assist Devices (LVAD) as a bridge to heart transplantation (HTx) or as a destination therapy is increasing. Near half of the patients had ventricular arrhythmias (VA) in the first year of LVAD support. Ablation is common method for recurrent ventricular tachycardias in LVAD patients. Even there are many case reports about successful VT ablations in LVAD patients there is no report about consequences of RF energy delivery inside LVAD or ablation catheter contact – entrapment to the rotor of the LVAD. Method Mock circulation models were created for three mostly used LVAD models ( Figure 1) (HeartMate3, HeartMate2, HVAD) Sheep heart was located inside the mock circulation model and 4mm non-irrigated RF ablation catheter and RF generator used for RF energy delivery tissue ( sheep heart) , ostium, mid and rotor of the LVAD)(Figure 1). During RF delivery flow parameters of the LVAD systems were noted also external noncontact flow monitor located out flow canula of the LVAD. All LVADs out flows were tested for 24 hours after RF energy delivery for long term malfunction. Also RF ablation catheters were tested for mechanical and functional disfunctions after contact of the LVAD rotors. Results No malfunctions were observed during and after RF energy delivery inside the LVADs. Only LVAD flow parameters temporary decreased in HeartMate 3 when the catheters had a contact to the rotor of the LVAD. This phenomenon occurred irrespective of RF energy delivery status. There were no changes in HVAD and Heartmate 2. After 24 hours continuous testing of the flow of the LVADs any changes were not observed . Impedance changes were noticed during RF energy delivery. Impedance values were dropped when RF catheter moved from tissue to the ostium of the LVAD in all models. Small increases observed during contact to the rotor of the LVAD in HeartMate 3 ( Figure 2). No mechanical damage were observed on the tip of the catheters after contact to the rotors also RF lesion dimensions were compared before and after the contact and there were no differences. Conclusion RF energy delivery and catheter entrapment of the RF catheters to the rotors of the LVADs caused no changes in LVAD functioning in ex-vivo conditions in a mock circulation.

Use of Percutaneous Left Ventricular Assist Device Before Durable Device Implantation in Patients With Cardiac Cachexia: Case Series.

Frailty and malnutrition in patients with heart failure are barriers to durable left ventricular assist device (D-LVAD) support and heart transplantation. Moreover, cachexia in patients with advanced heart failure carries a high mortality risk. There are no guidelines for these patients other than increased caloric intake and rehabilitation. Patients suffering from cardiac cachexia and heart failure may benefit from temporary, percutaneous assist device support to improve the underlying heart disease and reverse the catabolic state. We retrospectively reviewed patients from January 2017 to January 2022. All patients who received Impella support (5.0 or 5.5, Abiomed) before D-LVAD implantation were screened. Those who met the criteria for cardiac cachexia were included. Patient demographics, nutritional and biochemical markers, and survival data were collected. A total of 14 patients were included. The majority of patients were male (85.7%) with ischemic cardiomyopathy (64.3%). Caloric intake, physical strength, and ambulation improved. Prealbumin levels improved from a median of 13.7-18.0 mg/dl ( p < 0.006) while on Impella 5.0 or 5.5 support. All patients survived to discharge and the 6 month follow-up. In conclusion, use of the Impella device improves cardiogenic shock symptoms and, consequently, may improve cachexia status prior to D-LVAD implantation.

(1038) Racial Disparities in the Use of Ventricular Assist Devices (VADs) in US Children Listed for Heart Transplantation

(1038) Racial Disparities in the Use of Ventricular Assist Devices (VADs) in US Children Listed for Heart Transplantation

(1037) What to Do with a Squeaky Wheel? Ventricular Assist Device Use in Children with Mechanical Valves in the Action Database

(1037) What to Do with a Squeaky Wheel? Ventricular Assist Device Use in Children with Mechanical Valves in the Action Database

(1181) Successful Use of Percutaneous Right Ventricular Assist Device with Oxygentaor (Oxyrvad) as a Bridge to Lung Transplantation

(1181) Successful Use of Percutaneous Right Ventricular Assist Device with Oxygentaor (Oxyrvad) as a Bridge to Lung Transplantation

(73) Successful Use of Right Ventricular Assist Device after Pulmonary Endarterectomy

(73) Successful Use of Right Ventricular Assist Device after Pulmonary Endarterectomy

Efficacy of Prolonged Impella 5.5 Support as Bridge to Heart Transplantation: Current Concepts and Future Direction.

