Use Of Left Ventricular Assist Devices Research Articles

Optimizing Triage of Ambulatory Patients With Advanced HeartFailure: 2-Year Outcomes From REVIVAL.

Left ventricular assist device (LVAD) use remains uncommon in advanced heart failure (HF) patients not dependent on inotropes. Before considering a randomized trial comparing a strategy of earlier use of LVAD to continued medical therapy, a better understanding is needed of the clinical trajectory of ambulatory patients with advanced systolic HF on optimal guideline-directed medical therapy (GDMT). REVIVAL enrolled 400 patients with advanced ambulatory systolic HF,≥1 HF mortality risk marker (≥2 HF hospitalizations past year; or HF hospitalization and high natriuretic peptide; or no HF hospitalizations but low peak oxygen consumption, 6-minute walk, serum sodium, HF survival score or Seattle HF model predicted survival), and no LVAD contraindication at 21 LVAD centers from July 2015 to June 2016. Patients were followed for 2 years or until a primary outcome (death, durable ventricular assist device, or urgent transplant). Clinical outcomes and health-related quality of life were evaluated. Mean baseline left ventricular ejection fraction was 21%, median 6-minute walk was 341 m, and 92% were Interagency Registry for Mechanically Assisted Circulatory Support profiles 5 to 7. Adherence to GDMT and electrical device therapies was robust. Composite primary outcome occurred in 22% and 37% at 1 and 2 years, with death alone in 8% and 16%, respectively. Patients surviving for 2 years maintained GDMT intensity and had no decline in health-related quality of life. Structured, serial follow-up at programs with expertise in caring for advanced ambulatory systolic HF patients facilitates triage for advanced therapies. Better strategies are still needed to avoid deaths in a small but significant group of patients who die without advanced therapies. REVIVAL patients not selected for VAD or transplant have robust survival and patient-reported outcomes, which challenges advocacy for earlier VAD implantation. (RegistryEvaluation of Vital Information for VADs in Ambulatory Life [REVIVAL]; NCT01369407).

Left ventricular assist device in the presence of subcutaneous implantable cardioverter defibrillator: data from a multicenter experience

Abstract Background Left ventricular assist devices (LVADs) are an increasingly used strategy for the management of patients with advanced heart failure (HF).Subcutaneous implantable cardioverter defibrillator (S-ICD) might be a viable alternative to conventional ICDs, with a lower risk of short- and long-term of device-related complications and infections. Purpose:The aim of this multicenter study was to evaluate the outcomes and management of S-ICD recipients who underwent LVAD implantation. Methods:The study population included patients with an S-ICD who underwent LVAD implantation for advanced HF despite optimal medical therapy. Results:The study population included 30 patients (25 male;median age 45 [38-52] years).The HeartMate III was the most common LVAD type. Median follow-up in the setting of concomitant use of S-ICDs and LVADs was 7 months (1-20).There were no reports of inability to interrogate S-ICD systems in this population.Electromagnetic interference (EMI) occurred in 21 (70%) patients.The primary sensing vector was the one most significantly involved in determining EMI.Twenty-seven patients (90%) remained eligible for S-ICD implantation with at least one optimal sensing vector.The remaining 3 patients (10%) were ineligible for S-ICD after attempts of reprogramming of sensing vectors. Six patients (20%) experienced inappropriate shocks due to EMI. Six patients (20%) experienced appropriate shocks.No S-ICD extraction because of need for antitachycardia pacing,ineffective therapy or infection was reported. Conclusions: Concomitant use of LVAD and S-ICD is feasible in most patients. However, the potential risk of EMI oversensing, IS,and undersensing in the post-operative period following LVAD implantation should be considered.Careful screening for EMI should be performed in all sensing vectors after LVAD implantation.

Special Considerations for Advanced Heart Failure Surgeries: Durable Left Ventricular Devices and Heart Transplantation.