To the Editor: Zaky et al.1 recently published an interesting article titled, “Impella 5.5 Support beyond 50 Days as Bridge to Heart Transplant in End-Stage Heart Failure Patients” that demonstrated efficacy of the Impella 5.5 regarding its ability to provide adequate prolonged hemodynamic support and maintain durability in four cases. The four patients presented in cardiogenic shock with a history of heart failure with or without chronic kidney disease. Due to contraindications to left ventricular assist device use, they received Impella 5.5 support for a mean duration of 70 days (range 54–83). All patients were able to ambulate by day 6, with the only device malfunction being loss of placement signal in one patient and the only complication being bilateral posterior cerebral artery infarcts of unknown cause in another patient. All four patients had devices with intact pump function on explantation and underwent successful heart transplantation. The authors note only one other report in the literature of prolonged Impella 5.5 support as bridge to heart transplantation and no reports in the existing literature of malfunctions or complications in patients with prolonged use (>50 days). Adding on to their discussion of the relevant literature, we wanted to note our published experience with a patient on prolonged Impella support beyond 50 days.2 The patient was a 51-year-old male with decompensated heart failure, chronic kidney disease, and cirrhosis who was sequentially supported with axillary intra-aortic balloon pump, Impella 5.5, and venoarterial extracorporeal membrane oxygenation (V-A ECMO) prior to triple organ, heart-liver-kidney transplantation. The patient was supported on Impella 5.5 for 79 days, comparable to the mean duration of support in the case series published by Zaky et al.1 Total length of temporary mechanical circulatory support (MCS) was 95 days prior to successful transplantation. During the period of Impella support in our patient, he had an episode of heparin-induced thrombocytopenia (HIT) at 30 days treated with argatroban and, subsequently, sepsis at 78 days, prompting Impella explant and initiation of V-A ECMO. Studies have evaluated the risk of these patterns of complications in patients supported with Impella and have shown an association between Impella support and HIT and sepsis.3–5 Our case report corroborates the findings of the reported case series.1 While our collective findings do demonstrate the efficacy of Impella 5.5 support for prolonged temporary MCS as a bridge to heart transplantation beyond the duration of less than or equal to 14 days as approved by the Food and Drug Administration, rates of complications during prolonged support have not been fully delineated. These potential complications do appear to be significant; however, they have not affected survival to transplantation based on our single-center experience. Multicenter, longitudinal studies are warranted to examine the risk and significance of complications of prolonged Impella support before prolonged use of this device becomes an established and widely applied bridging strategy.

The Growing Use of Ventricular Assist Devices in Children: Addressing Evolving Challenges with a Multidisciplinary Collaboration Between Palliative Care and Heart Failure (SA310A)

The Growing Use of Ventricular Assist Devices in Children: Addressing Evolving Challenges with a Multidisciplinary Collaboration Between Palliative Care and Heart Failure (SA310A)

OPTN/SRTR 2021 Annual Data Report: Heart

The past 5 years have posed challenges to the field of heart transplantation. The 2018 heart allocation policy revision was accompanied by anticipated practice adjustments and increased use of short-term circulatory support, changes that may ultimately serve to advance the field. The COVID-19 pandemic also had an impact on heart transplantation. While the number of heart transplants in the United States continued to increase, the number of new candidates decreased slightly during the pandemic. There were slightly more deaths following removal from the waiting list for reasons other than transplant during 2020, and a decline in transplants among candidates listed as status 1, 2, or 3 compared with the other statuses. Heart transplant rates decreased among pediatric candidates, most notably among those younger than 1 year. Despite this, pretransplant mortality has declined for both pediatric and adult candidates, particularly candidates younger than 1 year. Transplant rates have increased in adults. The prevalence of ventricular assist device use has increased among pediatric heart transplant recipients, while the prevalence of short-term mechanical circulatory support, particularly intra-aortic balloon pump and extracorporeal membrane oxygenation, has increased among adult recipients.