Heart transplantation and durable left ventricular assist devices (LVADs) represent two definitive therapies for end-stage heart failure in the modern era. Despite technological advances, both treatment modalities continue to experience unique risks that impact surgical and perioperative decision-making. Here, we review special populations and factors that impact risk in LVAD and heart transplant surgery and examine critical decisions in the management of these patients. As both heart transplantation and the use of durable LVADs as destination therapy continue to increase, these considerations will be of increasing relevance in managing advanced heart failure and improving outcomes.

Reversibility of precapillary pulmonary hypertension and outcomes after heart transplantation bridged with left ventricular assist devices: Insight from the United Network for Organ Sharing

BackgroundIn light of the updated lowered threshold for diagnosing pulmonary hypertension (PH), the reversibility of precapillary PH with left ventricular assist device (LVAD) and the associated post-heart transplantation (HT) outcomes remain unclear. MethodsUsing data from the United Network for Organ Sharing database, we aimed to investigate predictors of persistent precapillary PH in HT recipients bridged with LVAD and examine the interrelated post-HT survival using the updated pulmonary vascular resistance (PVR) cutoff of >2 Wood units for precapillary PH. ResultsAmong 2169 HT recipients bridged with LVAD, 1299 had PVR >2 at baseline; 551 (42.4%) of whom normalized their PVR ≤2 and 748 (57.6%) remained with elevated PVR >2 after LVAD implantation. Female sex (adjusted odds ratio [aOR]; 2.22, 95% confidence interval [CI], 1.61-3.07; P < .001) and inotrope treatment at listing (aOR, 1.31; 95% CI, 1.03-1.66; P = .028) were associated with persistently elevated PVR after LVAD. Conversely, longer duration of LVAD support (aOR, 0.74; 95% CI, 0.65-0.84; P < .001) and use of HeartMate II (aOR, 0.74; CI, 0.59-0.93; P = .011) were found to be protective against persistently elevated PVR after LVAD. Persistently elevated PVR >2 after LVAD was associated with increased risk of death compared with those who normalized their PVR (adjusted hazard ratio [aHR], 1.26; 95% CI, 1.01-1.57; P = .037). However, the normalized PVR post-LVAD group had comparable survival with those with PVR ≤2 at baseline (aHR, 0.76; 95% CI, 0.57-1.02; P = .07). ConclusionsMany recipients of HT bridged with LVAD remain with PVR >2 after LVAD implantation, which is associated with increased risk of death after HT compared with patients with normalized PVR after LVAD.

Left ventricular assist device and transcatheter edge-to-edge mitral valve repair in advanced heart failure: allies or enemies?

The implantation of left ventricular assist devices (LVADs) has been increasing, with good long-term results, in parallel with a growing population with advanced heart failure (HF). However, in some European countries, LVADs are still underused, with one of the main issues being the patient's late referral. On the contrary, the use of transcatheter edge-to-edge mitral valve repair (TEER) has exponentially increased over the past decade, expanding its potential use even in patients on the heart transplantation waiting list. Even though the study populations of the main trials that investigated the prognostic impact of LVAD and TEER are different, in clinical practice a clear distinction might not be so clear. Therefore, patients with refractory HF symptoms and significant mitral regurgitation should be thoroughly evaluated through a multidisciplinary Heart Team meeting with both an advanced HF specialist and interventional cardiologist, to avoid futile procedures and to define the optimal timing for advanced HF therapies, when they are indicated. We analyzed the main available studies and registries on both TEERs and LVADs and we compared their populations and outcomes, to provide the current evidence on the use of LVAD and TEER in the HF population, especially in the light of the recently released 5-year follow-up results, giving some insights on the Italian situation, and finally to stress the importance of a solid HF network between hospitals, aiming for advanced HF patients' timely referral for LVAD or heart transplants.

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.

Abstract 18632: Mechanical Circulatory Support in Patients Without Cardiogenic Shock Undergoing Percutaneous Coronary Intervention

Background: The use of mechanical circulatory support (MCS) devices for high-risk percutaneous coronary intervention (PCI) has increased over the last decade. However, data on outcomes between MCS device type have been mixed and long-term outcomes are limited. Our aim was to examine the association between intravascular microaxial left ventricular assist device (LVAD) or intra-aortic balloon pump (IABP) use in patients without cardiogenic shock undergoing PCI. Methods: This retrospective study analyzed administrative claims data from a large, insured population across the United States. Patients who underwent PCI without cardiogenic shock from 4/1/2016 to 7/31/2022 were included. Using inverse probability treatment weighting (IPTW), we assessed for the association between device type and all-cause mortality during the index admission, 30-days, and up to 1-year. Secondary outcomes included stroke, bleeding, incident dialysis, repeat revascularization, and total healthcare costs. Results: We identified 2,879 patients undergoing PCI without cardiogenic shock, the mean (SD) age was 68.2 (12.5) years, 27% (n=764) were women, and 61% (n=1,757) had a primary diagnosis of acute myocardial infarction (AMI). After IPTW, intravascular LVAD use was not associated with a statistically significant difference in in-hospital (Odds ratio [OR] 1.30; 95% Confidence interval [CI]: 0.88-1.91, P =0.19) or 30-day (OR 1.19; 95% CI:0.84-1.69, P =0.33) mortality compared to IABP use. At 1-year, intravascular LVAD use was associated with a significant increase in mortality (Hazard ratio 1.23; 95% CI:1.04-1.46, P =0.01). Compared to those receiving an IABP, index admission mean total costs ($81,970 vs. $65,298; P &lt;0.001) and mean monthly costs ($11,030 vs. $14,133; P &lt;0.001) up to 1-year were significantly higher in those receiving an intravascular LVAD. There was no significant association between device type and stroke, bleeding, incident dialysis, and repeat revascularization at any timepoint (all, P &gt;0.05). Conclusions: In patients without cardiogenic shock undergoing PCI, intravascular LVAD use was associated with higher costs but not associated with lower mortality. Randomized data is needed to improve device selection for these patients.

Impact of Frailty on Left Ventricular Assist Device Clinical Outcomes

Frailty is a clinical syndrome prevalent in older adults and carries poor outcomes in patients with heart failure.We investigated the impact of frailty on left ventricular assist device (LVAD) clinical outcomes. The Nationwide Readmission Database was used to retrospectively identify patients with a primary diagnosis of heart failure who underwent LVAD implantation during their hospitalization from 2014 to 2020. Patients were categorized into frail and nonfrail groups using the Hospital Frailty Risk Score. Cox and logistic regression were used to predict the impact of frailty on inpatient mortality, 30-day readmissions, length of stay, and discharge to a skilled nursing facility.LVADs were implanted in 11,465 patients who met the inclusion criteria. There was more LVAD use in patients who were identified as frail (81.6% vs 18.4%, p <0.001). The Cox regression analyses revealed that LVAD insertion was not associated with increased inpatient mortality in frail patients (hazard ratio 1.15, 95% confidence interval 0.81 to 1.65, p=0.427). Frail patients also did not experience a higher likelihood of readmissions within 30days (hazard ratio 1.15, 95% confidence interval 0.91 to 1.44, p=0.239).LVAD implantation did not result in a significant increase in inpatient mortality or readmission rates in frail patients compared with nonfrail patients. These data support continued LVAD use in this high-risk patient population.

Care and Monitoring of Pregnant Patients With Left Ventricular Assist Devices.

Cardiovascular disease is one of the leading causes of maternal mortality in the United States. Although still rare, pregnancy in patients with left ventricular assist devices (LVADs) is becoming more common. Typical indications for the use of LVADs in reproductive-aged females include ischemic cardiomyopathy, nonischemic (familial) dilated cardiomyopathy, peripartum cardiomyopathy, and some forms of myocarditis. An LVAD drains blood through a cannula placed into the apex of the left ventricle and then returns it to the proximal aorta bypassing the aortic valve allowing hemodynamic support in parallel with the native circulation. The physiologic changes associated with pregnancy, mainly increased blood volume and hypercoagulability, may adversely affect patients with LVADs, leading to many experts recommending against pregnancy. Maternal-fetal medicine specialists should have a central role within a multidisciplinary team required to provide optimal care for this high-risk group of patients.

The Association of the UNOS Heart Allocation Policy Change With Transplant and Left Ventricular Assist Device Access and Outcomes

In October 2018, the allocation policy for adult orthotopic heart transplant (OHTx) in the United States was changed, with the goal of reducing waitlist mortality and providing broader sharing of donor organs within the United States. This study aimed to assess the association of this policy change with changes in access to OHTx versus left ventricular assist devices (LVADs), overall and in key sociodemographic subgroups, in the United States from 2016 to 2019. We identified all patients receiving OHTx or LVAD between 2016 and 2019 using the National Inpatient Sample. Controlling for medical co-morbidities, prepolicy trends, and within-hospital-year effects, we fit a dynamic logistic regression model to evaluate patient and hospital factors associated with receiving OHTx versus LVAD before versus after policy change. We also examined the frequency of temporary mechanical circulatory support in the same fashion. We identified 2,264 patients who received OHTx and 3,157 who received LVADs during the study period. In its first year of implementation, the United Network for Organ Sharing policy change of 2018 was associated with no overall change utilization of OHTx versus LVAD. In OHTx recipients, the frequency of use of temporary mechanical circulatory support changed from 15.6% in the before period to 42.6% in the after period (p<0.001). Although the policy change was associated with differences in the odds of receiving an OHTx versus LVAD between different regions of the country, there were no significant changes based on age, gender, race/ethnicity, insurance status, or rurality. In conclusion, the United Network for Organ Sharing policy change on access to OHTx was associated with no overall change in OHTx versus LVAD use in its first year of implementation although we observed small changes in relative odds of transplant based on rurality. Shifts in regional allocation were not significant overall, although certain regions appeared to have a relative increase in their use of OHTx.

Clinical Outcomes of Left Ventricular Assist Device Pump Infection.

Few studies have focused on the clinical outcomes and risk factors of left ventricular assist device (LVAD) pump infection, and no standard treatment for LVAD pump infection has been established. Therefore, we used a therapeutic flowchart to manage LVAD pump infections. We retrospectively evaluated 220 patients who underwent continuous-flow LVAD implantation between January 2005 and March 2021 at Osaka University, Japan. First, we performed wound debridement, negative-pressure wound therapy, antibiotic treatment, and omental flap transposition. Subsequently, we administered conservative treatment, scheduled implantable LVAD exchange, or emergent removal of the implantable LVAD and exchange for extracorporeal LVAD or percutaneous LVAD (IMPELLA). Pump infections occurred in 32 patients. The survival rates of patients with pump infections during LVAD support were 93%, 74%, and 61% at 180 days, 1 year, and 2 years after LVAD pump infection, respectively. Fifteen patients underwent successful heart transplantation. Bridge-to-bridge surgery, preoperative use of venoarterial extracorporeal membrane oxygenation or percutaneous LVAD, high lactate dehydrogenase levels, and driveline infection were significantly associated with pump infection. Our study reveals that poor preoperative condition and driveline infection were significant risk factors for LVAD pump infection.

Comparative Effectiveness of Percutaneous Microaxial Left Ventricular Assist Device vs Intra-Aortic Balloon Pump or No Mechanical Circulatory Support in Patients With Cardiogenic Shock

Recent studies have produced inconsistent findings regarding the outcomes of the percutaneous microaxial left ventricular assist device (LVAD) during acute myocardial infarction with cardiogenic shock (AMICS). To compare the percutaneous microaxial LVAD vs alternative treatments among patients presenting with AMICS using observational analyses of administrative data. This comparative effectiveness research study used Medicare fee-for-service claims of patients admitted with AMICS undergoing percutaneous coronary intervention from October 1, 2015, through December 31, 2019. Treatment strategies were compared using (1) inverse probability of treatment weighting to estimate the effect of different baseline treatments in the overall population; (2) instrumental variable analysis to determine the effectiveness of the percutaneous microaxial LVAD among patients whose treatment was influenced by cross-sectional institutional practice patterns; (3) an instrumented difference-in-differences analysis to determine the effectiveness of treatment among patients whose treatment was influenced by longitudinal changes in institutional practice patterns; and (4) a grace period approach to determine the effectiveness of initiating the percutaneous microaxial LVAD within 2 days of percutaneous coronary intervention. Analysis took place between March 2021 and December 2022. Percutaneous microaxial LVAD vs alternative treatments (including medical therapy and intra-aortic balloon pump). Thirty-day all-cause mortality and readmissions. Of 23 478 patients, 14 264 (60.8%) were male and the mean (SD) age was 73.9 (9.8) years. In the inverse probability of treatment weighting analysis and grace period approaches, treatment with percutaneous microaxial LVAD was associated with a higher risk-adjusted 30-day mortality (risk difference, 14.9%; 95% CI, 12.9%-17.0%). However, patients receiving the percutaneous microaxial LVAD had a higher frequency of factors associated with severe illness, suggesting possible confounding by measures of illness severity not available in the data. In the instrumental variable analysis, 30-day mortality was also higher with percutaneous microaxial LVAD, but patient and hospital characteristics differed across levels of the instrumental variable, suggesting possible confounding by unmeasured variables (risk difference, 13.5%; 95% CI, 3.9%-23.2%). In the instrumented difference-in-differences analysis, the association between the percutaneous microaxial LVAD and mortality was imprecise, and differences in trends in characteristics between hospitals with different percutaneous microaxial LVAD use suggested potential assumption violations. In observational analyses comparing the percutaneous microaxial LVAD to alternative treatments among patients with AMICS, the percutaneous microaxial LVAD was associated with worse outcomes in some analyses, while in other analyses, the association was too imprecise to draw meaningful conclusions. However, the distribution of patient and institutional characteristics between treatment groups or groups defined by institutional differences in treatment use, including changes in use over time, combined with clinical knowledge of illness severity factors not captured in the data, suggested violations of key assumptions that are needed for valid causal inference with different observational analyses. Randomized clinical trials of mechanical support devices will allow valid comparisons across candidate treatment strategies and help resolve ongoing controversies.

TOP5: Heart Transplant versus LVADs: Is destination therapy the new goal?

Background: With improving survival of patients following acute coronary syndromes and chronic heart failure, more patients are reaching the end stage of illness requiring heart transplantation (HT) as a finalgoal therapy. Mechanical circulatory support (MCS) devices like the left ventricular assist device (LVAD) play a major role as destination therapy or bridging therapy for this patient demographic. The improvement of modern LVADs paired with the increase of life expectancy, and the underwhelming engagement of HT donation in the US, ponders on the suggestibility of redirecting efforts for destination or bridging therapy for a growing population. This study assesses the tendencies of LVAD use in comparison to those of HT performance, and analyses the direct correlation with one another as predictive values for future directives in the AHF population. Methods: National data from the Organ Procurement & Transplantation Network (OPTN) was retrieved for the use of LVADs, the performance of primary HT and re-do HT over the last 30 years. Upon data retrieval, descriptive statistics were identified for 6 different groups (ages 18-34, 35-49, 50-64, above 65 years, and the collective adult cohort) including annual growth rate, and comparison within the group means. A regression analysis was performed to determine the variable relationship between LVAD placement and performance of HT. Results: Since 1992, a total of 75098 HT, and 21041 LVAD placements have been performed in the US. There is a significant difference in the number of HT and LVAD placements performed (LVAD vs PT: p=0.0001; LVAD vs re-do HT: p=0.0001). However, upon regression analysis, 64% of LVAD placement determines the subsequent bridging to HT, and the annual growth rate of LVAD placement has a positive significant correlation with the relatively sustained number of HT performed yearly (Coefficient of 0.87; Confidence interval 95%, p=0.000). When comparing LVAD placement to primary HT performance and re-do HT, a significant increase will continue to occur based on the thus-far determined growth rate across all age groups (p= 0.0001). Thus, suggestive that within the upcoming years, the number of LVADs placed will equal the amount of HT performed. Conclusions: With the continuance in evolution and improvement of LVADs in the AHF population and the uneven number of HT performed, this study outlines that the growing tendencies of MCS should be prioritized in lieu of HT availability or strategies to increase donation culture. The prioritization of MCS should aim for a better and comprehensive understanding of the role of these devices and adequate management in a long-term basis.Figure 1. LVAD, primary transplant and transplant repeat annual growth rate

Reciprocal interferences of the left ventricular assist device and the aortic valve competence.

Patients suffering from end-stage heart failure tend to have high mortality rates. With growing numbers of patients progressing into severe heart failure, the shortage of available donors is a growing concern, with less than 10% of patients undergoing cardiac transplantation (CTx). Fortunately, the use of left ventricular assist devices (LVADs), a variant of mechanical circulatory support has been on the rise in recent years. The expansion of LVADs has led them to be incorporated into a variety of clinical settings, based on the goals of therapy for patients ailing from heart failure. However, with an increase in the use of LVADs, there are a host of complications that arise with it. One such complication is the development and progression of aortic regurgitation (AR) which is noted to adversely influence patient outcomes and compromise pump benefits leading to increased morbidity and mortality. The underlying mechanisms are likely multifactorial and involve the aortic root-aortic valve (AV) complex, as well as the LVAD device, patient, and other factors, all of them alter the physiological mechanics of the heart resulting in AV dysfunction. Thus, it is imperative to screen patients before LVAD implantation for AR, as moderate or greater AR requires a concurrent intervention at the time of LVADs implantation. No current strict guidelines were identified in the literature search on how to actively manage and limit the development and/or progression of AR, due to the limited information. However, some recommendations include medical management by targeting fluid overload and arterial blood pressure, along with adjusting the settings of the LVADs device itself. Surgical interventions are to be considered depending on patient factors, goals of care, and the underlying pathology. These interventions include the closure of the AV, replacement of the valve, and percutaneous approach via percutaneous occluding device or transcatheter aortic valve implantation. In the present review, we describe the interaction between AV and LVAD placement, in terms of patient management and prognosis. Also it is provided a comprehensive echocardiographic strategy for the precise assessment of AV regurgitation severity.

Biventricular assist devices and total artificial heart: Strategies and outcomes.

In contrast to the advanced development of the left ventricular assist device (LVAD) therapy for advanced heart failure, the mechanical circulatory support (MCS) with biventricular assist device (BVAD) and total artificial heart (TAH) options remain challenging. The treatment strategy of BVAD and TAH therapy largely depends on the support duration. For example, an extracorporeal centrifugal pump, typically referred to as a temporary surgical extracorporeal right ventricular assist device, is implanted for the short term with acute right ventricular failure following LVAD implantation. Meanwhile, off-label use of a durable implantable LVAD is a strategy for long-term right ventricular support. Hence, this review focuses on the current treatment strategies and clinical outcomes based on each ventricle support duration. In addition, the issue of heart failure post-heart transplantation (post-HT) is explored. We will discuss MCS therapy options for post-HT recipients.

Sex disparities in left ventricular assist device implantation outcomes: A systematic review and meta-analysis of over 50 000 patients.

Left ventricular assist devices (LVAD) represent an important therapeutic option for patients progressing to end-stage heart failure. Women have been historically underrepresented in LVAD studies, and have been reported to have worse outcomes despite technological optimisation. We aimed to systematically explore the evidence on sex disparities in the use and outcomes of LVAD implantation. A systematic database search with meta-analysis was conducted of comparative original articles of men versus women undergoing LVAD implantation, in EMBASE, MEDLINE, Cochrane database and Google Scholar, from inception to July 2022. Primary outcomes were stroke (haemorrhagic and ischaemic) and early/overall mortality. Secondary outcomes were LVAD thrombosis, right VAD implantation, major bleeding, kidney dysfunction, and device/driveline infection. Our search yielded 137 relevant studies, including 22 meeting the inclusion criteria with a total of 53 227 patients (24.2% women). Overall mortality was higher in women (odds ratio [OR] 1.35, 95% confidence interval [CI] 1.05-1.62, p= 0.02), as was overall stroke (OR 1.32, 95%CI 1.06-1.66, p= 0.01), including ischemic (OR 1.80, 95%CI 1.22-2.64, p= 0.003) and haemorrhagic (OR 1.72, 95%CI 1.09-2.70, p= 0.02). Women had more frequent right VAD implantation (OR 2.11, 95%CI 1.24-3.57, p= 0.006) and major bleeding (OR 1.40, 95%CI 1.06-1.85, p= 0.02). Kidney dysfunction, LVAD thrombosis, and device/driveline infections were comparable between sexes. Our analysis suggests that women face a greater risk of adverse events and mortality post-LVAD implantation. Although the mechanisms remain unclear, the difference in outcomes is thought to be multifactorial. Further research, that includes comprehensive pre-operative characteristics and post-operative outcomes, is encouraged.

Microaxial Left Ventricular Assist Device in Cardiogenic Shock: A Systematic Review and Meta-Analysis.

Microaxial left ventricular assist devices (LVAD) are increasingly used to support patients with cardiogenic shock; however, outcome results are limited to single-center studies, registry data and select reviews. We conducted a systematic review and meta-analysis, searching three databases for relevant studies reporting on microaxial LVAD use in adults with cardiogenic shock. We conducted a random-effects meta-analysis (DerSimonian and Laird) based on short-term mortality (primary outcome), long-term mortality and device complications (secondary outcomes). We assessed the risk of bias and certainty of evidence using the Joanna Briggs Institute and the GRADE approaches, respectively. A total of 63 observational studies (3896 patients), 6 propensity-score matched (PSM) studies and 2 randomized controlled trials (RCTs) were included (384 patients). The pooled short-term mortality from observational studies was 46.5% (95%-CI: 42.7–50.3%); this was 48.9% (95%-CI: 43.8–54.1%) amongst PSM studies and RCTs. The pooled mortality at 90 days, 6 months and 1 year was 41.8%, 51.1% and 54.3%, respectively. Hemolysis and access-site bleeding were the most common complications, each with a pooled incidence of around 20%. The reported mortality rate of microaxial LVADs was not significantly lower than extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pumps (IABP). Current evidence does not suggest any mortality benefit when compared to ECMO or IABP.

Characteristics and outcomes of left ventricular assist device recipients transplanted before and after the new donor heart allocation system

Abstract Background Concerns about the impact of the new donor heart allocation system on post-transplant outcomes have emerged after its implementation. We sought to evaluate the characteristics and outcomes of left ventricular assist device (LVAD) recipients transplanted before and after the implantation of the new policy on October 18, 2018. Methods Data on bridge to transplantation adult LVAD patients January 2015 and October 2021, with durable LVAD as a (BTT), was queried from the United Network of Organ Sharing (UNOS) registry. The main outcomes were 30-day all-cause mortality, 30-day fatal graft failure, 1-year all-cause mortality, treated acute rejection at one year and renal replacement therapy (RRT) for acute renal failure. Results In our study, 7096 patients met the inclusion criteria including 2,435 in the new allocation system. The transplanted patients in the new allocation system era had older donor age, longer ischemic time and higher proportion of newer generation LVADs. Adjusted 30-day all-cause mortality was significantly lower for LVAD recipients in the new allocation system era (sub-hazard ratio [SHR] 0.36, 95% Confidence intervals [CI] 0.27–0.48, p&amp;lt;0.001) without differences in the risk of fatal graft failure and one-year mortality. Significantly lower adjusted 30-day mortality with HVAD and HM3 devices than HM2 in the new allocation system era was found, without differences in one-year mortality. Acute allograft rejection requiring treatment was significantly lower (Odds Ratio 0.78, 95% CI 0.65–0.94, p=0.01) whereas a trend towards higher risk of renal failure requiring RRT was identified. Conclusions Despite changing donor characteristics and longer ischemic times, post-transplant outcomes in LVAD recipients have not worsened with the implementation of the new allocation system and this finding is related to the use of newer generation continuous flow LVADs. Funding Acknowledgement Type of funding sources: None.

Selection and management considerations to enhance outcomes in patients supported by left ventricular assist devices.

Left ventricular assist devices (LVADs) are life-saving therapies for patients in end-stage heart failure (HF) with reduced ejection fraction regardless of candidacy for heart transplantation. Multiple clinical trials have demonstrated improved morbidity and mortality with LVADs when compared to medical therapy alone. However, the uptake of LVADs as a therapeutic option in a larger section of end-stage HF patients remains limited, partly due to associated adverse events and re-hospitalization. Accurate assessment and staging of HF patients is crucial to guide appropriate use of LVADs. Innovative methods to risk stratify patients and manage cardiac and noncardiac comorbidities can translate to improved outcomes in LVAD recipients. Inclusion of quality of life metrics and measurements of adverse events can better inform heart failure cardiologists to help identify ideal LVAD candidates. Addition of machine learning algorithms to this process may guide patient selection to improve outcomes. Patient selection and assessment of reversible medical comorbidities are critical to the postoperative success of LVAD implantation. Identifying patients most likely to benefit and least likely to experience adverse events should be a priority.

Racial and Sex Inequities in the Use of and Outcomes After Left Ventricular Assist Device Implantation Among Medicare Beneficiaries

While left ventricular assist devices (LVADs) increase survival for patients with advanced heart failure (HF), racial and sex access and outcome inequities remain and are poorly understood. To assess risk-adjusted inequities in access and outcomes for both Black and female patients and to examine heterogeneity in treatment decisions among patients for whom clinician discretion has a more prominent role. This retrospective cohort study of 12 310 Medicare beneficiaries used 100% Medicare Fee-for-Service administrative claims. Included patients had been admitted for heart failure from 2008 to 2014. Data were collected from July 2007 to December 2015 and analyzed from August 23, 2020, to May 15, 2022. Beneficiary race and sex. The propensity for LVAD implantation was based on clinical risk factors from the 6 months preceding HF admission using XGBoost and the synthetic minority oversampling technique. Beneficiaries with a 5% or greater probability of receiving an LVAD were included. Logistic regression models were estimated to measure associations of race and sex with LVAD receipt adjusting for clinical characteristics and social determinants of health (eg, distance from LVAD center, Medicare low-income subsidy, neighborhood deprivation). Next, 1-year mortality after LVAD was examined. The analytic sample included 12 310 beneficiaries, of whom 22.9% (n = 2819) were Black and 23.7% (n = 2920) were women. In multivariable models, Black beneficiaries were 3.0% (0.2% to 5.8%) less likely to receive LVAD than White beneficiaries, and women were 7.9% (5.6% to 10.2%) less likely to receive LVAD than men. Individual poverty and worse neighborhood deprivation were associated with reduced use, 2.9% (0.4% to 5.3%) and 6.7% (2.9% to 10.5%), respectively, but these measures did little to explain observed disparities. The racial disparity was concentrated among patients with a low propensity score (propensity score <0.52). One-year survival by race and sex were similar on average, but Black patients with a low propensity score experienced improved survival (7.2% [95% CI, 0.9% to 13.5%]). In this cohort study of Medicare beneficiaries hospitalized for HF, disparities in LVAD use by race and sex existed and were not explained by clinical characteristics or social determinants of health. The treatment and post-LVAD survival by race were equivalent among the most obvious LVAD candidates. However, there was differential use and outcomes among less clear-cut LVAD candidates, with lower use but improved survival among Black patients. Inequity in LVAD access may have resulted from differences in clinician decision-making because of systemic racism and discrimination, implicit bias, or patient preference.